Guideline for Registration of Pharmaceutical Premises in Nigeria

Nigeria has fifteen health regulatory bodies under the federal Ministry of Health. Each regulatory body is responsible for regulating a profession. The Pharmacists Council of Nigeria (PCN) is one of the regulatory agencies, and it's responsible for regulating the pharmacy profession in all aspects and ramifications. One of its functions is registering and licensing pharmaceutical premises in Nigeria. Pharmaceutical premises are places where drug activities take place.

Which includes:

• Manufacturing
• Storage
• Dispensing And many more

CATEGORIES OF PHARMACEUTICAL PREMISES IN NIGERIA

• Retail Pharmacy
• Wholesale/ Distributions
• Importation

1. Category C (Less than 10 products)
2. Category B (10- 19 products)
3. Category A (20 or more products)

• SDDC
• Mega distribution
• Manufacturing

1. Manufacturing (1 product)
2. Manufacturing (2 products)
3. Manufacturing ( 3 or more)

• Multinational
• Patent and proprietary medicine stores.
• Hospital Pharmacy

GUIDELINES INTERM OF LOCATIONS, SIZES AND STRUCTURES OF PREMISES

All pharmaceutical premises should be located 200 meters from other pharmaceutical premises. Patent medicine stores should be located 400 meters from pharmaceutical premises. Patent medicine stores should be 200 meters from another patent medicine stores

Dimensions

1. 15 m2 for patent medicine shops (PMVs)
2. 30 m2 for retail pharmacy
3. 70 m2 Wholesale
4. 70 m2 Distributor /Importation
5. 1,000 m2 mega drug distribution center (MWC) and wholesale public center (PWC)
6. 300 m2 for a zonal public wholesale center (ZPWC)
7. 70 m2 per shop within CWC of not less than 100 shops space

CAC Registration

All pharmaceutical premises except PPMV should have at least one pharmacist on the board of directors for the company. Only a premise owned by a registered pharmacist or a group of pharmacists or a Pharmacist and family members like father, mother, son, daughter or brothers can be registered as retail premises. The pharmacist director should have the largest share in the company (for retail).

DOCUMENTS REQUIRED

Accompanying documents included:

1. Application letter to register the premises
2. Current Annual license for superintendent pharmacist
3. Remittance receipts
4. Letter of resignation from previous employment (if applicable)
5. Letter of appointment as superintendent Pharmacist
6. A legal agreement between the superintendent pharmacist and the owner of the premises
7. CAC Certificate of the company
8. Articles and Memorandum of Associations
9. Particulars of directors
10. NYSC certificate
11. Letter of undertaking by a pharmacist that he has only one full-time job
12. Letter of undertaking by the managing director that all pharmaceutical activities will be under control and direct supervision of the superintendent pharmacist

Note: 5,6 and 12 are not required, if you are a pharmacist, you own the company, and you are the superintendent pharmacist

ALSO READ: Common Mistakes and How Pharmacists Can Help Prevent Them?

For manufacturing, in addition to the above documents, the applicant is required to forward."

1. List of products to be manufactured 
2. List of equipment for production and quality control
3. List and sources of supply for raw materials
4. Standard operating procedures (SOP)
5. Factory layout
6. Environmental impact assessment report
7. Productions flow chart
8. Water sources and treatment facilities
9. Water analysis report
10. List of staff showing qualifications and job description
11. Organogram
12. Disposal of poison books

" The Superintendent Pharmacist is responsible for the day-to-day activities in the premise and responsible for the professional aspects of the premise "

TYPE OF INSPECTIONS BEFORE AND AFTER OPENING A PHARMACY

Location approval inspection

It can be conducted on an existing structure or land where the proposed pharmacy premises will be registered. It's to know if other registered premises exist near the premises you want to register. Once you get location approval from PCN, you can continue building or renovating your proposed premise. But you have to develop and register your belief within six months of getting location approval from PCN; if not, the license can be revoked and given to another person. After location approval, you are expected to renovate or develop your structure in line with guidelines given to you by inspectors during location approval.

PCN will visit again for a final inspection before registration. They will write an inspection report based on the facilities and staff you have on your premises.

REGISTRATION FEES FOR PHARMACEUTICAL

Type of facility	Location approval (N)	Premises inspection (N)*		New	Renewal
		New	Renewal
Retail	15, 000	15,000	15,000	15,000	7,500
Wholesale/ Distributions	20,000	100,000	100,000	150,000	100,000
Importation A. 20 or more products B. 10- 19 products C. < 10 products	20,000	300,000 150,000 100,000	300,000 150,000 100,000	500,000 350,000 200,000	350,000 200,000 150,000
Manufacturing One-line Two-line Three lines	100,000 200,000 300,000	100,000 200,000 300,000	100,000 200,000 250,000	100,000 200,000 300,000	100,000 150,000 300,000
PPMV	5000	5000	5000	5,000	5,000
MDDC		500,000	500,000
SDDC.		200,000	1,000,000
CWC	500,000

MDDC Is a mega drug distribution center, and SDDC is a State drug distribution center; * Inspection fees are payable in alternate years

PHARMACISTS LICENSE REGISTRATION

The registration fees for pharmacists are based on the years of practice (post-induction)

Years of practice	Fees (N)
NYSC / 0 to 9 years	1,500
10 to 14 years	3,000
15 to 49 years	4,500
50 years above	free
Pharmacists registered outside of Nigeria	(US) 100

OFFENSES AND FINES

• Absence of superintendent pharmacist.

1. First visit - compliance directives
2. Second visit - compliance directives.
3. Third visit - N20,000 (fine)

• The absence of a pharmacist or an attendant having access to control drugs will attract a payment of N20,000 fine
• Absence of a poison register in the premises a fine of N10,000
• Inadequate reference Books relevant to the area of practice. 1st visit - compliance directives, and N5,000 for the second visit.
• Failure to display pharmacist and premises licenses - 1st visit - compliance directives 2nd visit N5,000 for pharmacy and pharmacist, N2, 500 for PPMV, N 1000, 000 for a manufacturer, distributor (N50,000), PWC (N30,000), CWC (N200,000), MWC (N100,000), NGO Warehouse (N50,000), importers (N100,000), Wholesale (N20,000), retail (N5,000).