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

Notices

Guidance for the issuing of Licences for Pharmacy Premises

7. Basis for evaluation of applications

 

7.1 Applications will be dealt with in chronological order of receipt of a complete application;

 

7.2 An application for a licence for a pharmacy premises will be deemed to be complete when all documents required in terms of the relevant application form, including compliance with Good Pharmacy Practice as contained in rules published in terms of Section 35A of the Act and, where applicable, a licence issued in terms of Section 22C of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), have been received by the Director-General;

 

7.3 In the case of a new site where a licence issued in terms of Section 22C of the Medicines and Related Substances Act, 1964 (Act No. 101 of 1965), is required this licence must be obtained prior to the issuing of a licence for the pharmacy premises;

 

7.4 The applicant may be requested to provide additional information in support of a complete application;

 

7.5 In the case of an application which is incomplete, any outstanding information or documentation must be received by the Director-General within 30 (thirty) days of a request being submitted to the applicant. In cases where the requested information or documentation is not received by the Director-General within the required 30 (thirty) days the application will lapse. The applicant will be required to submit a new application accompanied by the applicable fee;

 

7.6 Applications are evaluated on the basis of the population of the sub-district or place to be served by the proposed pharmacy and the distance between the proposed pharmacy premises and existing community pharmacies;

 

7.7 The population figures used will be based on the latest available statistics provided by Stats SA;

 

7.8 In the case of applications for a pharmacy in a shopping centre, the number of retail establishments in the centre is considered;

 

7.9 In considering applications, the norm relating to the population to be served is considered first, followed by the norm relating to proximity to other community pharmacies. In the case of a pharmacy to be located in a shopping centre, the population and proximity to other community pharmacies is not taken into consideration;

 

7.10 Other factors which may be considered in the evaluation of applications include, but are not limited to the provision of services to patients with special needs or disabilities, the age of the population, as well as factors which may affect the number of people passing the premises;

 

7.11 In the case of an application for the relocation of a pharmacy within the same sub-district or place only the norms relating to proximity as contemplated in clauses 6.3.3 and 6.3.4 will be considered;

 

7.12 In the case of an application for the relocation of a pharmacy to a different subdistrict or place norms relating population as contemplated in clause 6.1.2 and proximity as contemplated in clauses 6.1.3, 6.3.3 and 6.3.4 will be considered.