Ghana - Renew License to Manufacture Drugs and other Regulated Product

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Procedure

How to Apply:

1. Renewal of license shall be made to the FDA three Months to expiry of the current licensed issued by the authority.
2. Purchase the application form at the Food and Drugs Authority (FDA) at the regional or district office at the head office in Accra or visit the FDA website portal to download website or click the links below to download (application form)
3. Read carefully through the application forms as there contain different section and fill the accurately.
4. Submit the completed application form in duplicate (two copies) along with copies of the supporting documents (listed below) to the FDA regional and district office or the head office.
5. Pay the processing fees, upon which you will be issued with a receipt.Note that the fee is non- refundable.
6. If the authorized official is satisfied that all the conditions are meet as required for the application, you will be notified of the outcome and issued with the renewed licence.

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Required Documents

• Write a duly signed cover letter stating the intended purpose addressed to;

THE CHIEF EXECUTIVE

FOOD AND DRUGS AUTHORITY

P. O. BOX CT 2783

CANTONMENTS-ACCRA

GHANA.

• Copy of initial certificate issued
• Proof of paymentof the prescribed fee for the licencing of the facility

Note:

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

Office Locations & Contacts

Food and Drugs Authority (FDA):
Address: No. 17 Indian Ocean Street, Nelson Mandela Avenue, Accra
Telephone (+233) – 302-233200/ 235100
(+233) – 0299802932/3 (Hotline)
0800151000 (Toll free)
Email address: [email protected]
Regional FDA contact link branch
Website: website

Eligibility

• Manufactures and manufacturing industries in Ghana registered with the FDA

Fees

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

Validity

• The license is valid for one year and renewable thereafter

Documents to Use

(application form)

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• If all the requirements have been met, the license process shall be carried out within a period of thirty (30) working days of the receipt of the application.

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

PARTICULARS OF APPLICANT :

• Name of Company
• Contact details (postal/location /email address, telephone/fax number)

DETAILS OF MANUFACTURE :

• Type of product being manufacture

ITEMS BEING MANUFACTURED :

• 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)

DECLARATION BY THE APPLICANT

Need for the Document

• Drug and other regulated product manufacturesare required to register and obtain a manufacturing licencefrom 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.
• Such Companies/business that are registered with the Food and Drugs Authority (FDA) must renew their licence to keep enjoying the incentives that come with registration with FDA.

Information which might help

(guideline)

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

(Food and Drugs Authority (FDA)

Others

More information which might help people.