NAFDAC Guidelines for The Clearing of Imported Donated Items at Ports of Entry in Nigeria

The Guidelines of the National Agency For Food and Drug Administration and Control (NAFDAC) for the clearing of Imported Donated Items at Ports of Entry in Nigeria (forming the focus of this article) are for the interest of the general public and in particular importers of donated products into Nigeria.

It is necessary to emphasize that, no regulated product shall be manufactured, imported,advertised, offered for sale, distributed or used in Nigeria unless it has been registered in accordance with the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related legislations and the accompanying Guidelines.

The notable provisions of these guidelines are as follows:

Documentation For Clearance

– Applicants intending to clear donated items should submit an application letter on the company’s letter head addressed to the Director-General, NAFDAC.

– The following information should be attached to the application letter;

1. A Single Goods Declaration (SGD) Form

2. A Commercial invoice

3. PAAR (Pre-Arrival Assessment Report)

4. A Form M

5. A Bill of Lading/Airway Bill

6. Packing List

8. Letter of Undertaking stating that the product(s) will not be sold used until satisfactory laboratory report is out. The letter should also state that in event of the product(s) being  substandard or illegally imported, or unfit for human consumption, the product(s) will be forfeited to the Federal Government for destruction.
9. Evidence of approval from Director General, NAFDAC to import donation items.

9. Photocopy of payment advice.

10.Photocopy of NAFDAC Receipt of payment.

Physical Examination

– Physical examination of the consignment should be conducted by NAFDAC with other relevant goovernment agencies at the port of Entry or Importer’s premises warehouse where applicable.

– Samples of the imported product shall be drawn during physical examination by NAFDAC inspectorsand forwarded to the relevant NAFDAC laboratory for analysis.

Release Of The Consignment From The Port of Entry

– The finished pharmaceutical product should be granted second endorsement for release to the importer’s warehouse within 24 hours of sample collection.

– The Finished Pharmaceutical Product can only be marketed and used after a satisfactory laboratory evaluation.

Tariff

As advised by NAFDAC.

Notes

– The importation of unapproved donated items should be regarded as a violation.

– Imported donated items must be limited to the number and quantity of the product approved.

– Approval for importation can be obtained through a written application submitted to the Director-General,NAFDAC on the donor’s letter head paper, stating the following:

1. The profile of the donor

2. The purpose of the donation

3. The target population

5. The list of regulated products indicating the batch numbers, appropriate date markings and quantity
6. No donated item must be sold or distributed for sale to the public

6. The following conditions must be met for issuance of approval :

• Regulated products shall have a minimum of 6 months shelf life on arrival at any of the designated ports.
• Regulated products on Federal Government Import Prohibition List as published by the Nigerian Customs Service.
• Permits shall be obtained for restricted and controlled regulated products from the relevant directorates.

Timelines

– The timeline for cost assessment and issuance of payment advice is Ten (10) minutes.

– The timeline for issuance of 1st Endorsement is Thirty (30) minutes.

– The timeline for Physical inspection as determined by the Joint Task Force is Two (2) hours.

– The timeline for issuance of 2nd Endorsement is Fifteen (15) minutes.