Ghana - Get Permit for Orphan Drugs

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Procedure

Apply In-Person:

1. To Get Permit for Orphan Drugs in Ghana, the applicant should contact the Foods and Drugs Authority (FDA) office Contact link
2. Applicant must obtain the application form for Orphan Drugs.
3. Read carefully through the application forms as there contain different section.
4. These forms must be filled with the necessary details.
5. The applicant has to make sure he or she has all the required documents that are required for this process to be successful and they can be found under the "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. The application should be submitted through the authorized local agent by the regulatory contact person to the Ghana postal address.
8. Please complete each section of this application form as a Word document then submit a printedversion of the completed form, along with the supporting documents (listed below) to the FDA regional office or the head office for verification and processing.
9. A DERD investigating panel/committee will be formed to investigate, if the product/drug is of benefit to the general public and that it will not harm them in any way and write a report on their finding.
10. The applicant may be summoned for an interview by the DERD investigation panel.
11. If the authorized official is satisfied with the report issued by the panel, stating that the product/drug Safety, quality or efficacy of the product/drug comply with conditions of registration, you will be notified of the approval and issued with the certificate of registration.
12. Generally, the processing time for this procedure takes up to 1 or 2 months.

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Required Documents

Please attach a copy each of the following documents:

• A covering letter from the local representative
• A completed FDA application form for the registration of allopathic medicines (please refer to the FDA website [www.fdaghana.gov.gh Link]).
• Samples of the product as per the FDA’s sample schedule.
• A covering letter addressed to the CEO of the Authority,
• Non-refundable application fee for registration of medicines (Refer to FDA fee schedule)
• Drug master file of active pharmaceutical ingredient (To be submitted as per CTD format)
• Qualitative and quantitative composition of product (including excipients and their role in the formulation)

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

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

Eligibility

• Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA.
• Domestic and foreign drug manufacturers, re-packers or re-labellers are also required to list all of their commercially marketed drug products.

Fees

A fee is payable on Permit for veterinary products of this form. Please see the fees on our website Link or Link

Validity

• Permit for veterinary products valid for 3 years.

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

• Generally, the processing time for this procedure takes up to 1 or 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.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• The manufacture has the responsibility to assure the quality, safety and efficacy of veterinary vaccines manufactured in its manufacturing facility. The Food and Drugs Authority’s (FDA) guidelines for the registration of veterinary vaccines provide guidance to applicants intending to register their product in Ghana. In addition, the guidelines publish the required format and content for submitting a veterinary vaccine registration application to the FDA, and further provide guidance that ensure that products and manufacturers meets the minimum established regulatory requirements to do business in Ghana.

Required Information

General information:

• Applicant name
• Residential address of the applicant
• Email id address of the applicant
• Name of contact person
• Current phone and fax numbers
• The name, physical address, telephone number, fax number, and e-mail address of the manufacturer shall be provided.
• Where different activities of manufacture of a given product are carried out at different manufacturing sites, the information on the following should be provided.
• Name of the Manufacturer
• Full Physical address of the Manufacturing Site
• Activity at the manufacturing site
• List of the countries in which product has been registered
• List of countries in which product has been withdrawn
• List of the countries where an application for marketing in any country has been rejected, suspended, deferred or is pending.

Need for the Document

• FDA approval is required for colour additives used in food, drugs, cosmetics, and some medical devices. Certain high-risk colours also require FDA colour batch certification of every individual batch. Colour additives may only be used in compliance with their approved uses, specifications, and restrictions.
• Drug and other regulated product manufactures are required to register and obtain a veterinary drug registration certificate 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 help

An Orphan drug is

• A pharmaceutical product which remains commercially undeveloped due to low commercial returns, or
• A drug intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders, or
• Drugs intended to treat rare diseases that the sponsors are reluctant to develop them under usual marketing conditions.
• “A Rare Disease” means a disease condition which occurs in a small percentage of the population

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

These guidelines can be found on FDA website link

Others

More information which might help people.