Ghana - Apply for License to Manufacture of Drugs for Sale

Advertisement

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 License to Manufacture of Drugs for Sale. contact link
2. Read carefully through the application forms as there contain different section.
3. 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.
4. Payment of appropriate fees should be made and that can be found under the "Fees" section of this page.
5. Pay the processing fees upon which his/her will be issued with a receipt.
6. The FDA will dispatch an inspector to the facility premises for inspection to determine if Good Distribution Practice (GDP) and Good Storage Practice (GSP) during storage and dispatch of product that quality control, and quality assurance of the products is practise.
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 the applicant will be required to 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 Expert committee formed by the FDA are satisfied that all the conditions are meet as required for the application, the applicant will be notified of the outcome and issued with the licence by the register/authorized official.
10. Generally, the processing time for this procedure takes 1 month.

Advertisement

Required Documents

• Application form
• Articles of Association
• Copy of Pharmacists I.D
• Attorney General Certificate
• Personal identification Number
• Memorandum of understanding
• List of drugs to be manufactured for year the license applies
• The certificate of incorporation or registration
• MOA & AOA or Partnership deed / LLP agreement
• Pan card
• Age proof
• ID and address proof of director
• Passport size photograph
• Board resolution on the letterhead
• Affidavit from directors
• Sale deed document of the premises
• NOC from the owner

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.

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
Contact link

Eligibility

• Any person/company/partnership firm/LLP can apply for drug license.
• A competent (registered pharmacist from the state pharmacy council) person with experience shall apply.

Fees

• Refer to the FDA approved structure fees Link or contact the FDA for fees and bank details.

Validity

• License is valid for a period of 3 years.
• The license should be prominently displayed at the place of business during the business hours.

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 30 days.

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 Food and Drugs Authority (FDA), formerly, Food and Drugs Board (FDB) is the regulatory authority with the responsibility of implementing the Food and Drugs Law of 1992, (PNDCL 305b). Part seven of the Public Health Act, 2012, Act 851 mandates the Food and Drugs Authority (FDA) to protect and promote public health by ensuring that food and drugs consumed in Ghana are wholesome and safe.

Required Information

• Name of the company
• Mailing address of company( 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 certificate for the applicant’s procedure.
• Branches details if any.
• Site information.
• Relevant qualification.
• Relevant experience.
• Site activities.
• Declaration

Need for the Document

• A drug license is required to sell/distribute/store medicine. It can be obtained from appropriate Ghana government department.
• This license will be helpful to follow the rules and regulations set by regulatory department.

Information which might help

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

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

More information can be obtained via link

Others

More information which might help people.