ADR Adverse Drug Reaction
API Active Pharmaceutical Ingredient
ARV Anti-Retroviral
ASASA Advertising Standards Authority of South Africa
AU African Union
CAMS Complementary and Alternative Medicines
CM Complementary Medicines
CMS Council for Medical Schemes
CPD Continual Professional Development
CIOMS Council for International Organizations of Medical Sciences
DHCP Dear Healthcare Professional
DoH Department of Health (National)
eCDT Electronic Common Technical Document
EMA European Medicines Agency (previously EMEA)
FDA Food and Drug Administration (USA)
GCP Good Clinical Practice
GLP Good Laboratory Practice
GDP Good Distribution Practice
GMP Good Manufacturing Practice
GPP Good Pharmacy Practice
GWP Good Wholesaling Practice
GxP Good 'x' Practice
HS Health Supplement
HPCSA Health Professions Council of South Africa
IMI Intra-Muscular injection
IPI Inactive Pharmaceutical Ingredient
IMSM Interchangeable Multi-source Medicine
INCB International Narcotics Control Board
INN International Non-proprietary Name
IVD In-vitro Diagnostic Device
MRF Medicine Registration Form (old format)
MCA Marketing Code Authority
MCC Medicines Control Council
NADEMC National Adverse Drug Event Monitoring Centre
NHREC National Health Research Ethics Committee
Ops & Admin Operations and Administration
OTC Over The Counter
PI Package Insert
P&A Pharmaceutical and Analytical
PIL Patient Information Leaflet
PIT Pharmacist Initiated Therapy
PnA Pharmaceutical and Analytical
PSUR Periodic Safety Update Report
QA Quality Assurance
QMS Quality Management System
S1 Schedule 1 etc for S0-S8
SADC South African Development Community
SAHPRA South African Health Products Regulatory Authority
SAPC South African Pharmacy Council
SCI Sub-Cutaneous Injection
SAMED South African Medical Device Industry Association
SR-PINS Safety-Related Package Insert Notifications
SEP Single Exit Price
WHO World Health Organisation
WMA World Medical Association
‘Authority’ and ‘MCC’ Means the Medicines Control Council (MCC) as defined in the Medicines and Related Substances Act 101 of 1965 as amended.
‘Ethics booklet’ Means ethics policy set by the HPCSA and published as booklets.
‘Gazette’ Means Government Gazette
‘Health Product’ Means medicines, medical devices and IVDs
‘Medicines Act’ Refers to the Medicines and Related Substances Act 101 of 1965
‘Manufacturer’ Refers to both an applicant or the holder of the registration certificate in terms of the Medicines Act.
‘Medical device’ Includes ‘IVDs’ unless specified otherwise.
‘Medicine’ Means both medicine and scheduled substance unless specified otherwise.
‘Old Medicine’ Means medicines for which an application for registration has been submitted in terms of s14 of the Medicines Act but which have not yet been registered.
‘Pharmacy Act’ Means to the Pharmacy Act 53 of 1974
‘Pharmacy professionals’ Means all categories of person registered with the Pharmacy Council.
‘Council’ Means Pharmacy Council as defined in the Pharmacy Act 53 of 1974
‘MCC Guideline’ Means guidelines published by the Medicines Control Council in terms of the Medicines and Related Substances Act 101 of 1965
‘Medicines’ Includes complementary medicines (CAMS) unless specified otherwise.
‘Pharmacy Council Rules’ Means rules published in terms of the Pharmacy Act 53 of 1974 and includes the GPP document.