This guideline has been developed taking the following applicable legislation into consideration—
| (a) |
the Constitution of the Republic of South Africa Act, 108 of 1996 and with particular reference to Chapter 2, being the Bill of Rights; |
| (b) |
the Promotion of Administrative Justice Act, 3 of 2000; |
| (c) |
the Pharmacy Act, 53 of 1974; |
| (d) |
the Regulations relating to the practice of pharmacy (GNR.1158 of 20 November 2000); |
| (e) |
the Regulations relating to the registration of persons and the maintenance of registers (GNR. 1160 of 20 November 2000); |
| (f) |
the Regulations relating to the ownership and licencing of pharmacies (GNR. 553 of 25 April 2003); |
| (g) |
the Rules relating to good pharmacy practice (GG 27112 Board Notice 129 of 2004 published on 17 December 2004, as amended); |
| (h) |
the Medicines and Related Substances Act, 101 of 1965; and |
| (i) |
the General Regulations published under the Medicines Act (GNR. 856 of 25 August 2017) |
| 5.1.1 |
Section 3 of the Pharmacy Act, 53 of 1974 provides for the objects of Council, which includes inter alia— |
| (a) |
to assist in the promotion of health of the population of the country [s3(a)]; |
| (b) |
to advise the Minister of Health or any other person on any matter relating to pharmacy [s3(b)]; |
| (c) |
to uphold and safeguard the rights of the general public to universally acceptable standards of pharmacy practice in both the public and private sector [s3(d)]; |
| (d) |
to establish, develop, maintain and control universally acceptable standards for the registration of a person who provides one or more or all the services which form part of the scope of practice of the category in which such person is registered, of professional conduct required of persons to be registered and control over persons registered in terms of the Pharmacy Act[s3(e)(ii)(iv)]; and |
| (e) |
to maintain and enhance the dignity of the pharmacy profession and the integrity of the persons practicing the profession [s3(g)]. |
| 5.1.2 |
Section 4 of the Pharmacy Act provides for the general powers of Council, which includes inter alia— |
| (a) |
in such circumstances that may be prescribed, or where otherwise authorised by the Pharmacy Act, Council may remove any name from the register [s4(d)]; |
| (b) |
subject to the provisions of the Pharmacy Act, Council may investigate the activities at a pharmacy [s4(i)]; and |
| (c) |
Council may consider any matter affecting the pharmacy profession and to make representations or take such action in connection therewith as Council may deem advisable [s4(k)]. |
| 5.1.3 |
Section 14 of the Pharmacy Act provides inter alia for the recording of pharmacies— |
| (a) |
the various categories of pharmacies which may be recorded [s14(a)]; |
| (b) |
Council may in the prescribed manner refuse to record any pharmacy which does not comply with the prescribed conditions [s14(h)]; and |
| (c) |
Council may require in the prescribed manner, persons authorised in terms of Section 22A of the Pharmacy Act to record the prescribed information with Council [s14(i)]. |
| 5.1.4 |
Section 22 of the Pharmacy Act read together with the Regulations relating to the ownership and licencing of pharmacies (GNR. 553 of 25 April 2003), provides for the requirements of licensing of a pharmacy— |
| (a) |
a person who wishes to own a pharmacy must apply to the DG for a licence for the premises wherein or from which such pharmacy business is to be conducted. The DG has the discretion to grant or refuse to issue such licence [s22(1)]; |
| (b) |
the DG in determining whether an applicant complies with the conditions for ownership of a pharmacy may request the assistance of Council [regulation 8(2)]; |
| (c) |
a person issued with a licence must record with Council, the name, address, date of the licence, licence number and any other particulars as prescribed [s22(2)]; |
| (d) |
the recording of such licence must be within 30 days from the date of issue of the licence by the DG [regulation 8(4) and 8(5)] of the ownership regulations; |
| (e) |
a pharmacy must be conducted under the continuous personal supervision of a pharmacist in accordance with good pharmacy practice as determined by the Council [s22(4)]. This pharmacist shall be responsible to Council for any acts performed on behalf of the owner, including any acts or omissions by the owner which may involve disciplinary action by Council [s22(5)], unless the Responsible Pharmacist satisfies Council that the responsibility for such act rests upon another pharmacist employed by the owner; |
| (f) |
Council has the right to inspect the pharmacy premises. The Registrar shall provide the DG and the person who made the application with a written report of the findings of the inspection if it is found that the inspected premises are not suitable for the business of a pharmacy [s22(6)]; |
| (g) |
the DG may cancel or suspend a licence which does not comply with the licencing conditions [s22(7)]. If the licence is cancelled or suspended, the premises shall from the date of such cancellation or suspension be considered unsuitable for the carrying on of the business of a pharmacy [s22(8) and regulation 9(a)]; and |
| (h) |
the DG may withdraw a licence where the owner of the licence is a pharmacist, and such pharmacist has been suspended from practicing as a pharmacist or has been removed from practicing as a pharmacist in terms of section 45(1) of the Pharmacy Act [regulation 9(g)]. |
| 5.1.5 |
Section 35A of the Pharmacy Act, read together with the Rules relating to good pharmacy practice (GG 27112, BN 129 of 2004 published on 17 December 2004) prescribes that all practicing pharmacists are obliged to ensure that the pharmaceutical services they provide are of a high quality and comply with Good Pharmacy Practice Standards as published by Council. |
| 5.2 |
Regulations relating to the registration of persons and the maintenance of registers |
The Regulations relating to the registration of persons and maintenance of registers (GNR. 1160 published on 20 November 2000) provides for the categories of persons that may be registered with the Council, the requirements for registration and the removal of registration.
| 5.2.1 |
Regulation 2 provides, for purposes of registration, inter alia the following categories of persons: |
| (a) |
a company entitled to carry on the business of a pharmacy; |
| (b) |
a close corporation entitled to carry on the business of a pharmacy; |
| (c) |
a pharmacy owner; and |
| (d) |
a responsible pharmacist. |
| 5.2.2 |
Regulation 67 provides for the role of the Council in the registration of a pharmacy. Regulation 67(1) provides that in order to register a pharmacy, the person must apply to Council, identifying the category of pharmacy, the responsible pharmacist for the premises wherein or from which the applicant wishes to carry on the business of a pharmacy, and the owner of the pharmacy; |
| 5.2.3 |
Regulation 68 provides that if the Registrar is satisfied that the applicant complies with the requirements for registration, then the pharmacy must be registered. However, if the Registrar is not satisfied that the applicant meets all the requirements for registration, the Registrar may refuse to register the pharmacy; |
| 5.2.4 |
Regulation 72 makes provision for the removal of the registration of a pharmacy: |
| (a) |
if the pharmacy does not comply with any of the conditions of registration; |
| (b) |
if the responsible pharmacist fails to perform the duties of a responsible pharmacist; and |
| (c) |
if the pharmacy fails to comply with good pharmacy practice. |
| 5.2.5 |
In terms of Regulation 75, the pharmacy may be restored to the register of pharmacies provided it can show that the pharmacy once again complies with the conditions of registration. |
Statistics Act, 1999
