Pharmaceutical Licence In South Africa

Any person desiring to own a pharmacy in terms of section 22A of the Act must submit an application form to the Director-General, and comply with the Pharmacy Act, 53 of 1974, and its Regulations:

  1. ection 22 and 22A of the Pharmacy Act, 53 of 1974
  2. Regulations relating to the ownership and licensing of pharmacies

Application forms are available from the link: http://www.health.gov.za/index.php/affordable-medicines/category/270-pharmacy-premises-licence  and the applicant must also complete an online application available on the link: http://interns.pharma.mm3.co.za/PasswordRequests/GroupOwnerPasswordRequestEmail 

User Manual for applicants wishing to apply for a new pharmacy licence, change ownership, relocate an existing pharmacy is available here (click to download). A document detailing Design guidelines for Pharmacies is also available here (click to download) to assist applicants in meeting criteria.

Applications

Application forms related to existing pharmacies are accessible by the responsible pharmacist online or alternatively Group owner login allows the authorised person access the forms. Follow the links to download application forms listed below:

2021 Application form – Automated dispensing unit

2019 Application form – Change of name or trading title

2021 Application form – Change of address without relocation

2021 Application form – Pharmacy Closure

2019 Application form – Recording of the Pharmacy after change of address without relocation

2021 Application form – Recording of a PCDT Permit

2019 Application form – Primary Health Care Clinics

2021 Application form – Web access rights to pharmacy owners

2021 Application form – Access Rights to Group Pharmacy

2019 Application form – Satellite Pharmacy

2021 Application form – Approval of premises-internal changes

2021 Application form – Duplicate certificate for registered facilities

2021 Application form – Installation of a Remote Automated Dispensing Unit

2019 Application form – Business within a Business

2019 Application form – Change of Owner Name (not change of ownership)

Resolution Letter

Fees

Recording Change of name of owner (NOT change of ownership)6589.00
Annual Fee -Community Pharmacy3696.00
Annual Fee -Consultant Pharmacy3461.00
Annual Fee -Institutional Pharmacy3696.00
Annual Fee -Satellite Pharmacy1782.00
Annual Fee -Wholesale and Manufacturing Pharmacy14435.00
Application for a duplicate Certificate: Change of name (pharmacy)2306.00
Application for a duplicate Certificate: Change of name (pharmacy)2306.00
Application for duplicate registration certificates – Diploma in Pharmacy2306.00
Application for Recording Grade A Pharmacy6918.00
Application for recording of new pharmacy owner2324.00
Application for recording of new pharmacy premises12258.00
Application for review of pre-registration examination paper in terms of pharmacy act 53 of 1974977.00
Approval of pharmacy premises- internal changes2903.00
GENERAL-Good Pharmacy Practice (GPP) Document325.05
Good Pharmacy Practice Standards325.05
Person- evaluation of a qualification in pharmacy obtained outside the Republic (applicant is a non- South African citizen)14145.00
Person- evaluation of a qualification in pharmacy obtained outside the Republic (applicant is a South African citizen)7194.00
Pharmacy- an application to conduct a separate practice or business within a retailpharmacy or establishing a retail pharmacy within another business3260.00
Pharmacy Evaluation – verification of an RPL assessment/ file3291.00

A pharmacy is defined in the Pharmacy Act, 53 of 1974, as any place wherein or from which any service specially pertaining to the scope of practice of a pharmacist is provided.

A facility where pharmaceutical services are rendered is considered a pharmacy if

  • it is registered with Pharmacy Council as a Pharmacy or
  • has a Licence issued by the NDOH which is recorded with Pharmacy Council

Click here to confirm registration or recording of a pharmacy.