The Regulatory Requirements For Starting A Pharmaceutical Business In Nigeria

INTRODUCTION

A Pharmaceutical business in Nigeria can either operate as a retail pharmacy outlet, a community pharmacy, a hospital pharmacy, or an online pharmacy. Considering the growing demand for drugs and medicine to meet the needs of patients and consumers, it is important to understand the laws regulating the operation of pharmaceutical businesses in Nigeria. Individuals who operate pharmaceutical businesses in Nigeria must be well guided by the laid-down laws concerning registration, licensing, and operation.

The registration and operation of pharmaceutical businesses in Nigeria are regulated by the Corporate Affairs Commission, National Agency for Food and Drug Administration Control, Pharmacists Council of Nigeria (PCN) under the Companies and Allied Matters Act (CAMA)¹, National Agency for Food and Drug Administration Control Act², Pharmacists Council of Nigeria (PCN) Act³. This article seeks to highlight the regulatory requirements for theregistration of a pharmaceutical business in Nigeria.

REGISTRATION AT CORPORATE AFFAIRS COMMISSION (CAC)

As a first vital step, the Companies and Allied Matters Act, 2020 (CAMA) requires any entity seeking to do business in Nigeria to be registered by Corporate Affairs Commission (CAC). An individual seeking to operate a pharmacy in Nigeria has the option of registering either as a sole proprietorship⁴, a limited partnership⁵, a limited liability partnership⁶ or a private limited liability company.⁷ The individual is required to make an application to the Corporate Affairs Commission (CAC) in the prescribed form accompanied with the necessary documents provided by the Companies and Allied Matters Act, 2020 (CAMA).

ROLE OF NAFDAC

The National Agency for Food and Drug Administration Control Act established the National Agency for Food and Drug Administration Control ("NAFDAC") whose functions as it relates to pharmaceutical businesses, include the following:⁸

1. To regulate and control the importation, exportation, manufacture, advertisement, distribution, sale, and use of food, drugs, cosmetics, medical devices, bottled water, Chemicals, and detergents (Regulated Products)
2. To compile standard specifications regulations and guidelines for the production, importation, exportation, sales, distribution, and registration of regulated products;
3. To undertake the registration of foods, drugs, cosmetics, medical devices bottled water, Chemicals, and detergents;
4. To grant authorization for the import and export of narcotic drugs and psychotropic substances as well as other controlled substances;
5. To collaborate with National Drug Law Enforcement Agency (NDLEA) in the bid to eradicate drug abuse in Nigeria;
6. To issue guidelines, grant approvals, and monitor the advertisement of food, drugs, cosmetics, medical devices, bottled water, Chemicals, and detergents;
7. To carry out such activities as are necessary or expedient for the performance of its functions.

In light of the above functions, we see that the responsibility of NAFDAC is to enforce established regulations over the production and circulation of drugs. The responsibility of NAFDAC lies in ensuring that pharmaceutical products made and sold by pharmaceutical businesses meet standard specifications and the distribution of quality pharmaceutical products to the public.

REGISTRATION AT THE PHARMACISTS COUNCIL OF NIGERIA (PCN)

By the provisions of the Pharmacists Council of Nigeria Act (1992 No. 91) ("the Act")⁹, every pharmacy in Nigeria, whether it is a manufacturing and retail pharmacy, a community pharmacy, a hospital pharmacy¹⁰or an online pharmacy¹¹ must be duly registered with the Pharmacists Council of Nigeria (PCN). In other words, operating a pharmacy in Nigeria without being duly registered with the PCN is illegal, whether the name is registered with the CAC or not.

The Act establishes the Pharmacist Council of Nigeria ("the Council"), as the body with the sole responsibility of registering, monitoring, regulating, and controlling all aspects of pharmaceutical practice in Nigeria. According to the Act, the PCN is responsible for the accreditation of training institutions, registration and licensure of all Pharmacists, Pharmaceutical Premises (Manufacturing, Importation, Distribution, Wholesale, Retail, Hospital Pharmacies) as well as the issuance of Permit to Pharmacy Technicians and registration and Licensure of Patent and Proprietary Medicine Vendors. This Council is in charge of the inspection and registration of pharmaceutical retail, wholesale, and manufacturing premises. The Council in the exercise of the powers conferred upon it Sections 1 and 24 of the PCN Act made following regulations:

1. The Registration of Pharmaceutical Premises Regulations, 2005
2. PCN Operational Fees and Guidelines for Registration, 2019
3. Pharmaceutical Premises Location, Inspection, Structure, Monitoring and Enforcement Regulation,2021
4. PHN Online Pharmacy Regulations 2020

The Registration of Pharmaceutical Premises Regulations, 2005 makes provision for registration requirements of new pharmaceutical premises and renewal of old premises categorizing them into;

1. Premises sought to be registered as a retail pharmacy: Regulations 2 provides that where the premises sought to be registered as a retail pharmacy; the company shall be wholly owned by a registered pharmacist or in partnership with other registered pharmacists.¹²
2. Pharmaceutical premises involved in wholesale, distribution, and importation of ale, drugs, poisons, and devices: For pharmaceutical premises involved in wholesale, distribution, and importation of drugs, poisons, and devices, it is required that at least one registered pharmacist should be on the Board of Directors of the Company. The business shall be carried out under the direct personal control and management of a Superintendent Pharmacist.¹³
3. Pharmaceutical Manufacturing Premises: Where the primary object of the company is pharmaceutical manufacturing, it is required that at least one registered pharmacist should be on the Board of Directors of the Company; the business shall be carried out under the direct personal control and management of a Superintendent Pharmacist.¹⁴

Registration of a new pharmaceutical retail, distribution, or importation premises

For the registration of a new pharmaceutical retail, distribution, or importation premises, the following documents are required to be submitted to the Registrar of the Council, through the Director of Pharmaceutical Services of the State where the premises is to be operated accompanied by the following:¹⁵

• An application letter (in the company's letter headed paper) to register premises;
• A duly completed Application Form;
• annual licence to practice pharmacy;
• prescribed fees in bank draft payable to the Council;
• A letter of resignation from previous employment (if applicable);
• The letter of acceptance of resignation (if applicable);
• The letter of appointment as the superintendent pharmacist in the new premises (where applicable);
• The legal agreement between the superintendent pharmacist and his employer (where applicable);
• The Company's certificate of incorporation (evidence of registration of business name in respect of pharmacist-owned retail premises);
• Certified copy of the company's Articles and Memorandum of Association;
• Certified copy of particulars of the company's Directors;
• NYSC Discharge or Exemption Certificate (where applicable);
• A letter of undertaking by the superintendent pharmacist to the effect that he has only one pharmaceutical job;
• A letter of undertaking by the Managing Director of the company to the effect that all pharmaceutical businesses would be under the direct, personal, control and management of the Superintendent of the Pharmacist;

Registration of Pharmaceutical Manufacturing Premises

In addition to the documents listed above, where the pharmaceutical premises sought to be registered is for manufacturing, the application for registration is to be accompanied by the following:¹⁶

• The list of products to be manufactured;
• list of equipment for Production and Quality Control Departments;
• list and sources of suppliers of raw and packaging materials;
• standard operating procedures (SOP);
• factory layout;
• Application for registration or renewal of manufacturing and retail pharmacy
• production Flow Chart ;
• water source and treatment facilities;
• water analysis report (Raw and treated water);
• list of qualified staff showing qualifications and duty ;
• organogram ;
• disposal of poison records;
• prescribed inspection fees payable to the Pharmacists Council of Nigeria;
• product licenses for all products (Routine inspection); and
• list of all distributors and distributions records (Routine inspection).

On the receipt of the above-named documents, an inspection of the pharmaceutical premises shall be carried out to ensure compliance with the requirements for the registration of such premises. Inspection of any sector of the pharmaceutical industry for registration usually attracts a fee of N10,000.00 (Ten thousand naira) for the first two visits and subsequent visit shall attract the sum of N20,000.00 (Twenty thousand naira) per visit.¹⁷

It is important to state that pharmaceutical premises are not to be located in motor parks, petrol stations, clustered environments, around open marketplaces and kiosks, containers or stalls. Also pharmaceutical premises shall be sited not less than two hundred meters from each other.¹⁸

Furthermore, only names registered by the Pharmacists Council of Nigeria is to be used on the signpost of a pharmacy and registered pharmacist-owned premises only shall display the Pharmaceutical Society of Nigeria (PSN) Pharmacy Emblem.¹⁹

ONLINE PHARMACY

Seeing that pharmaceutical businesses can operate digitally, the PCN made provisions for Online Pharmacy Regulations 2020. The regulations provide that Internet-based pharmaceutical service providers in Nigeria are to be registered with the PCN.²⁰ It also provides that a pharmacist can only register on one internet-based platform.²¹ The application form is to be completed and submitted to the Registrar, PCN by a Superintendent Pharmacist to be designated by the Internet pharmaceutical service provider accompanied by necessary documents on behalf of the Provider.²²

Upon submission of the documents, the PCN shall inspect the Providers and shall from time to time carry out follow-up inspections throughout the supply chain.²³

The Council is empowered to issue licence to all registered internet based pharmaceutical service providers based in Nigeria in line with Good Pharmacy Practice (GPP) and upon registration and licensing, the online site must have the prescribed PCN Registered Online Pharmacy Sites Emblem (ROPSE).²⁴

PENALTY FOR NON-COMPLIANCE

It is to be noted that pharmaceutical premises that remain unregistered by the 31st day of January of every year shall in addition to paying the fee prescribed, pay a fine equivalent of 50% (fifty percent) of the applicable fee and pharmaceutical premises that remain unregistered by the 31st day of March of each year, shall be closed. ²⁵

Furthermore, any person who contravenes or fails to comply with the provisions of these regulations shall be guilty of an offense and liable on conviction to a fine of N20,000.00 (twenty thousand naira).²⁶

For online internet pharmaceutical service providers, the Pharmacists Council of Nigeria Online Pharmacy Regulations, 2020 provides that all unregistered online internet pharmaceutical service providers premises and sites shall be closed by the PCN.²⁷ Where an emblem of the PCN is found on an unauthorized internet site or platform, such site shall also be closed down.²⁸

It is an offence for any pharmacist to register or attempt to register more than one online site or premises. Anyone who does that shall be investigated by the investigating panel, be referred to the Disciplinary Tribunal of the PCN for appropriate action²⁹and the site will be closed down.

A person who fails to comply with the provisions of the Regulations shall be guilty of an offence and liable on conviction to a term of imprisonment of not less than 6 months or a fine of not less than N250,000 (Two Hundred and Fifty Thousand Naira) or both.³⁰

CONCLUSION

It is silhouetted against the foregoing that any person seeking to operate a pharmaceutical business in Nigeria either to manufacture or distribute must firstly register with the relevant agencies, obtain the required license (s) and comply with the rules and regulations laid down. Failure to meet these requirements will lead to sanctions/penalties by the Pharmacists Council of Nigeria.

Footnotes

1. The Companies and Allied Matters Act, 2020

2. National Agency for Food and Drug Administration Control Act Cap N.1 LFN 2004

3. Pharmacists Council of Nigeria Act (1992 No. 91)

4. Part E of the Companies and Allied Matters Act, 2020

5. Part D of the Companies and Allied Matters Act, 2020

6. Part C of the Companies and Allied Matters Act, 2020

7. Part B of the Companies and Allied Matters Act, 2020

8. Section 5, National Agency for Food and Drug Administration and Control (NAFDAC) Act Cap N1 Laws of the Federation of Nigeria (LFN) 2004

9. (Cap P17 LFN 2004)

10. Reg. 7, Registration of Pharmaceutical Premises Regulations, 2005

11. Reg. 1, The Online Pharmacy Regulations, 2020

12. Registration of Pharmaceutical Premises Regulations, 2005

13. Reg. 3, Registration of Pharmaceutical Premises Regulations, 2005

14. Reg. 4, Registration of Pharmaceutical Premises Regulations, 2005

15. Reg. 1, Registration of Pharmaceutical Premises Regulations, 2005

16. Reg. 2(1), Registration of Pharmaceutical Premises Regulations, 2005

17. Reg. 10, Registration of Pharmaceutical Premises Regulations, 2005

18. Reg. 3,Pharmaceutical Premises Location, Inspection, Structure, Monitoring and Enforcement Regulation,2021

19. Reg. 8, Registration of Pharmaceutical Premises Regulations, 2005

20. Reg. 1, The Online Pharmacy Regulations, 2020.

21. Reg. 20 (4), The Online Pharmacy Regulations, 2020

22. Reg. 2, The Online Pharmacy Regulations, 2020

23. Reg. 8, The Online Pharmacy Regulations, 2020

24. Reg. 5, The Online Pharmacy Regulations, 2021

25. Reg. 9, Registration of Pharmaceutical Premises Regulations, 2005

26. Reg 12, Registration of Pharmaceutical Premises Regulations, 2005

27. Reg. 19(2), The Online Pharmacy Regulations, 2020

28. Reg. 20(2), The Online Pharmacy Regulations, 2020

29. Reg. 20(5), The Online Pharmacy Regulations, 2020

30. Reg. 22(3), The Online Pharmacy Regulations, 2020

Originally published July 20, 2022

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.