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Tanzania - Renew License to Manufacture of Drugs for Sale


Procedure

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Apply In-Person:

  1. Applicant shall visit the Food and drugs authority (FDA) regional office in Accra and the applicant can get their renewal application form for License to Manufacture of Drugs for Sale.
  2. The contact link of the Food and drugs authority (FDA) can be found below contact link
  3. Read carefully through the application forms as there contain different section.
  4. Please complete each section of this application form as a Word document then submit printed version of the completed form along with the copies of the supporting documents listed below the “Required Documents” section of this page to the FDA regional and district office or the head office.
  5. Payment of appropriate fees should be made and that can be found under the "Fees" section of this page.
  6. Pay the processing fees upon which his/her will be issued with a receipt.
  7. The completed renewal application form submitted to the respective office.
  8. This will be followed by an inspection of applicant by the respective office.
  9. After investigations the respective offices will submit their findings to the county food & drugs products working group.
  10. The working group will make recommendations on the application and forward their report to board for the final board approval.
  11. Upon a successful approval the License to Manufacture of Drugs for Sale applicant is notified and he/she will be required to pay renewal registration fee to the board and submit the receipt as proof of payment.
  12. Once the renewal registration processing is done the renewed License to Manufacture of Drugs for Sale is issued to the applicant by the County government.
  13. Generally, the processing time for this procedure takes 1 month.




Required Documents

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  • Application form
  • Copy of current License to Manufacture of Drugs for Sale.
  • Copy of Pharmacists I.D.
  • Attorney General Certificate.
  • Memorandum of understanding.
  • Copy of previous License to manufacture drugs for sale, Wholesaler Dealers License and Premise License.
  • A copy of previous annual practice license.
  • List of drugs to be manufactured for year the license applies.
  • Non-Ghanaians to attach current work permit.
  • Proof of payment.






Office Locations & Contacts

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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: 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: location link



Eligibility

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  • Ghanaians and non-Ghanaians who has a valid License to Manufacture of Drugs for Sale.



Fees

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  • Refer for fees link for this procedure: link or contact the FDA for fees and bank details.
  • A fee for this procedure is GHS 5000 per Product.



Validity

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  • License is valid for a period of 1 year.
  • Each manufacturing license shall expire on the 31st December



Documents to Use

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Please attach documents that can be used by people. e.g. links




Sample Documents

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Please attach sample completed documents that would help other people.



Processing Time

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  • The Processing time for this procedure takes 1 month.



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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

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  • Any person who intends to renew license to manufacture drugs should make an application in the prescribed form for the licensing of the premises and the application shall be accompanied by the prescribed fee.




Required Information

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  • Name of the company
  • Applicants name
  • Registration number
  • Email address
  • Cell phone number
  • ID/passport/alien ID number
  • Nationality
  • Premise name & address
  • Premise location, county, town, road and building
  • Signature of the applicant
  • Other professionals working in this premise




Need for the Document

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  • Each manufacturing license shall expire on the 31st December of every year and the renewal is subject to compliance with conditions prescribed by the food and drug authority.



Information which might help

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  • Application form should obtain the respective office.
  • Applicant must fill the application form and submit to the respective office along with required documents and prescribed fees.
  • 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.
  • Payment of appropriate fees should be made and that can be found under the "Fees" section of this page.
  • On completion of this process, the Board shall, within 30 days of receipt of the application issue to the applicant a license.



Other uses of the Document/Certificate

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




External Links

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Others

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More information which might help people.




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