REGULATORY COMPLIANCE GUIDELINES

Document NumberFile NameYearVersionDocument TypeDownload
Guidelines publication disclaimer Cover page20211Disclaimer
2.1IMPORTATION OF ANY MEDICINES AND / OR SPECIFIED SCHEDULE 5, SCHEDULE 6,
SCHEDULE 7 OR SCHEDULE 8 SUBSTANCES INTO THE REPUBLIC OF SOUTH AFRICA IN
TERMS OF THE PROVISIONS OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965
(ACT 101 OF 1965)
20202Guideline
2.44CULTIVATION OF CANNABIS AND MANUFACTURE OF CANNABIS-RELATED PHARMACEUTICAL PRODUCTS FOR MEDICINAL AND RESEARCH PURPOSES20172Guideline
5.01GUIDELINE FOR THE IMPORTATION AND EXPORTATION OF MEDICINES20111Guideline
5.05GUIDELINES FOR THE DESTRUCTION OF SCHEDULE 5 MEDICINES AND SUBSTANCES20202Guideline
5.07GUIDELINES FOR RECALL/ WITHDRAWAL
OF MEDICINES
20212Guideline
5.10GUIDELINE FOR RELEASE OF IMPORT HEALTH PRODUCTS AT PORT OF ENTRIES: REGULATORY COMPLIANCE UNIT20211Guideline
5.11GUIDE TO FEE DETERMINATION AND PAYMENTS OF PERMITS AND RELATED AUTHORIZATIONS IN REGULATORY COMPLIANCE UNIT20211Guideline
5.12GUIDELINES FOR MARKET SURVEILLANCE OF MEDICINES20211Guideline
5.16GUIDELINES FOR ADVERTISEMENT OF MEDICINES AND HEALTH PRODUCTS20211Guideline
5.18GUIDELINE FOR SAFE DISPOSAL OF UNWANTED / UNDESIRABLE PHARMACEUTICAL PRODUCTS: REGULATORY COMPLIANCE UNIT20211Guideline