SAHPRA: alternative regulatory and licencing requirements for certain alcohol based hand rubs

In response to the anticipated shortage of alcohol-based hand sanitisers for use in the health care system as a result of the outbreak of the COVID-19 pandemic, the Minister of Health has, under specific conditions:

• excluded certain alcohol-based handrubs used or purporting to be suitable for use to prevent or treat infection within a clinical environment from the provisions of Section 14(1) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) (the Medicines Act) and regulations 11 and 12 of the General Regulations made in terms of the Act (Government Notice No. R. 859 of 25 August 2017) (the General Regulations), and
• excluded manufacturers licenced in terms of section 22C(1)(b) of the Medicines Act, of the mentioned alcohol-based handrubs from regulations 23(1)(c)(ii), 23(1)(c)(iv), and 23(2)(aa) of the General Regulations made in terms of the Act (Government Notice No. R. 859 of 25 August 2017) (the General Regulations).
  The South African Health Products Regulatory Authority (SAHPRA) has drafted minimum licensing requirements for the manufacturers of said alcohol-based handrubs.

Download the notice with the minimum requirements from the SAHPRA website or click here.