The National Agency For Food and Drug Administration and Control (NAFDAC) Guidelines For The Registration Of Pesticides in Nigeria are for the interest of the general public in particular and manufacturers of pesticides made in Nigeria.
This article will be looking at the provisions of these guidelines.
Definitions of Terms
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“PESTICIDES” include:
– Herbicides, Insecticides, Rodenticides, Fungicides, Molluscides Nematicides, Repellents, Attractants, Insect growths regulators, Fumigants and Plant growth regulators. These are used in agriculture, public health, horticulture, and food storage.
-While some of the chemicals may be used without great hazard to health, others are so toxic that their use must be strictly controlled to protect humans, animals, and the general environment.
-Some pesticides quickly disappear or are broken down into harmless degradation products (they are environmentally friendly).Others persist after application and may breakdown to form even more poisonous products. Since unsafe levels may appear in foods, such as food crops, milk & meat products, it becomes imperative that the levels of pesticides in these products should be regulated and controlled.
– It is necessary to emphasize that, no Pesticide product shall be manufactured, imported, advertised, offered for sale, distributed or used in Nigeria unless it has been registered in accordance with the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related Legislations and the accompanying Guidelines.
-NAFDAC will not entertain new applications for the registration of imported regulated products on the Federal Government Import Prohibition List and NAFDAC Banned List.
Applications
Step 1 – Documentation
The following documents are uploaded on the NAPAMS portal after successful submission, all original documents will be presented upon request :-
– The application letter and print-out of the registration form are to be accompanied with two (2) sets of the following documents are to be submitted at the Liaison Office of the Director (LOD), R & R Directorate, NAFDAC:
- Evidence of Business Incorporation by Corporate affairs Commission (CAC).
- Evidence of payment to the Agency.
- Contract Manufacturing Agreement (where applicable).
- Evidence of Registration of Brand Name with Trademark Registry in the Ministry of Industry, Trade and Investment. This should be done in the name of the owner of the Trademark/Brand name as the case may be (where applicable).
- Evidence of satisfactory Inspection issued by the relevant Directorate or Good
Manufacturing Practice (GMP) certificate for product line (companies with registered products).
- Label or artwork of the product (should conform to Pesticide Labelling Guidelines).
- A Comprehensive Certificate of Analysis. The certificate of analysis must be presented on a letter-headed paper of the Quality Control Laboratory where the sample was tested/evaluated and should contain the under listed information:
a). The brand name of the product
b). The batch number of the product
c).The manufacturing and expiry dates
d). The name, designation and signature of the analyst
e). For more Information on the Inspection of manufacturing facility, applicants should visit the Veterinary Medicine and Allied Products Directorate section of the Agency’s website.
Step 2 – Product Approval Meeting
– Upon satisfactory Documentation review, GMP inspection of the production facility and laboratory analysis of product, products are presented for Approval Meetings.
– For products labels with compliance issues, compliant artworks may be submitted with a commitment letter from manufacturer stating that the commercial products will be in compliance.
Step 3- Issuance of Certificate
– For products approved at the meeting, an electronic Certificate of Product Registration is issued to the Applicant.
Labelling Information
– Labelling should be informative, accurate and in conformance with the Agency’s Pesticide Registration Regulations or any other relevant Regulations.
Tariff
As directed by NAFDAC.
Notes
It should be noted that :-
– It is the responsibility of the applicant to ensure safe disposal of all expired stock in consultation with the appropriate Government bodies.
– Local field trials under appropriate tropical climatic conditions for adaptability may be required for pesticides with insufficient safety and efficacy data in Nigeria.
– Failure to comply with these requirements may result in the disqualification of the application or lead to a considerable delay in the processing of a registration application.
– A successful application will be issued a Certificate of Registration with a validity period of five (5) years.