Ghana - Apply Licenses for Cosmetics Manufacturing and household Chemical Substance Premises

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Procedure

Apply In-person:

1. To Apply for Licenses for Cosmetics Manufacturing and household Chemical Substance premises in person, the Food and drugs authority (FDA) regional office in Accra application link
2. Read carefully through the application forms as there contain different section.
3. Please complete each section of this application form as a Word document then submit a printed version of the completed form, (two copies) one in hard copy and the other in a soft copy (in pdf on a CD-ROM) along with the supporting documents (listed below) to the FDA regional office or the head office for verification and processing.
4. Pay the processing fee, upon which you will be issued with a receipt.
5. The FDA will conduct an inspection on the establishment where the product will be manufactured or stored to determine if it complies with the current Good Manufacturing Practices (cGMP) regulation at an additional prescribed fees by the FDA.
6. GMP status report and the laboratory analysis of the product will be presented to Drug Registration committee for review and final decision-making.
7. A copy of the report finding will be given to the applicant and if any modification or upgrading is required, Corrective Action and Preventive Action Report (CAPA) report will be issued and you will be required to rectify the problem.
8. Upon successful implementation of the CAPA, the inspection team may conduct a follow-up inspection to ascertain the effectiveness of the implementation (where applicable).
9. The application will be further assessed and it if the authority is satisfied that there is the need to register the product and all requirements for its registration have been met, it will be registered and you will be issued with the certificate of registration.
10. Processing time for this procedure is 1 month.

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Required Documents

• Application link
• Covering letter
• Fully completed application form
• Signed declaration
• Certificate of incorporation/ commencement of business
• Site master file (where applicable)
• Process flow diagram (where applicable)
• Administrative requirement (e.g. environmental protection agency (EPA) permit (where applicable)
• Technical management agreement with any organization (where applicable)
• Factory layout/ floor plan (where applicable)
• Personnel medical test certificate (where applicable)
• Certified copy of power of attorney (where applicable)
• List of equipment and their capacity
• Name and address of suppliers of equipment
• Contract of agreement (where necessary)

Office Locations & Contacts

Food and Drug Authority (Head office):
Address: No. 17 Indian Ocean Street, Nelson Mandela Avenue, Accra, Ghana
Phone: (+233) – 302-233200/ 235100
Hotline Number: (+233) – 0299802932/3
Toll free: 0800151000
Contact details and Map link
Regional Offices link
Website link

Ministry of Health:
Address: Sekou Toure Avenue North Ridge Adjacent National Health Insurance Head Office
Accra P.O. Box M 44 Accra Ghana
Digital Address: GA-029-4296
Fax NO: +233 302 665651
Telephone: +233 302 665651
Email: [email protected]
Website link

Eligibility

• Citizens and companies in Ghana.

Fees

• Refer to the FDA approved fees link

Validity

• The certificate is valid for three years and subject to renewal at the end of this period

Documents to Use

• Application link
  

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• Processing time for this procedure is 1 month.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Foreign Companies must appoint a local agent to submit the application
• Complete the application the application form with the correct detail to avoid your application being denied
• All documents should be written in English and printed
• Translated document should be authenticated at the embassy

Required Information

• Name of the company
• Mailing address of company( include location of the post office)
• Physical address: (include legal name, number, street, city, and district)
• Contact detail(telephone /fax number, email address)
• Contact person’s information (legal name/email/telephone)
• List and other certificate for your procedure.
• Number of workers.
• Branches details if any.
• Declaration

Need for the Document

• The Public Health Act 2012, Act 851 is enforced and regulated by the Food and Drug Authority (FDA) and mandated is to implement, enforce and regulate the registration of cosmetic and house chemicals Products in Ghana.
• The aim of these is to maintain the integrity of the product for their intended purpose and avoid misleading the general public.
• No person/entity should produce, manufacture, supply, distribute, or sell to the general public any cosmetic and house chemicals product that has not yet been approved, registered, and licensed by the FDA.

Information which might help

More information might help people.

Other uses of the Document/Certificate

Please explain what other uses of obtaining the document/certificate. 
e.g. Birth certificate can be used as proof of identity.

External Links

• More information can be obtained via link
  

Others

More information which might help people.