September 17, 2019

NATIONAL AGENCY FOR FOOD & DRUG ADMINISTRATION & CONTROL PORTS INSPECTION DIRECTORATE

GUIDELINES FOR CLEARANCE OF IMPORTED CHEMICALS, PHARMACEUTICAL RAW MATERIALS AND RAW MATERIALS FOR OTHER REGULATED PRODUCTS IN NIGERIA

NAFDAC/PID/003/00

A. GENERAL
1. These guidelines are for the interest of the general public and in particular importers of all types of chemicals and raw materials used in the manufacture of regulated products in Nigeria.
2. Importation of chemicals, pharmaceutical and other raw materials should be by companies that manufacture regulated products in Nigeria and /or companies with approvals from NAFDAC.
3 It is necessary to emphasize that, no drug and related products shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with the provisions of decree 19 of 1993 (as amended) and the accompanying guidelines.
4 Please note that the importation of unregistered Agrochemicals or registered Agrochemicals by persons or companies other than the party that registered them or authorized by the party that registered them shall be regarded as a violation.
B. APPLICATION FOR REGULATED PRODUCTS
1 The applicant should notify NAFDAC in writing for the importation of chemicals, cosmetics and pharmaceutical raw materials on its official letterhead.
2 All companies importing chemicals, pharmaceutical raw materials and other raw materials must posses the due permit from the Narcotics and Controlled Substances Directorate, NAFDAC. However, pharmaceutical companies duly registered with the Pharmacists Council of Nigeria can import these substances without obtaining chemical permit with the exemption of Narcotics and Controlled chemical substances.
3 All controlled chemicals require a special permit from Narcotics and Controlled Substances Directorate, NAFDAC.
C DOCUMENTATION
1 The importer should make available to Ports Inspections Directorate, NAFDAC the following documents
i.     Copy of Narcotics Permit to import (where applicable)

ii.   Copy of Permit to clear (where applicable)

iii.  Evidence of valid product registration certificate with NAFDAC (where applicable)

iv. Original Certificate of Analysis issued by the manufacturer

2. The shipping documents should be submitted for obtaining “First Stamp”:

i. Single Goods Declaration (SGD) Form,

ii. Commercial Invoice

iii. Risk Assessment Report

iv. Form M

v. Bill of Lading/Airway Bill

vi. Packing List

3.  The Current Pharmacist’s Annual License to Practice as a Pharmaceutical Chemist issued by Pharmacist Council of Nigeria (where applicable)

4.  The Current Premises/Retention Certificate issued by Pharmacist Council of Nigeria (where applicable)

5. Originals of all the above documents should be sighted.

D.  TARRIFF

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

a. Inspection fee per consignment of an Agrochemical is Twenty thousand naira (N20, 000.00) plus 5% VAT

b. Laboratory Analysis fee per product of an Agrochemical of Fifty thousand naira (N50, 000.00) plus 5% VAT

a. Inspection fee per consignment of an Agrochemical is Twenty thousand naira (N20, 000.00) plus 5% VAT

b. Laboratory Analysis fee per product of an Agrochemical of Fifty thousand naira (N50, 000.00) plus 5% VAT

c. Chemicals less than 100MT            –           N5,000.00       Plus 5% VAT

d. Chemicals less than 1000MT          –           N20,000.00     Plus 5% VAT

e. Chemicals less than 2000MT          –           N50,000.00     Plus 5% VAT

f. Chemicals less than 4000MT          –           N100,000.00   Plus 5% VAT

g. Chemicals less above 4000MT        –           N150,000.00   Plus 5% VAT

h. Analysis fees per product –           N 5, 000.00     Plus 5% VAT

E.  PRESENTATION OF DOCUMENTS FOR PRE-RELEASE FIRST STAMP

1. In addition to the earlier listed documents, the following are required before a pre-release first stamp is endorsed on the original SGD Form.

i. A letter of undertaking stating that the product(s) will be forfeited if found unsatisfactory,

ii. The raw materials will be used to manufacture product(s) registered by NAFDAC,

iii. The address of warehouse where product will be

2.  The original SGD form after endorsement should be taken to the Custom Processing Unit at the relevant port of entry.

3. Evidence of payment for the imported consignment

F. PHYSICAL EXAMINATION

      1. Physical examination of the consignment should be conducted by NAFDAC Regulatory Officers with other relevant Government Agencies at the Port of Entry.
      2. Samples of the chemical, pharmaceutical or other raw materials (where applicable) should be drawn during physical examination by NAFDAC Regulatory Officers and forwarded to the relevant NAFDAC laboratory for analysis within 24 hours of drawing such samples.
      3. Official sample receipt should be issued to the importer or representative of the importer for the samples drawn from the imported consignment.

G. RELEASE OF CONSIGNMENT FROM THE PORT OF ENTRY

      • The raw material(s) should be released to the importer’s warehouse pending satisfactory Laboratory analysis which is within a period of ten work days from the date of sample collection.
      • The raw material/chemicals can only be offered for sale/use after a satisfactory Laboratory analysis

H. CORRESPONDENCE

All correspondence in respect of importation of Chemicals, cosmetic and pharmaceutical and other raw materials should be addressed to:

The Director,

Ports Inspections Directorate, NAFDAC

NAFDAC Laboratory Complex, Edmund Crescent, Medical Compound, Yaba, Lagos.

E-mail address: portsinspections@nafdac.gov.ng

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