** Agency implements ICH Q1 and Q7 Guidelines ** ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6
** Agency implements ICH Q1 and Q7 Guidelines ** ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6

Micro, Small & Medium Enterprises (MSME)

National Agency for Food and Drug Administration and Control (NAFDAC) identified the challenges of Micro, Small and Medium Enterprises (MSMEs)  in registration of their products with NAFDAC. The Agency has instituted several activities which include further review of guidelines and streamlined registration processes to handle their peculiar difficulties. The aim is to remove critical bottlenecks and bureaucratic red tapes that hinder the smooth registration and regulatory activities of MSMEs

MSME Classification adopted from National Policy on MSMEs:

 Size CategoryEmployment
1Micro EnterprisesLess than 10
2Small Enterprises10-49
3Medium Enterprises50-199
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The following guidelines are for MSMEs Enterprises:

Food Guidelines

SNGuidelines
1Guidelines for Inspection of Facilities for Manufacture of Food Products
2Guidelines For Establishment Of Cottage And Kitchen Scale Food Industries
3Guidelines for Inspection and Requirements for Bread Manufacturing Facility
4Guidelines for Inspection and Requirements for Packaged Water Facility in Nigeria
5Guidelines for Production Inspection of Micro Scale Food Manufacturing Facilities in Nigeria (New Applicants)
6Guidelines for Production Inspection of Small-Scale Food Enterprises in Nigeria (New Applicants)

Cosmetic Guidelines

SNGuidelines
1Guidelines for the Registration of Cosmetics made in Nigeria
2NAFDAC GMP Guidelines For Cosmetics Products
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Category of MSME Products

SNGuidelines
1Category of MSME Products
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The tariff applicable to Micro and Small-Scale Enterprises are extract from the General Tariff. Please note that the reduced tariff will be in existence for only three (3) months effective from 15th May, 2020.

Tariff extract for Micro and Small-Scale Enterprises

SNGuidelines
1Tariff extract for Micro and Small-Scale Enterprises
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Please visit our e-registration portal to apply online and upload all required documents

  • Micro scale – Required documents
    1. Evidence of Registration with Cooperate Affairs Commission (CAC)
    2. (Business Name and/ or incorporation)
    3. Site use Agreement (Where applicable)
    4. Evidence of Trademark approval we advise that you get this document as It helps
    5. To protect the product brand /or business name.
    6. One vetting Sample and three labels
    7. Fumigation certificate
    8. Copy of Receipt of Payment for production registration
    9. Food handlers certificate / medical fitnesscertificate for production staff, this should include the following: Sputum test, stool test, Urinary test,Widal test, Hepatitis B
  • Small Scale – Required documents:
    1. The application letter
    2. SOP for production,
    3. SOP distribution /Recall,
    4. SOP Quality assurance,
    5. SOP Cleaning of equipment,
    6. SOP receiving of packaging materials,
    7. SOP Personal Hygiene,
    8. SOP Water analysis were applicable and
    9. SOP for cleaning of the environment,
    10. Food handlers certificate/ medical fitness certificate for production staff should include the following parameters: Sputum test, stool test, Urinary test, Widal test, Hepatitis B Test.
    11. List or raw material and their source(s)
    12. Certificate of analysis of raw materials (optional for micro scale)
    13. Certificate of analysis of finished products (optional for micro scale)
    14. Certificate of fumigation
    15. Label/Packaging material.
  • Soft copy of all the documents submitted.

Frequently Asked Questions (FAQs)

Must a client make use of the services of a consultant on product registration?

NAFDAC does not encourage the use of consultants, however the use of consultant by any client is at his/her own risk

 

How much does it cost to register MSME (Micro, Cottage/kitchen) products?

Currently, Micro scale food is N36,737.50 while Micro Scale Cosmetic is 41,000.00

What is a micro scale facility?

A micro scale facility is a business enterprise with not more than five (5) employees. Its building can be purpose-built or adapted with minimum of a designated standard room that is not open directly to any source of contamination. However, there are products exempted under this scope. These include Meat products except dried, Milk & dairy products, Beverages, Packaged water, & vegetables

What is a small Facility?

A small scale facility is a facility with 1 to 10 employees. Its building can be purpose built or adapted. It must also have adequate space, capacity and equipment for its intended product (s) for registration.

How long does it take a product to be registered under MSME?

The timeline is ninety (90) working days.

What are the requirements for the registration of a product?

Trade Mark, SOPs, Product Label, Cert. of Fumigation, CAC, Food handlers test, Batch Formulation, (Trademark is optional for Micro scale)

Must a client have a Trademark before product registration?

NAFDAC encourages Trademark registration, however it is optional for micro scale.

Must I register my Company name with Corporate Affairs Commission (C.A.C) before i can register my product with NAFDAC?

It is mandatory for companies to register with Corporate Affairs Commission. It shows that the business is a legal entity and is on the public register of duly registered companies

Can I change my Factory location after registration?

A company can choose to change its factory location after registration by duly notifying and getting authorization from the Agency on the proposed relocation.

What is the validity period of my Listing Certificate?

The validity period for listing certificate is two (2) years.

How many products can I register under micro scale?

Not more than five (5) products can be registered under micro scale. It is important to note that Food Allergen Sources e.g. Stock fish cannot be processed in the same room alongside other non-allergen products.

Do I need NAFDAC Registration for Export?

Yes NAFDAC Registration Number for regulated products is mandatory.

What types of products one cannot register under Micro scale?

The under listed products are exempted under micro scale enterprise: Meat and meat products (except dried), Milk and dairy products, Fish & fish products (except dried), Beverages.

Frequently Asked Questions (FAQs)- Cosmetics

Does NAFDAC regulate cosmetics?

Yes, NAFDAC Act Cap N1 LFN empowers the Agency to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of cosmetics among other regulated products.

When can a cosmetic product be termed organic?

A cosmetic product is termed organic if it contains 70% agricultural ingredients.

Do I need to substantiate when I claimed my product contains vitamin E?

Claims such as vitamin E in cosmetic product in micro scale may not be substantiated

What is batch formulation?

A batch formulation is a list of all components/raw materials of the dosage form to be used in the manufacturing process.

What type of water is best for production of cosmetics?

The use of distilled, de-ionized or purified water is recommended for the production of cosmetic products.

Can I do street advertising or advert of my products on social media platforms once i get my Listing Cert without notifying NAFDAC?

No regulated product shall be advertised in Nigeria unless it has been registered in accordance with the provisions of NAFDAC ACT CAP F33 LFN 2004 however, you are advised to seek approval in advance before shooting any advert (Cosmetics and Medical Devices Advertisement Regulations)

Are there ingredients that are banned in cosmetics by NAFDAC?

Yes, ingredients such as Lanolin in baby lotion and Boric acid in baby powder are banned. Hydroquinone above 2%, mercury and its salts, corticosteroid in body creams are also banned. Other banned or restricted ingredients in cosmetics include bithionol, vinyl chloride, methanol, halogenated silicylanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbons propellants and hexachlorophene.

Can i use plastic based equipment (e.g bowls) for production of cosmetics?

The use of stainless steel equipment is recommended in the production of cosmetics.

Where best do I source my chemicals for my production?

There are many chemical marketers in Nigeria but not all of them are listed with NAFDAC . You are therefore advised to source your chemicals from NAFDAC Listed Chemicals marketers. For further enquiries on the list of NAFDAC Listed marketers, please visit Chemical Evaluation Directorate of NAFDAC, NAFDAC Isolo Office Complex, Lagos or call 09063977319, 07-4609762.

What type of cosmetic products is allowed under micro scale?

The following cosmetics products are allowed under Micro and small scheme Petroleum Jelly, Shea Butter, Hair Cream (Oil based), Oils e.g. Coconut oil, Laundry detergents, Starch, Liquid Air Freshener, Soaps

Must a client submit certificate of analysis for cosmetics (raw materials / finished products) under micro scale?

Under micro scale production, certificate of analysis of raw material or finished products are optional.

Can I make claims on my cosmetic products?

Any claims that cannot be substantiated is not allowed in cosmetics products.

Does Food Handler Test apply to cosmetic products?

Medical Certificate of fitness of personnel handling cosmetic products is required.  Food Handlers Test is required in food industries.

What is the minimum labelling requirement on a cosmetic product?

Accordion ContAll cosmetic products labels shall state the brand name (where applicable), the product statement of identity ,batch number, net content, manufacturing and expiry date, manufacturer’s name and country of origin, NAFDAC Registration number , storage condition, list of ingredients and any other information as may be prescribed by NAFDAC .ent

Frequently Asked Questions (FAQs)- Food

Must a client make use of service of a consultant on product registration?

NAFDAC does not encourage the use of consultants, however the use of consultant by any client is at his/her own risk.

How much does it cost to register 1 MSME(Micro, Cottage/Kitchen) product?

Currently, Micro scale Food is ₦36,737 .50 while Micro scale Cosmetic is ₦41000.00

What is micro scale facility?

A micro scale facility is a enterprise with not more than nine (9) employees. Its building can be purpose built or adopted with a minimum designated standard room that is not open directly to the source of contamination.  However there are products exampled under this scope. They include meat products except dried, milk & dairy products, beverages, package water and vegetables.

How long does it take a product to be register under MSME?

Timeline is ninety(90) working days

What are the requirements for registration of a product?

Trade Mark, SOPs, CAC, Certificate Fumigation, Food Handler Test, Product Label, Batch Formulation. (Trade Mark optional for Micro scale).

Must a client have a Trade Mark before product registered?

NAFDAC encourage trademark registration however is optional for Micro scale.

Do I need NAFDAC Registration for Export?

Yes, NAFDAC registration Number for regulatory products is mandatory.

Can I change my factory location after registration?

A company can choose to change its factory location after registration after dully notifying and getting authorization from the agency on the purpose of relocation.

What is the validity period of the listing certificate?

The validity period for listing certificate is two(2) years

How many products can be registered under Micro scale?

Not more than five(5) products can be registered under Micro scale. It is important to note that food allergy sources e.g. stock fish cannot be processed in the same room alongside with non-allergy products.

What type of products one cannot register under Micro Scale?

The under listed products are exempted under micro scale enterprise: Meat and Meat products(except dried), Milk  and Dairy products, Fish and Fish product(except dried).

Frequently Asked Questions (FAQs)
- on the Palliative Program

https://napams.org

Will a factory inspection be conducted for the MSME palliative scheme?

Yes, factory inspections will be conducted after the ease of the lockdown exercise.  However, arrangement can be made for virtual inspection, which may be done at any time

Those who had already made payments, can they still be part of the palliative?

No, the palliative tariffs are only applicable to fresh applicants as from 15th MAY 2020.

Where can I find the MSME guidelines on the NAFDAC website?

On the website; https://www.nafdac.gov.ng/our-services/msme/

The guidelines can be located on the MSME Page.

How will you know when the first 200 zero tariffs are exhausted?

The system will automatically pick the first 200 people qualified for the zero tariffs.

Who do we contact if we have any problem lodging any complaint?

The complaints contact phone numbers are can be located on the right-hand bottom of the MSME Page.

How does one qualify for Micro or Small under the MSME Palliatives?

Below are the definitions of MSMEs in terms of personnel:

  • Micro Enterprise (1-9 Personnel)
  • Small Enterprise (10-49 Personnel)
  • Medium Enterprises (50-199)

However, an applicant in the micro category may only apply for registration of 1-5 different products and can qualify for the Micro palliative separately for each product. While an applicant making applications for more than 5 products qualifies for the Small scale.

Can I qualify for the palliative if my product is not food or cosmetic?

NO, the palliative is applicable to only people registering food or simple cosmetic products. Complex cosmetics with multicomponent formula, pressurised sprays, etc cannot qualify for Micro/small enterprise product

Can someone paying for re-analysis of a failed product qualify for the palliative?

No, someone making payments for re-analysis must pay for the laboratory fees from the current original 2020 tariff.

Are hand sanitizers qualified under the NAFDAC MSME scheme?

No, hand sanitizers are not under the MSME scheme. Check under the Drug & Medical devices page of the website for information on registration of hand sanitizers.

Can renewal applications qualify for the MSME Palliative?

No, the renewal applications are already entitled to 50% discount from the current 2020 original tariff.

Is there a step by step procedure guide for registering of products under MSME?

Yes, a comprehensive step by step procedure on how to register products under MSME (Micro & Small) is located on the MSME page. https://www.nafdac.gov.ng/our-services/msme/

What is the duration for the MSME Palliative? Is it 3 or 6 month?

The duration of the  MSME Palliative program is 6 months.

What is the duration for the late renewal administrative waiver?

The duration for the MSME late renewal administrative waiver is 3months.

Is there a list of approved MSME products that are eligible for the MSME palliative?

Yes, you can follow: https://registration.nafdac.gov.ng on the website to find the approved list of MSME products eligible for the palliative.

Why am I unable to upload my documents on the registration portal?

Maybe the size of your document is too large. The size of the document should not exceed 500KB.

Why do different pack sizes of same product attract charges for laboratory analysis, license and not treated as one?

Each pack size is evaluated separately, and registration is on individual product identity.

Why is inspection conducted for change in formulation of product even when a facility has a current Good manufacturing practice?

Because the change in formulation may alter the identity of the initial product whose food safety profile must be accessed before approval.

After registration, am I permitted to change my label?

No, company should apply for such intended change and receive the Agency’s approval.

What is the process I must undergo, if I am relocating my factory from one place to another?

The Agency should be notified, and due process followed for approval.

How do I know how to include an acceptable best before date on my food product for registration?

By conducting a shelf life study to know how long the product can stay for before and still remain wholesome and safe for human consumption.

Can I print labelling information such as best before date, production date and batch number on a sticker and affix on my product, instead of printing directly on my pack?

No, such information must be printed directly on the product pack.

I heard some food colours are banned and are not permitted to be used in food processing and packaging. How do I know those?

You may need to visit the Agency’s website for clarification  on food additives regulations: https://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/All_Regulations/Food-Additivies-Regulations-2019.pdf

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