MINIMUM REQUIREMENTS FOR PRESCRIPTION WHOLESALE PHARMCY
A. DOCUMENTS TO BE SUBMITTED
1. A completed, filled, signed and stamped application form for registration
of premises
2. Premises layout and sketch
3. A copy of taxpayer identification number issued by MRA
4. Copy of certificate of registration of the pharmacist with PMRA.
5. PMRA copy of valid practicing certificate of the pharmacist
6. Signed contract or commitment letter from the full time personnel
7. A copy of business registration from Registrar of businesses
8. A copy of payment receipt from PMRA
B. DOCUMENTS TO BE SUBMITTED
1. The premises should be constructed and maintained so as to protect the
medicines from weather, ground seepage and the entrance and harbouring of
vermin and pests.
2. The premises should be maintained in a good state of repair. The condition of
the buildings should be reviewed regularly, and repairs effected where
necessary. Special care should be exercised to ensure the building; repair or
maintenance operations do not hazard the products.
3. The premises should provide sufficient space to suit the operations to be
carried out, allow efficient flow of work and permit effective communication
and supervision.
4. Floors and walls should be free from cracks and made of impervious
materials for easy cleaning.
5. The building should be effectively lit and properly ventilated.
6. The building should be adequately secure with no access to unauthorized
persons.
7. Minimum total floor space of 60 square meters with one side not less than 5
meters and minimum height of 2.5 meters from floor to the ceiling
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8. Minimum continuous floor space of 30 square meters for the sales and
administrative area. Within the 30 square meters, there shall be a pharmacist
office or administrative office with a full view of the sales area for the
responsible pharmacist and records shall be maintained in this office or area.
9. Toilets should be well ventilated and should not open directly to the
wholesale pharmacy.
10. The store should have adequate shelving for medicines.
11. Medicines and other supplies should be arranged on shelves in an orderly
manner off the floor.
12. The store should be provided with temperature control mechanisms like fans
and or air conditioners.
13. Storeroom should be provided with fire fighting equipment (fire extinguisher,
steel bucket of sand).
14. Segregated storage should be provided for rejected, expired and unusable
returns.
15. No unregistered medicines should be kept in stock or sold.
16. Van selling should be restricted to items on general sales list
C. EQUIPMENT AND REFERENCE BOOKS
1. Pallets and elevators where necessary, can be provided for easy storage of
bulky medical supplies.
2. Current editions of publications must be made available-
2.1 British National Formulary.
2.2 Malawi Standard Treatment Guidelines.
2.3 PMRA Act No. 9 of 2019.
2.4 PMRA Regulations
2.5 Good Distribution Practise guidelines
D. RECORDS
1. Records of sources of allied substances, receipt of goods should be available
on file
2. Records of stock movement and balances available for each allied substances
e.g. tally cards or bin cards
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E. HUMAN RESOURCES
1. Prescription wholesale pharmacy operations shall be carried out under the
direct full time supervisor of a pharmacist who shall be responsible for the
funding, procurement, clearing, receipting, storage, distribution and
documentation relating to medicinal products.
2. The services of a locum pharmacist may be used for a period not exceeding 3
months and upon approval granted by the Authority
F. STORAGE AND SECURITY
The storage areas for pharmaceutical products and allied substances shall
be well covered and off the floor in an area:
a) that are secured and with adequate space
b) that is laid out to allow clear separation of different materials and
products to minimize risks of mix up
c) with access to materials and goods restricted to authorised personnel
d) that temperature sensitive products shall be kept in a temperature
controlled facility
e) with separate areas for recalled, expired or rejected and shall be kept
under lock and key.
f) with special and segregated areas for storage of flammable and
explosive substances, highly toxic substances.
g) with space for storage of cleaning materials
h) Burglar bars installed
