The South African Pharmacy Council (SAPC) has noticed with concern that ‘change in ownership’, ‘relocation’ and ‘internal changes’ of some pharmacies is carried out without the necessary approvals from the relevant authorities. This is inconsistent with regulations and provisions of the Pharmacy Act, 53 of 1974, and may result in disciplinary action.
Pharmacy owners are reminded that it is imperative to follow all due processes when making any of the following changes: a relocation, a change in ownership or any internal changes to the pharmacy. Approval must be sought after from the relevant authorities, i.e., South African Pharmacy Council (SAPC), National Department of Health (NDoH) and/or South African Health Products Regulatory Authority (SAHPRA), where applicable.
Regulation 7 of the Regulations relating to the Ownership and Licensing of Pharmacies (2003) provides conditions for the ownership of a pharmacy in terms of the Pharmacy Act, 53 of 1974, in South Africa – these requirements should be adhered to at all times by persons owning pharmacies. Among the requirements of Regulation 7 is that the owner of the pharmacy shall provide the Director-General: Health with proof that they are able to comply with standards of Good Pharmacy Practice as determined by the SAPC, and where applicable, Good Manufacturing Practice or Good Distribution Practice as determined by SAHPRA. Further to this, the prospective owner shall satisfy the criteria for the determination of a need for the pharmaceutical service in respect of an area for which the application is made in terms of Regulation 7(2), which includes, amongst others, details of the location of the proposed pharmacy premises and the benefit to members of the specific community which the pharmacy intends to serve.
A pharmacy that has relocated without informing Council and the NDoH may not get approval for the ‘new location’ as it may not meet the criteria stated above.
Once you are licensed, it is important that you are compliant and adhere to all regulatory requirements to avoid a withdrawal of the licence. The Director-General may withdraw a licence issued in terms of Regulation 8(3) if the person issued with such a licence does the following:
- fails to comply with any of the conditions of ownership or the licensing requirements in terms of the Pharmacy Act and these regulations;
- disposes of the whole or any part of his, her or interest in a pharmacy or the body corporate that owns such pharmacy to any person not authorised to own a pharmacy or have any direct or indirect beneficial interest in a pharmacy;
- contravenes any provision of the Pharmacy Act, the Medicines Act or any other legislation applicable to such pharmacy; and/or
- fails to comply with the registration or recording requirements prescribed in terms of the Act and fails to comply with Good Pharmacy Practice or Good Manufacturing or Distribution Practice referred to in regulation 7 (1) (a).
In terms of the Regulations relating to the registration of persons and the maintenance of registers (2000), Chapters IX, X and XI, any person, company, or close corporation that that does not comply with the requirements and conditions for the registration of a company/close corporation/person entitled to carry on the business of a pharmacist, may be removed from Council’s registers.
The SAPC urges both owners and responsible pharmacists to get approval from Council for any structural changes made in the pharmacy. This is done by applying for approval of premises (internal changes) to avoid contravening any regulations and possible licence withdrawal, the relevant application form may be accessed at: https://www.sapc.za.org/Pharmacies_Applications.
