Guidelines for warehouse inspection by Nigeria’s NAFDAC
GUIDELINES FOR WAREHOUSE INSPECTION BY NIGERIA’S NAFDAC
Lex Artifex LLP, ferma lege in Nigeria, has introduced the F&D Helpdesk to assist individuals and companies involved in the manufacturing, distribution, exportation, and importation of regulated food and drugs in meeting the requirements set by Nigeria’s National Agency for Food and Drug Administration and Control (“NAFDAC"). This publication gives a snapshot of the regulatory guidelines for food and drug warehouse inspection by NAFDAC.
Warehouse inspection is a prerequisite to issuance of Chemical Import Permit or Listing certificate (authorization to market chemicals).
· A formal application by the company must be made for warehouse inspection
· The letter of application must include the names of the chemicals, the quantities of the chemicals and uses for which the chemicals are intended.
· The Application must be signed by Managing Director/CEO or the Technical Officer of the company.
DOCUMENTS REQUIRED FOR WAREHOUSE INSPECTION BY NIGERIA’S NAFDAC
The following documents are required:
1. Evidence of company registration
2. Certified true copy of Memorandum and Articles of Association of the company.
3. Evidence of particulars of directors of the company
4. Two (2) passport photographs of the technical officer with name and company written on the back of the passport.
5. Evidence of the appointment letter, acceptance letter, and credentials of the technical officer.
6. Standard Operating Procedure (SOP) for storage/handling of chemicals duly signed by Managing Director/CEO or Technical officer with name and designation.
7. Evidence of payment for Warehouse inspection.
8. Evidence of payment of rent for a minimum of one year or evidence of ownership in case of companies using their own warehouse.
9. Evidence of previous Listing Certificate. (Not applicable to new applicants)
10. Evidence of previous Chemical Import Permit indicating importation and Permit to clear (Not applicable to new applicants).
11. Evidence of sales (invoice) and local purchase. (Not applicable to new applicants)
12. Stock and disposal records. (Not applicable to new applicants)
13. Evidence of waste disposal
14. List of customers indicating full contact address (no P.O. Box), phone number, email and status (marketer or end-user). (where applicable)
15. Medical Fitness Certificate for the technical officers (this should be done biannually).
· Submission of application and review of documents
Through appointment as legal representatives and solicitors, Lex Artifex LLP can assist food and drug manufacturers, SpA, importers and distributors in filing the application and all the required documents with the relevant authority in Nigeria.
· Warehouse Inspection as scheduled.
· Processing of Permit
Upon satisfactory inspection of the warehouse, the Permit applied for is processed.
For unsatisfactory inspection, a Compliance Directive is issued within two (2) work days.
· Payment of the prescribed tariff
TIMELINES FOR WAREHOUSE INSPECTION BY NIGERIA’S NAFDAC
· A processing period of fifteen (15) business days from the time of submission of the application should be allowed.
· The timeline for processing is suspended when there is a compliance directive and shall resume when the applicant complies and communicates compliance with the Agency.
· Warehouse Inspection is conducted annually for importers and marketers of restricted and agrochemicals. It is conducted every 2 years for importers and marketers of industrial and laboratory chemicals.
· Timeline stops once compliance directive is issued.
All documents must be in English language.
REGULATORY REQUIREMENTS FOR WAREHOUSE INSPECTION BY NIGERIA’S NAFDAC
1. A technical officer with scientific background with a minimum of Ordinary National Diploma; OND or its equivalent shall be responsible for explaining and discussing the exact chemical nature and use of the items for which application is submitted. He is also responsible for the handling and storage of the chemicals.
2. The Technical officer must be present during inspection of facility and must be the officer whose passport photograph was submitted.
3. No technical officer is allowed to represent more than one company (subsidiaries included).
4. Companies with foreign technical officers must submit work permit.