Nigeria

I. HERBAL MEDICINE

According to Herbal Medicine and Related Products Labelling Regulations of 2019, dietary supplements are classified as "Herbal Medicine and Related Products".

Herbal Medicine is defined as:

(i)           finished medicinal product containing plant and their preparation presented with therapeutic or prophylactic claim and includes all preparations containing a plant material in part or wholly.

(ii)          preparation or admixture of herbal medicinal products presented with prophylactic or therapeutic claim; and

(iii)         preparations or mixtures used for restoring, correcting, or modifying organic functions in man or in animal

II. HERBAL MEDICINE REGISTRATION IN NIGERIA

Dietary supplements manufactured, imported, exported, advertised, sold or distributed in Nigeria must be registered in accordance with the provisions of The National Agency for Food and Drug Administration and Control (NAFDAC) Act CAP N1 (LFN) 2004.

According to The Guidelines for Registration of Imported Herbal Remedies/Dietary Supplements In Nigera and The Herbal Medicines and Related Products Registration Regulations 2019, the following documents must be provided:

Online NAFDAC Registration

• An online registration will be filed out by us, FCI.
• The completed online application needs to be printed on the company’s letterhead.

(i)           Registration Declaration

• This document must be notarized by a Notary in Nigeria.

(ii)          Power of Attorney from the manufacturer to the local applicant

• Issued by the manufacturer of the product.
• Signed by the MD, GM, Chairman or President of the Company.
• Stating the names of the products to be registered.
• Stating an ‘authority to register product with NAFDAC’.
• Stating the state ownership of brand name(s)/Trademark.
• This document must be notarized in the country of manufacturing. The document must be valid for at least 5 years.   

(iii)         Contract Manufacturing Agreement

• Stating names and designations of the signatories.
• Stating the names of all the products.
• Signed by both parties.
• This document must be notarized in the country of manufacturing.                

(iv)         Evidence of Business Incorporation in Nigeria

• Issued by the "corporate affairs commission" in Nigeria.                                             

(v)          Certificate of Free Sale

• Stating the name of the manufacturer. 
• Stating the product name(s).
• This document must be issued by a relevant health/regulatory body.
• This document must be authenticated by the Nigerian Embassy in the country of origin. In countries where no Nigerian Embassy or High Commission exists, any other Embassy or High Commission of any Common wealth or West African country can authenticate the document. 

(vi)         Certificate of Analysis matching the sample batch number

• In written, on the quality control laboratory letterhead.

(vii)        Evidence of registration of the brand name in Nigeria

• A Certificate of Registration of Brand Name with the ""trademark Registry in the Ministry of Commerce"" in Nigeria; and
• Evidence of Trademark approval from the ""Federal Ministry of Commerce & Tourism"" in Abuja. "                                  

(viii)       GMP or ISO certificate   

• Evidence of the Good Manufacturing Practice inspection for the manufacturer.          

(ix)         GMP invitation

• An invitation addressed to NAFDAC to inspect the factory abroad.
• Written by the manufacturer.                                                                             

(x)          Artwork label and leaflet insert

• The coloured artwork label for each product; and
• The coloured leaflet insert for each product.       

III. CONTENT AND OMPOSITION OF HERBAL MEDICINE IN NIGERIA

In Nigeria, there are no defined formulation regulations for herbal medicine.

Vitamins, minerals, enzymes, and amino acids are acceptable. Products are successfully registered if they are added in amounts that are not considered “Toxic”.

IV. MANDATORY LABELLING REQUIREMENTS OF HERBAL MEDICINE IN NIGERIA

The labelling of dietary supplements in Nigeria is regulated by the Herbal Medicine And Related Products Labelling Regulations of 2019. Labelling should be informative, accurate and compliant with the Agency’s Herbal Medicines & Related Products Regulations.

Mandatory labelling requirements must be in English and include:

(i)           The brand name, botanical, or common name, if any, shall be qualified as herbal, homeopathic, animal, or mineral medicinal product and or admixture thereof.

(ii)          A quantitative list of all ingredients of the product by their botanical or common names.

(iii)         The net content of the product in terms of weight, measure, or numerical count and shall be in metric unit.

(iv)         The name and full factory location address of the manufacturer.

(v)          Adequate directions for safe use of the product, including amount for use in specific age groups.

(vi)         The lot or batch number.

(vii)        The manufacture and expiration dates.

(viii)       The storage conditions.

(ix)         Dosage, instructions, and frequency of administration.

(x)          Indication for the product.

Both nutrition and health claims are regulated in Nigeria.

V. NUTRITION CLAIMS

According to The Food Fortification Regulations of 2019, claims such as “Source of [Vitamin/Mineral]”, “Good Source of [Vitamin/Mineral]” and “Excellent Source of [Vitamin/Mineral]” can only be used when certain conditions have been met.

VI. HEALTH CLAIMS

According to The Agency’s Pre-Packaged Food (Labeling) Regulation Of 2019, generally, no claims concerning medicinal (preventive, alleviative or curative) effects can be used and no advertisement which describes any food shall include the word “nutritious” or any other words of the same significance.

More specific,

(i)           The product name shall not be suggestive of therapeutic claim.

(ii)          Each product shall have a distinct design not similar to any other registered product.

(iii)         The labelling shall be based whenever possible on data derived from human experience.

(iv)         No implied claims or suggestions of Herbal Medicine and Related Products may be made, if there is inadequate evidence of safety or a lack of substantial evidence of effectiveness.

(v)          Where a claim of effectiveness or therapeutic indication labelling is made for any Herbal Medicine and Related Products, it shall carry boldly and in close proximity to the claim, a statement to the fact that such claim has not been evaluated by NAFDAC, unless such claim has been clinically proven and deemed satisfactory by the Agency.