Health is wealth, and like other vital aspects of human life, health cannot be compromised. This necessitates the importance of upholding the industry standards related to pharmaceutical operations. In Nigeria, this industry is properly regulated by the Pharmacy Council of Nigeria and other relevant agencies such as NAFDAC, SON, MAN, etc. This article offers a detailed guideline on how to set up a pharmaceutical company in Nigeria in line with acceptable industry standards, legal regulations, and best practices.
What is a pharmaceutical company?
A pharmaceutical company is a registered entity engaged in either the production, marketing, importation, sale, or distribution of pharmaceutical products.[1] In Nigeria, the pharmacy business is governed by the Pharmacy Council of Nigeria, which oversees and regulates the standard of pharmacy practice and business.[2]
What are the types of pharmaceutical companies in Nigeria?
Generally, the Pharmacy Council of Nigeria is saddled with the responsibility of regulating, licensing, controlling, and registering pharmacists, pharmacy technicians, patent and proprietary medicine vendors, satellite medicine facilities, pharmacies, and pharmaceutical premises where drugs, medicines, and poisons are manufactured, imported, exported, distributed, stored, dispensed, or sold in Nigeria.[3] However, depending on the purpose or type of pharmaceutical activity the company engages in, a pharmacy company can either be a retail pharmaceutical company, a community pharmaceutical company, or a wholesale or manufacturing pharmaceutical company.[4] We will now consider the qualification for the operation of these companies.
Retail Pharmaceutical Company
Typically known as a chemist or drug store, it is a type of pharmaceutical company that is engaged in retail pharmaceutical practice. To legally operate a retail pharmaceutical company, the company must have a licensed Nigerian pharmacist or pharmacists as part of the board of directors who shall solely or jointly own the company.[5] In addition, this type of company can either be a Nigerian-owned company or a foreign-owned company. It must be noted that for both companies, a Nigerian pharmacist or pharmacists must be a member of the board of directors who shall solely or jointly own not less than 40% of the issued share capital of the company.
Wholesale, Manufacturing, Distribution, and Importation Pharmaceutical Company
Where the company engages in wholesale, manufacturing, importation, and distribution pharmaceutical business, at least one member of the board of directors must be a registered pharmacist and must equally be a shareholder in the company.[6]
Community Pharmaceutical Company
This type of company can be described as a healthcare facility company that provides pharmaceutical services to people in a local area or community.[7] The qualification for registration of this type of company is the same as that of a retail pharmaceutical company.
How to set up a Pharmaceutical Company in Nigeria
The following steps are to be followed when setting up a pharmaceutical company in Nigeria:
1. Incorporation with the Nigerian Corporate Registry
The company must be registered with the Corporate Affairs Commission before the commencement of operations. In practice, there is no minimum share capital requirement for registration of a pharmaceutical company in Nigeria. However, where such a company has foreigners as directors or shareholders, the minimum share capital will be one hundred million shares.
2. Registration of Premise with PCN
- The premise for which the pharmaceutical activity will be carried on must be registered and licensed by the Pharmacy Council of Nigeria. An application letter shall be submitted to the Registrar of the Council through the Director of Pharmacy Service where the premise is located. Additional documents include:
- A duly completed Form B (PCN’s Application Form for the Registration of Premises);
- A photocopy of the Annual License to practice or an application for the retention of name on the Pharmaceutical Register (Form J);
- The prescribed inspection and registration fees, in bank draft, payable to the Council;
- A photocopy of the letter of resignation from previous employment (if applicable);
- The Letter of Acceptance of Resignation (if applicable);
- The Letter of Appointment 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 pf business name is acceptable 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 as issued by the Corporate Affairs Commission(CAC);
- A photocopy of the 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;
- A Pharmacists Inter-state Movement Form (where applicable), duly completed;
- Evidence of a Pharmacist on the Board of Directors; and
- The Current Annual License of the Pharmacist Director.
For Manufacturing, Importation, and Distribution Pharmaceutical Companies, the following documents are to be attached alongside those listed above;
- The list of products to be manufactured;
- An Organogram;
- The list of staff qualifications and duties;
- The Factory layout;
- The production flow-chart.
- The list of equipment in the production and quality control departments.
- The Source of water and water treatment facilities;
- The Water analysis report of raw and treated water.
- The list and source of suppliers of raw materials and packaging materials;
- Standard Operating Procedures (SOP);
- Standard Cleaning Procedures
The Pharmaceutical Inspectors have the power to seal up a premise for non-registration.[8] Part of the requirements for the site and location of the premise is must not be located in an open market space, motor park, clustered center, kiosk, petrol station.[9]
3. Inspection by Pharmacy Inspectors
An inspection of the premises will be carried out by the Pharmacy Inspectors under the Monitoring department of the PCN to ensure compliance with the provisions of the regulation.[10]
4. Payment of Registration and Retention of Premise Fee
Along with the registration, payment of the prescribed registration and retention of the premise fee with respect to the registered premise will be made to the PCN.[11]Non-compliance attracts penalties such as fines and/or sealing-up by the Pharmacy Inspectors.
How Lex-Praxis Helps You Register a Pharmaceutical Company in Nigeria
Setting up a pharmaceutical company in Nigeria requires strict compliance with regulatory and licensing requirements. At Lex-Praxis, we provide professional legal support to entrepreneurs and investors seeking to establish and operate compliant pharmaceutical businesses in Nigeria.
Our firm offers end-to-end legal and regulatory services to ensure a smooth registration process, including:
Our Services Include:
• Pharmaceutical company registration with CAC
• NAFDAC product registration and approvals
• Pharmacists Council of Nigeria (PCN) licensing
• Regulatory compliance advisory
• Corporate governance and company secretarial services
• Contract drafting and review
• Ongoing compliance support
With extensive experience in pharmaceutical regulatory law in Nigeria, we help clients avoid delays, penalties, and regulatory setbacks. Whether you are a local entrepreneur or a foreign investor, we ensure your pharmaceutical business is legally structured and fully compliant with Nigerian laws.
Why Choose Lex-Praxis?
✔️ In-depth knowledge of pharmaceutical regulations
✔️ Proven track record in business registration
✔️ Fast, efficient, and transparent process
✔️ Dedicated legal support from start to finish
By partnering with Lex-Praxis, you gain access to expert legal guidance that protects your investment and positions your business for long-term success.
Get Started Today
Ready to register your pharmaceutical company in Nigeria?
Let Lex-Praxis handle the legal process while you focus on building your business. Click the WhatsApp icon on this page or send us an email HERE to get started.
📧 Email: [email protected]
🌐 Website: www.lexpraxisng.com
📞 Call/WhatsApp: 09160546551
Book a consultation today and take the first step toward launching your pharmaceutical business in Nigeria.
[1] https://classic-attorneys.com/blog-2021-07-06-how-to-register-a-pharmaceutical-company-in-nigeria/
[2] Section 4(b) Pharmacy Council of Nigeria Act 2022
[3] Section 4 (h) Pharmacy Council of Nigeria Act 2022
[4] Section 27 Pharmacy Council of Nigeria Act 2022
[5] Section 6 Registration and Licensing of Pharmaceutical Premises Regulations
[6] Section 27, Section 4 Registration and Licensing of Pharmaceutical Premises Regulations
[7] Section 71
[8] Section 7 Pharmaceutical premises location structure monitoring enforcement regulation https://pcn.gov.ng/wp-content/uploads/2024/11/Pharmaceutical-Premises-Location-Inspection-Structure-Monitoring-and-Enforcement-Regulation.pdf
[9] Section 3 https://pcn.gov.ng/wp-content/uploads/2024/11/Pharmaceutical-Premises-Location-Inspection-Structure-Monitoring-and-Enforcement-Regulation.pdf
[10] Section 2 https://pcn.gov.ng/wp-content/uploads/2024/11/Pharmaceutical-Premises-Location-Inspection-Structure-Monitoring-and-Enforcement-Regulation.pdf
[11] Section 24 https://pcn.gov.ng/wp-content/uploads/2024/09/Pharmacy-Council-of-Nigeria-Act-2022-publication.pdf
