Ghana - Renew of Biological Product Registration

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Procedure

Apply In-Person:

1. To Renewal of biological product in person, the applicant has to approach the Food and drugs authority (FDA) regional office in Accra. Application link
2. Application form can be downloaded from this application link
3. Before visiting the office, the applicant needs to perform some pre-processes which are explained in further steps.
4. The applicant must prepare an application letter on the company letterhead addressed to the Director General requesting to get the concerned product registered.
5. Make sure that you have all the documents listed in the “Required Documents” section of this page.
6. Visit the office and submit the application package to the Liaison Office of the Director (LOD).
7. After documentation review, required GMP inspection and Product analysis in lab, products are sent for approval meetings. For product labels with compliance issues, compliant artwork may be submitted with a commitment letter from the manufacturer.
8. For products approved at the meeting, a ‘Notification of Registration’ is issued to the applicant while a ‘Compliance Directive’ is issued to those not approved.
9. Once all the requirements are met, the applicant will be issued a renewed Certificate of Registration.

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Required Documents

• Application link
• Proof of premises registration
• Previously issued license
• Certificate of Pharmaceutical Product
• Product Quality Review document
• Manufacturing License
• Certificate of Registration of Brand Name/Trademark
• Notarized Declaration
• Power of Attorney/Contract Manufacturing Agreement

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
Contact link
Location link

Eligibility

• Any biological product license holder, whose license expiration is just a month ahead, can apply.

Fees

• Please see the fees on our website link
  

Validity

• Validity for this procedure is 1 year.

Documents to Use

• Application 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

• An application for renewal should be initiated not later than 30 calendar days to the date of expiration of the current/valid Licence.
• The application should be made on the company’s letterhead which should contain the current/valid email address and telephone number of the applicant.
• The applicant should provide the details of the product(s) for renewal and clearly state the purpose in the body of the letter along with the contact details of the manufacturer of the product(s) (i.e. name, address email, and telephone number of the contact person).

Required Information

• Company Name and Type
• Tax Identification Number
• Registration Certificate Number
• Incorporation Date
• Company physical and mailing address
• Contact number and email address
• Applicant names
• Source and category of the product
• Product Description and HS code
• Manufacturer name and address
• Particulars of the product
• Card details

Need for the Document

• Every license to Manufacture of Drugs for Sale must be renewed once in every five years of its validation period.
• The certification helps in ensuring the 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 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.