Ghana - Apply for a Blood Facility License

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Procedure

Apply In-Person:

1. Applicant visit the Food and drugs authority(FDA) regional office in Accra and the applicant can get their application form for Blood Facility License –contact link
2. All information sought in this form shall be provided to enable the FDA process the application.
3. Please complete each section of this application form as a Word document then submit a printed version of the completed form, along with the supporting documents to the FDA regional office or the head office for verification and processing.
4. 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.
5. Payment of appropriate fees should be made and that can be found under the "Fees" section of this page.
6. The FDA will dispatch an inspector (medical officer) to the facility premises for inspection to determine if Good Manufacturing Practice (GMP) during the collection, testing, processing, storage, dispatch, quality control, and quality assurance of the products.
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 applicant 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. If the authorized official is satisfied that all the conditions are meet as required for the application, applicant will be notified of the outcome and issued with the licence.
10. The Processing time for this procedure is 1 month.
    

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Required Documents

• Application form (one comb-bound hard copy and one electronic copy.
• Physical address with phone number and email address.
• 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 request by the FDA.

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 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
Location link

Eligibility

• All Individuals /corporation/cooperative association/hospitals are eligible.
• Applicant must be a Ghanaian citizen.
  

Fees

• Storage and distribution for transfusion and further manufacture – RS 500/-
• Storage , cross- match and distribution for transfusion and /or further manufacture –RS 1000/-
• Collection ,testing, processing , packaging /labelling ,storage, Release and distribution to other blood facilities and health centre -RS 1,500/-
• Testing , processing into blood products, packaging/labelling, storage, release and distribution to health centre and medical stores- RS 3,000 /-
• BI-Annual facility compliance fees- 900/-
  

Validity

License is valid for a period of 3 (three) years and renewable thereafter.

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

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

It is the National Regulatory Authority mandated by the public Health Act, 2012 (Act 851) to regulate food, drugs, food supplements, herbal and homeopathic medicines, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco and tobacco products.

Required Information

• Legal name of blood facility
• Other name used (include trade name, doing business-as, previous names, etc.)
• Trading as(individuals/corporation/cooperative association/hospitals)
• Mailing address of applicant ( 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)
• Contact person’s signature.
  

Need for the Document

This blood facility license is used for can donate blood or blood products is legally to other hospitals and other states/country.

Information which might help

To maintain your license status, the facility shall be inspected annually to ensure that the facility remains in compliance with the license requirements.

Other uses of the Document/Certificate

Please explain what other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

More information can be obtained via this link

Others

More information which might help people.