Ghana - Get Permit for Local Scientific Advice Meeting

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Procedure

Apply In-Person:

1. To Get Permit for Local scientific advice meetingin Ghana, the applicant should contact the Foods and Drugs Authority (FDA) office Contact link
2. Applicant must obtain the application form for local scientific advice meeting.
3. Documents that are needed for this procedure are mentioned under “Required Documents” section of this page.
4. These forms must be filled with the necessary details.
5. The application should be submitted through the authorized local agent by the regulatory contact person to the Ghana postal address.
6. Applicant should attach photocopies of documents (whichever is necessary) along with the applicant from while submitting it at the office.
7. The Fee for this procedure has to be paid as per authority’s request.
8. Submit the completed form in two copies along with the supporting documents to the respective office.
9. If all above mentioned procedures were followed properly by the applicant, the application form will be viewed by concerned authorities and the applicant will be notified regarding their certificate.
10. The applicant after seeing the notification can go to the FDA office and applicant get the certificate.
11. Generally, the processing time for this procedure takes up to 1 or 2 months.

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Required Documents

• Application form
• Proof of identity

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

• Applicant must be Ghanaian citizen.

Fees

• There is no fee for this procedure.

Validity

• This Permit validity 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

• Scientific advice is prospective in nature. FDA does not pre-evaluate the results of the studies and in no way concludes on whether the benefits of the medicine outweigh the risks.
• Scientific advice from EMA is not legally binding on FDA or on the medicine developer with regard to any future marketing authorization applications for the medicine concerned.

Required Information

• Applicant name
• Residential address of the applicant
• Email id address of the applicant
• Name of contact person
• Current phone and fax numbers
• Declaration

Need for the Document

• The meetings also allow FDA to determine if there is a need for additional expertise at an earlier stage in the procedure.
• Preparatory meetings are particularly important for first-time users of these procedures, for micro-, small- and medium-sized enterprises (SMEs), and for companies seeking general advice on specific types of medicinal products or therapies.

Information which might help

Preparatory meetings are an opportunity for companies to:

• Introduce their proposed development programme and receive feedback from Agency staff;
• Receive feedback on the list of questions to be included in the request for scientific advice, with a view to obtaining satisfactory answers;
• Identify additional issues to be included in the request for scientific advice;
• Obtain more detailed information concerning the procedure for obtaining scientific advice or protocol assistance;
• Ask regulatory questions that are outside the scope of scientific advice;
• Establish contact with Agency staff involved with the application.

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.