Ghana - Report Clinical Site Close-Up

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Procedure

Apply In-Person:

1. To Apply for Report Clinical Site Close-Up in person the applicant has to approach the Food and drugs authority (FDA) regional office in Accra. Contact link
2. Applicant can be downloaded the application from this application link
3. All information sought in this form shall be provided to enable the FDA to process the application.
4. Applicant has to enter all information in the application form.
5. Applicant must make sure to carry both photocopies and originals of all documents are necessary for completing this procedure.
6. Applicant must make sure to carry all necessary documents that are mentioned under “Required Documents” section of this page. (Both photocopies and originals)
7. Applicant should attach photocopies of documents (whichever is necessary) along with the applicant while submitting it at the office.
8. Fee for this procedure has to be paid as per the authority’s request.
9. If all the 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 report.
10. They can visit the office and get their report after getting that notification.
11. Generally, the processing time for this procedure 1 month.

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Required Documents

• Application link
• All supporting documents as specified on the application form.
• Citizens need to be in possession of a valid national identity card copy.
• Companies need to be in possession of a valid company registration certificate copy.
• license fee as stated in the food and drugs authority’s fees schedule.
• Any other documents that may be requested 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 Area,
SHIASHIE, ACCRA.
Contact link

Location: Accra
Address: Food and Drugs Authority
17 Nelson Mandela Ave, Accra, Ghana
JRG9+2Q Accra, Ghana.
Contact number: +233 30 223 3200
Website Link
Contact link
Location link

Eligibility

• Hospitals and pharmacies in Ghana.
• Drugs and other regulated product manufacturers in Ghana.

Fees

• A Fee for this procedure has to be paid as per the authority’s request.

Validity

• Validity for this report is 1 year.

Documents to Use

• Application link
  

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• The Processing time for this procedure is 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

• The public health act 2012, act851 is enforced and the food and drug authority (FDA) exists to protect public health by assuring the safety, efficacy, and security of human and veterinary.

Required Information

• Name of the organization
• Mailing address of organization( include location of the post office)
• Physical address: (include legal name, number, street, city, and district)
• Contact detail(telephone /fax number, email address)
• Contact person’s information (legal name/email/telephone)
• List and other certificates for your procedure.
• Branches details if any.
• Site information
• Protocol title
• Protocol identification number
• Clinical trial certificate number
• Name and address
• Telephone number
• Email address of the principal investigator
• E-mail address of sponsor
• Date of last recruitment
• Reason for closure
• Date of report
• clinical site personnel involved with the study
• Other information
• Declaration

Need for the Document

• Drug and other regulated product manufacturers are required to register and obtain a storage facility for drugs and other regulated product licenses from the food authority (FDA) after meeting the acceptable standards as set by the FDA before commencing operation.

Information which might help

• An application for the importation of a product may be rejected for several reasons. This may include, but is not limited to:
  • A product not registered with the Authority.
  • A product with a potential for abuse
  • A product found to be fake, substandard, and/ or adulterated.
  • A controlled drug when the national quota for that particular drug has been exhausted
  • All importers are required to renew their company license with the Authority annually.
  • Products imported shall be inspected by officials of the Authority at the port of entry before they are released to the importer.
  • The above notwithstanding, any statute governing importation procedures and tax liabilities shall apply to an imported product.

Other uses of the Document/Certificate

Please explain what other uses of obtaining the document/certificate. 
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.