Medicines and Related Substances Regulations (SI.No.163 2019).

The Botswana Government Gazette, published on December 27, 2019, contains the Medicines and Related Substances Regulations, 2019. These regulations, issued under the Medicines and Related Substances Act (Cap. 63:04), outline the registration, licensing, import, export, and control of medicines, cosmetics, and complementary medicines in Botswana. The document includes detailed procedures for the registration of medicines, exemptions for individual patients, wholesale, and donated medicines, as well as licensing requirements for pharmaceutical operations, manufacturing facilities, pharmacies, and dispensaries. It also covers record-keeping, post-market surveillance, adverse medicine reactions, counterfeit medicines, and clinical trials. Additionally, the regulations specify the classification and description of medicines, prescription requirements, storage, and disposal of medicines, and advertising and promotion guidelines. The document emphasizes the importance of compliance with good manufacturing practices and provides guidelines for inspections and audits. Regarding veterinary drugs, the regulations include specific provisions for the registration and control of veterinary medicines. Veterinary medicines must undergo a rigorous registration process similar to that for human medicines, ensuring their safety, efficacy, and quality. The regulations mandate that veterinary medicines be manufactured in compliance with good manufacturing practices and that they be properly labeled with information on their use, dosage, and potential side effects. The import and export of veterinary medicines are also regulated, requiring permits and adherence to specific guidelines to prevent the entry of counterfeit or substandard products. Additionally, the regulations address the licensing of facilities involved in the manufacture, storage, and distribution of veterinary medicines, ensuring that these facilities meet the required standards for hygiene, safety, and quality control. The regulations also include provisions for the monitoring and reporting of adverse reactions to veterinary medicines, as well as the recall of products that do not meet safety or quality standards. These measures are designed to protect animal health and ensure that veterinary medicines available in Botswana are safe and effective.