On Friday, 25 August 2017, the Minister of Health repealed and replaced, in its entirety, the General Regulation made under the Medicines and Related Substances Act, 1965 (the Medicines Act). It has been a very busy few months for the Ministry, as these regulations follow the recent significant amendments made to the Medicines Act which have introduced the stringent regulation of medical devices in a manner similar to that of medicines, as well as the promulgation of a set of medical device specific regulations. The regulatory framework now consists of a comprehensive statute regulating both medicines and medical devices, and two separate sets of regulations: 1) regulating medical devices and in vitro diagnostic medical devices; and 2) the new general regulations which has as its focus the regulation of medicines (the New Regulations).
The New Regulations include the following new provisions:
- Transferring registered combination medical devices to a new register for medical devices.
- Levying continued obligations on licence holders to ensure the safety and efficacy of their registered medicines by, for example, reporting quality, safety or effectiveness concerns related to any medicines to the Authority and risk management activities associated therewith, and extends the SAHPR's regulatory reach post the issuing of the relevant registration.
- The ordering of medicines by members of the supply chain must now be made in accordance with the listed requirements set out in regulation 34 (Particulars which must appear on order for medicines or scheduled substance). This will bring an additional administrative burden to bear on manufacturers who import, distributors, wholesalers and retailers.
- An avenue exists for wholesalers wishing to purchase medicines from another wholesaler to do so on application for an exemption from the restriction contained in section 22H of the Medicines Act.
- The advertising of veterinary and complementary medicines is now regulated by regulation 42 (Advertising of medicines). Additionally, verbal advertisements (for Schedule 2-6 medicines) to health care professional must be followed with written information.
Finally, although one might be excused for being excited by the title to regulation 46 (Timeframes for considering applications), the regulation itself does not specify a particular timeframe but instead provides for the SAHPR to determine the timeframes within which it will acknowledge receipt of an application for registration and communicate the subsequent acceptance of the application.
The medicines and medical devices regulatory landscape is rapidly changing. Webber Wentzel will be hosting a roundtable discussion on these changes and how to manage the current confusion in the medical device market. More detail on this event will follow.