How to Register a Pharmaceutical Company in Nigeria – Life Sciences, Biotechnology and Nanotechnology

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With the emergence of the Companies and Allied Matters Act, 2020 and the ever-effective Pharmacy Council of Nigeria, incorporation of a pharmaceutical company has been simplified, thereby encouraging everyone, regardless of their area of ​​specialization, to own a laboratory pharmaceutical. business and investing in the pharmaceutical industry; one of the fast growing and lucrative industries in Nigeria.

WHAT IS A PHARMACEUTICAL COMPANY?

A pharmaceutical company is a company that produces, markets and distributes drugs to patients with the aim of curing them, vaccinating them or relieving their symptoms.

LEGAL AND INSTITUTIONAL FRAMEWORK FOR PHARMACEUTICAL COMPANIES IN NIGERIA

The supreme regulatory body for all pharmaceutical companies in Nigeria is the Pharmacy Council of Nigeria. This organization is responsible for the registration and approval of all pharmacists, pharmaceutical premises (manufacture, import, distribution, wholesale, retail, hospital, pharmacies, etc.) as well as the issuance of permits to technicians in pharmacy and, finally, the registration and approval of sellers of patented and proprietary medicines.

The main legislation that governs activities affiliated with pharmaceutical companies is the Pharmacists Council of Nigeria Order 1992.

PROCEDURE FOR REGISTRATION OF A PHARMACEUTICAL COMPANY IN NIGERIA.

The procedure for registering a pharmaceutical company mainly depends on the category of the pharmaceutical company that the individual seeks to establish, as each category attracts certain particular requirements.

However, some procedures have general applications regardless of the category of pharmaceutical company that is registered. These procedures include:

  1. Incorporation of the company with the Corporate Affairs Commission either as a limited liability company or as a public limited company. A private company limited by shares is always recommended due to the ease of incorporation and low capital requirement. The documents to be submitted to the Corporate Affairs Commission for the incorporation of the company include:

  2. ) Name availability

  3. ) Application for company registration

  4. ) Identity documents of directors

  5. ) Memorandum and articles of association

  6. ) Payment of registration fees and stamp duty

  7. ) Residence permit (when one of the subscribers is a foreigner)

  8. ) Birth certificate (when one of the subscribers is a minor)

  9. ) Resolution of the board of directors and certificate of incorporation (when one of the subscribers is a legal entity)

  10. Certificate of competence and current practice license of the pharmacist who will be a director of the company
  • Application for registration of new pharmacy premises must be submitted to the Registrar of the Council, through the Director of Pharmaceutical Services of the State where the premises are to be operated.

The following documents must be submitted as application documents:

A.) A letter of application (on company letterhead) to register the premises;

B.) A completed Form B (NCP Application Form for Premises Registration);

C.) A photocopy of the annual license to practice or an application to maintain the name on the pharmaceutical register (Form J);

D.) The prescribed inspection and registration fees, by bank draft, payable to Council;

E.) Photocopy of resignation letter from previous employment (if applicable);

F.) Letter of acceptance of resignation (if applicable);

G.) The letter of appointment in the new premises (if applicable);

H.) The legal agreement between the superintendent pharmacist and his employer (if applicable);

  1. ) Certificate of incorporation of the company (proof of business name registration is acceptable for retail premises owned by a pharmacist);

J.) Certified copy of the company’s articles of association and memorandum of association;

K.) Certified copy of the details of the directors of the company as issued by the Corporate Affairs Commission (CAC);

L.) A photocopy of the NYSC discharge or exemption certificate (if applicable);

M.) A letter of commitment from the superintendent pharmacist to the effect that he exercises only one pharmaceutical employment;

N.) A letter of commitment from the general manager of the company that all pharmaceutical companies would be under the direct, personal control and management of the Superintendent of Pharmacist;

O.) A completed Pharmacist Interstate Movement Form (if applicable);

P.) Testimony of a pharmacist member of the board of directors; and

Q.) The current annual license of the Chief Pharmacist.

  • Requests the Pharmacy Board of Nigeria to inspect the premises to ensure compliance with all regulations laid down by the Pharmacy Board of Nigeria with respect to location, proximity to other pharmacies, size, height , the storage room and other necessities of the premises of the pharmaceutical company.

ADDITIONAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICAL MANUFACTURING PREMISES.

A pharmaceutical retail, wholesale, distribution and import business shares the same procedure as a pharmaceutical manufacturing business. However, for a pharmaceutical manufacturing coming, in addition to the procedure listed above, the company is required to make available to the Council the following elements:

A.) The list of products to be manufactured;

B.) An organizational chart;

C.) List of personnel qualifications and functions;

D.) The factory layout;

E.) The production flowchart;

F.) The list of equipment for production and quality control departments;

G.) Water source and water treatment facilities;

H.) The raw and treated water analysis report;

I.) List and source of suppliers of raw materials and packaging materials;

J.) Standard Operating Procedures (SOPs);

K.) Standard cleaning procedures; and Payment of Inspection Fee – by bank draft of N130,000.00 payable to the Pharmacists Council of Nigeria

Co-written by Utang Asuquo

The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.