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ZAMBIA Drug Registration Requirements in

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					            Drug Registration Requirements in Zambia

Registration procedure for drugs and Pharmaceuticals in Zambia:

The Pharmacy and Poisons Board, under the Ministry of Health of the Government
of the Republic of Zambia conducts the registration procedure for Drugs and
Pharmaceuticals in Zambia. The requirements are that a written application, a
sample of which is enclosed at annexure I has to be submitted to the Registrar
with the dossier. The procedure and the requirements are given in the annexure
II.
- A registration fee of ZMK 759,060 or its US$ equivalent (1US$=Zambian
Kwacha 4,700 as on 30.9.2003) is payable per product with a minimum of two
samples.
- The Pharmacy and Poisons Board of Zambia is also the Main regulatory
authority.

          PHARMACY & POISONS BOARD (MINISTRY OF HEALTH)

1. PRODUCT REGISTRATION REQUIREMNTS IN ZAMBIA -STATUTORY
INSTRUMENT NO. 47 OF 1993.

The applicant is required to submit an application, a sample(s) and dossiers(s) for
each product which should contain the following information:-
(a) the name and address of the applicant in full
(b) the name and address of the medicine
(c) the dosage form of the medicine
(d) the active constituents of the medicine
(e) the indications of the medicines and method of use
(f) the centra-indications, warnings and precautions of the medicine
(g) the composition (ingredients of the medicine and the reasons for their
inclusion of if non-active as well as their specifications such as BP, USP etc)
(h) the shelf-life (this should be supported bv stabilitv studies data)
(i) the containers and packaging (should give full description i.e technical
specifications)
(j) the labeling should be part of the dossier and should contain the following
information:
- the name of the medicine
- the pharmacological properties
- the names and quantities of active ingredients
- the quantity of medicines i.e. 100ml, 1000 tablets etc.
- the directions for use
- the contra-indications, warnings and precautions
- the storage instructions
- the manufacture date
- the batch number
- the expiry date
- the license number
- the name and address of the manufacturer
- the method of sale, e.g. General sale, Pharmacy sale only or Prescription sale
only.

- (Comment: - where the space on the label may not be adequate to
accommodate all the necessary labeling information above, it may be included in
the package insert)

(k) the distributor's name and address
(1) an original copy of the World Health Organization (WHO) pharmaceutical
certificate of quality and free sale certificate addressed specifically to Zambia
(m) the name and designation of the person signing the application
(n) where the medicine is to be imported for Zambia for the first time:-
- the chemistry of the medicine
- the pharmacological data
- the toxicological data
- the teratology
- the clinical studies
- the countries in which the sale of the medicine has been authorized.
(o) the final product specifications and certificate of analysis.
(p) the certificates of analysis of all the raw materials used.

2. PRODUCT REGISTRATION FEES FOR A PRODUCT TO BE IMPORTED INTO
ZAMBIA AS A FINISHED PRODUCT - STATUTORY INSTRUMENT NO. 111 OF 1999.

= 4217 fee units equivalent to ZMK 759,060.00 (1fee unit = K180)

(1US$=Kwacha 4,700 as on 30.9.2003)

				
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posted:8/18/2012
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