Guidelines for application for registration of drugs

Drug registration implements one of the legal requirements for marketing of medicinal products in Tanzania. The Tanzania Food, Drugs and Cosmetics Act, 2003 prohibits the sale, offer or supply of unregistered drugs. The Act also prescribes that drugs shall only be registered if they are in the public interest, meet appropriate standards of safety, efficacy and quality and are manufactured in facilities which comply with GMP requirements.

 Drug registration guidelines provide guidance to applicants who may wish to market their pharmaceutical products in the Tanzanian market. They intend to assist applicants in the preparation of acceptable application documents.

 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.

 The guidelines are divided into the following sections:

• Abbreviations
• Preamble
• Glossary of Terms
• General information
• Application form
• Part I: Summary of Product Characteristics
• Part II: Documentation for Active Pharmaceutical Ingredient (s)
• Part III: Documentation on Quality of Finished Product
• Part IV: Documentation on Pre-Clinical Data
• Part V: Documentation on Clinical Data
• Part VI: Documentation on Therapeutic Equivalence studies
• Part VII: Documentation on Fixed Dose Combination Products
• Appendix I: Anatomic Therapeutic Chemical Classification system 
• Appendix II: International comparator products for equivalence assessment of interchangeable multi-source (generic) products

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