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					The Kenya Pharmacy Practice Bill, 2012 (SMK&A draft 23.7.2012 kpa draft 08/08/2012   1

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                   THE KENYA PHARMACY PRACTICE BILL, 2012


ARRANGEMENT OF CLAUSES


Clause

PART I – PRELIMINARY

   1. Short title and Commencement.
   2. Interpretation
   3. Application


PART II – ESTABLISHMENT OF THE KENYA PHARMACY PRACTICE COUNCIL
  4. Establishment of the Council
  5. Headquarters
  6. Membership of the Council
  7. Vacation of office
  8. Conduct of business of the Council
  9. Functions of the Council
  10. Powers of the Council
  11. Regulations
  12. Salaries and allowances
  13. Staff of the Council
  14. Common seal of the Council
  15. Liability of the Council and the Council
  16. Registrar of the Council


PART III – PHARMACISTS AND PHARMACEUTICAL TECHNOLOGISTS

   17. Register of pharmacists
   18. Roll of pharmaceutical technologists
   19. Application for registration
   20. Specialists Register
   21. Qualification for registration
   22. Certificate of registration or enrolment
   23. Annual Licence
   24. Corrections to the register
   25. Publication of details of registered pharmacists
   26. Professional misconduct.
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   27. Restriction on directions by the Council
   28. Appeal against directions, etc
   29. Time of operation of direction for deletion of name
   30. Registration or restoration of name where appeal dismissed
   31. Deletion of name from register for conduct outside Kenya
   32. Surrender of Certificate on deletion of name
   33. General restrictions as to unpersons registered under this Act.
   34. pharmaceutical technologists to display name and certificate of enrollment
   35. Pharmacist to display name and registration certificate.
   36. Bodies corporate.
   37. Carrying on of business by personal representatives.
   38. Premises to be registered
   39. Authorized seller of poisons.


PART IV – EDUCATION AND TRAINING
  40. Education and training and acquisition of experience
  41. Continuing professional development
  42. Information to be given by institutions or other providers
  43. Refusal or withdrawal of approval of courses, qualifications and institutions

PART V – DISCIPLINARY PROCEEDINGS
  44. Disciplinary Proceedings

PART VI – FINANCIAL PROVISIONS

   45. Funds for the Council.
   46. Financial year.
   47. Annual estimates.
   48. Accounts and audit.
   49. Investment of funds.
   50. Annual reports.
   51. Special reports.


PART XV - TRANSITIONS

   52. Transitional Provisions
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                                             A Bill For

 An Act of Parliament to provide for the establishment of the Kenya Pharmacy Practice Council
 and to provide for regulation of pharmacy education and training, requirements for registration,
  the practice of pharmacy, the ownership of pharmacies and the investigative and disciplinary
                         powers of the council; and connected purposes.

                         ENACTED by the Parliament of Kenya as follows -



                               PART 1 – PRELIMINARY
Short title         1.         This Act may be cited as the Kenya Pharmacy Act and shall come
                               into force on such a date as the Cabinet Secretary may appoint by a
                               notice in the Gazette.


Interpretation      2.         In this Act, unless the context otherwise requires-


                                “Cabinet Secretary” means the Cabinet Secretary for the time
                               being responsible for health;

                               “Council” means the Kenya Pharmacy Practice Council established
                               under Section 4 of this Act.

                               “drug” includes:
                                  (a) any medicine, medicinal preparation, medicinal substance,
                                      therapeutic substance or vaccine medi
                                  (b) ;
                                  (c) any substance included in any publication mentioned in the
                                      Schedules; or
                                  (d) any substance or mixture of substances including any
                                      medicine, medicinal preparation or therapeutic substance
                                      prepared, sold or represented for use in-
                                             (i) the diagnosis, treatment, mitigation or prevention
                                             of a disease, disorder or abnormal physical state, or
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                                             the symptoms thereof, in man or animal; or
                                             (ii) restoring, correcting or modifying organic
                                             functions in man or animal;

                              “enrolled pharmaceutical technologist” means a pharmaceutical
                              technologist whose name appears on the roll;

                              “Pharmacy and Poisons Act” means the repealed Pharmacy and
                              Poisons Act, Chapter 244 Laws of Kenya;

                              “practitioner” means a person who requires registration under this
                              Act

                              “Principle Registrar of Births and Deaths” means a person
                              appointed as such under the Births and Deaths Registration Act;

                              “qualified”, in relation to a medical practitioner, dentist or
                              veterinary surgeon, means permitted by law to practice his or her
                              profession as such in Kenya;

                              “Register” means the Register of Pharmacists kept under Section
                              17 of this Act

                              “registered pharmacist” means a person whose name is entered in
                              the register;

                              “Registrar” means the Registrar appointed under the provisions of
                              Section 16;

                              “Regulatory Officer” means a person appointed by the Council as
                              such under this Act;

                              “Roll” means the roll of pharmaceutical technologists kept under
                              Section 17;

                              “sell” includes offer, advertise, keep, expose, transmit, convey,
                              deliver or prepare for sale or exchange, dispose of for any
                              consideration whatsoever, or transmit, convey or deliver in
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                              pursuance of a sale, exchange or disposal as aforesaid;

                              “Special Registers” means the Special Registers kept under Section
                              19 of this Act



Application         3.        This Act applies to regulation of the profession of pharmacy.


                              PART II – ESTABLISHMENT OF THE COUNCIL
Establishment of    4.        There is established the Kenya Pharmacy Practice Council.
the Council         (1)
                              The Council shall be a body corporate, with perpetual succession
                    (2)       and a common seal and shall be capable, in its corporate name, of –
                                 (a) suing and being sued;
                                 (b) taking, purchasing or otherwise acquiring, holding or
                                     disposing of movable or immovable property;
                                 (c) entering into contracts;
                                 (d) borrowing and lending money; and
                                 (e) performing such other things or acts necessary for the
                                     proper performance of its functions under this Act which
                                     may lawfully be done by a body corporate.
Headquarters        5.        The headquarters of the Council shall be in Nairobi, but the
                    (1)       Council may establish branches anywhere in Kenya.
                              The Council may hold its sittings at any place in Kenya.
                    (2)
                              The Chief Executive Officer of the Council is the Registrar.
                    (3)
Membership of the   6.        The Council shall consist of -
Council             (1)
                                    (a) a non-executive chairperson to be appointed by the
                                        Cabinet Secretary;
                                    (b) the Principal Secretary to the State Department for the
                                        time being responsible for pharmaceutical services or his
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                                          or her designate;
                                    (c)   the Principal Secretary to the State Department
                                          responsible for of Finance or his or her designate;
                                    (d)   the Director of Medical Services or his or her designate;
                                    (e)   the Chief Pharmacist or his or her designate;
                                    (f)   one representative from the pharmacy training academia
                                          or his or her designate;
                                    (g)   One pharmacist representing the Pharmaceutical Society
                                          of Kenya or his or her designate;
                                    (h)   One pharmacist representing the Federation of Kenya
                                          Pharmaceutical Manufacturers or his or her designate;
                                          and
                                    (i)   The Registrar who shall be the secretary of the Council.
                                    (j)   The chief pharmaceutical technologist or his designate
                                    (k)   Four members from Kenya pharmaceutical association


                              A person shall be qualified for appointment to the Council if such
                    (2)       person -
                                   (a) is a citizen of Kenya;
                                   (b) is a person of high moral character and proven integrity;
                                       and
                                   (c) has the requisite knowledge and experience in matters
                                       relating to the practice of the profession of pharmacy.
                              In addition to the qualifications listed in subsection (2) above, the
                    (3)       Chairperson to the Council must possess the following minimum
                              qualifications:
                                  (a) a University degree in pharmacy ;and
                                  (b) at least 10 years experience in any field relating to the
                                      subject matter of this Act.
                                  (c) A minimum of a diploma in pharmacy and
                                  (d) At least 15 years experience in pharmacy in field relating to
                                      the subject matter of this Act.
                              In addition to the qualifications listed in subsection (2) above, the
                    (4)       Registrar must possess the following minimum qualifications:
                                  (a) a University post graduate degree in pharmacy; and
                                  (b) at least 10 years experience in any field relating to the
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                                      subject matter of this Act.
                              No person shall be qualified for appointment as member of the
                     (5)      Council if such person –
                                  (a) is a member of Parliament;
                                  (b) is a member of a County Assembly or Executive;
                                  (c) is adjudged bankrupt; or
                                  (d) is convicted of an offence and sentenced to imprisonment
                                      for a term of six months or more.
                              In appointing members of the Council, regard shall be had of the
                     (6)      need for regional balance and the realisation of the principle that at
                              least one third of the members must be from either gender.
                              The members of the Council shall, at their first meeting, elect a
                     (7)      vice-chairperson from amongst the members appointed under sub-
                              Sections (1)(b) to (m).
                              The chairperson and the vice-chairperson of the Council shall not
                     (8)      be of the same gender.
                              The members of the Council shall hold office for a term of three
                     (9)      years and shall be eligible for re-appointment for one further term
                              of three years.
                              The members of the Council, appointed under subsection (1) (f),
                     (10)     (g), and (h) shall be appointed by the Cabinet Secretary, by a notice
                              in the Gazette
Vacancy   in   the   7.       The office of the chairperson or of a member of the Council shall
Council              (1)      become vacant if the holder -
                                 (a) dies;
                                 (b) resigns from office by writing under the person’s hand
                                     addressed to the Cabinet Secretary;
                                 (c) is convicted of an offence and sentenced to imprisonment
                                     for a term of six months or more without the option of a
                                     fine;
                                 (d) is unable to discharge the functions of his office by reason
                                     of physical or mental infirmity;
                                 (e) conducts himself in a manner that is considered by the
                                     Cabinet Secretary to be inconsistent with membership of
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                                      the Council and that brings the School into disrepute;
                                  (f) is absent without the permission of the chairperson from
                                      three consecutive meetings of the Council without good
                                      cause; or
                                  (g) is declared bankrupt.
                              A person who is appointed in place of a member whose office has
                       (2)    become vacant under this Section shall hold office for the
                              remainder of the term of office of that member.
Conduct of business    8.     The conduct and regulation of the business and affairs of the
of the Council                Council of the Council is provided in the First Schedule.
functions   of   the   9.     The primary object of the Council is regulation, registration ,
Council                (1)    enrollment and control of the practice of pharmacy, and related
                              matters in the public interest.
                              Without prejudice to subsection (1) above, the Council shall-
                       (2)       (a) establish and maintain a register of pharmacists and a roll
                                     of pharmaceutical technologist for the registration of a
                                     person who provides one or more or all of the services
                                     which form part of the scope of this Act;
                                 (b) issue practising certificates to persons registered under this
                                     Act and to cancel or suspend such certificates in terms of
                                     this Act;
                                 (c) set standards and requirements in respect of the education,
                                     training, acquisition of experience and continuing
                                     professional development that it is necessary for
                                     pharmacists and pharmaceutical technologist to achieve in
                                     order to be entered in the Register, roll or any special
                                     Register established by the Council;
                                 (d) ensure the continued fitness to practice of pharmacist or
                                     pharmaceutical technologistss;
                                 (e) promote the practice of the professions and to foster
                                     research into, and develop knowledge, of such professions
                                     or callings;
                                 (f) regulate, control and supervise all matters affecting the
                                     training of persons in, and the manner of the exercise of,
                                     the professions and callings specified in this Act;
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                                  (g) define and enforce ethical practice and discipline among
                                      persons registered under this Act;
                                  (h) encourage co-operation between the Council and other
                                      stakeholders in the pharmaceutical sector;
                                  (i) take such steps as appear to the Council to be necessary or
                                      desirable to advance the standing effectiveness of persons
                                      registered under this Act in Kenya;
                                  (j) present the views of persons registered under this Act on
                                      national, regional and international issues;
                                  (k) evaluate any examinations, training courses and
                                      qualifications of foreign institutions for the purposes of
                                      registration in any of the professions or callings specified in
                                      this Act;
                                  (l) assist in the promotion of the health of the population of the
                                      Kenya;
                                  (m) uphold and safeguard the rights of the general public to
                                      universally acceptable standards of pharmacy practice in
                                      both the public and the private sector;
                                  (n) establish, develop, maintain and control universally
                                      acceptable standards in pharmaceutical education and
                                      training;
                                  (o) conduct examinations and grant certificates, and to charge
                                      such fees in respect of such examinations or certificates as
                                      may be prescribed;
                                  (p) consider any matter affecting the pharmacy profession, and
                                      make representations or take such action in connection
                                      therewith as the council deems advisable;
                                  (q) evaluate and monitor the standards of qualifying
                                      examinations, courses and training for persons registered
                                      under this Act;
                                  (r) ensure that compliance with existing legislation is being
                                      promoted and controlled through a process of active
                                      inspection and investigation;
                                  (s) advise the Cabinet Secretary on measures for the protection
                                      of the health of consumers;
                                  (t) ensure adequate and effective standards and guidelines;
                                  (u) monitor compliance with this Act through its agencies and
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                                      any other agencies of State authorized under this Act; and
                                  (v) advise the Cabinet Secretary on the implementation of this
                                      Act; and
                                  (w) perform any other function that may be conferred or
                                      imposed upon the Council by or in terms of this Act or any
                                      other enactment.


Powers    of   the   10.      The Council shall have powers necessary or expedient for the
Council              (1)      proper performance of its functions under this Act.


                               Without prejudice to subsection (1) above, in the discharge of its
                     (2)      functions under this Act, the Council may–
                                 (a) enter into association with such other bodies or
                                     organizations within or outside Kenya as it may consider
                                     desirable or appropriate and in furtherance of the purpose
                                     for which the Council is established;
                                 (b) control, supervise and administer the assets of the Council
                                     in such manner and for such purposes as best promote the
                                     purpose for which the Council is established;
                                 (c) receive any grants, gifts, donations or endowments and
                                     make legitimate disbursements there from; or
                                 (d) open banking accounts for the funds of the Council;
                                 (e) may establish such committees as it may consider necessary
                                     for the performance of its functions and the exercise of its
                                     powers under this Act; and
                                 (f) may co-opt in such committees persons whose knowledge
                                     and experience is necessary to enable to the committee
                                     effectively discharge its functions.
                                 (g) appoint any officer or inspector to perform any duty or act
                                     on behalf of the council in terms of this Act and to
                                     prescribe and determine their powers and duties;
                              The Council may, by resolution either generally or in any particular
                     (3)      case, delegate to any Committee of the Council or to any member,
                              officer, employee or agent of the Council, the exercise of any of
                              the functions or duties of the Council under this Act.
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                              The Council shall be transparent to the profession and the general
                    (4)       public in achieving its objects and in performing its functions and
                              executing its powers.
Regulations         11.       The Council shall make regulations for the better carrying out of
                    (1)       the provisions of this Act.
                              without prejudice to the generality of sub-section (1) , the Council
                    (2)       may make regulations to–
                                 (a) prescribe anything which in terms of this Act is to be
                                     prescribed or done by regulation or which, in the opinion of
                                     the the council, is necessary or convenient to be prescribed
                                     for carrying out or giving effect to the functions and
                                     generally for giving effect to this Act;
                                 (b) prescribe the manner of record keeping and standard
                                     operating procedures;
                                 (c) prescribe the minimum standards in respect of the
                                     construction and location of pharmacies and the equipment
                                 (d) provide for arrangements for the obtaining, keeping,
                                     handling, use and security of medicinal products or medical
                                     devices;
                                 (e) the conditions in which medicinal products are to be stored;
                                 (f) provide for the availability or condition of facilities or
                                     equipment at the premises used to carry out certain
                                     activities including the conducting of clinical procedures
                                     such as the taking of blood and the undertaking of
                                     consultations with patients;
                                 (g) provide for the condition of the business premises
                                 (h) provide for management of waste including the adequate
                                     procedures for the safe destruction and disposal of
                                     medicinal products kept on the premises including the
                                     physical state, safety and security of the premises;
                                 (i) prescribe standards of pharmacy education and training
                                     including:
                                         (i) , accreditation of training institutions,
                                         (ii) prescribe the unit standards for pharmaceutical
                                              education and training required from a person
                                              entitled to be registered in terms of this Act;
                                         (iii)pre-registration examination or evaluation to ensure
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                                               competence of a person applying for registration in
                                               terms of this Act;
                                          (iv) pre- enrollment examination or evaluation to ensure
                                               competence of a person applying for enrollment
                                          (v) supplementary training of a person registered in
                                               terms of this Act;
                                          (vi) recognise qualifications, competencies and skills for
                                               purposes of registration and enrollment in terms of
                                               this Act;
                                          (vii)        provide for the additional qualifications,
                                               specialties or titles that may be registered in terms
                                               of this Act;
                                  (j) provide for the staffing and supervision of pharmacy
                                      related, facilities and the services to be provided therein
                                      and
                                  (k) establish disciplinary committees for discipline of staff of
                                      the Council or professionals in the pharmaceutical industry.
                              The Council shall adhere to the principle of public participation in
                     (3)      making regulations.
                              Regulations made in terms of subsection (2) shall have no effect
                     (4)      until they have been published in the Gazette.
    Salaries and     12.      The Cabinet Secretary shall, on the advise of the Salaries and
    allowances                Remuneration Commission, determine the allowances of the
                              members of the Council of the Council.
    Staff of   the   13.      The Council may appoint such officers or staff as are necessary for
    Council          (1)      the proper discharge of the functions of the Council under this Act,
                              upon such terms and conditions of service as the Council may
                              determine.
                              The principles of ethnic, regional and gender balance shall guide
                     (2)      all staff appointments.
                               The Government may, upon request by the Council, second to the
                     (3)      Council such number of public officers as may be necessary for the
                              purposes of the Council.
                              A public officer seconded to the Council shall, during the period of
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                       (4)     secondment, be deemed to be an officer of the Council and shall be
                               subject only to the direction and control of the Council.
    Common Seal                The common seal of the Council shall be kept in such custody as
    of the Council     14.(1   the Council may direct and shall not be used except on the order of
                       )       the Council.


                               The common seal of the Council when affixed to a document and
                       (2)     authenticated shall be judicially and officially noticed and unless
                               and until the contrary is proved, any necessary order or
                               authorization of the Council under this Section shall be presumed
                               to have been given.


    Liability of the   15.     No act or thing done by a member of the Council or any officer,
    Council and                employee or agent of the Council shall, if the matter or thing is
    the Council
                               done in good faith for executing the functions, powers and duties
                               of the Council render the member, officer, employee or agent
                               personally liable to any action, claim or demand whatsoever.
    Registrar   of     16.     There shall be a Registrar of the Council who shall be the Chief
    the Council        (1)     Executive Officer of the Council.
                               (2) The Registrar shall perform such duties and exercise such
                               powers, in addition to those required under the provisions of this
                               Act to be performed and exercised, as the Council may from time
                               to time direct.
                               PART III – PHARMACISTS AND PHARMACEUTICAL
                               TECHNOLOGISTS


    Register           17.     The Registrar shall keep a register of pharmacists in the prescribed
                       (1)     form.


                               The Registrar shall keep a Roll of pharmaceutical technologists in
                       (2)     the prescribed form.


                               Any person may inspect a register or roll kept in terms of this Act
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                    (3)       and may make copies of any entry therein at all reasonable times
                              on payment of such fee as may be prescribed by the Council.
                              Subject to subsection (5), the last published copy of the register, as
                    (4)       read with any supplementary list printed and published under the
                              authority of the Council shall be prima facie evidence in all legal
                              proceedings of the facts recorded therein, and the absence of the
                              name of any person from such a copy shall be evidence, until the
                              contrary is proved, that that person is not registered or not enrolled.
                              In the case of a person—
                    (5)           (a) whose name does not appear in a copy referred to in
                                      subsection (4) and whose name has been added to the
                                      register or the roll concerned after the date on which the
                                      copy was published, a certificate, signed by the registrar
                                      concerned, that the person’s name has been entered in the
                                      register shall be prima facie evidence that the person is
                                      registered in that register;

                                  (b) whose name appears in a copy referred to in subsection (4)
                                      though it was erased from the register or roll concerned
                                      after the date on which the copy was published, a
                                      certificate, signed by the registrar, that the name of the
                                      person has been erased from the register or the roll shall be
                                      prima facie evidence that the person is not registered or
                                      enrolled on that register and roll respectively;

                                  (c) who has been suspended from practice in terms of this Act,
                                      a certificate, signed by the Registrar, that the person has
                                      been so suspended from practice for a period specified in
                                      the certificate shall be prima facie evidence that the person
                                      has been suspended from practice for that period.

                              A person shall be guilty of an offence and liable to a fine not
                    (6)       exceeding five hundred thousand shillings or to imprisonment for a
                              period not exceeding two years or to both such fine and such
                              imprisonment if the person—
                                  (a) makes or causes to be made an unauthorised entry or
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                                      deletion in a register, roll or a certified copy thereof ;

                                  (b) extracts therefrom or on a certificate of registration or
                                      certificate of enrollment;

                                  (c) procures or attempts to procure for himself or another
                                      person registration or a certificate of registration or
                                      certificate of enrollment by means of fraud, a false
                                      representation or the concealment of a material fact;

                                  (d) makes or causes to be made in connection with an
                                      application for registration or application of a certificate of
                                      enrollment a false declaration in a document used for the
                                      purpose of establishing his identity;

                                  (e) willfully destroys or injures or renders illegible or causes to
                                      be destroyed, injured or rendered illegible an entry in a
                                      register or Roll;

                                  (f) without the permission of the Registrar, willfully destroys,
                                      mutilates or renders illegible or causes to be destroyed,
                                      mutilated or rendered illegible a certificate of registration;
                                      or an enrollment certificate or

                                  (g) forges or utters, knowing it to be forged, a document
                                      purporting to be a certificate of registration;

    Application        18.    Every application by a person to be registered as a pharmacist or
    for registration          enrolled as a pharmaceutical technologist shall be made in writing
                              in the form prescribed and shall be addressed to the Registrar.
    Specialists        19     1) The council may establish and maintain a register of pharmacists
    registers          (1)    who have acquired special knowledge and experience in particular
                              specialties of pharmacy.
                              2) The council may establish and maintain a roll of pharmaceutical
                              technologists who have acquired special knowledge and experience
                              in specialties of pharmaceutical technology.
                              If the Council establishes a register in terms of subsection (1), it
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                    (2)       may make regulations providing for the requirements to be
                              satisfied by a person before he may be entered in the register,
                              including the -

                                            (a) experience to be obtained by him, the nature and
                                                duration of the training to be undertaken by him and
                                                the

                                            (b) degree, diploma or certificate, to be held by him;
                                                and

                                            (c) the conditions under which any person may be
                                                exempt from the requirements, experience or
                                                training referred to in paragraph (a); and

                                            (d) the conditions governing the practice of pharmacists
                                                who have been registered in the register, including
                                                conditions restricting the practice of any such
                                                pharmacist to a particular branch of the pharmacy
                                                profession; and

                                            (e) the circumstances in which the Council may remove
                                                a person’s name from the register.

                              Every application by a person to be entered in the Roll of
                    (3)       pharmaceutical technologists shall be made in the prescribed form
                              and shall be addressed to the Registrar.

                              The council may establish and maintain a roll of pharmaceutical
                              technologists who have acquired special knowledge and experience
                    4         in specialties of pharmaceutical technology

                               If the Council establishes a roll in terms of subsection (3), it may
                              make regulations providing for the requirements to be satisfied by
                              a person before he may be entered in to a roll , including the -

                                            (f) experience to be obtained by him, the nature and
                                                duration of the training to be undertaken by him and
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                                               the

                                            (g) degree, diploma or certificate, to be held by him;
                                                and

                                            (h) the conditions under which any person may be
                                                exempt from the requirements, experience or
                                                training referred to in paragraph (a); and

                                            (i) the conditions governing the practice of
                                                pharmaceutical technologists who have been
                                                enrolled in the roll, including conditions restricting
                                                the practice of any such pharmaceutical
                                                technologists to a particular branch of the
                                                pharmaceutical technologists; and

                              the circumstances in which the Council may remove a person’s
                              name from the roll




    Qualifications     20.    The following persons are eligible for registration as pharmacists:
    for registration   (1)       a person who is at the commencement of this Act already
                                     registered as a pharmacist under the provisions of the
                                     repealed Pharmacy and Poisons Act or

                                  a person who satisfies the Council that he holds at least a
                                     Bachelor of Pharmacy degree ,whether of Kenya or from
                                     another country which the Council considers acceptable.

                              A person is entitled to have his or her name entered in the Roll of
                       (2)    pharmaceutical technologists if :
                                  (a) a person who is at the commencement of this Act already
                                      enrolled as a pharmaceutical technologist under the
                                      provisions of the repealed Pharmacy and Poisons Act; or
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                                   (b) the person who satisfies the Council that he or she holds a
                                       diploma in pharmacy from an institution in Kenya which
                                       is approved by the Council or an institution not in Kenya
                                       which is approved by the Council.

    Certificate of    21      Upon the registration of a pharmacist, the Registrar shall, on a
    registration or   (1)     payment of the prescribed fee, issue a Certificate of Registration in
    enrolment
                              the prescribed form.
                              No fee shall be payable if the pharmacist was, at the
                      (2)     commencement of this Act, already registered under the Repealed
                              Pharmacy and Poisons Act.
                              The Registrar shall issue to every pharmaceutical technologist
                      (3)     whose name is entered in the Roll, a certificate of enrolment in the
                              prescribed form, upon payment of the prescribed fee.
                              No fee shall be payable if the pharmaceutical technologist was, at
                      (4)     the commencement of this Act, already enrolled under the
                              Repealed Pharmacy and Poisons Act.
    Annual            22.     a)Every registered pharmacist who intends to practice in a
    licence.          (1)     professional capacity, shall require in addition to the certificate of
                              registration issued under Section 21, an annual licence in a
                              prescribed form for which he shall pay to the Registrar the
                              prescribed fee which shall be prescribed by the Council.
                              b) Every enrolled pharmaceutical technologists who intends to
                              practice in a professional capacity, shall require in addition to the
                              certificate of enrollment issued under Section 21, an annual licence
                              in a prescribed form for which he shall pay to the Registrar the
                              prescribed fee which shall be prescribed by the Council.


                              Any sum payable under subsection (1) shall be applied by the
                      (2)     Council in such manner as may be prescribed by the Cabinet
                              Secretary.
                              Every annual practice licence shall:
                      (3)        (a) bear the date on which it is issued;
                                 (b) be effective from that date; and
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                                  (c) expire at the end of the licence year in which it is issued.
                              The licence year shall be from 1st January to 31st December in
                      (4)     each year.
                              For the purposes of this Section, a person is deemed to practice in
                      (5)     a professional capacity if the person engages exclusively in the
                              profession-
                                  under his name or under any other authorized style as sole
                                      proprietor of a pharmacy practice; or
                                  in partnership with other pharmacists; or
                                  in partnership with other pharmaceutical technologists
                              A person shall not be deemed to practice in a professional capacity
                      (6)     where the person is employed-
                                         by the Government or any other public body; or
                                         by any state corporation as defined by the state
                                             Corporations Act; or
                                         as an employee of any person or partnership engaged in
                                             his profession where all fees and charges earned by
                                             him in his professional capacity ensure to the
                                             benefit of his employer, notwithstanding that he is
                                             employed in his professional capacity.
                              A person is considered to be in a partnership under subsection (5)
                      (7)     above if the person is entitled to receive a share of the profits
                              earned by such a partnership for the person’s own financial benefit
                              and is liable to bear a share of any losses incurred by such
                              partnership.
                              The Registrar shall note on the register of licensed practitioners the
                      (8)     date of issue of every annual practice license.
    Correction to     23.     The Registrar shall –
    the    Register   (1)        (a) delete from the register or the roll the name of a registered
    and the Roll
                                     pharmacist or pharmaceutical technologists who has died;
                                 (b) delete from the Register or roll any entry which the Council
                                     directs him to delete if the Council find that the entry was
                                     procured by fraud;
                                 (c) correct in accordance with the Council’s directions an entry
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                                      in the Register or roll which the Council direct him to
                                      correct as being in their opinion an incorrect entry; and
                                  (d) make from time to time any necessary alterations in the
                                      Register or Roll, including deletions, alterations and
                                      insertions as he may by virtue of this Act be required to
                                      make.
                              If the Registrar sends a letter by registered post or by email to a
                      (2)     registered pharmacist or enrolled pharmaceutical technologists,
                              using the address on the register, inquiring whether the person has
                              ceased to practice as a pharmacist or pharmaceutical technologists
                              as or has changed his address and the Registrar receives no reply
                              to the letter within six months from the date of posting it he may
                              delete the name of that person from the register or roll.
                              Despite subsection (2), the Council may, on the application of the
                      (3)     person whose name has been so deleted and on payment of such
                              fee as may be prescribed, direct the Registrar to restore the name to
                              the register or roll.
                              The Principal Registrar of Births and Deaths shall without delay,
                      (4)     upon receiving notice of the death of a registered pharmacist or
                              pharmaceutical technologists, transmit to the Registrar a certificate
                              under his own hand of the death, with particulars of the place and
                              time of death.
    Publication       24.     Whenever a name is added to or deleted from the Register or Roll
    details      of   (1)     for any cause, the Registrar shall without undue delay publish in
    registered
                              the Gazette the fact of the addition or deletion and the reason,
    pharmacists
    and enrolled              together with the name and the address of the person concerned.
    pharmaceutica
    l technologists

                              The Registrar shall as soon as conveniently may be after the first
                      (2)     day of January in every year, publish in the Gazette a list of the
                              names, qualifications and address of all registered pharmacists and
                              enrolled pharmaceutical technologists.
    Professional      25      The provisions of this section apply to-
    misconduct        (1)        (a) a person applying to have his name registered or
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                                  (b) enrolled ;
                                  (c) a registered pharmacist or any person employed by him in
                                      the carrying on of his business;
                                  (d) a person whose name has been deleted from the register or
                                      roll or any person employed by him as aforesaid.


                                  A person under subsection (1) who has at any time been
                    (2)           convicted, whether within or outside Kenya, of a criminal
                                  offence or been guilty of misconduct, being in a case falling
                                  within subsection(1) or a conviction or misconduct which took
                                  place either before or after the deletion of the name, which in
                                  the opinion of the Council renders the convicted or guilty
                                  person unfit to have his name on the register or roll, the
                                  Council may, after inquiring into the matter-
                                         (a) in a case falling within paragraph (a) of subsection
                                             (1), direct that the applicant's name shall not be
                                             registered or enrolled, until the Council otherwise
                                             directs;
                                         (b) in a case falling within paragraph (b) of subsection
                                             (1), direct the Registrar to delete the name of the
                                             registered pharmacist or enrolled pharmaceutical
                                             technologists from the register or roll respectively;
                                         (c) enrolled pharmaceutical technologistss or person
                                             employed by him/her.

                                            (d) in a case falling within paragraph (c) of subsection
                                                (1), direct that the name removed from the register
                                                or roll shall not be restored thereto or shall not be
                                                restored thereto until the Council otherwise directs,
                                                and where the Council directs that a name shall be
                                                deleted or shall not until the Council otherwise
                                                directs be registered or enrolled or restored to the
                                                register or roll, the Council may also direct that no
                                                application to the Registrar in respect of its
                                                registration or enrollment, or as the case may be, its
                                                restoration to the register or roll, shall be entertained
                                                thereafter until the expiration of such period as may
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                                             be specified in the direction or until the fulfillment
                                             of such conditions as may be so specified.
                              Where the name of any person has been deleted from the register
                      (3)     or roll in pursuance of a direction under paragraph (b) of
                              subsection (2), the Council may, either of its own motion or on the
                              application of that person, direct the Registrar to restore the name
                              to the register, either without fee or on the payment to the Registrar
                              or Roll of such fee as may be prescribed in the behalf, not
                              exceeding the fee prescribed for registration in pursuance of
                              Section 22.
                              The Registrar shall-
                      (4)        (a) give notice of any direction under this Section to the person
                                     to whom the direction relates; and
                                 (b) give notice of any refusal of an application made under
                                     subsection (2) to the applicant.
                              Any notice shall be sent by registered letter which, in the case of a
                      (5)     registered pharmacist, shall be addressed to his address on the
                              register.
    Restrictions on   26.     Where an act or omission which under subsection (1) of Section 25
    directions by     (1)     may be made the ground of a direction by the Council involving
    the Council.
                              the cesser or restriction of the right of a person to have his name
                              registered or enrolled is an act or omission on the part of an
                              employee of that person, the Council shall not give any such
                              direction unless proof is given to its satisfaction of some one or
                              more of the facts specified in subsection (2) of this Section and the
                              Council is of the opinion that, having regard to the facts so proved,
                              that person ought to be regarded as responsible for the act or
                              omission.
                              The facts as to some, one or more of which the Council must be
                      (2)     satisfied before giving direction as is mentioned in subsection (1)
                              are-
                                  (a) that the act or omission in question was instigated or
                                      connived at by the person;
                                  (b) that the person or an employee of his had been guilty at
                                      some time within twelve months before the date on which
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                                      the act or omission in question took place of a similar act or
                                      omission and that the person had, or reasonably ought to
                                      have had, knowledge of that previous act or omission;
                                  (c) if the act or omission in question was a continuing act or
                                      omission, that the person had, or reasonably ought to have
                                      had, knowledge of its continuance; or
                                  (d) in the case of a criminal offence being an offence under this
                                      Act, that the person had not used due diligence to enforce
                                      the execution of this Act.
                      27      A person aggrieved by a direction of the Council under Section 25
                      (1)     or by the refusal of an application made under subsection (2) of
                              that Section may at any time within one month from the date on
                              which notice of the direction or, as the case may be, of the refusal
                              is given to him appeal to the High Court against the direction or
                              refusal, and the Council may appear as respondent in any such
                              appeal.


                              The High Court may make such order as it considers fit in the
                      (2)     matter and any order of the High Court on any such appeal shall be
                              final.
                              It shall be the duty of the Registrar to make such alterations in the
                      (3)     register or roll as are necessary to give effect to an order under
                              subsection (2).
    Time of           28      A direction under paragraph (ii) of subsection (1) of Section 25
    operation of              shall not take effect until the expiration of one month from the
    directing
                              giving of notice of the direction as required by subsection (3) of
    for deletion of
    name.                     that Section or, where an appeal to the High Court is brought
                              against the direction, until the appeal is determined or withdrawn.
    Registration or   29      If the High Court has dismissed an appeal against a direction under
    restoration of            subsection (1) of Section 25 that a name shall or shall not be
    name where
                              deleted from the register or roll, until the Council otherwise directs,
    appeal is
    dismissed                 be registered or enrolled or restored to the register or roll, a
                              direction by the Council authorizing the registration or restoration
                              of the name shall not take effect unless it is approved by the
                              Cabinet Secretary.
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    Deletion of         30.   If by reason of a conviction or of professional misconduct the
    name from                 name of a pharmacist or pharmaceutical technologist registered in
    register for
                              Kenya, whether before or after the conviction or misconduct, is in
    conduct
    outside Kenya             any other country removed, deleted or struck from the register of
                              pharmacist or pharmaceutical technologist, by whatever name or
                              style designated, of that country, or if by any other order or process
                              the pharmacist or pharmaceutical technologists is in any such
                              country disentitled to practice as a pharmacist or pharmaceutical
                              technologist, by whatever name or style designated, the Council
                              may direct the Registrar to delete the name of the pharmacist from
                              the register or the roll, but without prejudice to the provisions of
                              subsection (2) of Section 26.
    Surrender of        31.    A person whose name is deleted from the register or the roll for
    certificate on      (1)   any reason shall forthwith surrender his certificate of registration or
    deletion       of
                              certificate of enrollment to the Registrar for cancellation.
    name
                              A person refusing or failing to comply with the provisions of this
                        (2)   Section shall be guilty of an offence and liable to a fine not
                              exceeding five hundred thousand shillings, or to imprisonment for
                              a term not exceeding one year or to both.
    General             32.   No person other than a registered pharmacist shall, except as
    restrictions as     (1)   provided for in Sections 34 and 35-
    to
                                 (a) carry on, either on his own behalf, or on behalf of another,
    Persons      not
    registered or                    the business of pharmacy;
    not     enrolled             (b) in the course of trade or business, prepare, mix, compound
    under this Act                   or dispense a drug except under the immediate supervision
                                     of a registered pharmacist or ; or
                                 (c) assume, take, exhibit or in any other way make use of any
                                     title, emblem or description reasonably calculated to
                                     suggest that he is registered as a pharmacist or enrolled
                                     pharmaceutical technologists.
                        2     No person other than an enrolled pharmaceutical shall, except as
                              provided for in Sections 34 and 35-
                                 (d) carry on, either on his own behalf, or on behalf of another,
                                     the business of pharmacy;
                                 (e) in the course of trade or business, prepare, mix, compound
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                                      or dispense a drug except under the immediate supervision
                                      of an enrolled pharmaceutical technologists; or
                              assume, take, exhibit or in any other way make use of any title,
                              emblem or description reasonably calculated to suggest that he is
                              registered as an enrolled pharmaceutical technologists.
                              A person who contravenes subsection (1) commits an offence and
                       (2)    is liable to a minimum of one hundred thousand shillings for each
                              offence or to imprisonment for a term of three years or both.
                              For the purpose of paragraph (c) of subsection (1), the use of any
                       (3)    of the words “pharmacist”, “druggist”, “chemist”, “medical”
                              pharmaceutical technologists or any other similar word or
                              combination of words in any language shall be deemed to be
                              reasonably calculated to suggest that the owner of the business and
                              the person having control, of the business on the premises are
                              registered pharmacists or pharmaceutical technologists.
                              Nothing in this Section shall extend to or interfere with the supply
                       (4)    of drugs to a particular person by a medical practitioner or his
                              assistant working under his immediate supervision, direction and
                              control, a qualified dentist or a qualified veterinary surgeon, for the
                              purpose of legitimate medical treatment, dental treatment or
                              veterinary treatment, as the case may be.
                              Nothing in this Section shall make it unlawful for any person to
                       (5)    sell any nonpoisonous drug provided that such drug is sold in its
                              original condition as received by the seller or to require such
                              person to be registered as a pharmacist or pharmaceutical
                              technologists.
    Pharmacist to      33.    No person shall carry on the business of pharmacy unless the
    display name       (1)    name, certificate of registration and annual license of the person
    and
                              having control of the business are conspicuously exhibited in the
    registration
    certificate.              premises in which the business is carried on
    Pharmaceutica
                              No person shall carry the business of a pharmaceutical technologist
    l technologists
    to       display   (2)    unless the name and certificate of enrolment of the person having
    name         and          control of the business are conspicuously exhibited in the premises
    registration              in which the business is carried on.
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    certificate               A person who contravenes the provisions of this Section commits
                    (3)       an offence and is liable upon conviction to a fine not exceeding one
                              hundred thousand shillings, or to imprisonment for a term not
                              exceeding one year, or to both.
    Bodies          34        Notwithstanding anything contained in the foregoing provisions of
    Corporate       .(1)      this Part, it shall not be necessary for a body corporate carrying on
                              the business of a pharmacist to be registered under this Act where-
                                  (a) a copy of the certificate of incorporation of the body
                                      corporate is lodged with the Council ;
                                  (b) the business is under the management of a superintendent
                                      who is a registered pharmacist and a member of the Council
                                      of directors of the body corporate, and who is not acting in
                                      a similar capacity for any other body corporate;
                                  (c) in each set of the premises where the business is carried on,
                                      the business, so far as concerns the retail sale of drugs, is
                                      carried on by the superintendent, or subject to the directions
                                      of the superintendent, by a manager or assistant who is a
                                      registered pharmacist;
                                  (d) in each set of premises where business is carried on, the
                                      name and certificate of registration of the person in control
                                      of the business be conspicuously displayed.

                              2) Notwithstanding anything contained in the foregoing provisions
                              of this Part, it shall not be necessary for a body corporate carrying
                              on the practice of a pharmaceutical technologists to be registered
                              under this Act where-
                                  a) copy of the certificate of incorporation of the body corporate
                                  is lodged with the Council ;
                                  b)the business is under the management of a superintendent
                                  who is an enrolled pharmaceutical technologists and a member
                                  of the board of directors of the body corporate, and who is not
                                  acting in a similar capacity for any other body corporate;
                                  (e) in each set of the premises where the business is carried on,
                                       the business, so far as concerns the retail sale of drugs, is
                                       carried on by the superintendent, or subject to the directions
                                       of the superintendent, by a manager or assistant who is an
                                       enrolled pharmaceutical technologists;
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                                  (f) in each set of premises where the practice is carried on, the
                                      name and certificate of registration of the person in control
                                      of the practice be conspicuously displayed.




                              A) Any emblem, description or title which may be used by a
                      (2)     registered pharmacist, may be used by a body corporate lawfully
                              carrying on the business of the pharmacist.
                              b) Any emblem, description or title which may be used by an
                              enrolled pharmaceutical technologist may be used by a body
                              corporate lawfully carrying the practice of a pharmaceutical
                              technologist.
    Carrying     on   35      Notwithstanding anything in the foregoing provisions of this Part,
    business     by   (1)     if a registered pharmacist or enrolled pharmaceutical technologists
    personal
                              dies, or becomes of unsound mind or is adjudged bankrupt or
    representatives
    .                         enters into an arrangement with his creditors, his representatives
                              may, with the permission of the Council and subject to such
                              directions and conditions as the Council may deem fit to impose,
                              carry on the business, and it shall not be necessary for the
                              representatives to be registered if the business is continued only
                              under the personal management and control of a registered
                              pharmacist and for such period not exceeding five years as the
                              Council may decide, and if the provisions of subsection (1) of
                              Section 33 are complied with.


                              Any title, emblem or description which may lawfully have been
                      (2)     used by the registered pharmacist may continue to be used by his
                              representatives as long as they are authorized by the Council to
                              carry on the business.
                              For the purposes of this Section an arrangement with creditors
                      (3)     means a composition or scheme made in pursuance of the law for
                              the time being in force relating to bankruptcy and includes a deed
                              of arrangement to which Deeds of Arrangement Act applies.
    Premises to be    36.         a) No person shall carry on the business of a pharmacist
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    registered      (1)               except in premises registered in accordance with this
                                      Section


                        ( 2)      NO person shall carry on the business of a pharmaceutical
                                  technologist in premises registered in accordance with this
                                  section.
                               Applications for the registration of premises shall be made to the
                    (3)        Council in the prescribed form, and shall be accompanied by such
                               fee, as shall be by the council in respect of the registration of any
                               set of premises.
                               The registration of any premises under this Section shall become
                    (4)        void upon the expiration of thirty days from the date of any change
                               in the ownership of the business carried on therein.
                               The Council may, for good and sufficient reason to be stated in
                    (5)        writing, refuse to register or may cause to be deleted from the
                               register any premises which in the Council's opinion are or have
                               become unsuitable for the carrying on therein of the business of a
                               pharmacist.
                    6          The Council may, for good and sufficient reason to be stated in
                               writing, refuse to register or may cause to be deleted from the
                               register any premises which in the Council's opinion are or have
                               become unsuitable for the carrying on therein of the business of a
                               pharmaceutical technologists.
                               It shall be the duty of the Registrar to keep a register in the form
                    (7)        prescribed of all premises registered under the provisions of this
                               Section.
                               A registered or an enrolled person who changes his address shall
                    (8)        notify that fact to the registrar within one month after the change.
                               A person who contravenes the provisions of subsection (1) or (2)
                    (9)        commits an offence and liable, upon conviction, to a fine not
                               exceeding three hundred thousand shillings or to imprisonment for
                               a term not exceeding three years or to both.
                    37.(1      A person lawfully carrying on the business of pharmacist in
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                     )        accordance with the provisions of this Part shall be an authorized
                              seller of poisons as provided for under the Kenya Food and Drugs
                              Authority Act.
                     (2)      A person lawfully carrying on the business of pharmaceutical
                              technologists in accordance with the provisions of this Part shall be
                              an authorized seller of poisons as provided for under the Kenya
                              Food and Drugs Authority Act.
                              PART IV – EDUCATION AND TRAINING

    Education and    38.      In connection with its general function under Section 9(1), in so far
    training and              as that function relates to the education, training and acquisition of
    acquisition of
                     (1)
    experience
                              experience of pharmacist or pharmaceutical technologists and
                              prospective pharmacist or pharmaceutical technologists, the
                              Council may—
                                   set the standards of proficiency for the safe and effective
                                       practice of pharmacy which it is necessary for a person to
                                       achieve in order to be entered in the Register as a
                                       pharmacist or, as the case may be, a pharmaceutical
                                       technologists; and
                                   set—
                                              (i) the standards of education, training and
                                                   experience that providers of education and
                                                   training must meet in order to enable a person
                                                   undertaking such education or training, or
                                                   acquiring such experience, to achieve the
                                                   standards referred to in paragraph (a) having
                                                   regard, in particular, to the outcomes to be
                                                   achieved; and
                                              (ii) any requirements to be satisfied for admission
                                                   to, and continued participation in, education and
                                                   training for prospective pharmacists or
                                                   prospective pharmaceutical technologist, which
                                                   may include requirements as to fitness to
                                                   practise unimpaired by health.
                              The Council shall publish the standards and requirements set under
                     (2)      this section, as they exist from time to time, in such manner as it
                              considers appropriate.
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                              The Council shall—
                    (3)          (a) ensure that all providers in Kenya concerned with the
                                     education and training of prospective pharmacists and
                                     prospective pharmaceutical technologist are notified of the
                                     standards and requirements set under subparagraphs
                                     (1)(b)(i) and (1)(b) (ii); and
                                 (b) take appropriate steps to satisfy itself that those standards
                                     and requirements are met.
                              The Council may—
                    (4)          (a) approve, or arrange with others to approve, courses of
                                     education or training which the Council is satisfied confer,
                                     or would confer, on persons completing them successfully
                                     the standards of proficiency referred to in paragraph (1)(a);
                                 (b) approve, or arrange with others to approve, such other
                                     courses of education or training as the Council considers
                                     appropriate;
                                 (c) approve, or arrange with others to approve, qualifications
                                     which are granted following success in an examination, or
                                     some other assessment, taken as part of an approved course;
                                 (d) approve, or arrange with others to approve, such tests of
                                     competence, or tests of proficiency in the knowledge and
                                     use of English, as the Council may require; or
                                 (e) approve, or arrange with others to approve—
                                             (i) institutions,
                                             (ii) other    providers,    including    tutors,    of
                                                  postgraduate education and training which leads
                                                  to an approved qualification, if the Council
                                                  considers that they are properly organised and
                                                  equipped for conducting the whole or part of an
                                                  approved course;
                                             (iii)approve, or arrange with others to approve,
                                                  premises as being suitable for postgraduate
                                                  education and training which leads to an
                                                  approved qualification.
                              In connection with subsection (4), the Council may approve, or
                    (5)       arrange with others to approve—
                                     (a) a course of education or training run outside Kenya
                                         which is intended to lead to an approved qualification;
                                     (b) an institution or other provider of a course of education
                                         or training to which paragraph (a) refers.
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                              The Council shalla by reference to which the standards of
                    (6)       education, training and experience referred to in subparagraph
                              (1)(b)(i) are set; and
                                  (a) the criteria that will be taken into account in deciding
                                      whether to grant approval under subsection (4), as they
                                      exist from time to time.
                              The Council shall publish and maintain a list of the courses of
                    (7)       education and training, qualifications and institutions or other
                              providers , including tutors,-
                                 (a) which are for the time being approved under this Act; or
                                 (b) which have been approved under this Act but which are no
                                     longer so approved, together with a record of the periods in
                                     respect of which approval was given.
                              References in this Part to an approved course of education and
                    (8)       training, an approved qualification, an approved test or an
                              approved institution or other provider are references to such a
                              course, qualification, test, institution or other provider approved
                              under subsection (4).
    Continuing      39        In connection with its general function under Section 9(1), in so far
    professional    (1)       as that function relates to the continuing professional development
    development
                              of pharmacist or pharmaceutical technologists, the Council shall—
                                  (a) set the standards of proficiency for the safe and effective
                                      practice of pharmacy which it is necessary for a pharmacist
                                      or pharmaceutical technologists to maintain in order to have
                                      their registration renewed; and
                                  (b) set the standards of continuing professional development
                                      which it is necessary for a pharmacist or pharmaceutical
                                      technologists to maintain in order to continue to meet the
                                      standards of proficiency referred to in paragraph (a).
                              The Council must publish the standards set under this section, as
                    (2)       they exist from time to time, in such manner as it considers
                              appropriate.
                              The Council may—
                    (3)          (a) consult such persons as it considers appropriate about the
                                     development of criteria by reference to which compliance
                                     with the standards set under paragraph (1)(b) is to be
                                     monitored; and
                                 (b) publish those criteria as they exist from time to time in such
                                     manner as it considers appropriate.
                              The Council may—
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                    (4)           (a) adopt and maintain a framework relating to the
                                      requirements and conditions to be met by pharmacist or
                                      pharmaceutical technologistss in respect of their continuing
                                      professional development; and
                                  (b) require pharmacist or pharmaceutical technologistss—
                                      (i) to complete an annual declaration regarding their
                                           compliance with such requirements and conditions in
                                           respect of their continuing professional development as
                                           they are obliged to meet by that framework, and
                                      (ii) to submit records about any continuing professional
                                           development undertaken by them to the Registrar for
                                           review.
                              The framework adopted by the Council under paragraph (4)(a)-
                    (5)       (b)must include provision relating to—
                                      (i) the amount and type of continuing professional
                                           development that a pharmacist or pharmaceutical
                                           technologists is required to undertake;
                                      (ii) the information to be provided by a pharmacist or
                                           pharmaceutical technologists about the continuing
                                           professional development that the pharmacist or
                                           pharmaceutical technologists has undertaken and the
                                           form and manner in which that information is to be
                                           provided;
                                      (iii)the times at which information about the continuing
                                           professional development that a pharmacist or
                                           pharmaceutical technologists has undertaken is to be
                                           provided including any continuing professional
                                           development that relates to an annotation in respect of a
                                           particular specialisation that is to be recorded in the
                                           Register;
                                      (iv) the keeping of records about the continuing professional
                                           development       undertaken     by     pharmacist     or
                                           pharmaceutical technologistss; and
                              (a) must require that any continuing professional development that
                                  is undertaken by a pharmacist or pharmaceutical technologists
                                  in accordance with it is relevant to—
                                      (i) the safe and effective practice of pharmacy, and
                                      (ii) a learning need for the individual pharmacist or
                                           pharmaceutical technologists that is relevant to the
                                           current scope of the practice of pharmacy including any
                                           specialisation of that individual pharmacist or
                                           pharmaceutical technologists and the environment in
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                                            which they practice.
                              The Council must publish the framework adopted by it under
                      (6)     paragraph (4)(a), as it exists from time to time, in such manner as it
                              considers appropriate.
                              The Council must make such provision in regulations as it
                      (7)     considers appropriate with respect to pharmacist or pharmaceutical
                              technologistss who fail to comply with any requirements of the
                              framework adopted by the Council under paragraph (4)(a).
                              Regulations under subsection (7) must-
                      (8)     (a) make provision for the circumstances in which the Registrar
                                  may remove the entry of a pharmacist or pharmaceutical
                                  technologists from the Register, or impose such other remedial
                                  measures as may be prescribed in the rules, where the
                                  pharmacist or pharmaceutical technologists-
                                  (i) has failed to comply with the requirements or conditions of
                                       the framework adopted by the Council under paragraph
                                       (4)(a) relating to the continuing professional development
                                       of pharmacist or pharmaceutical technologistss; or
                                  (ii) has made a false declaration about compliance with those
                                       requirements or conditions;
                              (b) make provision for the Registrar to send a statement in writing
                                  to the pharmacist or pharmaceutical technologists concerned at
                                  the pharmacist or pharmaceutical technologists’s last known
                                  address giving that pharmacist or pharmaceutical technologists
                                  notice of the removal and the reasons for it and of right of
                                  appeal to the High Court; and
                              (c) make provision for the suspension of a pharmacist or
                                  pharmaceutical technologists’s entry in the Register pending
                                  the outcome of any appeal against a decision to remove the
                                  pharmacist or pharmaceutical technologists from the Register.
    Information to    40.     This section applies to any institution or other provider in Kenya
    be given by               by which, or under whose direction—
    institutions or
                      (1)
    other providers
                                 (a) any relevant course of education or training is, or is
                                     proposed to be, given; or
                                 (b) any test of competence is, or is proposed to be, conducted
                                     in connection with any such course or for any other purpose
                                     connected with this Act.
                              Whenever required to do so by the Council, any institution or other
                      (2)     provider to which this section applies must give to the Council
                              such information and assistance as the Council may reasonably
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                              require in connection with the exercise of its functions under this
                              Act.
                               Where an institution or other provider refuses any reasonable
                     (3)      request for information made by the Council under this section, the
                              Council may, in accordance with this Act, refuse to approve or
                              withdraw approval from, any course of education or training,
                              qualification, test or institution or other provider to which the
                              information relates.
    Refusal or       41       Subsection (2) below applies to a case where, as a result of any
    withdrawal of             information acquired by the Council, the Council is of the opinion
    approval of
                     (1)
    courses,
                              that—
    qualifications                (a) the standards set under this Act are not, or will not, be met
    and                               by an institution or other provider; or
    institutions                  (b) an institution or other provider is not observing the
                                      requirements referred to in section this Act
                              In a case to which this subsection applies, the Council may—
                     (2)          (a) impose such probationary or remedial arrangements
                                      including action plans for providers of new courses or such
                                      conditions as may be prescribed; or
                                  (b) refuse to approve, or withdraw approval from, any course
                                      of education or training, qualification, test, or institution or
                                      other provider to which that opinion relates.
                              If the Council is considering taking any action under subsection
                     (3)      (2), the Council must act in accordance with subsections (4) below.
                              The Council shall-
                     (4)         (a) notify the institution or other provider concerned of its
                                     opinion, setting out its reasons; and
                                 (b) inform the institution or other provider of the period within
                                     which it may make observations on the matters raised,
                                     which must not be less than one month beginning with the
                                     date on which the reasons are sent to the institution or other
                                     provider under paragraph (a).
                              The Council may take no further steps before the expiry of the
                     (5)      period about which the institution or other provider has been
                              informed under paragraph (4)(b).
                              Where, under this Section, approval of a course of education or
                     (6)      training or an institution or other provider is withdrawn, the
                              Council must use its best endeavours to secure that any person
                              who, at that time, is undertaking that course or is studying at that
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                              institution or with that other provider is given the opportunity to
                              attend an approved course conducted by an approved institution or
                              other provider.
                              Where, under this section, approval of a qualification, a course of
                    (7)       education or training or an institution or other provider is
                              withdrawn, that withdrawal does not affect the entitlement of any
                              person to be entered in a part of the Register on the basis of the
                              award of a qualification to that person before the date on which the
                              decision withdrawing approval from that qualification, the course
                              of education or training which led to the award of that qualification
                              or, as the case may be, the institution or other provider that
                              conducted the course that led to the award of that qualification, had
                              effect.
                              Part V - DISCIPLINARY PROCEEDINGS
    Disciplinary    42.       If a pharmacist or pharmaceutical technologists is convicted of an
    proceedings               offence under this Act or under the Penal Code whether the offence
                    (1)
                              was committed before or after the coming into operation of this
                              Act or is, after inquiry by the Council, found to have been guilty of
                              any infamous or disgraceful conduct in a professional respect,
                              either before or after the coming into operation of this Act, the
                              Council may, subject to subsection (9), remove his name from the
                              register or the roll.
                               Upon any inquiry held by the Council under subsection (1) the
                    (2)       person whose conduct is being inquired into shall be afforded an
                              opportunity of being heard, either in person or by an advocate.
                              For the purpose of proceedings at an inquiry held by the Council,
                    (3)       the Council may administer oaths and may, subject to the
                              provisions of rules made under subsection (6), enforce the
                              attendance of persons as witnesses and the production of books and
                              documents.
                              Subject to the foregoing provisions of this section and to rules as to
                    (4)       procedure made under subsection (6), the Council may regulate its
                              own procedure in disciplinary proceedings.
                              The power to direct the removal of the name of a person from the
                    (5)       register or roll or to cancel the licence of a person shall include a
                              power exercisable in the same manner to direct that during such
                              period as may be specified in the order the registration of a person's
                              name in the register or roll or the licence granted to him shall not
                              have effect.
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                              The Council may develop rules for the carrying out of disciplinary
                     (6)      proceedings under this Section.
                              PART VI – FINANCIAL PROVISIONS
    Funds of the     43.      The funds of the Council shall consist of –
    Council
                                  (a) Appropriations and budgetary allocations from the
                                      Consolidated Funds;
                                  (b) such monies or assets as may accrue to the Council in the
                                      course of the exercise of its powers or the performance of
                                      its functions under this Act;
                                  (c) gifts, grants or donations as may be given to the Council;
                                  (d) monies that may be borrowed by the Council for the
                                      discharge of the functions of the Council; and
                                  (e) monies from any other source provided for the Council.
    Financial year   44.      The financial year of the Council shall be the period of twelve
                              months ending on the thirtieth day of June in each year.
    Annual           45.      At least three months before the commencement of each financial
    estimates        (1)      year, the Council shall cause to be prepared estimates of the
                              revenue and expenditure of the Council of that year.
                              The annual estimates shall make provisions for all estimated
                     (2)      expenditure of the Council for the financial year concerned and in
                              particular, shall provide for -
                                  the payment of the salaries, allowances and other charges in
                                      respect of the staff of the Council;
                                  the payment of pensions, gratuities and other charges in
                                     respect of benefits which are payable out of the funds of
                                     the Council;
                                  the acquisition and maintenance of the buildings and grounds
                                      of the Council;
                                  the funding of training, research and development activities of
                                      the Council;
                                  the proper maintenance, repair and replacement of any
                                     installation and of the equipment and other movable
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                                      property of the Council;


                                  the creation of such funds to meet future or contingent
                                     liabilities in respect of benefits, insurance or replacement
                                     of buildings or installation or equipment and in respect of
                                     such other matters as the Council may think fit.
                              The annual estimates shall be approved by the Council before the
                    (3)       commencement of the financial year to which they relate, and shall
                              be submitted to the Cabinet Secretary for approval and after the
                              Cabinet Secretary has given approval, the Council shall not
                              increase any sum provided in the estimates without written consent
                              of the Cabinet Secretary.
                              No expenditure shall be incurred for the purposes of the Council
                    (4)       except in accordance with the annual estimates approved under
                              subsection (3), or in pursuance of an authorization of the Council
                              given with the prior approval of the Cabinet Secretary
    Accounts and    46.       The Council shall cause to be kept all proper books and records of
    audit           (1)       account of the income, expenditure, assets and liabilities of the
                              Council.
                              The Cabinet Secretary for the time being responsible for finance
                    (2)       may prescribe the form of any book required to be kept under
                              subsection (1) and unless a form has been prescribed, a form
                              suitable for the purpose shall be used.
                              Within a period of three months after the end of each financial
                    (3)       year, the Council shall submit to the Auditor General the accounts
                              of the Council in respect of that year together with-
                                  (a) a statement of the income and expenditure of the Council
                                      during the financial year; and
                                  (b) a statement of the assets and liabilities of the Council on
                                      the last day of that financial year.
                              The accounts of the Council shall be audited and reported upon by
                    (4)       the Auditor –General in accordance with the provisions of the
                              Public Audit Act, 2003.
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    Investment of     47.     The Council may invest any of its funds in securities in which for
    funds             (1)     the time being trustees may by law invest trust funds or in any
                              other securities which the Treasury may, from time to time
                              approve.
                              The Council may place on deposit with such bank or banks or
                      (2)     financial institutions as it may determine, any moneys not
                              immediately required of the purposes of the Council.
    Annual            48.     The Council shall cause an annual report to be prepared for each
    Reports           (1)     financial year.
                              The Council shall submit the annual report to the Cabinet Secretary
                      (2)     within three months after the end of the year to which it relates.
                              The annual report shall contain, in respect of the year to which it
                      (3)     relates –
                                  the financial statements of the Council;
                                  a description of the activities of the Council;
                                  such other statistical information as the Council considers
                                     appropriate relating to the work of the Council;
                                  any other information relating to the functions that the Council
                                     considers necessary.
                              The Cabinet Secretary shall, within thirty days, after receiving the
                      (4)     annual report, transmit it to the National Assembly.
    Special reports   49.     The Council may, at any time, submit a special report to the
                              National Assembly with respect to any aspect of the functions of
                              the Council which the Council considers should, in the national
                              interest, be brought to the attention of the National Assembly
                              because it affects a wide cross Section of the populace and there
                              could be disastrous consequences if a report thereon is not brought
                              to the attention of the National Assembly.
                              PART VII - TRANSITIONAL PROVISION
    Cap. 244          50.          Upon the date of coming into operation of this Act the former
                      (1)          Board shall be dissolved and—
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                                  (a) all assets and liabilities of the former Board relating to the
                                      practice of pharmacy shall be transferred to and vest in the
                                      Council without further assurance and the Council shall
                                      have all powers necessary to take possession of, recover
                                      and deal with such assets and discharge such liabilities;

                                  (b) every agreement relating to the practice of pharmacy,
                                      whether in writing or not, and every deed, bond or other
                                      instrument to which the former Board was a party or which
                                      affected the former Board, and whether or not of such a
                                      nature that the rights, liabilities and obligations thereunder
                                      could be assigned, shall have effect as if the Council were a
                                      party thereto or affected thereby instead of the former
                                      Board and as if for every reference (however worded and
                                      whether express or implied) therein to the former Board
                                      there were substituted in respect of anything to be done on
                                      or after such date of coming into operation a reference to
                                      the Council.

                                  (c) any proceedings relating to the practice of pharmacy
                                      pending immediately before such date of coming into
                                      operation to which the former Board was a party shall be
                                      continued as if the Council was a party thereto in lieu of the
                                      former Board;

                                  (d) the pharmacy related Committees of the former Board shall
                                      become the Committees of the Council and shall continue
                                      as such until further provision in that behalf is made under
                                      section 10;

                                  (e) Any register which was in existence under the former Act
                                      immediately before the fixed date shall be deemed to have
                                      been established under this Act and shall continue in
                                      existence under the appropriate name specified.

                                  (f) Every person who, immediately before the fixed date, was
                                      registered in a register in terms of a repealed Act shall be
                                      deemed to have been registered on the appropriate register
                                      in terms of this Act, subject to the same conditions,
                                      restrictions or limitations, if any, as applied to him
                                      immediately before the fixed date.

                                  (g) Every person who, immediately before the fixed date, was
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                                      in a roll in terms of a repealed Act shall be deemed to have
                                      been enrolled on the appropriate roll in terms of this Act,
                                      subject to the same conditions, restrictions or limitations, if
                                      any, as applied to him immediately before the fixed date.

                                  (h) Any person who immediately before the fixed date, was
                                      practicing a profession in the former Act in relation to
                                      which registration was not compulsory under the former
                                      Act may apply to the Council within six months from the
                                      fixed date for registration on that register.

                              In this section unless the context otherwise requires
                    (2)       “the former Act” means the Pharmacy and Poisons Act
                              “the former Board” means the Pharmacy and Poisons Board
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                                   FIRST SCHEDULE (S. 8)

   PROVISIONS AS TO THE CONDUCT OF BUSINESS AND AFFAIRS OF THE
                            COUNCIL

Meetings of     1.         The Council shall meet at least four times in each year.
the Council.
Special         2.         The Chairperson may at any time convene a special meeting of the
meetings.                  Council and shall do so within fifteen days of a written requisition for
                           the meeting signed by at least three members.

Chairperson     3. (1)     The Chairperson shall preside at all meetings of the Council , which he
to preside.                is present and in the case of his absence, the Vice Chairperson shall
                           preside.


                     (2)   At a meeting of the Council at which neither the Chairperson or Vice
                           chairperson is present, the members of the Council present shall elect
                           one of     their number to preside, and the person so elected shall have
                           all the powers of the chairperson with respect to that meeting and the
                           business transacted thereat.
Quorum.         4.         The quorum for the conduct of the business of the Council shall be nine
                           members.
Voting          5.         The decisions of the Council shall be by a majority of votes, and the
procedure.                 Chairperson of the meeting shall have an original and a casting vote.
Validity of     6.         The validity of any proceedings of the Council shall not be affected by
proceedings.               any vacancy among the membership thereof, or by any defect in the
                           appointment of a member thereof.
Minutes.        7.         Minutes of the proceedings at meetings of the Council shall be kept in
                           such a manner as the Council directs, and, on the written request of the
                           Cabinet Secretary, shall be made available to him or any person
                           nominated by him.
Committees      8.         The Council may establish such committees as may be necessary for the
of       the               performance of the functions of the Council and may, subject to the
Council.                   provisions of this Act, delegate powers conferred on it to any such
                           committee.
 Power of the   9.         Subject to the provisions of this Schedule, the Council shall regulate its
Council to                 own procedure.
regulate own
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procedure.

Disclosure of   10.       If a member of the Council is directly or indirectly interested in any
interest        (1)      contract, proposed contract or other matter before the Council and is
                         present at a meeting of the Council at which the contract, proposed
                         contract or other matter is the subject of consideration, he shall, at the
                         meeting and as soon as reasonably practicable after the commencement
                         thereof, disclose the fact and shall not take part in the consideration or
                         discussion of, or vote on, any questions with respect to the contract or
                         other matter, or be counted in the quorum of the meeting during
                         consideration of the matter.
                         A disclosure of interest made under this subsection shall be recorded in
                (2)      the minutes of the meeting at which it is made
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MEMORANDUM OF OBJECTS AND REASONS

The purpose of this Bill is to provide for regulation of professionals in the Pharmaceutical sector
and to ensure that the training offered in the pharmaceutical field is up to standard. The Bill
therefore brings the regulation of the pharmaceutical sector under an independent body and
attempts to fill in the gaps in the current regime.

The Constitution of Kenya 2010 has also necessitated law reform in order to ensure compliance.
Already a draft Health Law and a draft Food and Drugs Authority Act are under consideration.
The Bill is divided into the following parts:

Part I is the preliminary section
Part II provides for the establishment of the Council
Part III provides for registration and regulation of Pharmacists and Pharmaceutical Technologists
Part IV provides for education and training of Practitioners in the field of Pharmacy
Part V provides the disciplinary procedure under the Act
Part VI contains the financial provisions
Part VII contains the transitional provisions


Dated …………………………………………………………… 2012.



……………………………
CABINET SECRETARY FOR HEALTH
Foot notes
The composition of the council and the board in all bills should be strictly pharmaceutical
oriented persons.

				
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