(2000; 29 pages)
The broad policy of the Ministry of Health aims at ensuring that all drugs manufactured, imported or exported, distributed or sold in Botswana are of acceptable quality, safety and efficacy. The process of drug registration forms an important basis for evaluating and assuring drug safety, efficacy and quality. Therefore, all drugs manufactured, imported/exported, distributed or sold in Botswana should be registered.
The registration of drugs and related substances in Botswana is governed by the provisions and requirements of the Drugs and Related Substances Act, 1992 and the Regulations, 1993. The Drugs Advisory Board has developed these guidelines to guide applicants when applying for drug registration.
Section I covers the introductory background and definitions as they apply to the guidelines. Section II of these guidelines provides general guidance on the kind of information to be submitted as part of completing Form 1 MH 2048 Application for Registration of a Drug.
Section III provides the applicant with a self-checking mechanism that also serves as an evaluation report. Accurate completion of the table in Section III is expected to expedite the processing and evaluation of applications. It should therefore be attached to each MH 2048 submitted.
Section IV provides a specific guidance to manufacturers/applicants on stability data as considered desirable and acceptable by the Ministry of Health in supporting the stability hence the shelf life of the various dosage forms. It is the responsibility of the manufacturer to ensure that stability studies are carried out in accordance with the guidelines.
This set of guidelines replaces all previous guidelines on drug registration distributed by the Drugs Regulatory Unit until March 2000.