Guidelines for warehouse inspection by Nigeria’s NAFDAC GUIDELINES FOR WAREHOUSE INSPECTION BY NIGERIAN’S NAFDAC Lex Artifex LLP, law firm 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). STEP 1 · 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 NIGERIAN’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). STEP 2 · Submission of application and review of documents Through appointment as legal representatives and solicitors, Lex Artifex LLP can assist food and drug manufacturers, exporters, importers and distributors in filing the application and all the required documents with the relevant authority in Nigeria. STEP 3 · Warehouse Inspection as scheduled. STEP 4 · 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 NIGERIAN’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 A FOOD AND DRUG WAREHOUSE Personnel 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. Facility Location 1. Storage and handling of chemicals in residential buildings and or area is prohibited 2. Applicants shall have a warehouse that will be inspected for adequacy and appropriateness for the storage of chemicals. 3. The facility provided will depend on the nature of the chemicals stored. 4. Commercial warehouses are not allowed for storage of restricted and agrochemicals. Storage 1. The facilities provided will depend on the nature of the chemicals in the warehouse. Some chemicals are required to be stored under controlled (below ambient) temperature to maintain their potency for the validity period. 2. Companies that intend to store thermo-labile (heat sensitive) chemicals should provide a cold room/refrigerators, cold boxes or an air-conditioned room depending on the specific temperature required. 3. Other facilities required for chemical storage include adequate illumination, ventilation, provision of pallets, First Aid Facilities, Personal Protective Equipment, and Fire extinguishers. 4. Chemicals should be stacked on pallets away from the walls with adequate space for movement within the warehouse. Status labels should be used accordingly. 5. Food grade chemicals or pharmaceutical raw materials should be separated from industrial chemicals. 6. Expired, obsolete or damaged chemicals should be separated, quarantined, documented and reported to the Agency. 7. Flammable chemicals should not be stored close to sources of ignition or sparks. 8. Chemicals that can be easily oxidized should be kept away from oxidizing agents. Labeling Information on the Chemicals 1. All Chemicals should be properly labeled according to the Globally Harmonized System (GHS) of labeling and classification of Chemicals. 2. Chemicals should be labeled in English and should include but not limited to the following-Brand/Generic name, batch number, production date and expiry date, name and the address of the manufacturer, Hazard symbols, country of origin, net content/weight, viscosity, specific gravity, flammability, percentage purity. Safety Requirements 1. Personnel are to be provided with nose masks, hand gloves, eye goggles, overalls, and safety boots. 2. Appropriate water supply should be in place. 3. First aid box and fire extinguishers are to be placed at strategic locations. 4. Condition monitoring devices are to be provided for sensitive chemicals. 5. Documentation 6. Companies should keep proper records of chemicals imported, sold and or purchased locally 7. (Disposal/utilization records). 8. Disposal records of expired chemicals should also be kept with a certificate of destruction issued by authorized agencies. ABOUT LEX ARTIFEX LLP Lex Artifex LLP is the window for manufacturers, exporters, and distributors of regulated food and drug products seeking licensing in Nigeria and seeking access to the Nigerian market. We are a one-stop shop for legal compliance and due diligence services in Nigeria. We provide clients with legal guidance through every step of the trade process and beyond. To learn more about the Lex Artifex LLP's F&D Helpdesk and how we can help you with your food and drug warehouse inspection by Nigerian’s NAFDAC, please email: lexartifexllp@lexartifexllp.com; call +234.803.979.5959.

Guidelines for warehouse inspection by Nigeria’s NAFDAC

GUIDELINES FOR WAREHOUSE INSPECTION BY NIGERIA’S NAFDAC

Lex Artifex LLP, law firm 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).

STEP 1

· 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).

STEP 2

· Submission of application and review of documents
Through appointment as legal representatives and solicitors, Lex Artifex LLP can assist food and drug manufacturers, exporters, importers and distributors in filing the application and all the required documents with the relevant authority in Nigeria.

STEP 3

· Warehouse Inspection as scheduled.

STEP 4

· 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

  • Personnel

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.

  • Facility

Location
1. Storage and handling of chemicals in residential buildings and or area is prohibited
2. Applicants shall have a warehouse that will be inspected for adequacy and appropriateness for the storage of chemicals.
3. The facility provided will depend on the nature of the chemicals stored.
4. Commercial warehouses are not allowed for storage of restricted and agrochemicals.

Storage

1. The facilities provided will depend on the nature of the chemicals in the warehouse. Some chemicals are required to be stored under controlled (below ambient) temperature to maintain their potency for the validity period.
2. Companies that intend to store thermo-labile (heat sensitive) chemicals should provide a cold room/refrigerators, cold boxes or an air-conditioned room depending on the specific temperature required.
3. Other facilities required for chemical storage include adequate illumination, ventilation, provision of pallets, First Aid Facilities, Personal Protective Equipment, and Fire extinguishers.
4. Chemicals should be stacked on pallets away from the walls with adequate space for movement within the warehouse. Status labels should be used accordingly.
5. Food grade chemicals or pharmaceutical raw materials should be separated from industrial chemicals.
6. Expired, obsolete or damaged chemicals should be separated, quarantined, documented and reported to the Agency.
7. Flammable chemicals should not be stored close to sources of ignition or sparks.
8. Chemicals that can be easily oxidized should be kept away from oxidizing agents.

Labeling Information on the Chemicals

1. All Chemicals should be properly labeled according to the Globally Harmonized System (GHS) of labeling and classification of Chemicals.
2. Chemicals should be labeled in English and should include but not limited to the following-Brand/Generic name, batch number, production date and expiry date, name and the address of the manufacturer, Hazard symbols, country of origin, net content/weight, viscosity, specific gravity, flammability, percentage purity.

Safety Requirements

1. Personnel are to be provided with nose masks, hand gloves, eye goggles, overalls, and safety boots.
2. Appropriate water supply should be in place.
3. First aid box and fire extinguishers are to be placed at strategic locations.
4. Condition monitoring devices are to be provided for sensitive chemicals.
5. Documentation
6. Companies should keep proper records of chemicals imported, sold and or purchased locally
7. (Disposal/utilization records).
8. Disposal records of expired chemicals should also be kept with a certificate of destruction issued by authorized agencies.

ABOUT LEX ARTIFEX LLP

Lex Artifex LLP is the window for manufacturers, exporters, and distributors of regulated food and drug products seeking licensing in Nigeria and seeking access to the Nigerian market. We are a one-stop shop for legal compliance and due diligence services in Nigeria. We provide clients with legal guidance through every step of the trade process and beyond.
To learn more about the Lex Artifex LLP’s F&D Helpdesk and how we can help you with your food and drug warehouse inspection by Nigeria’s NAFDAC, please email: lexartifexllp@lexartifexllp.com; call +234.803.979.5959.