REGISTRATION AND REGULATORY AFFAIRS DIRECTORATE
GUIDELINES FOR ADVERTISEMENT OF REGULATED PRODUCTS IN NIGERIA
1. These guidelines are for the interest of the general public and in particular, industries in Nigeria that have registered regulated products.
2. It necessary to emphasize that no regulated product shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with the provisions of ACT CAP F33 LFN 2004 (formerly decree 19 of 1993)) and the accompanying guidelines.
3. These guidelines are also to advise the stakeholders in NAFDAC regulated products to seek advert approval in advance of shooting.
4. Consumer promotions shall not be allowed for medicinal products.
5. Consumer promotions of other regulated products shall be valid for a maximum of fifteen (15) weeks.
6. Prescription-only-medicines (POM) shall be advertised only in medical/scientific journals.
7. All herbal medicinal products (without established clinical studies) labels and advert materials shall include the caveat, “these claims have not been evaluated by NAFDAC”.
8. All approved adverts shall be valid for one year from the date of approval.
1. The applicant should address a letter for advertisement and/or product launch on company’s letter head to the Director (Registration & Regulatory Affairs).
2. Applicant shall submit duly filled Application Form
1. The following documents shall accompany the application:
i) Two copies of the receipt for the purchase of the form(s),
ii) Evidence of product registration,
iii) A letter of introduction of Advert Agent from the Applicant, (where applicable)
iv) GSM telephone No. of the Applicant/Advert Agent.
2. Materials to be submitted are:
i) TV (Script/Storyboard),
ii) Radio (Script)
iii) Outdoor (Script/Artwork)
iv) Press (Script/Artwork)
v) Product samples in all pack sizes
vi) Recorded Advert messages in CD/VCD/DVD.
The labeling of all products must comply with the labeling requirements as registered.
All payments to the Agency should be in Bank Draft payable to National Agency for Food and Drug Administration and Control (NAFDAC).
1. Application Form per product: N250.00
2. New Application per product, per medium, per concept, per language N10, 000.00 + 5% VAT.
3. Revalidation/Renewal: per product, per medium, per concept, per language: N6000.00 + 5% VAT.
4. Consumer promotions per product, per medium, per concept, per language: N15, 000.00 + 5% VAT.
5. Corporate Advertisement per medium, per concept, per language:
i. 2-4 Products: N 20,000.00 plus 5% VAT
ii. 5-9 Products: N 70,000.00 plus 5% VAT
iii. > 10 Products: N 100, 000.00 plus 5% VAT
6. Variants per medium, per concept, per language:
Each product advert concept that mentions other product formulation(s) e.g. tablet, syrup, flavours of the same product is N 10, 000.00 plus 5% VAT for the major focus and N2,500.00 plus 5% VAT for each variant.
7. Same Advert for Press and Outdoor per product, per concept, per language: N 5, 000.00. plus 5% VAT.
8. Same concept in more than one language: N10, 000.00. plus 5% VAT per language.
1. Incomplete documentation shall lead to process delay.
2. Time line for advert processing shall be 20 work days.
All correspondences in respect of Advertisement should be addresses to the:
Central Laboratory Complex
Tel: 01-4772456, 01-4748627
NAFDAC Website: http://www.nafdac.gov.ng
E-mail address: firstname.lastname@example.org. «back to Laws and Treaties