If you plan to register a pharmaceutical company in Nigeria, then it is important you read this detailed article on how to set up a pharmaceutical company.
In this article, we would show you who is eligible to register a pharmaceutical company, the requirements for registration and also the procedure for obtaining the license to set up and run the business.
If you have any question, please feel free to contact us or leave a comment and be sure your questions would be answered.
Definition of a Pharmaceutical Company
A pharmaceutical company is a company that produces, markets and distributes medical drugs to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms.
The law that provides for the registration and regulation of the pharmaceutical industry in Nigeria is the Pharmacist Council Of Nigeria Decree 1992 Nigeria. The Pharmacist Council of Nigeria (PCN)is the self-regulatory organisation that regulates the licensing, operations and monitoring of Pharmaceutical business in Nigeria.
Procedure To Register A Pharmaceutical Company
A pharmaceutical company can either be registered as a private limited company or a public limited company. However, the preferred choice for registration would be to register as a private limited company.
Also, there are three categories of pharmaceutical companies that can be registered in Nigeria. The categories include pharmaceutical retail, wholesale and manufacturing.
Requirements for registration
A pharmaceutical retail company
A retail pharmaceutical company is a company that sells drugs to individuals and usually known as a pharmacy, chemist or a drugstore.
A retail pharmaceutical company must be fully owned by a registered pharmacist or in partnership with other registered pharmacists.
A Pharmaceutical wholesale Company
This type of company imports and distributes drugs, poisons and devices.
This type of company only requires at least one registered pharmacist on the Board of Directors of the Company. However, the business must be carried out under the direct personal control and management of a Superintendent Pharmacist.
A Pharmaceutical Manufacturing Company
A pharmaceutical company can be into the business of manufacturing of drugs.
In order to register this type of business, there must be at least one registered pharmacist on the Board of Directors of the Company. The business must be carried out under the direct personal control and management of a Superintendent Pharmacist.
Step 1: Company Registration
As stated earlier, before starting a pharmaceutical business, it is advisable to register as a private limited company. A private limited company is the most preferred choice for a business start-up due to the ease of registration in terms of costs and requirements.
There is no specific share capital threshold hence, the company can be registered with one million share capital.
Step 2: Application for inspection of premises
After registering the company, it is important to take steps towards getting the business license which comes after the inspection and approval of the premises to be used as the business premises.
What this means is that before you commence the pharmaceutical business, the Pharmaceutical inspectors from the PCN would physically visit the business premises and inspect to ensure due compliance with the provisions of the Regulation.
According to the law on the inspection of premises of pharmaceutical companies, the following guidelines must be strictly adhered to.
- The pharmaceutical premises must not be located in a motor park, environment close to a location where commercial activities and enterprise are standing and growing;
- Must not be a market place including kiosks and roadside retail.
- Pharmaceutical premises within a shopping centre shall not be more than three and they shall be well spaced out.
- Pharmaceutical premises shall be sited not less than two hundred meters from each other.
- If the pharmaceutical premises is surrounded or covered completely by a growing market or standing close to it, then the business must be moved to another suitable location two years after formal notification to do so by the Council.
Required Details To Register A Pharmaceutical Retail, wholesale or distribution company
Application for the registration of a new pharmaceutical retail, distribution or importation 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:
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 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.
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.
