| 67. |
Requirements and conditions for the registration of a pharmacy |
A person authorised and registered to carry on the business of a pharmacist in terms of the Act who wants to open a pharmacy must—
| (1) |
not less than sixty (60) days prior to the opening of any pharmacy, submit to the registrar— |
| (a) |
a duly completed application on a form approved and provided by council for the registration of: |
| (i) |
the pharmacy in one or more of the prescribed categories of pharmacies; |
| (ii) |
a responsible pharmacist for each one of the premises wherein or from which he, she or it wants to carry on the business of a pharmacist; and |
| (iii) |
the person as pharmacy owner; and |
| (b) |
a copy of any lease agreement, sublease agreement or other agreement in terms of which the applicant has the right to occupy the proposed pharmacy premises; |
| (c) |
a copy of the site plan of the erf, and floor plan of the building, if applicable, indicating the location of the pharmacy premises in relation to adjoining or surrounding businesses and access to and from such premises; |
| (d) |
a copy of the plan of the layout of the actual pharmacy premises; |
| (e) |
a copy of any suretyship(s), financing-, infrastructure-, outsourcing-, sale-purchase or any other agreement(s) relating to the ownership, fixed costs, management, administration, financing or acquisition of the pharmacy; and |
| (f) |
in the event of a partnership of persons, a copy of the partnership agreement, stating the name of the pharmacist designated to accept responsibility for the duties as prescribed in regulations 24 and 25 of the Regulations Relating the Practice of Pharmacy; and |
| (2) |
pay the registration fees as determined by the council. |
| (1) |
if he or she is satisfied that an application in terms of regulation 67 complies with the requirements of these regulations or the Act register such pharmacy; or |
| (2) |
if he or she is not satisfied that the application complies with the requirements of these regulations or the Act submit such application for consideration to the council and the council may— |
| (a) |
refuse to register the pharmacy; or |
| (b) |
register the pharmacy subject to such conditions as it may deem fit; or |
| (c) |
register such pharmacy. |
| 69. |
Every pharmacy registered in terms of regulation 68 must be issued with a registration certificate by the registrar. |
| 70. |
A pharmacy must, subject to such conditions as may be determined by the council, if applicable, be conducted under the direct personal supervision of a responsible pharmacist, in accordance with good pharmacy practice as published by council in rules. |
| 71. |
The council may inspect premises in which the business of a pharmacy is carried out and may provide the pharmacy owner or the responsible pharmacist with a written report of the findings of such inspection, if it is found that such pharmacy does not comply with the prescribed requirements or is, in the opinion of the council, unsuitable for the conduct of a pharmacy business. |
[Regulation 71 substituted by section 30 of Notice No. 4734, GG50528, dated 19 April 2024]
| 72. |
Removal from the register |
Except as provided for in sections 23, 24 and 39 of the Act, the council may direct the registrar to remove from the register of pharmacies, the name of pharmacy—
| (1) |
which does not comply with any of the conditions of registration of such pharmacy; |
| (2) |
if the responsible pharmacist fails to perform the duties of a responsible pharmacist as prescribed in terms of regulation 27 of the Regulations Relating to the Practice of Pharmacy; |
| (3) |
if the managing director or nominee of a company or the manager or nominee of a close corporation who owns a pharmacy fails to perform the duties as prescribed in regulations 24 or 25, as the case may be, of the Regulations Relating to the Practice of Pharmacy; or |
| (4) |
if the pharmacy fails to comply with good pharmacy practice as published by council in rules, |
if, after the pharmacy owner has been given notice in the manner prescribed in regulation 103 of the intention to remove the name of the pharmacy from the relevant register and to close such pharmacy business and who has been afforded an opportunity to furnish the council with written reasons, within 14 days after the date upon which the notice is deemed to have been received in terms of subregulation 103(2) and who fails to furnish acceptable reasons why its name should not be removed from the relevant register and why the pharmacy should not, as a result of such removal, be closed: provided that if the registrar is of the opinion that it is in the interest of the public, he or she may dispense with the required notice.
| 73. |
The pharmacy shall, as from the date on which notice of cancellation or withdrawal is deemed to have been received, be considered to be unsuitable for the carrying on of the business of a pharmacy. |
| 74. |
Temporary closure of a pharmacy |
The council may, if it has received a complaint constituting prima facie evidence of a contravention of the Medicines Act or the Act which is deemed to constitute a risk to public health and safety, apply to a Magistrate for the district in which the person or pharmacy practises or carries on the business of a pharmacist, and upon good cause being shown, obtain a warrant authorising an officer or inspector duly appointed by the council in terms of section 4(v) of the Act to either alone or with the assistance of the South African Police for a period not exceeding 90 days close a pharmacy pending an investigation: provided that the council shall provide reasons for the continued closure of the pharmacy concerned.
| 75. |
Restoration to the register |
The owner of a pharmacy whose pharmacy registration certificate has been cancelled or withdrawn and the name of the pharmacy has been removed from the register in terms of regulation 72 may have the name of the pharmacy restored to the register by—
| (1) |
submitting to the registrar: |
| (a) |
a duly completed application for restoration of the name of the pharmacy on a form as approved and provided by the council; and |
| (b) |
acceptable documentary evidence that the pharmacy again complies with the conditions for registration in terms of these regulations; and |
| (2) |
pay the prescribed restoration fee; and |
| (3) |
furnishing proof to the registrar that the pharmacy owner or responsible pharmacist, as the case may be, are fit and proper person(s) to own or conduct a pharmacy business: provided that if the registrar is not satisfied that the name of the pharmacy should be restored to the relevant register, the registrar must submit the application to the council for a decision. |
| 76. |
Transitional arrangements |
A pharmacy registered in terms of the Act at the commencement of these regulations shall be deemed to be registered in terms of regulation 68.
Statistics Act, 1999
