Do you have any cosmetic products you intend to import into Ghana or manufacture locally in Ghana? In this article, we will provide you a guide on how to register cosmetics in Ghana.
The registration of a cosmetic product involves the following;
- Review of the manufacturing process
- An assessment of safety and quality
- Compliance with Food and Drugs Authority (FDA) labeling regulations
To register cosmetics in Ghana with the FDA can be a very slow process and can take between 1-2 months to be completed from the date application is submitted with samples for laboratory tests.
The guidelines for cosmetics product registration are regulated by the Public Health Act, 2012 (Act 851). This guideline provides information on the requirements for the registration and licensing of premises for the manufacture of cosmetics and household chemical substances in Ghana. This includes information on Good Manufacturing Practices (GMP) requirements for cosmetics and household chemical substances manufacturing companies.
General Requirements for Registration of Cosmetics in Ghana (both locally manufactured and imported)
Cosmetics can be manufactured locally in Ghana and it can be also be imported. Below are the general requirements for registering cosmetics in Ghana;
- Application Letter
- Product Information and Specification
- Details of Applicant
- Details of Manufacturer
- Details of Local Agent
- Declaration
- General Product Specifications
- Administrative Status of the cosmetic product.
Application Letter
This should be addressed to the Chief Executive Officer, Food and Drugs Authority and any relevant documentation or reference material which will aid in the registration process should be attached.
Product Information and Specification
The product information consists of name of cosmetic product, formulation type, physical description of the cosmetic product, intended use, size and the variants of the cosmetic product. You have to disclose all information related to the product that you want to sell to the public to the Food and Drugs Authority.
It is important to disclose all the product specification to the Food and Drugs Authority. These specifications should include;
- Active ingredients, giving their approved names, chemical names, quantity of active ingredient in the formulation and specification of the cosmetic product.
- Other ingredients giving specifications, quantity and reasons for inclusion e. g preservative, fragrance, antioxidant etc.
- Does the product contain skin lightening agents? If yes, (Provide details)
- Proposed Shelf-Life of Cosmetic product
Details of Applicant
You have to provide all the necessary information to the Food and Drugs Authority with the name of the applying company/license holder, postal and business address, telephone number, email address and website etc.
Details of Manufacturer
When applying for a license to sell a product, it is important to disclose all the necessary information about the manufacturer to the FDA. For example, the manufacturer’s name/ company name, manufacturing site/location address, postal address/ business address, Telephone number, email address and website etc.
Details of Local Agent
Details of the local agent will be required for the registration process as well. This includes name of the local agent/company, postal address/ business address, telephone number, email address and website, contact person’s address.
Declaration
You have to declare that all the information contained in the application and in the appendices is correct and true and does not contain any information misleading the public. The declaration should be signed, stamped & dated by the Applicant(s).
Administrative Status of the Cosmetic Product
The administrative status requires applicant to disclose to the Food and Drugs Authority during the product registration, if the cosmetic product has been registered in the country of origin. If yes, then you need to provide a valid certificate of registration in respect of such a cosmetic issued by the appropriate authority.
Indicate whether the application for the registration of the cosmetic product has been made in any other country, If YES, list countries and attach copies of certificates.
Labelling
Products should not be described or presented on any label or in any labelling in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character in any respect. “label” includes any tag, brand, mark, pictorial or other descriptive matter, written, printed, embossed or impressed on or attached to the item or inserted in its container.
Labelling of a cosmetic products should;
- Provide information about the products
- Educate consumers about products they buy
- Helps consumers to make informed choices
- Helps consumers store and use products safely
Mandatory Labelling Requirements to enable you to register cosmetics in Ghana
No person shall offer for sale, sell distribute. import or otherwise dispose of prepackaged food or drug, unless the food or drug is marked or labelled with;
- The name of the cosmetic product
- List of ingredients, active ingredients, showing the amount of each present in the cosmetic product
- Date of manufacture and expiry date or best before date or use-by-date
- Any special storage conditions and handling precautions that may be necessary
- An indication of the net contents in the form of net mass or volume of the product where applicable
- Code marks or numbers indicating the batches of production or packaging of the cosmetic product
- Indicate the country of origin
- The name and address of the producer, manufacturer, importer, packer, distributor
- the name and address of the producer, manufacturer, importer, distributor or seller
- Instructions or directions for use warnings and precautions that may be necessary if it would be difficult to make appropriate use of the goods in the absence of such instructions or directions.
General Requirements for Labelling of Products
- Labelling should be informative and accurate.
- The print should be in a clear font and
The print should be indelible and not fade when exposed to sunlight. - The product name, package or label should not bear close resemblance to a
previously Registered product. - If the original label is in a local or foreign language, the product
information should be in English or a translation thereof. - All products that are not recommended for use in or by children, the
statement “not to be taken/used by children” should be included. - All products should bear the statement “keep out of the reach of children”
- Products meant for external use should bear the statement “for external use
only” - In addition, the name of product should not be offensive, unethical, socially
or traditionally unacceptable, superstitious, magical etc - All dosages should be stated in words.
- For products meant for children, the age ranges should be specified for
each dosage Regimen - The list of indications should correspond to the known activity of active
ingredients declared. - Product locally manufactured should bear FDA registration number
The information on a label should include, but not be limited to, the following:
(a) The name of the product, and the generic or INN/INCI
(b) A list of the active ingredients, where
applicable, showing the amount of each present in a dosage unit.
(c) The net content of the container
(d) The batch number
(e)Date of manufacture and best before/expiry date
(f) Directions for use, and any warnings or precautions that may be
necessary
(g) Any special storage conditions or handling precautions that may be
necessary
(h) Indications, frequency, route and conditions of use where applicable
(i) The names of any excipients known to be a safety concern
(j) Name, postal address and premises address of the manufacturer and
Distributor
(k) Country of origin
Related: How to register medical devices with FDA Ghana
Additional Registration Requirements for Imported Cosmetics
To register imported cosmetics products in Ghana, three processes are involved.
- Firstly, the importer must register for an importer’s licenses.
- Secondly, the importer needs to register the product.
- Thirdly, the importer needs to register the warehouse or storage facility, where the product will be kept.
Registration Requirement for Cosmetics Importer license
- Complete and submit an application form for registration as an importer of cosmetics to Ghana.
- Application Letter
- Documentation should be submitted either as comb-bound, CD or pen drive.
Registration Requirements for Imported Cosmetic products
- Complete and submit an application form for the Registration of Cosmetics or Household
- Chemical Substances Products
- Application Letter
- Attach a copy of business registration documents from Registrar Generals Department
- Submit a signed, stamped and dated Certificate of Analysis, Manufacturing License and
- Certificate of Free Sale from a competent certifying authority in the country of origin
- Six (6) samples of the products and two (2) of each variant or size where applicable.
- Registration fee (renewable after very three (3) years). Refer to fee schedule
- 1-30 Products -$150
- 31-500 Products -$90
- 501-1000 Products -$60
- 1000 Products -$15
- Documentation should be submitted either as comb-bound, CD or pen drive.
Registration Requirements for Warehouse Licensing
- Complete and submit an application form for warehouse licensing
- Application Letter
- Warehouse Licensing fee – renewable after every year
- Cottage Industry -GH¢120
- Small Scale Industry -GH¢240
- Medium Scale Industry -GH¢500
- Large Scale Industry -GH¢800
Foreign Manufacturing Facilities / Premises
Where applicable, foreign manufacturing facilities or companies may be required to pay the facility inspection fee for the conduct of GMP inspection in addition to other documentation required.
The manufacturing facility would be issued a Good Manufacturing Practice (GMP) certificate following a satisfactory inspection.
Based on the level of risk, foreign manufacturing facilities shall be inspected at least every 5 years provided there are no safety and quality issues related to the facility’s products during this period.
In the event that an applicant for the registration of cosmetics products to be marketed in Ghana is not a registered entity in Ghana, the applicant is required to appoint a local agent and duly notify the Authority.
Additional Requirements to enable you Register Locally Manufactured Cosmetics in Ghana
- Purchase and complete an Application Form for License to Manufacture
- Cosmetics/Household Chemical Substance (GH ¢5)
- An Application Letter
- Environmental Protection Agency Certificate
- Manufacturing Licensing Fee (renewable annually)
- Cottage Industry -GH¢ 50 per year
- Small Scale Industry -GH¢ 100 per year
- Medium Scale Industry -GH¢ 200 per year
- Large Scale Industry -GH¢ 400 per year
- Documentation should be submitted either as comb-bound, CD or pen drive
- Basic floor plan showing plant installation, where applicable
- Architectural engineering permit issued by the local authority, where applicable
Registration Requirements for locally manufactured Cosmetics
- Complete and submit an application form for the registration of cosmetics/household chemical substance
- Application Letter
- Attach Copy of Business Registration documents from the Registrar Generals’ Department.
- Six (6) samples of the products and two (2) of each variant or size where applicable.
- Registration Fee (Renewable after every three (3) years).
- Cottage Industry -GH¢ 300
- Small Scale Industry -GH¢ 600
- Medium Scale Industry -GH¢ 750
- Large Scale Industry -GH¢ 900
- Complete and submit application form for license to manufacture cosmetics.
Manufacturing/Storage Facility License
To ensure that your manufacturing/storage facility space and equipment are up to standard, the FDA will inspect your facility and award a license for products manufactured in Ghana.
Some of the things to consider when applying for a facility license include;
- Dedicated area for manufacturing and production
- Available storage space after production
- Well ventilated area
- Well illuminated area
- Free from pest and rodents (consider Fumigation)
- Consider Fire safety and other safety precautions
- Waste from site is well disposed off
Facility Inspection
Premises for the manufacture of cosmetics and household chemical substances shall be subjected to pre-licensing and post-licensing. Good Manufacturing Practices inspection in accordance with the requirements of the current ISO 22716. The inspection will be risk-based and will be informed by factors such as product and process risk, the manufacturer’s compliance history, risk associated with the use and relevant recalls carried out.
The purpose of this inspection is to verify that cosmetics substances produced, stored and distributed by the manufacturer consistently meet applicable regulatory requirements in the interest of public health and safety. The GMP inspection observations, if found to be satisfactory, will guide the Authority in its decision to issue a new manufacturing license or renew an existing manufacturing license in accordance with Section 131 of the Act. This process will be done when an application has been submitted to FDA for product registration.
Renewal of Cosmetics Licenses and how to re-register cosmetics in Ghana
The registration and licensing of the premises shall be renewed annually. An application for renewal of registration and licensing of premises shall be made at least 3 months before the expiry of the existing license by submitting an application letter and duly completed application form to the FDA.
Conclusion
The FDA exists to protect public health by assuring the safety, efficacy and security of human and veterinary drugs, food, biological products, cosmetics, medical devices, household chemical substances, tobacco and the conduct of clinical trials in the country and this guideline above is all you need to register cosmetics in Ghana.
Get your product registered and avoid product confiscation and hassles at the Ghana Ports when you ship your products.
What has your experience been in registering products at FDA? It will be good to hear from you
