Ghana - Register of Allopathic Drugs

Advertisement

Procedure

How to Apply:
Apply In-Person :

1. 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 (word doc application form)
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 fees, upon which you will be issued with a receipt.Note that the fee is non- refundable.
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 rectify the problem.
8. 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).
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

Application by an Agent:

• If the applicant is a foreign company, you will appoint a local agent through whom an application will be submitted and a qualified local agent
• Please see “Information which might help” section below for the FDA Guideline

Advertisement

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.

• Samples of the Drug as per FDA sample schedule:Sample Scheule
• 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.

Note:

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

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: Contact
Regional Offices:Branches
Website:WEbsite

Ministry of Health
Address:SekouToure AvenueNorth RidgeAdjacent National Health Insurance Head Office
Accra
P.O. Box M 44 Accra Ghana
Digital Address: GA-029-4296
FaxNO: +233 302 665651
Telephone: +233 302 665651
[email protected]
Website:Website

Eligibility

• Local and foreign organizations

Fees

• Application Fees: Fees Contact the FDA for Bank details

Validity

• The certificate valid for three years and it’s subjected to renews and the end of this period

Documents to Use

• Application form in word document: Form

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• A new application will be processed within 6 months submission of the application and you will be required to provide any requested additional data within 12 months. In case additional time is required, a formal request must be submitted to the FDA.

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

• Ensure to complete the application for, as per instructed on the form, incomplete application will lead to delay in processing your application and in some case that application being denied.
• Foreign Companies must appoint a local agent to submit the application
• All documents should be written in English and printed
• Translated document should be authenticate at the embassy

Required Information

• Details of the product
• Details of the Applicant
• Declaration
• Contacts and Addresses
• International registration status
• Details of local representative

Need for the Document

• The Public Health Act 2012, Act 851 is enforced and regulated by theFood and Drug Authority (FDA) who’s mandated is to implement, enforce and regulate the registration of Allopathic drugs 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 anyAllopathic drugs product that has not yet being tested,approved, registered and licenced by the FDA.

Information which might help

• FDA GUIDELINES FOR REGISTRATION OF ALLOPATHIC DRUGS: Guidelines

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

FDA:FDA

Others

More information which might help people.