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Pharmacy Act, 1974 (Act No. 53 of 1974)

Board Notices

Guideline for the Removal of Pharmacy registration/recording as a result of non-compliance with good pharmacy practice and other pharmacy legislation

7. Process for the removal of the registration/recording of a pharmacy

 

In terms of this guideline, and taking into consideration Regulation 72 of the Regulations relating to the registration of persons and the maintenance of registers:

 

(a) the Council may direct the Registrar to give written notice to the owner and the responsible pharmacist (if there is one registered) of the Council’s intention to remove the registration of the pharmacy. The pharmacy owner shall be the person identified as the owner as per the register of owners held by the Registrar in terms of Section 14 of the Pharmacy Act, unless it can be shown that an application for the change of ownership of the pharmacy has been lodged with the DG, which application has not yet been approved;

 

(b) the pharmacy owner, or a person acting on behalf of the owner, must be afforded the opportunity to furnish the Council with written reasons, within 21 working days, as to why the pharmacy registration should not be removed;

 

(c) once the Council is in receipt of the written reasons submitted by the owner or a person acting on behalf of the owner, as to why the pharmacy registration should not be removed, the Council shall review such reasons and make a decision whether to remove the registration of the pharmacy, alternatively to allow the pharmacy to remain registered subject to terms and conditions the Council may deem appropriate;

 

(d) once the removal of the registration/recording of the pharmacy has been approved by Council:
(i) the owner, or person acting on behalf of the owner shall be notified of the removal of the registration/recording and shall be required to cease operations of the pharmacy as of the date of such notification;
(ii) the registration/recording certificate of the pharmacy shall be cancelled as from the date of the abovementioned notification, and the owner shall be required to return such certificate to the Council;
(iii) the Board of Healthcare Funders (BHF), or any alternative body, that is authorised and responsible for the issuing of practice code numbers in terms of the Medical Schemes Act, 131 of 1998, shall be notified by Council that the registration/recording of the pharmacy has been removed;
(iv) in the event that the pharmacy in question is a manufacturing pharmacy or a wholesale pharmacy, the South African Health Products Regulatory Authority (SAHPRA) shall be notified, by the Registrar, that the registration/recording of the pharmacy has been removed;
(v) other relevant stakeholders, such as suppliers and distributors of medicines shall be notified, by the Registrar, that the registration/recording of the pharmacy has been removed;
(vi) the pharmacy owner and/or the responsible pharmacist shall be handed over to the Professional Conduct Unit of the Office of the Registrar for investigation in terms of Chapter V of the Pharmacy Act, should this process not already have commenced;
(vii) the Registrar shall notify the DG of the removal of the registration/recording of the pharmacy and shall request that the DG withdraw the pharmacy licence in terms of Regulation 9 of the Regulations relating to the ownership and licencing of pharmacies; and
(viii) Council shall conduct an inspection within 3 months of the removal of the registration/recording of the pharmacy.

 

(e) in the event of the pharmacy continuing to operate as a pharmacy, despite such removal of the registration/recording of the pharmacy, the Registrar shall inform SAHPRA and the necessary law enforcement agencies for possible investigation and criminal prosecution where necessary.