Ghana - Apply for Manufacturing and Formulation License

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Procedure

Apply In-Person:

1. To Apply for Manufacturing and Formulation License in Ghana, the applicant must visit the Food and drugs authority (FDA) regional office in Ghana. Contact link
2. Then, the applicant must obtain the application form from the relevant department.
3. Read carefully through the application form as there contain different section.
4. Please complete each section of this application form as a Word document then submit printed version of the completed form along with the copies of the supporting documents to the FDA regional and district office or the head office.
5. Make sure that his/her have all the documents listed in the “Required Documents” section of this page.
6. Please refer to the fees details in the “Fees” section of this page. Pay the processing fees, upon which his/her will be issued with a receipt.
7. The FDA will dispatch an inspector to the facility premises for inspection to determine if Good Distribution Practice (GDP) and Good Storage Practice (GSP) during storage and dispatch of product that quality control, and quality assurance of the products is practise.
8. 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 applicant will be required rectify the problem.
9. 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).
10. If the Expert committee formed by the FDA are satisfied that all the conditions are meet as required for the application, the applicant will be notified of the outcome and issued with the certificate by the register/authorized official.
11. Generally, the processing time for this procedure takes 1 month.

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Required Documents

• Application form
• Valid company registration certificate copy.
• Identification document (ID card, Passport, Birth certificate )
• Site Master File (SMF) of the facility. This shall include a sketch of the location plan of the establishment indicating a clear direction with identified landmarks to locate the facility
• Technical Management Agreement with any Organisation
• A certified true copy of Certificate of Incorporation and Certificate of Commencement of Business
• Building Plans showing plant installations
• Architectural engineering permit issued by the District, Municipal or Metropolitan Assembly where the facility is located.
• Payment receipt.
• Any other documents that may be request 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 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

Ministry of Food and Agriculture
Kinbu Rd, Accra, Ghana
HR23+M8 Accra, Ghana
Contact link
Location link

Eligibility

• Ghanaian citizens, Individuals/ companies are eligible.

Fees

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

Validity

• This license validity for 1 year.

Documents to Use

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

Sample Documents

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Processing Time

• The Processing time for this procedure takes 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

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

Required Information

• 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)
• Details of Manufacture
• 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 Document

• With respect to a country, any regulatory authorisation required to manufacture one or more products or classes of product as granted by the relevant governmental authority.

Information which might help

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Other uses of the Document/Certificate

Please explain what other uses of obtaining this document/certificate are.
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.