With the emergence of the Companies and Allied Matters Act, 2020 and the ever-efficient Pharmacy Council of Nigeria, the incorporation of a pharmaceutical company has been simplified, by so doing, encouraging everyone, irrespective of their field of specialization, to own a pharmaceutical company and invest in the pharmaceutical industry; one of Nigeria's fast-growing and lucrative industry.
WHAT IS A PHARMACEUTICAL COMPANY?
A pharmaceutical company is a company that produces, markets, and distributes medical drugs to patients with the aim of curing them, vaccinating them, or alleviating their symptoms.
LEGAL AND INSTITUTIONAL FRAMEWORK FOR PHARMACEUTICAL COMPANIES IN NIGERIA
The apex regulatory body for all pharmaceutical companies in Nigeria is the Pharmacy Council of Nigeria. This body is saddled with the responsibility of registering and licensing all pharmacists, pharmaceutical premises (manufacture, importation, distribution, wholesale, retail, hospital, pharmacies, etc.) as well as the issuance of permits to pharmacy technicians and, finally, the registration and licensure of patent and proprietary medicine vendors.
The primary legislation that governs activities affiliated with pharmaceutical companies is the Pharmacist Council of Nigeria Decree 1992.
PROCEDURE FOR REGISTRATION OF A PHARMACEUTICAL COMPANY IN NIGERIA.
The procedure for registering a pharmaceutical company majorly depends on the category of the pharmaceutical company the individual seeks to incorporate, as each category attracts certain peculiar requirements.
However, some procedures have general applications irrespective of the category of the pharmaceutical company that is being registered. These procedures include:
- Incorporation of the company with the Corporate Affairs Commission either as a private limited company or 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 includes:
- ) Availability of Name
- ) Application for Registration of Company
- ) Identification documents of the directors
- ) Memorandum and Articles of Association
- ) Payment of Registration fees and Stamp Duties
- ) Residence Permit (where any of the subscribers is a foreigner)
- ) Birth certificate (where any of the subscribers is a minor)
- ) Board resolution and certificate of incorporation (where any of the subscribers is a corporate body)
- Proficiency Certificate and Current Practicing License of the pharmacist who is to be a director in the company
- Application for the registration of new pharmaceutical premises is 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.
The following documents are to be submitted as the application documents:
A.) An application letter (in the company's letter headed paper) to register premises;
B.) A duly completed Form B (PCN's Application Form for the Registration of Premises);
C.) A photocopy of the Annual License to practice or an application for the retention of name on the Pharmaceutical Register (Form J);
D.) The prescribed inspection and registration fees, in bank draft, payable to the Council;
E.) A photocopy of the letter of resignation from previous employment (if applicable);
F.) The Letter of Acceptance of Resignation (if applicable);
G.) The Letter of Appointment in the new premises (where applicable);
H.) The Legal Agreement between the Superintendent Pharmacist and his employer (where applicable);
- ) The Company's Certificate of Incorporation (Evidence of registration of business name is acceptable in respect of Pharmacist-owned retail premises);
J.) Certified copy of the company's Articles and Memorandum of Association;
K.) Certified copy of Particulars of the company's Directors as issued by the Corporate Affairs Commission (CAC);
L.) A photocopy of the NYSC Discharge or Exemption Certificate (where applicable);
M.) A Letter of Undertaking by the Superintendent Pharmacist to the effect that he has only one pharmaceutical job;
N.) 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;
O.) A Pharmacists Inter-State Movement Form (where applicable), duly completed;
P.) Evidence of a Pharmacist on the Board of Directors; and
Q.) The Current Annual License of the Pharmacist Director.
- Application to the Pharmacy Council of Nigeria to the inspection of the premise to ensure compliance with all regulations as provided for by the Pharmacy Council of Nigeria as it relates to location, proximity to other pharmacies, size, height, storage room, and other necessities of the premise of the pharmaceutical company.
ADDITIONAL REQUIREMENTS FOR THE REGISTRATION OF PHARMACEUTICAL MANUFACTURING PREMISES.
A pharmaceutical retail, wholesale, distribution, and importation company shares the same procedure as a pharmaceutical manufacturing company. However, for a pharmaceutical manufacturing coming, in addition to the procedure enumerated above, the company is required to make available to the Council the following:
A.) The list of products to be manufactured;
B.) An Organogram;
C.) The list of staff qualifications and duties;
D.) The Factory layout;
E.) The production flow-chart;
F.) The list of equipment in the production and quality control departments;
G.) The Source of water and water treatment facilities;
H.) The Water analysis report of raw and treated water;
I.) The list and source of suppliers of raw materials and packaging materials;
J.) Standard Operating Procedures (SOP);
K.) Standard Cleaning Procedures; and Payment of the Inspection Fee – in bank draft of N130, 000.00 payable to the Pharmacists Council of Nigeria
Co-authored by Utang Asuquo
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.