Botswana Medicines Regulatory Authority’s Post

Mosadi thari ya Sechaba. Happy Mother's day.

GRAND-PA HEADACHE POWDER REINSTATED FOR USE IN BOTSWANA Botswana Medicines Regulatory Authority (BoMRA) is the National Regulatory Authority established in terms of the Medicines and Related Substances Act (2013) to provide for the, regulation of medicines, medical devices, cosmetics and other related substances in the public interest. Grand-Pa products, both powder and tablets, were suspended from registration in June 2021. The suspension followed the temporary supply halt initiated by the Market Authorization Holder, (MAH) GlaxoSmithKline CH South Africa, affecting Botswana and other markets. The Botswana Medicines Regulatory Authority (BoMRA) wishes to announce the reinstatement of Grand-Pa Headache Powder with new packaging for use in Botswana. The newly reinstated Grand-Pa Headache Powder product now comes in a revamped packaging system, stick packs made of Glazed Imitation Parchment (GIP) paper with a polythene layer. Registered pack sizes include 5, 12, 25, and 38 stick packs. Importation is strictly limited to products packed in the new Stick packs. The public is urged to always remain vigilant to ensure they buy or use the appropriate products. Any person found in possession of the previously registered Grandpa Products, not fitting the above mentioned pack sizes and packaging, will be subject to prosecution under Section 23 of the Medicines and Related Substances Act (MRSA). This section prohibits the importation, distribution, sale, storage, and advertising of unregistered medical products. Offenders may face a fine of up to P100,000.00 and/or imprisonment for a maximum period of 10 years.

Happy Ascension Day!

Re ipela ka lona #LabourDay

Happy Labour Day!

BOMRA PARTNERS WITH SAHPRA_Media R. TO STRENGTHEN REGULATION   The Botswana Medicines Regulatory Authority (BoMRA) and the South African Health Products Regulatory Authority (SAHPRA) have signed a memorandum of understanding (MoU) aimed at strengthening the regulation of medical products to safeguard public health in the two countries.   The partnership paves the way for the two regulators to collaborate and share information on the assessment of dossiers for medical products, which will result in efficiencies and commonality in the approval processes in both South Africa and Botswana.   The agreement also enables the parties to share information and build robust post-marketing monitoring and surveillance. it further presents for joint enforcement activities between SAHPRA and BoMRA This is especially crucial because South Africa plays an important role in the BoMRA value chain, with significant quantities of products originating from RSA or passing through its ports.   For his part, BoMRA Ag CEO Dr. Seima Dijeng, hailed SAHPRA as a s a very important strategic partner, the enduring relationship between Botswana and South Africa characterized by shared values, mutual respect, and ongoing economic cooperation. Therefore the Memorandum of Understanding (MoU) is a significant achievement in the journey of BoMRA  For her part, SAHPRA’s Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, said that the partnership is an important milestone in building capacity within the two regulators. It is also an opportunity to ensure robust intra-country post-marketing safety monitoring of health products and sharing of data that will lead to more vigorous monitoring of products once they are in the market.   BoMRA derives its mandate from the Medicines and Related Substances Act (MRSA of 2013), to regulate human and veterinary medicines, medical devices , cosmetics and complementary medicines to ensure that they conform to the set standards of safety, quality and efficacy.   SAHPRA on the other hand regulates (monitors, evaluates, investigates, inspects and registers) all health products. This includes clinical trials, complementary medicines, medical devices and in-vitro diagnostics (IVDs). Furthermore, the Authority is responsible for overseeing radiation control in South Africa. Its mandate is outlined in the Medicines and Related Substances Act, 101 of 1965 (as amended), as well as the Hazardous Substances Act, 15 of 1973.

Cautionary Statement on Benylin Pediatric 100mls cough syrup, Batch No 329304 and 329303

Virtual Stakeholder Engagement Invitation The detailed information and agenda regarding the stakeholder engagement will be communicated directly to the confirmed attendees. Any other issues or questions regarding this communication, please contact the Import/Export office at + 3620900 or email them to impex@bomra.co.bw / tmmolai@bomra.co.bw