Exclusion of certain Alcohol-Based Hand-Rubs from the Operation of Specified Provisions of the Medicines Act

On 26 June 2020 a notice was published in the Government Gazette by the Minister and Department of Health.

According to this Notice manufacturers, importers or distributors who are licenced in terms of the Medicines and Related Substances Act, No 101 of 1965 (Medicines Act) are excluded from the requirement that alcohol-based hand-rubs - where used or purporting to be suitable for use to prevent or treat infection within a health establishment as defined in the National Health Act, no 61 of 2003, or other high-risk environment – must be registered with SAHPRA for it to be sold on the market.

In this regard the exclusion includes specifically the requirement relating to:

1. Registration requirements for medicines;
2. Inclusion of professional information and a patient information leaflet;
3. The information of the registration of a responsible pharmacist, registered with the South African Pharmacy Council;
4. Compliance with good manufacturing, wholesaling or distribution practices;
5. The appointment and designation of a responsible pharmacist.

Specific conditions of the Exclusion include that:

Any medicine sold in accordance with this Notice must be: -

1. manufactured according to the WHO-recommended Handrub formulations, as provided in the “Guide to Local Production: WHO-recommended Handrub Formulations”and;
2. labelled in accordance with regulation 10 of the General regulations
   

An application for a licence in terms of Section 22C(1)(b) of the Medicines Act and the relevant regulations thereto relating to manufacture, import or distribution of the alcohol-based handrubs listed in this schedule, shall be accompanied by documentary evidence which include but is not limited to:

1. a Site Master File (SMF)
2. a Safety, efficacy and quality manual relating to the said handrubs which must include procedures for the conduct of analytical tests;
3. equipment inventory of equipment used in manufacturing of the handrubs;
4. master batch manufacturing record;
5. certificate of analysis and
6. signed declaration by responsible person for the licence holder which must confirm that:
   1. handrub is prepared according to the WHO Guide to Local Production document
   2. the handrub is tested according to and compliant with test methodology provided in the South African National Standards(SANS) 490:2013 document
   3. the concentration of ethyl alcohol or isopropyl alcohol used will be verified for each batch using gas chromatography, alcoholmeter, hydrometer or other chemical analysis of equivalent or greater accuracy
   4. the handrub is manufacturer under sanitary conditions with well-maintained and fit for purpose equipment
   5. the manufacturer will keep records relating to the manufacture of the handrub; and
   6. the handrub is safe for its intended use.

For continued sale of these products after this notice expires on 18 June 2021 they must be registered with SAHPRA and the manufacturer, importer or distributor of these products must comply with all the provisions of the regulations to the Medicines Act in this regard.

For more information read here