The Names and Scheduling Unit of SAHPRA evaluates the suitability and applicability of any proprietary name proposed to be used in connection with a medicine and evaluates the scheduling status of a medicine.
Proprietary Names
The naming of medicines is a potentially complex process, on the one hand bringing to bear a host of marketing, promotional, commercial and competitive issues. On the other hand, medicines are not ordinary items of commerce or, at the very least, are highly specialised articles of commerce with the potential to literally ‘kill or cure’. For this latter reason the marketing and sale of medicines is strictly regulated in all mature modern economies and societies, including South Africa.
The Medicine and Related Substances Act, 1965 (Act 101 of 1965) and its Regulations define the statutory requirements against which a proposed proprietary name shall be adjudged to be compliant or non-compliant. Thereafter, and in addition, the name is tested against the proposition that it may directly or indirectly pose public health or safety concerns, or may be misleading and may thereby place patients or consumers at risk.
The naming policy of SAHPRA is intended to inform product selection, promote health, and protect the public in the safe and effective use of medicines, and how it contributes to the safety, quality and efficacy of the prescribing, dispensing, administration and usage of medicines by health care professionals and the public of South Africa.
Scheduling
The scheduling of medicines and products containing substances already listed in the Schedules as well as those substances not yet contained in the Schedules (new chemical entities) are normally managed as part of the medicine registration process.
Three broad types of applications are considered by SAHPRA:
- applications for the registration of a medicine, which may include applications for the scheduling of a new chemical entity or applications for registration of a product containing a substance already listed in the Schedules (in accordance with such listing);
- applications for re-scheduling a substance that has already been listed in the Schedules;
- applications for listing a substance in the Schedules for prescribing by an authorised prescriber other than a medical practitioner or dentist.
In terms of the Medicines Act, a ‘Scheduled substance’ is defined as follows: “means any medicine or other substance prescribed by the Minister under section 22A”. Section 22A(2) empowers the Minister of Health “on the recommendation of SAHPRA”, to make the Schedules referred to in that section, Section 37A also empowers the Minister, again on the recommendation of SAHPRA, to amend the Schedules by notice in the Government Gazette. The official Schedules shall therefore always be those that have been published in the Government Gazette or amended by subsequent notice in the Gazette. All medicines are subject to a scheduling process on the basis of the substances (active pharmaceutical ingredients) they contain.
The primary consideration in scheduling a substance is its safety profile, in relation to the therapeutic indications for its use. Substances may be listed in one or more of eight Schedules.
However, substances may also be listed in more than one Schedule, based on dosage form, route of administration, strength, indication, dose, duration of treatment or a combination of these factors. Where a substance or medicine has been listed in more than one Schedule, the other Schedule(s) in which it is listed is/are indicated in parentheses after the inscription in a particular Schedule. Where exceptions are included in an entry, these have been emphasised by printing the word ―except in bold type.