LANGUAGEAll applications and supporting documents shall be in English and legible. Wherematerial is not originally in English, a copy in the original language and a full translationshould 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 bythe National Drug Regulatory Authority of the country from where the documentoriginates. Reports submitted only in a language other than English will not beaccepted.DATA PRESENTATIONAll information, data, tables, diagrams, attachments must be legible of font size 12 ormore and shall be presented on in soft copy on CD-ROM. All pages shall be numberedsequentially with the format page numbered as page x of y and have a table ofcontents indicating the sections and page numbers in the relevant sections of theapplication form. Before submitting the completed form, check that you have providedall requested information. Acronyms and abbreviations should be defined the first timethey are used in each part.OFFICIAL REFERENCES AND TEXTSWhen direct reference is made to specifications, quality control procedures and testmethods in official compendia (FDA officially recognised list of publications), text booksor standard publications, reprints or authenticated copies of relevant pages shall beenclosed. 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 locallymanufactured or imported, shall be made in writing via a cover letter.• The cover letter submitted with the dossier should include a clear statement bythe applicant indicating that the information submitted is true and correct.• If the applicant is a foreign company, it shall appoint a local agent through whoman application shall be submitted.• The local agent shall be a company registered with the Registrar General ofGhana and appointed as a representative of the foreign company in Ghana.• The application shall be submitted through the authorized local agent by theregulatory contact person to the following address:The Chief Executive OfficerFood and Drugs AuthorityP. O. Box CT 2783Cantonment-Accra |
Procedures to FollowNot Avaiable |
Responsible InstitutionFood And Drugs Authority
Legon, Accra |
Relevant Forms to Download |
Fees / ChargesNot Avaiable |