Importing Packaged Medicaments into Nigeria: What You Must Know

The Nigerian government regulates the importation of all medicinal products into Nigeria. All imports must be in compliance with the National Agency for Food and Drug Administration and Control (NAFDAC) Guidelines on the Import, Production, Distribution and Marketing of Medicinal Products in Nigeria. These guidelines are created to protect Nigerians from fake or tainted imported medicines which may have been manufactured without following good manufacturing practices. In order to import packaged medicaments into Nigeria you must get a permit from NAFDAC.

Listed here are some information you should know about the process:

The Import Permit from NAFDAC

To import packaged medicaments into Nigeria, you must first get a permit from NAFDAC. You will need to submit a completed permit application form to NAFDAC. The permit application should include the following information:

The name and address of the importer

The name and address of the manufacturer

A list of all products to be imported

The quantity and brand name of the products to be imported

The country of origin for the products

The purpose of importation

The address where the products will be stored and distributed

An indication of the packaging and labelling requirements for the products

NAFDAC will then review your request for an import permit and notify you if it is approved or not. If your request is approved, NAFDAC will also provide you with a permit corresponding to your request.

What is a “packaged medicament”?

“Packaged medicaments” in the Nigerian context is a drug product in a finished dosage form, in a commercial container or pack.

“Packaged medicaments” in this context includes but is not limited to oral, parenteral, ophthalmic, nasal, topical, vaginal, rectal, and pharyngeal products.

“Packaged medicaments” does not include biologicals, blood and blood products, vaccines, or radiopharmaceuticals.

What are the requirements for importing medicine in Nigeria?

You must provide the following:

1. A completed “Application for Permit to Import Medicament”

2. A completed “Application for Import License” with the fee of N200,000

3. Two copies of the label with the generic name of the product and the manufacturer’s details

4. Details of the manufacturer

5. The quantity of the product to be imported

6. The name and address of the importer

7. A copy of the invoice for the goods to be imported

8. Copy of a certificate of analysis of the goods to be imported

9. Copy of a certificate of quality control of the goods to be imported

10. Copy of a certificate for good manufacturing practice for the goods to be imported

11. Two copies of a packing list with details on quantity, item, and quantity in each pack

12. Three copies of a certificate of analysis from a recognized laboratory which is accredited by NAFDAC<><>

Importing Medicines for Personal Use

Nigerians can import medicines for personal use from the United States, Canada, the United Kingdom, and other European Union countries.

In order to import medicines from these countries you must have a valid prescription from the doctor who prescribed the medicine. The doctor must sign a letter of prescription which should be addressed to the container sealer. The container sealer will then send the letter to NAFDAC for verification.

Once NAFDAC confirms that the letter is authentic, they will send a letter of approval with the permit number to the container sealer.

It is important to note that if you are importing medicines for personal use you cannot sell or distribute them in Nigeria.

Conclusion

With all this information you should be well equipped to import packaged medicaments into Nigeria. Remember to always comply with the guidelines set out by the Nigerian government and NAFDAC.