NEWS

NATIONWIDE LOCKDOWN – BUSINESS CONTINUITY NOTICE

During this time of unprecedented disruption to all levels of society, we wish you all the very best, health and fortitude.We would like to advise you that MRA will continue to serve during the shut-down period. We are working from home and will be available via the normal contact routes – phones & emails.We look forward to supporting you with inter alia:

• compliance activities you are planning – Licensing and Quality Management System development;
• Regulatory activities, due diligences and dossier compilations;
• Training requirements – on-line sessions.

 Changes to Legislation: Medicines and Related Substances Act

The Medicines and Related Substances Act was amended on the 22nd of May 2017 by the promulgation of the Act 72 of 2008 and Act 14 of 2015 – the Medicines and Related Substances Amendment Acts.

• These changes to the legislation gave rise to the South African Health Products Regulatory Authority (SAHPRA), replacing the Medicines Control Council at the time of the first meeting of the SAHPRA Board.
• The SAHPRA Board was appointed by the Minister of Health for a 3-year term ending 30 September 2020 (GG. 41171 | 09.10.2017 | Notice No. 1091).
• SAHPRA was also delegated the responsibility of managing Radiation Control in South Africa – previously managed by Department of Health: Radiation Control.

The General Regulations to the Medicines Act were amended on the 25th of August 2017, with significant changes to the layout of the regulations, the labelling expectations and the categorisation of Health Products.Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs) were published on 9 December 2016. This is a separate set of regulations to the General Regulations to the Medicines and Related Substances Act and these regulations were effective on date of publication. Various communications were published by SAHPRA as to the implementation process for the regulations, including the need to license facilities involved with the importation, sale and logistics of MDs & IVDs.

Registration & Life-cycle News

eCTD / eSubmissions have been mandated as the only means of submitting new applications for registration for pharmaceutical and biological Health Products, starting 1 August 2019.Significant changes have been implemented for the ZA regional content for eCTD/eSubmissions. The introduction of several new template documents and guidelines requires considerably more regulatory work to go into the creation of registration applications than before.ZA is aligning itself with the EU variation guidelines in terms of classifications and processes. An addendum to the Amendment Guideline has been issued 10 May 2019.SAHPRA has been developing portals for electronic submissions. These include a portal for submission of variations as well as one to manage the licensing for companies involved with complementary medicines. These are in various stages of development and testing and 2020 will see these becoming operational.