Process Of Drug Registration And Importation With NAFDAC In Nigeria

NAFDAC registration

The way pharmacist seeks for information on how to start a new business is encouraging. In this blog, I have covered how to start a community pharmacy business and a patent medicine shop. In this post, I will focus more on how to import drugs into the country.

Most at times, an importer technically becomes the mega-distributor. There are four chains in the new line of drug distribution in Nigeria which is;

• Manufacturer/importer

1. Mega distribution centres
2. Coordinated whole sales centres
3. Wholesales centers
4. State drug distribution centres

To start an import/distribution business of drugs in Nigeria, the pharmacist must work hand in hand with three regulatory bodies. They are the Pharmacists Council Of Nigeria (P.C.N), the National Agency For Food And Drug Administration And Control (N.A.F.D.A.C) and finally the Cooperate Affairs Commission (C.A.C).
Read Also: Tips On Starting Off A Community Pharmacy Shop In Nigeria
Normally, a pharmacist who wants to import drugs should have gotten the requirements for PCN and CAC before going to NAFDAC. Those details have been covered in a previous post in this blog when I talked about how to start community pharmacy in Nigeria. Let us go over them again briefly.

Registration Of A Pharmaceutical Company With CAC

A person who wish to import drugs must register a business as a pharmaceutical company with CAC. Alternatively, appoint a duly registered pharmaceutical company in Nigeria using a power of attorney, authorising it to act on their behalf. Registration as a pharmaceutical company must comply with the requirements of the Pharmacists Council of Nigeria ("PCN").

Registration Of Pharmaceutical Company Premises

The next stage is registration of a premises otherwise knows as the store or warehouse where the imported good will be stored. The premises must meet NAFDAC and PCN requirements and must be duly registered by both body.

Registration Of Imported Product With NAFDAC

There are two processes in NAFDAC, which are;

1. Application to bring in samples and
2. Application for full registration

To save you the risk of spending and then getting the product rejected, it is best to start with the basics, which is the first step. The process involves an application to bring in samples into the country.

Application To Bring Samples

The pharmacist must send in three samples from three batches. To do this, it is important to import just these products. Since the product is new in the country and not yet legal, it is very vital to apply for clear and forwarding at the port. This requires authorization from quality control services. Failure to do this can get you arrested. The forms needed are the certificate of analysis from the manufacturer and certificate of manufacture and free sale issued by the regulatory body of the country of origin and authenticated by the Nigerian Mission (N.M) in that country. Where there is no NM, the British High Commission (B.H.C) or an Economic Community of West African State (E.CO.W.A.S) country mission authenticates it. These should be submitted to NAFDAC office.
Once the products gets here, the product(s) are analyse for quality and efficacy. This is very common for drugs that have little or no scholarly (articles) pieces of information on its effectiveness in blacks’ race even if it is effective in other countries. The period of analysis can range from months to years depending on many factors such as the method employed to do the analysis.
After analysis, NAFDAC officials will have to travel to the country where the drug is produced to inspect the manufacturing plant if it conforms to good manufacturing practice. This is only possible when you have submitted evidence that the manufacturers have documented files that permit them to manufacture drugs in their respective country which include;

• Manufacturers’ certificate.
• Evidence of good manufacturing practice.
• Evidence of certificate of pharmaceutical product that conforms to World Health Organization (W.H.O) format.
• Letter of invitation from the manufacturer to inspect factory abroad with full name and location of plant.

The manufacturing company should provide you with all these pieces of documents.

Another thing to note is that many of the manufacturing companies in Indian and China already have NAFDAC approve number. If the manufacturing plants already have a NAFDAC approve number, this stage is bypass.
Before you actually begin the journey in Nigeria for full registration, there are things you must put in place which is file evidence of power of attorney from the manufacturer, which authorise the pharmacist to act in such capacity as an importer of their products. This power of attorney must be notarized in the country of origin by a Notary Public and submitted to NAFDAC. For those who wish to import different drug products from the same manufacturer, the process must be repeated. For those who want to import different drugs from different manufacturers, the whole process will also be repeated.
Before renting or building a premise, one should do well to visit PCN and NAFDAC websites on guidelines on the requirements of a premise to be approved. The premise is where the drug will be stored before onward distribution. However, for drug manufacturers, their guidelines are more stringent to meet good manufacturing practice.
CAC register the business and its name in the country. That is the first step to take. This is followed by registration of the premise for the business by the PCN. The premise must follow PCN guidelines before it will be approved. Lastly, the premise, the drug to be imported must be approved by NAFDAC.

Application For Full Registration

The second phase will require the pharmacist to register the product with NAFDAC using an application form (form D-REG/001) together with a written application. This application is sent to the director registration and regulatory affairs. All vital pieces of information must be included in the form such as the generic name, the name of the manufacturer etc.
If the product is approved, the pharmacist must get hold of;

• Evidence of pre-production inspection/certificate of recognition issued by NAFDAC. This is issued after successfully inspecting the premise. Others are;
• Certificate of incorporation of the company issued by the CAC.
• Comprehensive certificate of analysis of the batch of the product submitted for registration from the manufacturer stating the name and date of the analysis.

Read Also: The Cost Of Starting A Community Pharmacy At Different Location In Nigeria

If the application is successful, a validity period of five years is granted for normal drugs and two years for drugs products with a listing.
Every pharmacist going into importation business must have the following, which must be submitted;

• Copy of his annual licence.
• Copy of current certificate of registration and retention of premise.
• Evidence of membership of states traditional medicine board (Herbal Medicines).
• Technical documentation (Herbal medicines).
• Evidence of Pharmaceutical Manufacturers’ Group of the Manufacturers Association Of Nigeria (P.M.G-M.A.N) membership.
• Three dossiers made out in accordance with the agency’s format.

The following must be noted from the very beginning;

1. New drugs with less therapeutic effects compared to others in the country may be rejected.
2. Labeling must comply with the guidelines in Nigeria.
3. Name must not bear similar resemblance with existing drug name in the country.
4. Drugs include medical devices, vaccines, chemicals, pesticides etc.

After approval for importation, many drug manufacturers require a minimum number of supply per month. For example, some companies require a distributor to buy at least 1000 cartoons every month. Failure to do this will get the person kicked out of the programme.

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