YOUNG PHARMACISTS SCHOLARS 2021

GUIDELINES FOR REGISTRATION OF PHARMACEUTICAL PREMISES IN NIGERIA

A PRESENTATION DELIVERED BY
PHARM SAIDU LAWAL BURJI TO
MEMBERS OF YOUNG
PHARMACISTS SCHOLARS
2/28/2021
About the presentation

The Young Pharmacists Scholars (YPS) is a mentoring platform providing support and

guidance regarding research and career progression among young pharmacists in

Nigeria. The platform has Nigerians studying in universities across the continents

(America, Asia, Africa, Australia and Europe). As part of the mentoring activities, the

platform has conducted and published many research; and two national workshop in

collaboration with Bayero University Kano. Also, the platform conducts a weekly

presentation on any career or research-related topic. The current presentation on

financial intelligence is part of the weekly presentation delivered by Pharm Sa'idu L Burji.

Burji is one of the active YPS scholar with vast experience and years of practice in

pharmacy administration and regulation.

Thank you!
INTRODUCTION

We have fifteen health regulatory bodies in Nigeria 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 function is the registration

and licensing of pharmaceutical premises in Nigeria. Pharmaceutical premises are places

where drug activities are taking place.

Which includes :

• Manufacturing

• Storage

• Dispensing

And many more

CATEGORIES OF PHARMACEUTICAL PREMISES IN NIGERIA

1. Retail Pharmacy

2. Wholesale/ Distributions

3. Importation

• Category C ( Less than 10 products

• Category B ( 10- 19 products)

• Category A (20 or more products

4. SDDC

5. Mega distribution

6. Manufacturing
 • Manufacturing ( 1 product)

• Manufacturing (2 products)

• Manufacturing ( 3 or more)

7. Multinational

8. Patent and proprietary medicine stores.

9. 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 centre (MWC) and wholesale public centre (PWC)

6. 300 m2 for a zonal public wholesale center (ZPWC)

7. 70 m2 per shops within CWC of not less than 100 shops space

CAC REGISTRATION

All pharmaceutical premises except PPMV should have at least one pharmacist as a

board of director 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. Remita receipts

4. Letter of resignation from previous employment (if applicable)

5. Letter of appointments as superintendent pharmacist

6. A legal agreement between superintendent pharmacist and 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 managing director that all pharmaceutical activities will be

under control and direct supervision of 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

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 propose pharmacy

premises will be registered. It's to know if other registered premises exist near the premise

you want to register. Once you get location approval from PCN, you can continue building

or renovation your proposed premise. But you have to develop and register your premise

within six months of getting location approval from PCN; if not, the approval 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 final inspection before registration. They will write an inspection

report based on facilities and staff you have on your premise

REGISTRATION FEES FOR PHARMACEUTICAL

Type of facility Location Premises inspection (N)* Registration fees

approval (N)
New Final 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 20,000
A. 20 or more products 300,000 300,000 500,000 350,000
B. 10- 19 products 150,000 150,000 350,000 200,000
C. < 10 products 100,000 100,000 200,000 150,000
Manufacturing

One-line 100,000 100,000 100,000 100,000 100,000

Two-line 200,000 200,000 150,000
200,000 200,000
Three lines 300,000 300,000 300,000
300,000 250,000
PPMV 5,000 5,000 5,000 5,000 5,000
MDDC 500,000 500,000
SDDC. 200,000 1,000,000
CWC 500,000

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

PHARMACISTS LICENSE REGISTRATION

The registration fees for pharmacists is 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
Pharmacist registered outside Nigeria (US) 100

OFFENSES AND FINES

1. Absence of superintendent pharmacist.

• First visit - compliance directives

• Second visit - compliance directives.

• Third visit - N20,000 (fine)

2. The absence of a pharmacist or an attendant having access to control drugs will attract

a payment of N20,000 fine

3. Absence of a poison register in the premises a fine of N10,000

4. Inadequate reference Books relevant to the area of practice. 1st visit - compliance

directives, and N5,000 for the second visit.

5. 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)

Thank you

For more information on registration of pharmacist and pharmaceutical premises, please contact PCN
office near you.
QUESTIONS AND ANSWERS

Is the payment of association dues LEGALLY part of the registration procedure?

No, Sir, it is not.

Can someone register without paying the dues?

Because PSN Chairman and ACPN Chairman are part of the inspection committee, and

they must sign as inspectors on the inspection report before sending it to Abuja for

approval, that's why they are using their power to make payments of associations dues

mandatory before signing. But you can register without paying the association dues,

depending on the state. It's not legally mandatory.

What will happen if a pharmacist wants to open a retail premise where there is no

pharmacy premise, but there are existing patent stores with the proximity of fewer than

200m to the premise he/she want to open?

Preference would be given to the retail Pharmacy

I learned that there is a high-level effort to reverse the existing law, which prohibits

working pharmacists to open their premise. What is the update in that regard?

The new law is not yet assented by the President commander in chief

Is PCN still Pharmacist Council or Pharmacy Council?

It is still the Pharmacists Council of Nigeria. We will only be the Pharmacy council of

Nigeria when the president signs the new PCN bill.

Thank you, Dr Burji, for this presentation.My question, a PhD student who is away for four

years and did not renew his licence. Since he actually didn't use the license for sure.
When renewing his license for this year, will he pay for only this year, or he will be

penalized?

He will pay for all the years plus penalties.

11 years plus, Sir. And he missed three years

50% of the license fee was added effective from 2020; 2018 4,000 ( 2000 license fee,

2000 penalties); 2019 4,000 ( 2000 license fee, 2000 penalties); 2020- 6,000 ( 3000

license fee, 3000 penalties); 2021 - 3000 license fee only if you register before the end of

March.

But if you register after March, you will pay 50% additional as penalties for late registration

THANK YOU ALL FOR LISTENING.

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+2348032391159