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NAFDAC | March 13, 2015

Guidelines for importing drugs and related products into Nigeria are intended for:

  • General public importing registered pharmaceuticals into Nigeria
  • Importers of registered pharmaceuticals into Nigeria
  • Importers of registered medical equipments into Nigeria

Pharmacists  and retention of premises licenses issued by Pharmacist Council of Nigeria

are exempt documents for clearance from the port of entry.

Nigeria only allows importing drugs by the pharmaceuticals companies that had  registered the product. Only drugs and other related products, that are registered in accordance with the provision Act Cap F33 LFN and accompanying guidelines can manufacture, import, export, advertise, sell or distribute in Nigeria.

Importation of unregistered or registered drugs that are not registered in accordance of the above mentioned Act shall be considered as a violence.

Vaccines and biologicals have to be maintained in functional cold chain monitoring devices at port entry and must be maintained in accordance with the suitable conditions at company's warehouse.

To import drugs and other related products into Nigeria you will need to meet 3 kinds of requirements:

  1. Application
  2. Documentations
  3. Tariff

And there 3 phases you have to go through to Import drugs and other related concerns into Nigeria:

  1. Presenting Documents for Pre-Release "First Stamp"
  2. Physical Examination
  3. Release of Consignments from The Port of Entry

Requirements :

1. Application :

To import any drug into Nigeria you have to apply with the NATIONAL AGENCY FOR FOOD & DRUG ADMINISTRATION & CONTROL (NAFDAC). The application has to be by the companies that registered the product(s) with NAFDAC or if the company is granted “Letter of Authorization” by the party that registered the products.

All such importations are restricted to only registered source(s) as stated on the Product Registration Certificate(s).

Before the consignment arrives at the port the applicant must have available the following pre-shipment information to the Inspections Directorate of NAFDAC before any drugs arrives in Nigeria from any part of the world:

  • Name of the drug product(s)
  • Manufacturer’s Name and Address
  • Quantity being imported
  • Various pack sizes, strength of the drug(s) and the dosage form
  • Batch number(s), Manufacture and Expiry dates
  • Conveying Vessel and expected date of arrival

2. Documentations :

To import drugs into Nigeria you will need the Annual License to Practice as a Pharmaceutical Chemist, issued by Pharmacist Council of Nigeria of the current pharmacist and/or  the Current Premises/Retention Certificate issued by Pharmacist Council of Nigeria.

Photocopy of Narcotics Permit to import and Permit to clear (where applicable).

Evidence of valid product registration certificate with NAFDAC and Certificate of Analysis (Original) issued by the manufacturer.

To obtain the "First Stamp" you will need the following documents:

  • Single Goods Declaration (SGD) Form
  • Commercial Invoice
  • Risk Assessment Report
  • Form M
  • Bill of Lading/Airway Bill
  • Packing List

To ensure safety, quality and efficacy of drugs NAFDAC appointed analysts to inspect and analyze products in following countries before shipment into Nigeria as follows:

India

QCS Consultant

China

NHU Labs Ltd.

Egypt

Inspection & Testing Group (ITG)

 

Before shipping into Nigeria all drugs and related products from the listed countries should be issued "Clean Report of Inspection and Analysis".

You have to make sure that all the above mentioned documents have their original copy sighted.

3. Tariff :

All payments to the Agency must be in bank draft in favor of National Agency for Food and Drug Administration & Control and the following fees, as appropriate should apply per product covering inspection and analysis :

Inspection fee per consignment (Packaged goods in not more than 20ft container) of

Product Type

Amount (Naira)

Ethical drug (prescription)

20, 000 + 5% VAT

OTC drug (non-prescription)

100, 000 +5% VAT

Vaccine(s) or biological product(s)

10, 000 + 5% VAT

Medical devices

10, 000 + 5% VAT

Cosmetic products

20, 000 + 5% VAT

 

Laboratory Analysis fee per product of

Product Type

Amount (Naira)

Ethical drug (prescription)

50, 000 + 5% VAT

OTC drug (non-prescription)

200, 000 + 5 % VAT

Vaccine(s) or biological product(s)

40, 000 + 5 % VAT

Medical devices

25, 000 + 5 % VAT

Cosmetic products

50, 000 + 5 % VAT

 

Phases :

1.Presenting Documents for Pre-Release "First Stamp":

In the first phase of importing drugs and other related goods into Nigeria the first phase it to get "First Stamp" on the Single Good Declaration (SGD) form. Before the Pre-Release "First Stamp" is endorsed on the original SGD form the followings are required with the previously mentioned documents:

  • A letter of undertaking stating that the product(s) will be forfeited if found unsatisfactory
  • The address of warehouse where product will be stored.

You will also need evidence of payment for the imported consignment.

 2. Physical Examination :

After the consignment arrives in Nigeria it goes through physical examination. This examination is conducted by NAFDAC with other relevant government agencies at the port entry.

Samples of the imported product(s) should be drawn during physical examination by NAFDAC and sent to to the relevant NAFDAC laboratory for analysis within 24 hours of drawing such sample. One-third (1/3) of the sample drawn should be given to the superintendent pharmacist of the company as retention sample.

3. Release of Consignments from The Port of Entry :

While the imported drugs goes through the physical examination process and waits for satisfactory

Laboratory analysis, they are sent to the importer's warehouse. The drugs cannot be marketed until it gets the satisfactory Laboratory analysis. It takes about 10 working days from the date of samples collected to get the satisfactory Laboratory analysis result. The analysis is done by NAFDAC.





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