The pharmaceutical sector is highly regulated because it directly affects public health. Anyone seeking to establish a pharmaceutical business in Nigeria must comply with applicable corporate, professional and regulatory requirements.

Q: What is the first step in setting up a pharmaceutical business in Nigeria?

A: Register the company with the Corporate Affairs Commission [CAC]. The company's objects should appropriately cover the proposed pharmaceutical activities. CAC does not prescribe a specific minimum share capital solely because a company is a pharmaceutical company, although additional requirements may apply where there is foreign participation.

Q: Is registering a company with CAC enough to start a pharmaceutical business in Nigeria?

A: No. Registering the company with the CAC is only the first step. Pharmaceutical businesses are highly regulated and may require approvals and licences from the Pharmacy Council of Nigeria [PCN] and, depending on the nature of the business, NAFDAC.

Q: What should I do after registering the company?

A: Determine the exact type of pharmaceutical business you intend to operate. This may include a community or retail pharmacy, wholesale and distribution, importation and exportation, pharmaceutical manufacturing, warehousing and storage, hospital pharmacy, or a Patent and Proprietary Medicine Vendor (PPMV) business.

Q: Does the type of pharmaceutical business matter?

A: Yes. The regulatory requirements depend on the nature of the business.

Q: Do I need a registered pharmacist?

A: Yes. A Nigerian registered and licensed pharmacist is required for regulated pharmaceutical businesses. The pharmacist's required role, ownership and involvement will depend on the type of business.

For example, certain businesses, including manufacturing, importation, exportation, storage, distribution and wholesale, have specific requirements regarding the involvement of a registered pharmacist who is also a shareholder.

Q: Where do I apply for a pharmaceutical premises licence?

A: Applications for the registration and licensing of pharmaceutical premises are made to the Pharmacy Council of Nigeria [PC]).

Q: What documents are generally required for PCN registration?

A: Depending on the type of business, the requirements may include:

CAC incorporation documents;
Current pharmacist licence;
Evidence of the pharmacist's required involvement;
Letter of appointment and undertaking;
Evidence of suitable premises;
Completed application forms; and
Payment of applicable fees.

Q: Are there additional requirements for pharmaceutical manufacturing?

A: Yes. Manufacturing premises are subject to additional technical and operational requirements. These may include

the factory layout,
production flow chart,
list of products,
equipment,
staff qualifications, water source and analysis reports,
suppliers' details,
Standard Operating Procedures (SOPs),
cleaning procedures and other quality-control documentation.

Q: Will the premises be inspected?

A: Yes. After submission of the application and required documents, the proposed premises may be inspected by the appropriate PCN inspection committee. The premises must satisfy the applicable requirements relating to location, structure, equipment and operational standards.

Q: Can I start operating before obtaining the required licence?

A: No. A pharmaceutical premises should not commence operations without the required registration and licence. Operating without the necessary approvals may expose the business to regulatory sanctions, including fines, closure and possible prosecution.

Q: Do I also need NAFDAC approval?

A: Depending on the nature of the business, yes. Pharmaceutical products manufactured or imported for sale in Nigeria are subject to applicable NAFDAC regulatory requirements, including product registration where required.

Q: Do pharmaceutical licences have to be renewed?

A: Yes. Pharmaceutical premises are subject to ongoing regulatory compliance, including annual licensing and renewal or retention requirements. Failure to maintain the required licences may result in penalties or enforcement action.

KEY TAKEAWAY

Setting up a pharmaceutical business in Nigeria involves more than registering a company with CAC. The type of business, pharmacist requirements, ownership structure, premises, PCN licence and applicable NAFDAC approvals must all be considered before commencing operations.

The exact requirements will depend on the nature and scope of the proposed pharmaceutical business.