Guidelines for Warehouse Inspection by Nigeria’s NAFDAC

Guidelines for warehouse inspection by Nigeria’s NAFDAC

GUIDELINES FOR WAREHOUSE INSPECTION BY NIGERIA’S NAFDAC

Lex Artifex LLP, regsfirma in Nigerië, ingestel die F&D Helpdesk aan individue en maatskappye wat betrokke is in die vervaardiging help, verspreiding, uitvoer, Vereistes vir voedsel- en dwelmregistrasie in Nigerië ("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).

STAP 1

· A formal application by the company must be made for warehouse inspection

· The letter of application must include the names of the chemicals, die hoeveelhede van die chemikalieë en gebruike waarvoor die chemikalieë bedoel is.

· The Application must be signed by Managing Director/CEO or the Technical Officer of the company.

DOKUMENTE BENODIG VIR PAARHUISINSPEKSIEBYNIGERAE28099SNAFDAC

Die volgende dokumente word vereis:

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), telefoon nommer, email and status (marketer or end-user). (waar van toepassing)

15. Medical Fitness Certificate for the technical officers (this should be done biannually).

STAP 2

· Submission of application and review of documents

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

STAP 3

· Warehouse Inspection as scheduled.

STAP 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) werksdae.

· 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

• Personeel

1. A technical officer with scientific background with a minimum of Ordinary National Diploma; ONDof die ekwivalent daarvan sal verantwoordelik wees om die presiese chemiese aard en gebruik van die items te verduidelik en te bespreek waarvoor die aansoek ingedien word. Hy is ook verantwoordelik vir die hantering en berging van die chemikalieë.

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 (filiale ingesluit).

4. Companies with foreign technical officers must submit work permit.

• Fasiliteit

Ligging

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.

stoor

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, ventilasie, 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, lotnommer, production date and expiry date, name and the address of the manufacturer, Hazard symbols, land van oorsprong, net content/weight, viskositeit, soortlike gewig, 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. dokumentasie

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.

KOSTE op registrasie by NAFDAC

Vrugtesap en nektarregulering van Nigerië, kontak ons ​​met die beskrywing of beeld van die spesifieke produk(s) probeer om te registreer, en ons sal die kosteberamings vir jou stuur. E-pos aan lexartifexllp@lexartifexllp.com, WhatsApp +234 803 979 5959.

OOR LEX Artifex LLP

Lex Artifex LLP is die venster vir vervaardigers, uitvoerders, en verspreiders van gereguleerde Food and Drug produkte soek lisensiëring in Nigerië en wat toegang verlang tot die Nigeriese mark. Ons is 'n eenstopwinkel vir regsdienste nakoming en due diligence in Nigerië. Ons bied kliënte met wetlike leiding deur elke stap van die handel proses en buite.

Om meer te wete te kom oor die Lex Artifex LLP se F&D Helpdesk and how we can help you with your food and drug warehouse inspection by Nigeria’s NAFDAC, stuur 'n epos: lexartifexllp@lexartifexllp.com; oproep +234.803.979.5959.