The Section 21 Unit (Orthodox Medicines for Human Use) of the South African Health Products Authority (SAHPRA) processes and evaluates applications from applicants (treating practitioners) for access to unregistered medication within South Africa (SA). The applicant establishes whether there is a need for a certain medicine; if the orthodox medicine for human use is unregistered within South Africa, the applicant will submit a Section 21 application (Orthodox Medicines for Human Use). The Section 21 application framework also allows for access to unregistered veterinary medicine and unregistered complementary medicines but the application procedures differ vastly for these unregistered medicines. It is important that the application is sent to the appropriate contact details for veterinary or complementary medicine Section 21 applications.
The unit’s employees come from backgrounds of veterinary medicine, pharmacology, pharmacy and animal science while our advisory committees have expertise in veterinary medicine fields such as: wildlife, microbiology, toxicology, pharmacology, epidemiology, poultry, porcine and companion animal medicine, theriogeniology and animal production/herd health.
Veterinary Medicines guidelines: SAHPRA develops/updates and implements science-based technical requirements for veterinary medicines.
Professional Information database of registered veterinary medicines (Link to a searchable database hyperlinked to the PIs)
Fees: Provide link to "SAHPRA Fees Gazette no 42474"
South Africa recognises the importance of global collaboration with other players in veterinary medicines registration and therefore obtained observer status in VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products) in February 2013. In our endeavour to harmonise with the rest of the VICH member/observer countries SAHPRA adopts VICH guidelines, and endorses the principles and practices described therein. This section outlines guidelines adopted and developed by SAHPRA. Please refer to the VICH website under the tab "Guidelines" for the official final text of the adopted guidelines and the EMA (CVMP) guidelines https://www.ema.europa.eu/en/veterinary-regulatory/research-development/scientific-guidelines.
These documents should be read in conjunction with the relevant sections of other applicable SAHPRA guidelines.
GL 1 – Validation of Analytical Procedures: Definition and Terminology
GL 2 – Validation of Analytical Procedures: Methodology
GL 3 – Stability Testing of New Veterinary Drug Substances and Medicinal Products
GL 4 – Stability Testing for New Veterinary Dosage Forms
GL 5 – Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products
GL 8 – Stability Testing for Medicated Premixes
GL 10 – Impurities in New Veterinary Drug Substances
GL 11 – Impurities in New Veterinary Medicinal Products
GL 17 – Stability Testing of New Biotechnological / Biological Veterinary Medicinal Products
GL 18 – Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients
GL 22 – Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing
GL 23 – Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing
GL 25 – Testing of Residual Formaldehyde
GL 26 – Testing of Residual Moisture
GL 28 – Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing
GL 31 – Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: Repeat-Dose (90 Days) Toxicity Testing
GL 32 – Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing
GL 33 – Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: General Approach to Testing
GL 36 – Studies to Evaluate the Safety of residues of veterinary drugs in human food: General Approach to Establish a Microbiological acceptable daily intake (ADI)
GL 37 – Guidance for Industry: Studies to Evaluate the Safety of residues of veterinary drugs in human food: Repeat-Dose Chronic toxicity testing
GL 43 – Target Animal Safety – Pharmaceuticals: Target Animal Safety for Veterinary Pharmaceutical Products
GL 45 – Quality – Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products
GL 46 – Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Metabolism study to determine the quantity and identify the nature of residues
GL 47 – Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Comparative metabolism studies in laboratory animals
GL 48 – Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker residue depletion studies to establish product withdrawal periods
GL 49 – Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Validation of analytical methods used in residue depletion studies
GL 51 – Statistical evaluation of stability data
GL 52 – Blood Level Bioequivalence Study
GL 53 – Electronic exchange of documents: electronic file format
Date Adopted by SOUTH AFRICA:
Report on adverse events
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