Ghana - Apply for Licenses for Medical Devices Manufacturing Premises

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Procedure

Apply In-person:

1. To Apply for Licenses for Medical Devices Manufacturing premises in person, the applicant has to approach the Food and drugs authority (FDA) regional office in Accra contact link
2. Application form can be downloaded from this link
3. Applicants obtain the application form for Good Manufacturing Practices Audit for medical devices, cosmetics, and household chemical substances.
4. Read carefully through the application forms as there have different section.
5. The applicant should make sure are eligible for Obtain Good Manufacturing Practices Audit for medical devices, cosmetics, and household chemical substances by reading the eligibility criteria that has been listed out under the “Eligibility” of this page.
6. Please make sure you have all the documents that are the listed down the '’Required Documents of this page.
7. 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) to the FDA regional and district office or the head office.
8. Payment of appropriate fees should be made and that can be found under the "Fees" section of this page.
9. The FDA will dispatch an inspector to the facility premises for inspection to determine if Good Distribution Practice (GDP) and good manufacturing practice and Good Storage Practice (GSP) during storage and dispatch of product that quality control, and quality assurance of the products is practice.
10. If the Expert committee formed by the FDA are satisfied that all the conditions are meet as required for the application, you will be notified of the outcome and issued with the license / permit by the register/authorized official.
11. The processing time for this procedure takes 1 to 2 months.

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Required Documents

• Application form link
• Attach a cover letter
• Attach valid certificate of pharmaceutical product from the country of origin.
• Valid manufacturing authorization from the country of origin and good manufacturing practice certificate.
• Valid manufacturing contract agreement between the applicant and manufacturer.
• Loan license manufacturing a valid manufacturing contract agreement
• Supporting documentation from the competent drug regulatory authority for the manufacturing license.
• Copy of certificate suitability of the European pharmacopeia (CEP) including any annexes (if applicable)
• Chemical pharmaceutical documentation
• Clinical study reports
• Nonclinical study reports for new chemical entities only

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 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

• Ghanaians and non –Ghanaians are eligible.
• Companies/organization must have registered in FDA.

Fees

Please see the fees on our website link

Validity

• Validity for this procedure is 1year.

Documents to Use

• Link
  

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• The processing time for this procedure takes 1 to 2 months.

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 main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of CGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives.

Required Information

• Application number
• Date of submission of the dossier
• Name of the first evaluator
• Name of the second evaluator
• Date of first evaluation
• Date of second evaluation
• Number of files and CD received
• Particulars of the product
• Trade name/property of the product
• Approved/international non-proprietary name (INN)/Generic name of the active pharmaceutical ingredient (API)
• Strength of API per unit dosage of the product
• Commercial presentation of the product
• Nature and content of container
• Description of the product
• Herbal medicines (VM) prescription
• Pharmacological classification
• Indication
• Proposed shell life and storage conditions
• Name and address of the applicant
  • Name
  • Company name
  • Address
  • Country
  • Telephone
  • Telefax
  • E-mail
• Name and complete address of the manufacture of the active pharmaceutical ingredients
  • Name
  • Company name
  • Address
  • Country
  • Telephone
  • Telefax
  • E-mail
• Manufacturing and marketing authorization /international registration status
• Name and complete address of the authorized local representative of the applicant (local agent)
  • Name
  • Company name
  • Address
  • Country
  • Telephone
  • Telefax
  • E-mail
• Prescribing information
• Product information for health professionals
• Patient information leaflet
• Labelling (outer and inner labels)
• Sample of the product as per FDA sample schedule
• Batch number of the FPPs used in
• Declaration

Need for the Document

• The certification helps in ensuring maintenance of the best level of hygiene and quality of the products, which further helps in increasing the confidence of customers in the quality of the products.

Information which might help

• CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
• Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
• This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
• This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

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.