Process Of Registration Of Pharmaceutical Manufacturing Company In Nigeria
Starting a pharmaceutical company is one of the best options to start a business. A pharmaceutical company could be either involves in one or all types i.e. research, manufacturing, trading, distribution and marketing etc.
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| Pharmaceutical manufacturing company registration |
There is a general drive by the government in Nigeria to encourage local production. Although the environment is not conducive for production, policies have changed a lot. But if you have the finance to begin production of drugs and medical equipment, this post is for you.
To produce drugs, the pharmaceutical manufacturing company must meet the world health organisation standard which is copied by the national agency for food and drug administration and control (NAFDAC) and the pharmacists council of Nigeria (PCN). They are good manufacturing practices (GMP). The others are registration procedures.
Read Also: Registration of drug importation with NAFDAC
To register a pharmaceutical production company in Nigeria, PCN and NAFDAC must be involved. The first step is to register business with the corporate affairs commission (CAC). There are two types of CAC. The first is a limited liability company which is a company solely on one line of business. I will encourage pharmaceutical manufacturing companies to choose enterprise as that will allow the company to do any kind of business in Nigeria. However, enterprise is more expensive.
PCN Requirements
Same as registration requirement for retail, distribution and importation outfit and shall also include:
1. List of products to be manufactured;
2. Organogram;
3. List of staff qualifications and duties;
4. Factory layout;
5. Production flow chart;
6. List of equipment in production and quality control department;
7. Source and water treatment facilities
8. Water analysis report of raw and treated water;
9. List and source of suppliers of raw materials and packaging materials;
10. Standard Operating Procedures (SOP);
11. Standard Cleaning Procedures;
12. Inspection fees-Draft
Note: All Correspondences with the Council must be on the Company’s letter head paper.
On receipt of the above named documents, inspection of the above pharmaceutical premises shall be carried out to ensure compliance with the regulation requirements for the registration of such premises.
Also note that the National Agency for Food and Drugs Administration and Control (NAFDAC) has a complementary role to play in this registration.
NAFDAC Requirements
Approval of the company by PCN will open the doors to apply to NAFDAC. The requirements of NAFDAC are more complex.
Application For Inspection
1.1 An application for Pre-registration Inspection should be made on the company’s letter-headed paper and addressed to: The Director-General (NAFDAC) through the Director, Drug Evaluation & Research Directorate.
Read Also: Structure and function of NAFDAC
The following information must be included in the pre-registration inspection letter;
* The exact location address (NOT P.O. Box) of the proposed factory
* functional e-mail address
* telephone number(s)
* products intended for registration (including the active ingredients, strengths, dosage form and pack sizes) should be stated.
1.2 the following supporting documents should be submitted together with the pre-registration inspection letter:
* Evidence of acceptance of product trademarks by Trademarks Registry.
* Artwork of product labels including Product Information Leaflets where applicable.
* If the application is approved, the company will be given the go ahead to start paying the processing fee.
Find out the processing fee. It varies depending on the product and other factors. Pay using remita.
1.3 Scheduling Of Facility For Inspection
The following documents should be made available during the inspection
* Copy of Letter of Authority to Manufacture on the formulation line
* Current Annual Licence to Practice of all Pharmacists in the company issued by the PCN.
* Batch Manufacturing Record & Batch Packaging Record for the products to be registered.
* List of all company SOPs
* SOPs for Production-related processes
* SOPs for Quality Control processes
* SOPs for Quality Management activities
* SOPs for Material Management
* SOPs for Equipment Cleaning and Maintenance
* SOPs for Packaging and Labelling operations
* Documentary evidence of Production Process Validation for the products to be registered.
* Documentary evidence showing Cleaning Validation of process equipment
* List of Production and Quality Control equipment and their sources of purchase
* Retainership Agreement with a Hospital or Clinic (with names and signature of both parties.
Read Also: Process Of Drug Production
* Certificates of Medical Fitness for personnel which should include at least the following test:
1. Sputum Culture and Sensitivity
2. Urinalysis
3. Stool Microscopy
4. Chest X-ray
5. Widal Test
6. Penicillin Hypersensitivity (for personnel in Beta-Lactam manufacturing facilities)
* Certificates of Analysis of Raw Materials and Finished Products.
* Product(s) Labels including Product Information Leaflets where applicable
* Any other relevant documents
To register a production company in Nigeria is straight forward. If you have any questions, you can contact me through the contact form or have your say.
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