Ghana - Apply for Club License

ProcedureEdit

Apply In-Person:

To apply for club license in Ghana, the applicant has to approach the Food and drugs authority(FDA) regional office in Accra contact link
The applicant has to approach the FDA office. Then, the applicants can get their application form.
Read carefully through the application forms as there contain different section.
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 to the FDA regional office or the head office for verification and processing.
Applicant must make sure to carry both photocopies and originals of all documents are necessary for completing this procedure.
Please refer to the fees details in the “Fees” section of this page.
The FDA will dispatch an inspector to the facility premises for inspection to determine if Good Manufacturing Practice (GMP) and Good Storage Practice (GSP) during the packing, processing, storage, labelling, sterilizing, testing, dispatch, quality control, and quality assurance of the products.
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 rectify the problem.
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).
If the Expert committee formed by the FDA are satisfied that all the conditions are meet as required for the application, you will be notified of the outcome and issued with the license by the register/authorized official.
Generally, the processing time for this procedure is taken 1 month.

Required DocumentsEdit

Application form
Site master file of the facility.
All supporting documents as specified on the application form.
Valid company registration certificate copy.
National identity card
License fee as stated in the food and drugs authority’s fees schedule.
Any other documents that may be request by the FDA.

Note: A copy of the submitted documents shall be endorsed by the FDA and returned to the applicant.

Office Locations & ContactsEdit

Cover Letter Addressed To:
The Chief Executive
Food and Drugs Authority
P.O. Box CT 2783
Cantonments – Accra
GHANA.

Return Completed Form To:
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

EligibilityEdit

Wholesale company or distributing entity is eligible.

FeesEdit

Refer to the FDA approved structure fees link or contact the FDA for fees and bank details.

ValidityEdit

The license is valid for one year and renewable thereafter.

Documents to UseEdit

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

Sample DocumentsEdit

Please attach sample completed documents that would help other people.

Processing TimeEdit

The Processing time for this procedure is taken 1 month.

InstructionsEdit

Please provide other instructions related to the certificate/documents.
E.g. the state office holds birth records since January 1908.

Required InformationEdit

Details of Manufacturer
Name of Business
Contact details (postal/email address/telephone/email address)
Location of proposed licensed premises
Street
Address
Postal Address (if different from business address above)
Contact details (email address/telephone/fax number)
Type of product
Describe the range of dosage forms/types of devices to be manufactured
Indicate whether manufacture (for human, animal or any other purpose)
State other products to be manufactured at the same premises (if applicable)
Contract Manufacture
Product/ Stage
Manufacturer
Address
Testing contracted to the manufacturer
Nature of Test
Name of Testing Laboratory/Service
Address
Products stages of manufacture, including testing
Key Personnel and Person(s) in charge of Quality/ Assurance
Person in charge of production (Full Name, Position in the company)
Relevant qualification (Name of Institution, Duration of Study, Certificates Awarded)
Relevant Experience (last job first) {Name of Company, Duration, Position Held}
Specification of the Plant
Equipment Type
Number of Units
Specified Production Capacity
Water Supply, Treatment and Waste Disposal
Number and Category of Employees
State proposed date of commencement of business
Any additional information which applicant wishes to provide
Declaration (Applicants and witness)

Need for the DocumentEdit

Drug and other regulated product manufactures are required to register and obtain a club license from the Food and Drugs Authority’s (FDA) after meeting the acceptable standards as set by the FDA before commencing operation.
The aim of these is to maintain the integrity of the product, for their intended purpose in relation to the Public Health Act, 2012, Act 851 of the Republic of Ghana.

Information which might helpEdit

Drugs and other regulated product manufactures are required to register from FDA office.

External LinksEdit

Link

OthersEdit

More information which might help people.