Ghana - Apply for Drug License (Retail, Wholesale, Pharmacy)

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Procedure

Apply In-Person:

1. Application form Drug License (Retail and Wholesale - Pharmacy) is available in the Food and drugs authority (FDA) regional office in Accra. Contact link
2. The applicant has to approach the FDA office. Then, the applicants can get their application form.
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 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.
5. Documents that are needed for this procedure are mentioned under “Required Documents” section of this page.
6. Applicant must make sure to carry both photocopies and originals of all the documents are necessary for completing this procedure.
7. A fee for this procedure is has to be paid as per the authority’s request.
8. The FDA will dispatch an inspector to the facility premises for inspection to determine if Good Manufacturing Practice (GMP) and Good Storage Practice (GSP) during the packing, processing, storage, labelling, sterilizing, testing, dispatch, quality control, and quality assurance of the products.
9. 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.
10. 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).
11. If the Expert committee formed by the FDA are satisfied that all the conditions are met as required for the application, the applicant will be notified of the outcome and issued with the license by the register/authorized official.
12. Generally, the processing time for this procedure is 1 month.

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Required Documents

• Application form
• The certificate of incorporation or registration
• MOA & AOA or Partnership deed / LLP agreement
• Pan card
• Ghana card
• Age proof
• Cancelled cheque (for bank account detail requirement)
• List of directors
• ID and address proof of director
• Passport size photograph
• Board resolution on the letterhead
• Affidavit from directors
• Sale deed document of the premises
• If rented, registered rent agreement
• NOC from the owner
• Architect attested Key plan and site plan
• Document requirement from competent person
  • Bio data as per preformed
  • Appointment letter of competent person
  • Proof of qualification
  • Experience certificate
  • Passport size Photo
  • ID proof
  • Address proof
  • Affidavit of the competent person
• 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

Food and Drugs Authority,
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
Health consultant in Accra, Ghana. 17 Nelson Mandela Ave, Accra, Ghana.
JRG9+2Q Accra, Ghana
Contact number- +233 30 223 3200
Location link

Eligibility

• Any person/company/partnership firm/LLP can apply for drug license.

Fees

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

Validity

• The license is valid for one year 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

Please provide other instructions related to the certificate/documents.
E.g. the state office holds birth records since January 1908.

Required Information

• Details of Manufacturer
• Name of Business
• Contact details (postal/email address/telephone/email address)
• Location of proposed licensed premises
• Street
• Address
• Postal Address (if different from business address above)
• Contact details (email address/telephone/fax number)
• Details of Manufacture
• Type of product
• Describe the range of dosage forms/types of devices to be manufactured
• Indicate whether manufacture (for human, animal or any other purpose)
• State other products to be manufactured at the same premises (if applicable)
• Contract Manufacture
• Product/ Stage
• Manufacturer
• Address
• Testing contracted to the manufacturer
• Nature of Test
• Name of Testing Laboratory/Service
• Address
• Products stages of manufacture, including testing
• Key Personnel and Person(s) in charge of Quality/ Assurance
• Person in charge of production (Full Name, Position in the company)
• Relevant qualification (Name of Institution, Duration of Study, Certificates Awarded)
• Relevant Experience (last job first) {Name of Company, Duration, Position Held}
• Water Supply, Treatment and Waste Disposal
• Number and Category of Employees
• State proposed date of commencement of business
• Any additional information which applicant wishes to provide
• Declaration (Applicants and witness)

Need for the Document

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

Information which might help

• Drugs and other regulated product manufactures are required to register from FDA office.

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

Link

Others

More information which might help people.