Ghana - Apply for Re-Analysis of Registration Products

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Procedure

Apply In-Person:

1. To Apply for re-analysis of registration products in person , The Applicant has to approach the Foods and Drugs Authority (FDA) Office Contact link
2. Applicant must obtain the application form for re-analysis of registration products.
3. Read carefully through the application forms as there contain different section.
4. Please complete each section of this application form as a Word document then submit a printed version of the completed form, along with the supporting documents (listed below) to the FDA regional office or the head office for verification and processing.
5. Documents that are needed for this procedure are mentioned under “Required Documents” section of this page.
6. Payment of appropriate fees should be made and that can be found under the "Fees" section of this page.
7. Applicant 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.
8. 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.
9. They will send the cosmetics material, medical devices and household chemicals you submit to the lab for testing.
10. Upon successful implementation of the CAPA, a follow-up inspection may be conducted by the inspection team to ascertain the effectiveness of the implementation (where applicable).
11. 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.
12. A decision to defer, approve or reject an application shall be done within sixty (60) days for a routine application.

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Required Documents

• Covering letter
• Certificate of registration from the Registrar- General’s department
• Samples of the product in the final package as specified in the Authority's sample Schedule.
• All supporting documents as specified on the application form
• Non-refundable application fee as specified in the Authority’s fee schedule
• Citizens need to be in possession of a valid national identity card copy.
• Companies need to be in possession of a valid company's registration certificate copy.
• Any other additional documents requested by the FDA.

Office Locations & Contacts

Cover Letter Addressed To:
The Chief Executive, Food and Drugs Authority
P.O. Box CT 2783, Cantonments – Accra GHANA.
Return Completed FormTo:
Chief Executive Officer, Food and Drugs Authority,
17 South Legon Commercial Areas, SHIASHIE, ACCRA.
Contact link

Location: Accra
Address: Food and Drugs Authority
Health consultant in Accra, Ghana. 17 Nelson Mandela Ave, Accra, Ghana.
JRG9+2Q Accra, Ghana
Contact number- +233 30 223 3200
Location link

Eligibility

• Local and foreign organizations must have register for RGD office in Ghana.

Fees

Please see the fees on our website link

Validity

• Permits shall be valid for ONE CALENDAR YEAR from the date of issue.

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• The processing time for this procedure takes 2 months.

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.gIn the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Excerpts from the Public Health Act 851-2012, Part 7 of the Food and Drugs Authority, section 127 states.

Required Information

• General information:
  
  • Full name, postal address and premises address of both the importer and exporter
  • Name/description of product
  • Total quantity of product, in dosage units
  • Product registration number
  • Name of manufacturer and country of origin
  • Batch number
  • Total CIF value
  • Name of port of shipments and approved port of entry
  • Date, company stamp and signature
• Name and address of the applicant
  • Name
  • Company name
  • Address
  • Country
  • Telephone
  • Telefax
  • E-mail
  • Name of superintendent/resident pharmacist
  • Signature of superintendent/resident pharmacist(if different from contact person)
• Date of incorporation of company: (please note that ONLY a body incorporated in Ghana can be appointed as a local agent for this application)
• Company registration number
• Name of superintendent/resident pharmacist
• Contact details of superintendent/resident pharmacist
• Registration number of superintendent/resident pharmacist
• BIOLOGICAL PRODUCTS TO BE LAB TESTING(Tick appropriately)
• The name of the cosmetic product, medical devices and household chemicals
• 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.

Need for the Document

• No person/entity should produce, manufacture, supply, distribute or sell to the general public any cosmetic and house chemicals Product that has not yet being approved, registered and licensed by the FDA.

Information which might help

The Food and Drugs Centre for Laboratory services and research (CLSR) has six (6) testing Laboratories and a Quality Assurance Outfit to develop, implement and maintain the QualityManagement System of the centre. The Testing Laboratories include:

• Drug Physicochemical
• Food Physicochemical
• Pharmaceutical Microbiology
• Food Microbiology
• Cosmetic / Household Chemical Substances
• Medical Devices
  

The Laboratory shall perform functions related to the quality of products regulated under this Part and shall in particular:
(a) analyse

• drugs,
• medical devices,
• herbal medicinal products,
• cosmetics,
• raw materials,
• medicine adjuvants,
• packaging materials,
• medicine delivery systems,
• systemic diagnostic agents, and
• any other product that the Authority considers a product of drugs for the purposes of this Part

(b) analyse

• foods,
• food packaging materials, and
• raw materials used in the manufacture of food
  

Other uses of the Document/Certificate

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

External Links

Link

Others

More information which might help people.