LANGUAGE
All applications and supporting documents shall be in English and legible. Where
material is not originally in English, a copy in the original language and a full translation
should be submitted, the accuracy of the translation is the responsibility of the applicant.
Authentication of the translation has to be done at the nearest Ghana Embassy or by
the National Drug Regulatory Authority of the country from where the document
originates. Reports submitted only in a language other than English will not be
accepted.
DATA PRESENTATION
All information, data, tables, diagrams, attachments must be legible of font size 12 or
more and shall be presented on in soft copy on CD-ROM. All pages shall be numbered
sequentially with the format page numbered as page x of y and have a table of
contents indicating the sections and page numbers in the relevant sections of the
application form. Before submitting the completed form, check that you have provided
all requested information. Acronyms and abbreviations should be defined the first time
they are used in each part.
OFFICIAL REFERENCES AND TEXTS
When direct reference is made to specifications, quality control procedures and test
methods in official compendia (FDA officially recognised list of publications), text books
or standard publications, reprints or authenticated copies of relevant pages shall be
enclosed. References to pharmacopoeias should be as per the current editions.
References should be provided for all in-house processes.
SUBMISSION OF APPLICATION
• An application for the registration of a veterinary medicinal product, either locally
manufactured or imported, shall be made in writing via a cover letter.
• The cover letter submitted with the dossier should include a clear statement by
the applicant indicating that the information submitted is true and correct.
• If the applicant is a foreign company, it shall appoint a local agent through whom
an application shall be submitted.
• The local agent shall be a company registered with the Registrar General of
Ghana and appointed as a representative of the foreign company in Ghana.
• The application shall be submitted through the authorized local agent by the
regulatory contact person to the following address:
The Chief Executive Officer
Food and Drugs Authority
P. O. Box CT 2783
Cantonment-Accra
Procedure to Follow
Not Avaiable
Responsible Institution
No. 17 Indian Ocean Street, Nelson Mandela Avenue, Shiashie
- Email: fda@fda.gov.gh
- Website: https://www.fdaghana.gov.gh/
- GPS: GA-237-7316
- Telephone: (+233)302-233200/ 235100
Relevant Forms to Download
Not Available
Online System
Link Unavailable
Fees/ charges
Not Avaiable
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