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Legal Framework for Carrying On Pharmaceutical Business in Nigeria
All aspects of pharmacy practice in Nigeria are regulated by the Pharmacists Council of Nigeria Act (1992 No. 91) (“the Act”).
The Act provides for the registration of pharmaceutical premises in Nigeria before commencement of a pharmaceutical business. 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. The Council is in charge of the inspection and registration of pharmaceutical retail, wholesale and manufacturing premises. The Council in exercise of the powers conferred upon it by the Act, made regulations guiding the registration of pharmaceutical premises as follows;
1. Registration of Pharmaceutical Premises
(a) The Registration of Pharmaceutical Premises Regulations, 2005 (“the Registration Regulation”), provides for registration of new pharmaceutical premises and renewal of old premises;
(b) It provides that where the premises sought to be registered is a retail pharmacy; the company shall be wholly owed by a registered pharmacist or in partnership with other registered pharmacist.
(c) For a pharmaceutical premises involved in wholesale, distribution and importation of drugs, poisons and devices, there shall be at least one registered pharmacist 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.
(d) Where the primary object of the company is pharmaceutical manufacturing, there shall be at least one registered pharmacist 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.
2. Inspection, Location and Structure of Pharmaceutical Premises
The Inspection, Location and Structure of Pharmaceutical Premises Regulations, 2005 (“the Inspection Regulation”) establishes a Pharmaceutical Inspectorate Division which consist of registered Pharmacists designated as pharmaceutical inspectors, appointed by the Council to enter into pharmaceutical premises and inspect to ensure due compliance with the provisions of the Regulation.
(a) The Inspection Regulation provides for the location of pharmaceutical premises. It shall not be located in motor parks, environment close to a location where commercial activities and enterprise are standing and growing; market places including kiosks and road side retail.
(b) It provides that any pharmaceutical premises surrounded or covered completely by a growing market or standing close to it shall be moved to another suitable location two years after formal notification to do so by the Council.
(c) Pharmaceutical premises within a shopping centre shall not be more than three and they shall be well spaced out.
(d) Pharmaceutical premises shall be sited not less than two hundred meters from each other.
Pharmaceutical practice in Nigeria is also regulated by the National Agency for Food and Drug Administration Act. The Act establishes the National Agency for Food and Drug Administration (“NAFDAC”). The Agency has a complementary role to play in the registration of pharmaceutical premises. It does the following;
(i) The Agency is in charge of evaluation and registration of Pharmaceutical products;
(ii) Post market surveillance and risk analysis of products;
(iii) Control of product import and export; and
(iv) Regulation of product promotion and public education.
3. Registration of Retail, Distribution and Importation Premises
For the registration of a new pharmaceutical retail, distribution or importation premises, the following documents shall be submitted to the Registrar, of the Council, through the Director of Pharmaceutical Services of the State where the premises is to be operated;
- An application letter (in the company’s letter headed paper) to register premises;
- A duly completed Form B (PCN’s Application Form for the Registration of Premises);
- A photocopy of the Annual License to practise 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 a 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 a 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.
On the receipt of the above named documents, inspection of the pharmaceutical premises shall be carried out to ensure compliance with the requirements for the registration of such premises.
4. Registration of Pharmaceutical Manufacturing Premises
The requirements for the registration of pharmaceutical retail, distribution and importation outfits are also required for manufacturing premises, including the following:
- The list of products to be manufactured;
- An Organogram;
- The list of staff qualification 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; and
- Payment of the Inspection Fee – in bank draft of N130, 000.00 payable to the Pharmacists Council of Nigeria.