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The Hashemite Kingdom of Jordan




   Provisional Law No. 80

      Of the year 2001

   Drug & Pharmacy Law
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We Faisal Bin Al-Hussein, the Regent of His Majesty, King
of the Hashemite Kingdom of Jordan.


In pursuance of paragraph (1) of Article (94) of the Constitution, and in
compliance with the decision of the Council of Ministers dated
18/9/2001, we do hereby approve in accordance with Article (31) of the
Constitution, the following provisional Law and order that it be
promulgated and put into temporary force, that the supplementary to the
laws of the State, provided that it be presented for discussion by the
Parliament on its first meeting:-
             Provisional Law No. (80) for the year 2001
                      Drugs & Pharmacy Law


Article (1):
This law shall be named the Drug and Pharmacy Law of the year 2001
and shall come into force 30 days after its publication in the Official
Gazette.


                              Definitions
Article (2):
The following words and expressions wherever mentioned in this law,
shall have the meanings specified hereunder, unless the context indicates
otherwise.
The Ministry:             Ministry of Health
The Minster:              Minister of Health
The Secretary General: Secretary General of the Ministry
The Directorate: Directorate of Medicine of the Ministry.
                                    3

Director: Director of the Directorate.
Health Director: Director of Heath of a Governorate or a District.


The Drug:
Any substance or a group of substances used to diagnose the diseases
affecting human being or cure the same, lessen the pain or protect human
body from such diseases, or a group of substances other than foodstuff
which have certain effect on human body or any of its functions.


The Higher Committee:
The Higher Committee on Medicine and Pharmacy formed under the
provisions of this law.


The Pharmacopoeia:
The Reference Book, which contains the Chemical, Biological,
Physiological and Pharmaceutical Specifications for the Medicines
specified therein, and is approved by a competent authority in the issuing
country.


The Pharmacopoeia Drug:
Any Medicine specified in the most recent publication of any
pharmacopoeia and approved by the Minister.

The New Drug:
Any Medicine that has no substitute with the same formula of its active
components registered within the Kingdom.

The Pharmaceutical Institution:
Any Drug Factory, Drugstore, public or private pharmacy.
The Profession:    The Pharmacy profession.
                                       4

The Association: The Jordan Pharmacists Association.
The Chairman:         The Head of Pharmacists.
The Pharmacist: Any person holding a degree in pharmacy from an
accredited university in the Kingdom, and registered in the pharmacists
register with the Association and authorized by the Ministry to practice
this profession.
The Inspector:
Any pharmacist authorized for inspection on any pharmaceutical
institution in pursuance of the Law.


The Physician:
Any General Practitioner, dentist or veterinarian as necessary.
                              Chapter One
                                    Drug
Article (3):
(A)- (1)       It shall be prohibited to circulate any drugs, serums and
               vaccines unless after registering the same with the Ministry
               and passing the proper decision defining the prices for them
               according to the provisions of this law under the penalty of
               legal responsibility in case of any breach of its provisions.
      (2)      It shall be prohibited to register any of the substances stated
               in Article (1) of this paragraph before the competent
               Committee has made sure that those substances are used
               safely and are active and of good quality.


   (B)      It shall be prohibited to circulate any infants milk formula and
            its special formula, and supplementary food, medical plants,
            natural   products,   disinfectants   and   detergents,   medical
                                  5

       equipment and supplies, pharmaceutical preparations containing
       vitamins and minerals, cosmetic preparations and any other
       substances related to treatment or cure of human beings from
       diseases, unless they are licensed according to the Minister’s
       Directions and Coordinating with the concerned official
       authorities.
Article (4)
(A)-      A Committee shall be constituted at the Ministry named
          (The Higher Committee for Medicine & Pharmacy) and
          chaired by the Minister, with the membership of:
          1-     The Secretary General – Deputy Chairman.
          2-     The Director of the Directorate.
          3-     The President
          4-     The President of Physicians Association
          5-     The Director of Pharmacy & Supplies of the Royal
                 Medical Services.
          6-     The Control Pharmaceutical Laboratory Director of
                 the Ministry.
          7-     Any of the Pharmacology Faculties Dean at any State
                 University in addition to a Pharmacist among the
                 members of their teaching staff not less than Associate
                 Professor in rank, to be nominated by the President of
                 the university for two years in turn.
          8-     The Dean of any of the Medicine Faculties at any
                 State Universities in addition to a physician from
                 among the teaching staff therein his rank is not less
                 than Associate Professor to be nominated by the
                 President of the University for two years in turn.
                                        6

                9-    A pharmacist representing the local pharmaceutical
                      industries.
                10-   A pharmacist owning and in charge of a Drugstore.
                11-   A pharmacist owning and in charge of a public
                      pharmacy.


(B)   It is conditional when appointing the members mentioned in
      articles (9-10 & 11) of paragraph (A) of this article that any of
      them has been in practice for at least ten years and they will be
      appointed for two years renewable for one time only by a decision
      of the Ministers Council upon a recommendation from the
      Minister.


Article (5) :
(A) : The Higher Committee shall be responsible for setting up the bases
      and standards in the following matters:-
      1-        Fulfillment of medical safety.
      2-        Rationalization of drug consumption.
      3-        Registration of drugs including its renewal and cancellation
                of such registration for any of them.
      4-        Licensing the circulation of medical herbs, infant milk
                formula and its special formula, and supplementary food and
                convalescence treatment drug, and cancellation of such
                circulation of any of them.
      5-        Authorization of manufacturing locations at the drug
                factories, serums and vaccines, infant milk formula, its
                special formula, supplementary food and pharmaceutical
                preparations which is containing vitamins and minerals as
                                         7

               well as inspection of these locations before registering their
               products and preparations.
      6-       Quick registration of any drugs known for their relative
               therapeutic characteristics.
      7-       Pricing of drugs and renewal of such pricing.
      8-       Objection to decisions concerning the registering of drugs,
               serums and vaccines, renewing their registration, pricing and
               usage licence issued by the competent Committees under the
               provisions of this law.
      9-       Quality control of drugs.
      10-      Taking note of drugs side effect.
      11-      Circulation of medical supplies.
      12-      Regulation of drug dispensing methods.
      13-      Approval of circulation of non-registered drugs imported in
               non-commercial quantities for certain patients defined by
               name.
      14-      Controlling of any substances or preparations related to
               treatment of diseases, or any other substances the Minister
               may deem necessary to have them under control.


(B)   The Minister shall, upon a recommendation from the Higher
      Committee, issue the instructions necessary for defining the
      procedures and requirements for executing any of the matters
      specified in paragraph (A) of this article.


Article (6):
(A)   The Higher Committee shall held a meeting upon a call from its
      Chairman or his deputy in case of his absence whenever necessary,
      and such meeting shall be deemed legal with the presence of at
                                     8

      least ten of its members provided that the Chairman or his deputy
      should be among them; and shall issue its resolutions either by
      plenary voting or by majority of at least eight votes.


(B)   The Minister may invite any person who is specialized and have
      enough experience in any issues presented to the Committee to
      take his opinion on those issues without giving him the right to
      vote in such meeting.


Article (7):
(A)   The Higher Committee shall form sub-Committees from among its
      members and others to study the following matters and refer the
      required recommendations in this concern to it.
      1- Types, components, method of dispensing, registration, method
         and period of filing of the medical prescriptions.
      2- Issuance of the National Treatment Guide and lists of the
         Classified Drugs according to their method of prescription and
         dispensing.
      3- The basis for replacement of any drugs dispensed under a
         medical prescription by others.
      4- Preparation, composition and provision of drugs by public and
         private pharmacies.
      5- Type of records, which should be kept by the Pharmaceutical
         Institution, its organization method and period of filing the
         same in addition to any other records and details.
      6- Specifications and colors of labels for drug usage.
      7- Information to be written on the interior and exterior packing of
         Drugs, serums and vaccines in addition to any specifications
         which must be shown in the internal leaflet.
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       8- Any other matters the Higher Committee may deem necessary
          to be studied.
(B)    The Minister, upon a recommendation from the Higher Committee,
       shall issue the instructions relevant to work procedures of the sub-
       Committees referred to in paragraph (A) of this article in addition
       to terms of membership in any of those sub-Committees, quorum
       for their meetings, passing their decisions and organization of their
       meetings.


Article (8):
Any Committee formed by virtue of the provisions of this law, each in its
own specialty, shall observe the bases, standards, procedures and
requirements set up by the Higher Committee under the legal powers
vested into it.


Article (9):
(A) – A Committee shall be formed to be called (the Technical
       Committee for Registration of New Drugs), and chaired by the
       Secretary General with the membership of:
       1- The Director – Deputy Chairman.
       2- The Head of Drug Registration Section of the Directorate.
       3- The Head of Import & Export Section at the Directorate.
       4- Two Physicians one of them is an-internist.
       5- A pharmacist specialized in pharmacokinetics.
       6- A pharmacist specialized in pharmacology or in clinical
          pharmacology.
       7- A pharmacist specialized in pharmaceutics.
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(B)   The members mentioned in clauses (4. 5. 6 & 7) of paragraph (9)
      of this article shall be nominated by virtue of a decision from the
      Minister for two renewable years.


(C)   This Committee shall be concerned in the following duties:
      1-       Licencing registration of the new medicine and specifying its
               method of prescription.
      2-       Study any objections related to such new medicine and issue
               its decision to that respect.
      3-       Study the new developments related to drugs, and their
               precautions and side effects, and take any proper decisions in
               that regard.


(D)   The Technical Committee for registration of new Drugs shall have
      a meeting, upon its Chairman call or his deputy in case of his
      absence, at least twice each month, and such meeting shall be
      deemed legal with the presence of at least six members, provided
      that the Chairman or his deputy is among them, and shall pass its
      resolutions either by plenary voting or by majority of at least five
      votes.


Article (10):
(A)   A Technical Committee shall be formed to study drugs that have
      substitute registered in the Kingdom, to be chaired by the Director
      and the membership of :-
      1- The Director of Supplies of the Ministry - Deputy Chairman.
      2- Drug Control Ministry Laboratory Director
      3- The Head of Drug Registration Section of the Directorate.
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      4- A pharmacist specialized in drug pharmacokinetics in addition
         to a specialist in pharmaceutics to be appointed by the Minister
         for two renewable years.
(B)   This Committee shall be concerned with the study of all matters
      related to drugs that have substitute registered in the Kingdom,
      including the following:-
      1- Licencing the registration of drugs that have registered
         substitute.
      2- Study the objections presented to it in concerning to the
         registration of these Drugs and taking the proper decisions in
         this respect.


(C)   This Committee shall have a meeting, upon a call from its
      Chairman or his Deputy in case of his absence, at least twice each
      month, and such meeting shall deemed legal with the presence of at
      least five of its members provided that the Chairman or his deputy
      is among them, and shall take its decision either by plenary voting
      or by majority of at least four votes.


Article (11):
(A)   A Committee shall be formed at the Ministry to be named (Drug
      Pricing Committee) chaired by the Director, with the membership
      of:-
      1- The Director of Procurement at the Ministry as a Chairman
         Deputy.
      2- The Head of Drug Pricing Section of the Directorate.
      3- An internist to be elected by the Minister.
      4- A pharmacist specialized in pharmacology or in clinical
         pharmaceutics to be elected by the Minister.
                                    12

      5- Two experts to be elected by the Minister provided that one of
         them is expert in cost accounting.


(B)   This Committee shall be concerned in the matters specified
      hereunder and refer its recommendation to the Minister to take the
      proper decision in this regard:-
      1- Recommending that a price list should be made for the new
         drugs and for those that have substitute registered within the
         Kingdom in addition to any substances deemed by the Higher
         Committee to be priced in whole or in part.
      2- Study any objections made on the prices of the registered drugs
         or of those submitted for registration of the priced materials.


Article (12) :
(A)   The Drug Pricing Committee shall hold a meeting upon a call from
      its Chairman or his deputy in case of his absence, whenever
      necessary, and such meeting shall be deemed legal with the
      presence of at least five members including the Chairman or his
      deputy, and shall make its recommendations either by plenary
      voting or by majority of at least four votes.
(B)   The Committee shall decide on any application presented to her by
      the competent registration Committees in not more than thirty days
      from the date of approving such registration. In case the Committee
      is not able to decide on any such application within this period, the
      Minister may grant the applicant a licence for drug import or
      manufacturing it, as may be necessary, for a period not exceeding
      nine months and with the price defined in such application and not
      exceeding the common price adopted in the country of origin
      during this period.
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(C) 1-         The applicant may object to the Minister’s decision on drug
               pricing within thirty days from the date of notification of this
               decision, and the Minister shall refer this objection to the
               Drug Pricing Committee to study the same and submit its
               recommendations in this relevance within thirty days from
               the date of its referral, and the Minister’s decision made in
               this regard shall be deemed final.
   2-          The Committee shall refer its recommendations relevant to
               Drug pricing applications to the Minister to take whatever
               decision proper in this respect, whereby the authorization for
               drug import or manufacturing granted under the provisions
               of paragraph (B) of this article shall be deemed null and void
               when the Minister has issued a decision for drug pricing
               according to the provision of this law, and the applicant shall
               abide by such pricing as of the date of notification of such
               decision.


Article (13):
(A)      The Minister may decide to form any Committee he may deem
         proper for the execution of the provision of this law, including the
         following Committees:-
         1-    The Committees for serums & vaccines
         2-    The Committees for the infants milk formula, their special
               formula and supplementary food.
         3-    The Committee for Pharmaceutical preparations, which
               contain Vitamins and minerals.
         4-    The Committee for medical herbs and natural products.
                                       14

      5-      The Committee for medical equipment and supplies
              including disinfectants and detergents.
      6-      The Committee for approving the manufacturing locations.
      7-      The Committee for cosmetic preparations.
(B)   The number of members of any Committee constituted under the
      provision of paragraph (A) of this article shall be determined and
      its Chairman nominated by a decision from the Minister, as well as
      duties and terms of membership of any of those Committees,
      quorum for their meetings, decision taking and organization of
      their meetings shall be defined under the directions of the Minister.


Article (14):
The Minister shall issue any directions required for organizing the work
of those Committees including the secretariat of the same.


Article (15):
(A)   The Ministers Council, in pursuance of the provisions of paragraph
      (b) of this article and upon the Minister and Higher Committee’s
      recommendation, may decide the following:
      1- Determine         the   percentage   of   profit   declared   to   the
           Pharmaceutical Institution on any drugs dispensed by a medical
           prescription.
      2- Determine a percentage to cover any administrative expenses
           for each drug and pharmaceutics drugstores, to be added to the
           cost for any drug, serums, vaccines, infants milk formula, their
           special formula and supplementary food and any other materials
           deemed to be priced by a decision from the Minister.
                                     15

(B)   The Minister may, upon a recommendation from the Pricing
      Committee, determine the price for each drug, infant milk formula
      and their special formula and supplementary food regardless of the
      cost price and the determined percentage of profit.


Article (16):
(A)   The pharmacist in charge of the drugstore or the technical manager
      of the manufacturing company shall, under the Minister’s
      instructions, submit in an application for renewing the registration
      of any drug which has been registered or re-registered for five
      years, and the competent Committee may approve the renewal of
      registration of such drug or determine a new price for the same or
      take a decision justifying the cancellation of its registration.
(B)   In case of non-submission of an application for renewing the
      registration of any drug during the period defined by the
      instructions issued under paragraph (A) of this article, such
      registration shall be revoked by a decision from the Minister taken
      upon the competent Committee’s recommendation, and shall take
      any necessary actions for preventing of circulating such drug.


Article (17):
The Minister, by a recommendation from the Committees formed under
this law, each according to its competency, may take any decisions
relevant to the following:
(A)   Re-evaluation of the conditions of manufacturing locations of the
      approved drug companies or revocation of such authorization or
      prohibition of circulation or import of their Drugs or cancellation
      of their registration from the Ministry’s registers by virtue of a
      justifying decision.
                                     16

(B)   Prohibition of import or circulation of any drug, or suspension or
      cancellation of its registration under a justifying decision.
(C)   Renewal of registration of any drugs that have been registered for
      five years or more.
(D)   Reconsideration of drugs prices.


Article (18):
The Custom’s employees may not have any clearance on any
consignment of any imported drugs or their raw materials or any exported
Drugs and it is also prohibited to import or export any drug or
manufacturing raw material unless by the approval of the Minister or his
representative.
                               Section Two
                              Pharmaceutics
                        Practice of this Profession
Article (19):
(A)   Pharmaceutics is a scientific and health profession, which provides
      a human service and has general, social and economical effects.
      The practice of this profession includes the preparation,
      composition, manufacturing, packing, portioning, import, storage,
      distribution, purchase for sale or dispensing of any drug, infant
      milk formula or their special formula and supplementary food, or
      Drug advertising for the sake of acquainting the physicians with
      this drug.
(B)   According to the provision of this law, this profession shall not be
      practiced by any person other than the pharmacists.
(C)   Practice of this profession shall involve the following pharmacists:-
      1- The owner, director and officials of any pharmaceutical
         institution.
                                      17

      2- The owner of any medical or drug control laboratory, as well as
           scientific research center or pharmaceutical consultation center
           and any officials working for any of the above.
      3- Officials of any Ministries, public and private institutions in
           their capacities as pharmacists.
      4- Officials working in the field of education.
      5- Officials working for stores of medical herbs preparations.


Article (20):
(A)   Any Jordanian Pharmacist who wishes to apply for a licence for the
      practice of this profession shall fulfill the following:-
      1-      He should be holder of the first university degree in
              pharmacy as a minimum prerequisite from a university
              accredited by the competent authorities.
      2-      He should not be sentenced for a felony or offense in breach
              of public honor and morals.
      3-      He should acquire the requirements for such license defined
              by the concerned authorities in pursuance of the operative
              legislation.
(B)   Any pharmacist who is a national of any Arab or foreign country
      and acquires the license requirements stated in paragraph (A) of
      this article may apply for a license for the practice of this
      profession, provided that he shall be treated on equal terms with
      any Jordanian pharmacist.


Article (21):
Any applicant for a licence should enclose the following documents with
his application:-
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A-    Copy of his university certificate or graduation document duly
      certified.
B-    Copy of Civil Statute Identity Card for the Jordanian national, or
      copy of citizenship document in addition to residence permit for
      the non-Jordanian national.
C-    Any other documents the Minister may deem necessary to be
      enclosed with such application.


Article (22):
In case all the requirements and terms for the licence are fulfilled, the
applicant, by a decision from the Minister or his representative, shall be
granted a licence for the practice of this profession, after collecting the
fees determined according to the regulations issued under this law.


Article (23):
Any pharmacist practicing this profession shall inform the Ministry and
the Pharmacists Association of his work location and of any alteration on
such location, within a period not exceeding seven days from the date of
his assuming such work or of the date of said alteration.


                   The Pharmaceutical Establishment
Article (24):
A-    It shall be prohibited to establish or own a pharmaceutical
      institution without the authorization of the Minister after the
      approval of the pharmaceutical Association.
B-    Any pharmacist working for any Governmental Department or
      Public Official Institution shall have no right to own a
      pharmaceutical institution or any shares therein except when such
      institution is a public share-holding company.
                                    19



C-    Terms for establishing or owning and licencing of any
      pharmaceutical institution in addition to any determined fees
      collectable from any such institution shall be defined under a
      bylaw to be issued for this purpose.


Article (25):
Any licence for a pharmaceutical institution shall be revoked by a
decision from the Minister in any of the following cases:-
A-    If any such institution does not Commence working within one
      year from the date of issuing the licence with the exemption of any
      Drug factory which will be granted a period of five years
      renewable under a justifying decision from the Minister.
B-    When closing such institution for more than consecutive six
      months without any reason acceptable by the Minister.
C-    In case this institution is transferred to another location without
      such transfer being approved by the Minister.
D-    If the pharmacist or owner of such institution does not abide by the
      terms for owning the pharmaceutical institution in pursuance of the
      regulations issued, and provisions of this law.
E-    If a sentence is issued by the competent courts against the
      pharmacist in charge or owner of such institution pronouncing him
      guilty of circulating any narcotics and hallucinates or misuse of the
      same contrary to the provisions of this law.
F-    If this institution is sold to a pharmacist not licenced to own the
      same according to the provisions of this law, or if the owner of said
      institution incorporates a partner who has no license for such
      ownership.
                                       20

G-    In case the real owner of the pharmaceutical institution has been
      approved to be other than the person licenced to own the same
      according to the provisions of this law.
H-    If it has been approved that the licence has been granted under
      falsified documents or by fraudulent means.


Article (26):
In case of death of the owner of any pharmaceutical institution, his heirs
shall have the right to maintain the same, provided that they should
appoint a full-time pharmacist to be in charge of it, none of those heirs
may sell his share except for other heirs or to a pharmacist in pursuance
of this law.


Article (27):
The pharmaceutical institution shall, in no case, refrain, illegally or for
monopoly, from dispensing any prescription or selling any Drug or
substance related to human health, they are not authorized to sell in
compliance with the provisions of this law when such Drug or substance
are in stock.


Article (28):
The owner of any pharmaceutical institution may, by the Minister’s
approval, store the Drugs outside the institution, when the designated
store meets the required terms according to the Minister’s instructions
issued for this purpose, and the pharmacist in charge of said institution
shall be responsible for such store.
                                    21

Article (29):
The owner of any pharmaceutical institution or the pharmacist in charge
shall inform the Ministry and the Association of any alteration in the
name or postal address of the pharmaceutical institution or in the name of
the responsible pharmacist within at most seven days from the date of
such alteration.

Article (30):
A-     It is conditional to have one or more responsible pharmacist in each
       pharmaceutical institution to manage the same on full-time basis.
       In case of his absence, he should appoint a substitute pharmacist to
       take charge of such institution provided that the former should
       advise the Ministry and the Association of this appointment.
B-     The pharmacist should not be charged for more than one
       Pharmaceutical Institution without the approval of the Minister,
       provided that the time will not contradicting working in the other
       institution.

Article (31):
In case of termination of the pharmacist’s responsibility towards the
pharmaceutical institution, he has to deliver his custody of any narcotics
and hallucinators to his successor and shall execute an official report of
such delivery to be signed by both to be kept with the institution after
sending a duplicate thereof to the Directorate.

Article (32):
The owner of a pharmaceutical institution, by approval of the Minister,
may transfer his pharmaceutical institution to another location if such
location is in compliance with the licencing terms provided for in this
law.
                                    22

Article (33):
The responsible pharmacist may not purchase any drugs unless from an
entity authorized to sell the same, and he, as well, shall not sell such
Drugs with expired date or medical samples or damaged or contraband
Drugs.

Article (34):
Drug dispensing from any pharmacy shall only be made after attaching
the usage label on its container.

Article (35):
It shall be prohibited to advertise, for promotion purposes, any drug or
substance that has medicinal characteristic, or infants milk formula or
their special formula and supplementary food, in any of the readable, or
visual or audible media or in any other mean unless by approval of both
the Minister and the Association with the exception of medicinal
publication and information directed to Health Authorities on condition
that such information are authenticated.

Article (36):
A-    The following shall be deemed inconsistent with the provisions of
      this law.
      1-     Any agreement, which provides that any physician shall
             receive, from the owner of any Drugstore or public
             pharmacy, any portion of the profits resulting from drugs
             sale.
      2-     Any agreement between any pharmacist in charge of any
             public pharmacy and the physician or between the owner of
             any drugstore and the physician that the medical
             prescriptions shall be written in certain way or bear any
             agreed markings.
                                      23



B-    The pharmacist may not venture to get customers to his pharmacy
      either directly of through brokers.


Article (37):
The Minister, by virtue of any provisions he decides, to authorize any
physician to purchase Drugs from any drugstore and prescribes the same
to his patients at the price determined for the public, if his clinic is
located in a village where there is no public or private pharmacy, and
such village is ten kilometers far from the nearest location where there is
a pharmacy, and such authorization shall be cancelled accordingly when
those terms are not observed.


Article (38):
As of the date of the provisions of this law coming into force, the title of
(Assistant Pharmacist) shall apply only to the following persons:-


A-    Assistant pharmacists who are authorized by the Ministry before
      the promulgation of this law.
B-    Jordanian graduates of Public and private Society Colleges who
      hold an Assistant Pharmacist Diploma certified by the competent
      authority.
                                Drugs Factory


Article (39):
Drugs factory is any pharmaceutical institution where drugs are
composed, prepared or portioned, or where raw materials are
manufactured in an industrial scale for wholesale purposes.
                                    24

Article (40):
A-    Pursuant of any operative legislation, it shall be prohibited to create
      or open any Drug factory unless after obtaining a licence from the
      Minister for that respect.
B-    Any natural or corporate person may establish or own a drug
      factory in consistence with the provisions of this law.
C-    It shall be prohibited to commence work at such factory unless
      after inspecting the same to make sure that it complies with the
      good-quality Drug manufacturing standards approved by the
      Minister or with any guides issued for this purpose and are
      approved by the Minister.


Article (41):
The terms required for licencing any drugs factory should be specified by
virtue of the bylaw in addition to the specifications, technical and health
conditions for such factory and people employed thereby as well as the
technical and administrative responsibility, provided that it should be
committed in all circumstances in the bases of the good quality drugs
manufacturing as well as any guide published for this purpose and
approved by the Minister according to the quality and nature of
production.


Article (42):
A–    Locally produced drugs shall be distributed by a drugstore
      established under the provisions of this law, or by any other
      distribution center affiliated to any drug factory, by the Minister’s
      approval and in pursuance of the basis and terms he may define for
      this purpose.
                                     25

B-    Any drugstore acting as an agent for any local manufacturing
      company shall advise the Ministry of any distribution contracts
      concluded for this end, and define the types of drugs each
      distributor is authorized to distribute.


Article (43):
A-    Each Drug factory must appoint a full-time pharmacist to act as the
      technical manager in charge, and in case of his absence, the
      pharmacist in charge shall take his place, provided that the Minister
      shall be notified of this procedure.
B-    The technical manager will participate with the full time
      pharmacist in the responsibility of recruitment.
C-    The factory management shall notify the Minister and the
      Association of the names of pharmacists working at the factory and
      in its various divisions and of any change at the time of its
      occurrence.


                                 Drugstore
Article (44):
A-    The drugstore is any pharmaceutical institution prepared for
      importing purchase, selling, storing any distribution of drugs to
      pharmacies and any entity authorized to sell those drugs.
B-    The drugstore shall have the right to trade in the items mentioned
      in paragraph (C) of article (57) of this law.


Article (45):
(A) 1- It is prohibited to establish or purchase any drugstore except by a
      full-time pharmacist.
                                    26

    2- Contrary to the provisions of article (1) of this paragraph, any
        drugstores established by non-pharmacists before the provisions
        of this law come into force, may maintain the ownership of their
        drugstores provided that a full-time pharmacist be appointed
        therein to assume the technical responsibility for the same.
(B)- Any pharmacist may not own more than one drugstore or own one
      drugstore and a public pharmacy at the same time with the
      exemption of those who has owned a drugstore or public pharmacy
      before the provisions of this law became operative, provided that
      he should appoint a full-time pharmacist to assume the technical
      responsibility for such drugstore or pharmacy as necessary.
(C) – It is permissible for more than one pharmacist to own one
      drugstore.


Article (46):
In case of merger of a number of drug companies in one company or in
case of purchase of any drugs by a drug company from another one where
both have an agent within the Kingdom, the Minister may therefore
authorize the establishment of a joint technical specifications defined for
that respect, to be responsible for the registration, import and export of
any drugs owned by this merger of companies provided that a pharmacist
be appointed to take charge of such drugstore.


Article (47):
Any drugstore may, by approval of the Minister, establish a branch in any
place within the Kingdom to store therein the drugs companies he
represents, as well as to sell and distribute those drugs, and it shall be
subject to any terms and specifications applicable to the main drugstore.
                                     27

Article (48):
The pharmacist in charge shall be present inside the drugstore during the
determined duty hours, and he shall, in case of his absence, authorize in
writing a full-time pharmacist to assume the technical responsibility for
the same during the former absence after informing the Ministry and the
Association of this authorization.


Article (49):
A-    Import of drugs shall be effect by the drugstore that is acting as an
      agent for the drug company.
B-    Any drugstore in its capacity as an agent for any Drug company
      may grant to distribute Drugs they import to any other drugstore
      provided that the pharmacist in charge of the importing drugstore
      shall be responsible for those Drugs, and has to inform the Ministry
      of any distribution contracts signed for this purpose and the Drug
      types they cover.


Article (50):
A-    The Minister, in coordination with the Association, may issue any
      instructions by which he defines the types of any registered drugs,
      which must be made available at all times in any drugstore, and are
      produced by the companies which he acts as an agent for. In case
      of failure to secure those drugs, he has to inform the Ministry of
      such incident and shall be subject to penalty of giving the right to
      import those drugs by any other pharmaceutical institution on
      condition that they are sold to public against the determined price.
B-    The Minister, under any terms he may determine, may give the
      permission to any pharmaceutical institution for medicinal security
      reasons to import any of the registered Drugs.
                                    28



Article (51):
A-    Any drugstore may not sell any priced Drug or preparation unless
      after printing or attaching the price tag approved by the
      Association on its original packing without erasing or correcting
      any figures of such price, and the pharmacist may refuse to accept
      such drug or preparation without being priced and return them to
      their origin on the expense of the latter otherwise, both the owner
      of such drugstore and the pharmacist in charge shall be deemed in
      breach of such procedure.
B-    It is conditional that the price tags must not cover the drug name,
      usage, expiry date, storage conditions and patch number.


Article (52):
A-    It shall not be permissible to change the country of origin of any
      registered drug unless by a recommendation from the competent
      Committee and the Minister’s approval.
B-    It shall be prohibited for any drugstore to import any registered
      drugs produced by any company they are agent for, from any
      different manufacturing locations other than the approved ones
      unless by the Minister’s approval given upon the competent
      Committee’s recommendation.


Article (53):
Drugs samples shall be given out for free scientific promotion purposes
and according to special instructions issued by the Minister including the
specifications and distribution terms for those samples.
                                    29

Article (54):
Drugstore may not oblige any pharmacy or any other entity licenced for
drug sale, to purchase any defined quantity of those drugs or infants milk
formula or their special formula and supplementary food.


Article (55):
A-    The owner of any drugstore shall be committed in the following:-
      1-     Keeping and storing drugs in their original packing in
             consistence with the approved terms.
      2-     Not opening any drugs original packing or portion any of
             them unless under the competent Committee’s approval.
      3-     Not altering the name, and expiry date of any medicine
             whether by printing, stamping or any other mean without the
             prior approval of the Directorate.
      4-     Taking any procedures necessary for changing the price tags
             inside pharmacies in case of any change made on the price of
             any drug.
B-    Any action performed in breach of the provisions of paragraph (A)
      of this article shall be deemed fraudulent and shall result in seizing
      any such Drug and in application of any penalties specified in this
      law to the owner of any such drugstore or pharmacist in charge
      when necessary.


Article (56):
Terms for transport and distribution of drugs as well as the technical
specifications for Drug transport means shall be decided under any
instructions issued by the Minister for this purpose.
                                   30

                         The Public Pharmacy
Article (57):
A-    The Public pharmacy is the pharmaceutical institution which has
      the exclusive right to prepare drugs and dispense the same as well
      as infants’ milk formula or their special formula and supplementary
      food directly for the public against the prices determined by the
      Ministry.
B-    The pharmacist has to provide any consultation relevant to drug
      usages.
C-    The public pharmacy may sell the following:
      1- Any medical instruments, equipment and supplies related to
         general medicine, veterinary and dentistry.
      2- Cosmetic preparations and perfumes.
      3- Veterinary Drugs in remote areas.
      4- Health supplies and children health requirements.
      5- Chemicals including insecticides and germicides.
      6- Audio and visual aids and their accessories.
      7- Laboratory instruments and supplies.
      8- Photography and x-ray accessories.
      9- Food for diabetics, special foodstuffs and weight losing
         substances.
      10-   Any other substances approved by the Minister upon a
         recommendation from the Association.


Article (58):
The Minister, by a recommendation from the Association, may determine
certain types of Drugs and substances to be made available in certain
public pharmacies as the public interest may require.
                                      31

Article (59):
The owner of any public pharmacy is committed to close his pharmacy on
a specified day during the week by the approval of the Health Director,
and shall notify the Association of this event except when there is only
one pharmacy within the limits of any town.

Article (60):
A-    When dispensing Drugs by the public pharmacy, the following
      terms should be adhered to :-
      1-     Not dispensing any drug which needs a medical prescription
             as a pre-requisite unless in the presence of the pharmacist in
             charge.
      2-     The assistant pharmacist may sell any drugs that are usually
             dispensed without any medical prescription.
B-    In case of any difficulty in separating any drugs, which are
      dispensed under a medical prescription in a special section within
      the pharmacy, the pharmacist in charge has to close it during his
      absence.

Article (61):
Any pharmacist working in a public pharmacy has to observe the prices
determined for any drugs and pharmaceutical preparations subject to
punishment by law.

Article (62):
Any pharmacist who is the owner of any pharmacy shall be technically
and financially responsible for managing the same, and he may assign
another pharmacist to assume the technical responsibility for the said
pharmacy, and the former may authorize the latter with the financial
responsibility for it on condition that he should inform the Ministry and
the Association of this event.
                                     32

Article (63):
A-    The Minister may grant any pharmacist, who does not own any
      pharmaceutical institution, a licence to open or purchase a public
      pharmacy in any of the following cases:-
      1-     When at least three years had passed on the date of his
             obtaining a licence to practice this profession.
      2-     After two years at least had passed on the date of his sale of
             a pharmacy he used to own or its licence had been cancelled
             upon his own request.
B-    Any pharmacist who has been granted a licence in pursuance of the
      provisions of paragraph (A) of this article shall provide a prior
      undertaking to remain in charge of his pharmacy for at least two
      years form the date of commencing his work.
C-    In case the pharmacist is not capable of managing his pharmacy for
      any reason acceptable by the Minister, he then may sign a contract
      with another pharmacist to be responsible of the same upon a
      recommendation from the Association Council.


Article (64):
In pursuance of the provisions of article (63) of this law:-
A-    It shall be permissible for a number of pharmacists to jointly
      establish or purchase a public pharmacy provided that one of them
      should work on full-time basis and remain responsible for this
      pharmacy for at least two years from the date of commencement of
      his work.
B-    More than one pharmacist may jointly establish or own any public
      pharmacy provided that the number of those pharmacies does not
      exceed at any time, the number of partners, and that the maximum
                                     33

      limit of any partners share in such partnership must not exceed
      (40%) of the total number of shares.
C-    Any pharmacist shall have no right to be a shareholder in more
      than one company of any companies specified in this article.

Article (65):
The Minister may grant licences for public pharmacies to provide
pharmaceutical service at night only, according to any bases determined
by the Higher Committee.
                         The Private Pharmacy
Article (66):
The Private pharmacy is any pharmaceutical institution capable of
preparing Drugs and dispensing the same, and is subordinate to a medical
institution or charity society for the purpose of executing its medical
responsibilities.

Article (67):
It shall be prohibited for any entity to open a private pharmacy except for
state hospitals or health centers or any health centers owned by any
charity societies registered with the Ministry of Social development,
which its aim is providing medical service for poor people.

Article (68):
A-    The Minister shall have the right to grant any company or
      institution   located   in   remote    areas,   where   there   is   no
      pharmaceutical service, a licence to open a private pharmacy to
      provide pharmaceutical services for people working there.
B-    In case of any Public pharmacy is available in any remote area
      indicated in paragraph (A) of this article, then the licence granted
      for the relevant company or institution shall be revoked after at
                                    34

      most one year, had passed on the date of making this service
      available there.


Article (69):
In order to liecence any private pharmacy, it is conditional to observe the
following:


A-    The said pharmacy must be located inside the premises of the
      licenced entity and not adjacent to main roads.
B-    The pharmacy should acquire the determined technical terms and
      specifications.
C-    Dispensing of drugs therein shall be made exclusively for the
      following patients:-


      1- Those who are staying in the State hospitals and patients seen in
         and out at clinics of the State Health Centers and any other
         categories defined by the Minister.
      2- Patients staying at a private hospital against the determined
         official price.
      3- Patients seen in any health centers owned by charity societies
         which provide medicine free, on condition that those medicines
         are stamped with the society’s official seal.
      4- Officials of any such company or institution provided that the
         dispensed drugs are stamped with the official seal of any of the
         above.
Article (70):
Private pharmacy should be managed by a pharmacist in charge who will
have the exclusive right to dispense any drugs available therein.
                                      35

Article (71):
The Minister shall issue a list in which he shall define the basic drugs to
be made available in any private pharmacies owned by any hospitals, in
addition to their quantities as the interest of the patients.



                    Pharmaceutical Inspection
Article (72):
A-    The Minister or his representative as well as the Director or any
      pharmacist working for the Ministry and authorized by them may
      make an inspection visits to any pharmaceutical institution,
      research centers or means of drug transport at any time to make
      sure that they are in compliance with the provisions of this law, and
      they shall enjoy the capacity of any juridical control force.
B-    The pharmacist in charge as well as all the officials of any
      pharmaceutical institution has to provide the inspector with all the
      facilities, to help him in carrying out the duties of his job.
C-    The inspection special report shall be executed on the form
      authorized by the Ministry.


Article (73):
The Director as well as the inspector and the health Director have the
right to inspect any place or location suspected of trading in or using any
drugs or dealing in any substances the Minister may decide to control
according to the operative legislation, and shall take whatever decision to
control the same and refer the breacher to the competent courts.
                                     36

                               Chapter Three
                      Narcotics & Hallucinators
Article (74):
The pharmacist in charge, who is licenced to dispense narcotics and
hallucinators, may dispense those items prepared for medical use to the
following persons:-
A-    For patients under a medical prescription from a licenced physician
      or dentist, provided that such prescription should meet all the terms
      specified in this law.
B-    For owners of any infested animals when such prescription is
      issued by a licenced veterinarian.
C-    For physicians under a medical prescription signed by them
      showing that the dispensed quantity is only for use in their own
      clinics, provided that quantities are determined by the Minister, and
      the physician shall keep any documents and records related thereto
      subject to inspection at any possible time.


Article (75):
A-    It is prohibited to dispense any special medical prescription
      containing any narcotics or hallucinators unless such prescription
      has met the following terms:
      1- It should be executed on the form approved by the Minister and
         including the diagnosis for the relevant case to insure its using
         for treatment purposes.
      2- It has to show the physician’s full name clearly, address,
         signature and seal.
      3- It must state the patient full name and address, as well as the
         date of its execution.
                                     37



      4- The name of the medicine and the quantity to be dispensed
          should be written both in figures and words.
      5- It shall be completed in a non-erasable or non-changeable
          substance.
      6- The prescribed dosage must not exceed the dosage decided in
          any pharmacopoeia approved by the Minister.
      7- Not more than three days should have passed on the date of
          executing such prescription.
      8- Period of usage must not exceed three days.
B-    Taking into consideration the provisions of clause (8) of paragraph
      (A) of this article, the pharmacist in charge must not dispense any
      prescriptions containing any narcotics and hallucinators to cancer
      patients except when the following terms are fulfilled:-
      1- The quantity dispensed must not exceed the quantity necessary
          for the daily dosage prescribed by the treating physician and for
          the period of maximum ten days.
      2- Any special medical prescription should show the Jordanian
          patient’s national number as well as the passport number for
          non-Jordanian patients.
      3- The special medical prescription should enclose the medical
          report prepared by the treating physician, which includes the
          drug history of such patient.


Article (76):
In case any special medical prescription does not fulfill any of the
provisions specified in article (75) of this law, or in case the pharmacist is
doubtful of its authenticity, he then must not dispense the same and must
                                     38



Inform the concerned officials of this Directorate or health Directorate in
writing of this incident.


Article (77) :
When dispensing any special prescription for narcotics and hallucinators,
the pharmacist should comply with its contents and he shall not make any
deletion or alteration to those contents unless such deletion or alteration
has been made by the physician who executed such prescription and is
made under his signature on such amendment.


Article (78):
It is not permissible for any person who acquires in legal ways under the
provisions of the narcotics and halllucinators operative law, any of the
items shown in the narcotics and hallucinators lists appended to it, to
extract the active substance therefrom or change, manufacture of prepare
any of the items stated in the lists referred to hereabove unless the nature
of his work requires that and has obtained a licence from the Minister to
do so.


Article (79):
The percentage of any narcotics and hallucinators shall be calculated on
the basis of the equantional figure shown in the equantional table for
narcotics and hallucinators annexed to this law as well as any
amendments approved by the Minister upon the recommendations of the
permanent Bureau for Drugs Fighting of the United Nations, and shall be
published in the official gazette.
                                     39



Article (80):
The Minister shall issue any instructions necessary for determining the
following:
(a)- Quantity of any narcotics and hallucinators any licenced persons or
     entities can acquire.
(b)- Medical Prescriptions form for any narcotics, hallucinators and
     preparations as well as any forms for the purchase of those items.
(c)- Pharmaceutical institutions request forms for the import and export of
     any narcotics and hallucinators in addition to any licence forms
     required as per the international protocols of which the Kingdom is
     a part of.
(d)- Registers for any narcotics, hallucinators and preparations as well as
     their book and method of registration of any persons or entities
     licencend to deal in narcotics and hallucinators.

Article (81):
The pharmacist should keep the prescriptions for any narcotics and
hallucinators as well as the registers, books and document related thereto
in case those prescriptions are not dispensed in whole, and shall keep any
documents relevant to any part thereof being dispensed or sold, for at
least five years from the date of the last entry therein and shall thereafter
be destroyed in the presence of the inspector.


Article (82):
(a)- The pharmacist in charge who has a licence to acquire any narcotics
     and hallucinators shall prepare during the first ten days of January of
     each year, a statement of those items, including any details required
                                     40




    on the previous year, in addition to any quantities dispensed by him
    as well as any quantities of the same remaining in stock.
(b)- The Minister may request the organization of any data he may deem
    necessary for the control of these items.

Article (83):
The pharmacist have to maintain the narcotics and hallucinators in their
original packing and keep them in sealed lockers prepared for this
purpose, and shall be the sole keeper of keys for those lockers.

Article (84):
Any person who maintains a licence for acquirsition of any narcotics and
hullucinators has to keep control of their stock, and make regular
inventory of the same. He also has to inform the Directorate of any
change or shortage on their stock and of any breaking in their packing at
the time of his acquaintance of such event.


Article (85):
The Minister shall upon any recommendation of the Directorate,
constitute an investigation Committee to examine any violations
presented to him committed by any pharmaceutical institutions in
relevance to narcotics and hallucinators, and in case of any unjustified
shortage or surplus in the stock of those items, he shall refer both, the
owner of the pharmacy, and the pharmacist in charge to the competent
courts.

Article (86):
The Minister, if he was convinced that any physician is in breach of the
provisions of this law as he fills out prescription with any narcotics and
                                     41




hallucinators, whether he personally uses such items or gives access to
any other person to obtain the same for any reason other that for
treatment, may take the following actions:-
A-    Issue a circular to pharmacies prohibiting the dispensing of any
      medical prescriptions containing any narcotics and hallucinators
      given by any breaching physician and withdraw the prescription
      book kept by such physician.
B-    Cancel the licence granted to any breaching physician.

Article (87):
A-    Any drug factory or drugstore shall have the right to file a request
      for import of any narcotics and hallucinators and the Minster under
      a justifying decision, may approve or disapprove such request.
B-    It is not permissible to clear any narcotics and hallucinators
      without the issuance of an import licence under the form approved
      by the Minister, and the Customs authorities’ Officials shall carry
      such import licence when conducting the clearing on these items
      and return the same to the Ministry after endorsing the form.
C-    It is prohibited to deliver any narcotics and hallucinators except for
      the licenced person at any pharmaceutical institution which is
      authorized to import those items.
                                    42

                           Drug Information


Article (88):
Drug information shall be organized under the instructions of the Minister
issued for this purpose.


Article (89):
The drug companies and factories or their agents, may, under the
Minister’s approval, establish a scientific bureau for drug information to
be concerned with the registered drugs owned by any such company or
factory in pursuance of the terms and instructions made under article (88)
of this law, provided that such information should be restricted to
pharmacists without prejudice to the right of any non-pharmacists
working in this field before the provisions of this law would become
operative.


                                Penalties
Article (90) :
In case of any violation by the Pharmacist in charge of the provisions of
this law, the Minister or his deputy may, under the inspector’s report, take
the following actions:-
A-    Giving a notice to such pharmacist.
B-    Warning to such pharmacist.
C-    Refer the pharmacist to the Disciplinary Council of the
      Association.
D-    Refer the pharmacist to the Competent Court.
                                       43


Article (91)
Any pharmacist who commits the following violations has to be referred
to the Association’s Disciplinary Council and shall be punished by the
following penalties:-
A-    Payment of a fine in the sum of (250 – 500) Dinars in case he, in
      contravention of the provisions of this law, would:
      1-       Publishing and advertising on any drug or substance of
               a medicinal characteristic, or on any infants milk formula or
               their special formula and supplementary food without the
               prior consent of both the Minister and the Association.
      2-       Did not close the pharmacy during his absence in case he
               could not dispense the drugs, which is expendable by
               a physician prescription.
      3-       Allow, any other person to sell those drugs contradicting the
               provisions of article (70) of this law.
      4-       Conclude any agreement contradicting to the provisions of
               paragraph (a) of article (36) of this law.
      5-       Display in his pharmacy any expired drugs where the
               Ministry shall have the right to seize those drugs when
               discovered.
      6-       Fail to observe the prices determined for any drugs,
               preparation and other items priced by the Ministry.
      7-       Sell or venture to sell any medical free sample or possess the
               same contradicting the provisions of article (33 & 53) of this
               law.
      8-       Illicitly or for monopoly refrain from dispensing or selling
               any drug or any other items he is licenced for, if such drugs
               or items are available in stock.
                                     44

     9-      Force the pharmacy or any other entity, which maintains a
             licence for drug sale, to purchase any specified quantity of
             any drugs, infants milk formula or their special formula and
             supplementary food.


B-   Payment of a fine for the sum of (100 – 250) Dinars in case he, has
     contradicted the provisions of this law, in the under-mentioned
     matters:-
     1- Venture, directly or through brokers, to procure customers to his
          pharmacy.
     2- Dispense any non-dispensable drug except under a medical
          prescription.
     3- Sell any drug or preparation priced by the Ministry without
          attaching to it the price tag specified by the Association.
     4- Fail to follow the instructions relevant to daily duty hours and
          time of closure of pharmaceutical institutions as well as any
          daily shifts and official holidays, contrary to the regulatory
          directions effected under the provisions of this law.
     5- Fail to abide by the order to close the public pharmacy on its
          weekly holiday.
     6- Sell any drugs to any physician who has no authorization to
          purchase the same.
     7- Grant in his capacity as the owner of any drugstore and agent
          the right for the drug manufacturing companies, to deliver any
          drugs to any other store without notifying the Ministry of any
          contracts he may have had concluded to this end.
     8- Fail to advise the Ministry of any contracts he may have had
          signed with the local manufacturing company.
                                    45



C-    Payment of a fine for the sum of (50 – 100) Dinars in case he has
      contradicted to the provisions of this, would:-
      1- Fail to observe any regulation relevant to the technical
          specification of the pharmaceutical institution as well as the
          terms for licencing the same affected under the provisions of
          this law.
      2- Fail, when abscent, to authorize in writing another pharmacist
          to assume the technical responsibility for the pharmacy, and to
          inform both the Ministry and the Association of such incident.
      3- Violate the provisions of article (29) of this law.
      4- Breach the provisions of paragraph (a) of article (30) of this
          law.


Article (92):
A-    Any pharmacist involved in the following actions shall pay a fine
      not less that (1000) Dinars and not exceeding (3000) Dinars:-
      1- If he joins another pharmacist in the ownership of a
          pharmaceutical institution, where in such case his licence will
          be cancelled.
      2- If he purchases any drugs from any entity unauthorized to sell
          the same, or when he sells any expired, damaged or smuggled
          drugs, where such drugs shall be seized when discovered.
      3- If he sells any drugs or items owned by any official and non-
          official entity without a licence to do so, whereby such drugs
          or items shall be seized and assigned to the Ministry.
                                    46

      4- If he sells any drugs to any drugstore unauthorized to purchase
          the same.
      5- If he dispenses any drugs from a private pharmacy to non-
          authorized persons.
      6- If he breaches the provisions of article (55) of this law.
      7- Should he possess, sell or distribute any drugs without
          a licence to do so, whereby such drugs shall be seized when
          discovered in his possession.
      8- When he commits any adulteration in preparing any drug or
          substance he has licence for, whereby such drugs or substances
          shall be seized when discovered in his possession.
B-    The same penalty specified in paragraph (a) of this article shall be
      applicable to any pharmacist who does not use, contrary to the
      provisions of this law, the licence granted to him for opening a
      pharmaceutical institution or when the real owner of the
      pharmaceutical institution has been confirmed to be other than the
      holder of the licence granted by the Minister, whereby such licence
      shall be revoked.


Article (93):
A penalty of not less than one month and not more than six months of
imprisonment, or payment of a fine not less than (1000) dinars and not
more than (3000) dinars or both penalties shall be applicable to any
person who would:-
A–    Impersonate a pharmacist or fraudulently claim himself, by any
      mean, to be a pharmacist.
B-    Illegally possess, sell or distribute any drugs, whereby such drugs
      shall be seized when discovered.
                                   47

C-   Sell any drugs to any unlicenced entity.
D-   Obtain a licence for opening or purchasing a pharmaceutical
     institution, whereby, such being the case, this licence shall be
     cancelled.
E-   Sell or dispense any substance as a medicine when such substance
     is otherwise, whereby such substance shall be seized when
     discovered.
F-   publish an advertisement for any drug or substance claimed to have
     the nature of a medicine or for any infants’ milk formula or their
     special formula and supplementary food without a prior approval
     from the Minister and the Association.
G-   Possess, sell or distribute any drugs, which had been confirmed to
     be illegally imported, whereby such drugs shall be seized when
     discovered.
H-   sell any drugs or items, which belongs to any official or non-
     official entity, without being licenced to do so, whereby such drugs
     or items shall be seized when discovered.
I-   Open a pharmaceutical institution without a licence, whereby such
     institution shall be closed when apprehended.
J-   Sell any drug contrary to the terms specified in paragraph (b) and
     clause (2) of paragraph (C) of article (12) of this law.
K-   Trade in any drugs or other items without registering, pricing or
     licensing the same.
L-   Import any drugs, without the prior approval of the Minister, in his
     capacity as an agent for the manufacturing company, from any
     locations other than the approved ones, or change the country of
     origin for any registered drug without the Minister’s agreement.
                                      48

Article (94) :
A – Any factory which commits any of the under-detailed action contrary
      to the provisions of this law shall be subject to following
      punishments:-


      1- Payment of a fine not less than (5000) Dinars and not more than
          (10,000) Dinars in case he does not observe the guidelines
          approved by the Minister as well as the bylaw issued under
          article (41) of this law.
      2- Payment of a fine not less than (1000) Dinars and not more than
          (3000) Dinars in any of the following cases:-

            If he dose not appoint a technical manager for the factory.
            If the factory acts contrary to the provisions of paragraph (a)
             of article (42) of this law.
B–    The Minister may take any of the acitons shown hereunder in case
      of any breach by the factory of any of the terms and requirements
      specified in this law.
      1- Cancel the licence.
      2- Close the factory.
      3- Confiscate the drugs.


Article (95):
The following persons shall be punishable by payment of a fine of at least
(250) dinars and not more than (500) dinars.
A–    Any person who obtains a Degree in Pharmacology and practices
      such profession without being licenced to do so.
                                    49

B-    Any physician who violates the provisions of article (37) of this
      law, and when such action is repeated by such physician his licence
      for drug sale shall be cancelled.


Article (96):
A - A punishment by twice the minimum limit for the penalties provided
      for in articles (91, 92, 93, 94, & 95) shall be applicable in case of a
      second violation for the first time, and by twice the maximum limit
      for such penalty in case of repeating the same violation for several
      times under the provisions of paragraph (b) of article (95) of this
      law.
B-    For the purpose of this law, committing of the same contravention
      during the three years following the time of committing the first
      contravention shall be deemed as being repeated.


Article (97):
Any person who commits, contrary to the provisions of this law, any
actions not provided for as such, shall be punished by payment of a fine
not exceeding (200) Dinars.


Article (98):
The Ministry, by a justifying recommendation from the director, may
close any public or private pharmacy or drugstore wherein a violation had
been committed, or he may suspend the breaching pharmacist from
practicing this profession until such violation has been removed or an
absolute judgment has been issued by the court to that respect.
                                     50



Article (99):
Nothing in this law shall prevent the application of any greater
punishment specified in any other law.


                          General Provisions
Article (100):
A–    The Minister may assign any of his powers provided for in this law
      to the Secretary General or the director.
B-    The director may assign any of his powers provided for this law to
      any official of the Directorate.
C-    It is conditional that the authorization specified in paragraphs (a, b)
      of this article should be made in writing and specific.


Article (101):
A-    The Ministry shall collect fees on the following:-
      1- Licencing any pharmaceutical institution.
      2- Licencing any pharmacist to practice such profession.
      3- Endorsing the approval of manufacturing sites.
      4- Approving the registration of any drug or items specified in
         article (3) of this law.
      5- Applying for renewing the registration of any drugs and for
         contesting such registration.
      6- Objecting to the pricing of any drugs or other items.
B–    The amount of fees referred to in paragraph (a) of this article as
      well as their percentages and methods of collection shall be defined
      under certain bylaws issued for this purpose.
                                     51



Article (102):
The Minister, by a recommendation from the Association Council, shall
issue the regulatory instructions related to the following matters:-
A-    Definition of daily duty hours and closing time for any
      pharmaceutical institution within the Kingdom or any area within
      the Kingdom, and control of the pharmaceutical institution’s
      abidance by the determined duty hours.
B-    The bases for the provision of the pharmaceutical service for the
      public at the public pharmacies at night and on official holidays.
C-    The annual leaves for the pharmaceutical institutions.


Article (103):
The Minister has to issue the instructions required for the application of
the provisions of this law, and publish the same together with those
issued by the Higher Comission in the official gazette.


Article (104):
The Ministers Council shall issue any regulations necessary for the
execution of the provisions of this law inclusive of :-
A–    The technical specifications and licencing terms for the
      pharmaceutical institutions.
B-    Examination of Drugs.
C-    Gratuities granted to the members of the Higher Committee and
      any other Committees, as well as the secretaries of those
      Committees, with the exclusion of officials of Ministries’ and
      government unless their meetings are held after official duty hours.
                                     52



Article (105):
The pharmacology profession practice law No. (43) for the year 1972 and
the amendments thereto shall be revoked, provided that the regulations
and instructions issued thereunder shall remain operative until they are
substituted by others in pursuance of the provisions of this law within
maximum of two years from the date when those provisions would come
into force.


Article (106):
The prime Minister as well as the Ministers shall be responsible for the
application of the provisions of this law.


                                                   (Signed)
Executed on: 18/9/2001                       Faisal Bin Al-Hussein
                                                 53



  Deputy Prime Minister &              Deputy Prime Minister            Prime Minister & Minster of
      Minister of Justice               & Minister of Interior                    Defence
      Faris Al-Nabulsi                   Dr. Awad Khlaifat                Eng. Ali Abu Al-Ragheb


   State Minister for Adm.         Minister of Municipal, Rural &        Deputy Prime Minister &
        Development                    Environmental Affairs            Minister of Economic Affairs
   Dr. Moh’d Al-Thnaibat             Dr. Abdul Razzaq Tbaishat            Dr. Moh’d Al-Haliaiqah
    Minister of Tourism &                Minister of Labour                 Minister of Finance
         Antiquities                        Eid Al-Fayez                     Dr. Micheal Marto
     Dr. Taleb Al-Rifa’i
Minister of Foreign Affairs &       Minister of Industry & Trade            Minister of Culture
Acting Minister of Information              Wasef A’azar               Mahmoud Al-Kayed Al-Hiyasat
   Abdul Elah al-Khateeb
        State Minister           Minister of Education & Minister of         Minister of Post &
  Abdul Raheem Al-Okour             Higher Education & Scientific            Communications
                                              Research                   Dr. Fawaz Hatem Al-Z’ubi
                                         Dr. Khalid Touqan
      Minister of Social                Minister of Planning            Minister of Youth & Sports
        Development                        Jawad Hadeed                Ma’amoun Moh’d Nour Eddin
      Tamam Al-Ghoul
 Minister of Awqaf, Islamic           Minister for legal Affairs             Minister of Health
   Affairs and Sanctuaries           Dr. Abed Al-Ashakhanbeh                Dr. Faleh Al-Naser
     Dr. Ahmad Hlaiyel
Minister of Water & Irrigation      Minister of Power & Mineral               Minister of State
     Dr. Hazem Al-Naser                 Resources and Acting              Mousa Khalaf Al-Ma’ani
                                 Minister of Public Works & Housing
                                   Eng. “Moh’d Ali “Al-Bataineh
   Minister of Agriculture                                                 Minister of Transport
Dr. Mahmout Ayed al-Dwairi                                                   Nader Al-Dahabi

				
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