ZAMBIA MEDICINES REGULATORY AUTHORITY …

1 ZAMBIA MEDICINES REGULATORY AUTHORITY . GUIDELINES FOR ESTABLISHMENT OF A PHARMACEUTICAL RETAIL. BUSINESS. PART A: PARTICULARS OF THE PREMISES. 1. The name of the applicant should be written in full 2. The physical and postal address of the applicant should be given in full (a) Plot number (b) Postal Box number (c) Name of Street/Road (d) Town/City (e) Telephone/fax number (f) Mobile Phone number (g) E-mail address 3. Name(s) occupation and physical address of Proprietor(s)/Directors should be given in full 4. The particulars of the Pharmacist should be given in full B: PERSONNEL.

2 1. The name of the full-time pharmacist should be given in full and should include the Health Professions Council of ZAMBIA (HPCZ) Full Registration Certificate and valid Practitioners Annual Practising Certificate. 2. The availability of a full-time pharmacy technologist(s) in the premises where a full- time pharmacist has been engaged is considered optional. 3. The particulars and responsibilities of support staff should be provided in full. ZAMBIA MEDICINES REGULATORY AUTHORITY , P. O. Box 31890, Lusaka, ZAMBIA , Tel: +260 211 220.

3 429, Telefax: +260 211 238458, E-mail: C: DETAILS OF INSPECTION/OBSERVATIONS. 1. The following certificates should be available: (a) Certificate of Incorporation issued by PACRA, (b) Certificate of registration (if pharmacist is one of the directors and will be pharmacist in charge), (c) Certificate of Payment: Business Levy issued by the local AUTHORITY , (d) Fire Safety Certificate issued by the local AUTHORITY 2. Premises, Facilities and Equipment: (a) The cleanliness, state of repair, tidiness, identity of the premises and the surrounding should be satisfactory.

4 (b) The safety and security of the premises: (i) Burglar bars on doors and windows should be adequate (ii) Fire extinguishers should be recently serviced, next date of service should be indicated on the sticker and the extinguishers should be placed at strategic positions. SOPS on how to operate the extinguishers should be available. (iii) Day and night security guards should be available and the name and contract agreement between the company and the hired security company should be in place. (iv) An alarm system is an added advantage (c) Internal arrangements (i) Relative partitioning of the premises The premises should be demarcated into main/front shop, dispensary, storeroom and toilet(s).

5 The size of the premises should about 100 Square metres. A copy of the flow plan should be attached. (ii) State of the Premises The artificial and Natural ventilation should be satisfactory the air conditioner should be well functioning and adequate windows and air vents should be available. The natural and artificial lighting should be satisfactory availability of adequate windows electric/solar light. The floor should smooth and easily washable. The walls should clean with coat of paint. The state of the roof/ceiling should be intact and not leaking (d) Storage facilities The following should be available: ZAMBIA MEDICINES REGULATORY AUTHORITY , P.

6 O. Box 31890, Lusaka, ZAMBIA , Tel: +260 211 220. 429, Telefax: +260 211 238458, E-mail: (i) Refrigerator, (ii) Lockable cupboard, (iii) Adequate shelving. (e) Dispensary (i) The following compounding equipment should be available: - distilled water, measuring cylinder, counting tray, balance and mortar and pestle. (ii) The following packaging and labelling material should be available: - Self-adhesive labels, self-sealing plastic packs and any other. (iii) The following facilities for safe storage and distribution of Controlled or Narcotics drugs and Psychotropic substances drugs should be available: Dangerous drugs register and lockable cupboard.

7 (f) Water supply, sanitation and toilets facilities The following should be available: - running water, water closet toilet(s), hand wash basin in the toilet, antiseptic soap and pedal waste bins. (g) Record keeping facilities The following should be available: - Computer, Bin cards, Prescription Files or books, Expiry products books and Receipt/issue books. (h) Category of MEDICINES to be dispensed should be stated as follows: (i) Prescription Only MEDICINES (POM). (ii) Pharmacy Sale (P). (iii) Veterinary MEDICINES (iv) Herbal MEDICINES (v) Narcotics Drugs and Psychotropic substances (i) The following reference materials should be available:- (i) ZAMBIA National Formulary (ZNF ) - recent edition is preferred (ii) British National Formulary (BNF) - recent edition is preferred (iii) Statutes: MEDICINES and Allied Substances Act ( ) of 2013.

8 Dangerous Drugs Act, Cap 95. Narcotic Psychotropic Substances Act, Cap 96. Health Professions Act ( ) of 2009. (iv) Standards of Pharmaceutical Practice (v) Martindale - recent edition is preferred (vi) British Pharmacopoeia - recent edition is preferred ZAMBIA MEDICINES REGULATORY AUTHORITY , P. O. Box 31890, Lusaka, ZAMBIA , Tel: +260 211 220. 429, Telefax: +260 211 238458, E-mail: (j) Pharmaceutical personnel should aware of the relevant statutes/laws (k) Fees:- Application for a grant of licence for premises to be operated as a retail pharmacy = 5, 000 fees (1 fee Unit= K180) = Inspection for grant of licence for premises to be operated as a retail Pharmacy = 4,223 fees Units (1 fee Unit= K180) = Total fees to be paid = + = K1, ---------------------------------------- ---------------------------------------- ------------------------------ ZAMBIA MEDICINES REGULATORY AUTHORITY , P.

9 O. Box 31890, Lusaka, ZAMBIA , Tel: +260 211 220. 429, Telefax: +260 211 238458, E-mail.