Guidelines for Application for registration of biologicals

The Tanzania Food, Drugs and Cosmetics Act, 2003 requires that, products intended to be marketed in this country meet appropriate standards of quality, safety and efficacy.  Also they should be manufactured in facilities, which comply with GMP requirements. 

Vaccine unlike other pharmaceutical products have to be handled with extreme care as some of them may revert to virulence thus causing disease instead of the purpose of proving protection or treatment.

It is in view of the above that all biological products which are (integral part of pharmaceutical products) have to be assessed for quality, safety and efficacy before they are approved for use in the country. One of the means for ensuring that, vaccines and immunological product meet the required standards is by evaluating and registering them prior to market authorization.

Guidelines for Application for registration of biologicalss have been prepared to assist applicants who intend to register vaccines and other immunological products in Tanzania.

The application notes have been developed by Tanzania Food and Drugs Authority (TFDA) to provide guidance to applicants on the content and format of the Chemistry, manufacturing and controls data of such products required for their complete scientific evaluation.  They also indicate the order of the material to be submitted and the requirements for registration.

It is therefore essential that every person who intends to market a medicinal product in Tanzania reads the whole of these guidelines carefully and follows strictly the instructions prescribed herein.  Submission of applications, which do not comply with the prescribed requirements, may result in delays, queries or rejection of registration.

These Guidelines have been arranged into five annexes (A to E):

Annex A: Summary of product characteristics

Annex B: Chemistry, manufacturing and controls of Immunogenic substances

Annex C: Finished Medicinal product

Annex D: Toxicological Data

Annex E: Safety and Efficacy Data

Appendix I:  Anatomical Therapeutic and Chemical classification system of Biologicals.

Appendix II: Information required on Package insert and

Appendix III: Labeling requirements

Applications for registration and appended documents are accepted in the format and Language as specified under general requirements in the guidelines notes.

A specimen of an application form is attached.

It should be noted that, submission of applications, which do not comply with the prescribed requirements may result in delays, queries or rejection of registration.

Biological include in vitro diagnostic antigens, immunoglobulin, antisera, antitoxins and toxoid:

The revised edition of the guidelines is now available. Click here for detail