1. Control of Veterinary Drugs in South Africa
By Prof Naidoo .
MMALENCOE MOROE-RULASHE
DAFF-SOUTH AFRICA.

2. Veterinary Drugs: SA South Africa is a closed market
All products require authorisation for
Sale
Manufacture
Wholesaling
Importation
Exportation
Bonding
Utilisation

3. Two General CATEGORIES
Prescription Only
Act 101/65
Veterinary Medicines
Antibiotics
Anaesthetics
Sedatives
Analgesics
etc
Over the Counter
Act 36/47
Stock Remedies
Parasites
Tetracyclines
Growth Promoters
Vaccines
Supplements

4. Act 101/1965 The main control act in South Africa Controlled by DoH:
SA Health Products Regulatory Authority (SAHPRA)
Controls by means of schedules
S0-S2: Over the counter (Human)
S3-S6: POM (Prescription Only Medicines)
S7-S8: Prohibited

5. Act 36/1947
Governs the use of stock remedies, agricultural remedies and feed (feed additives)
Controls by means of access
Sale from open shops
Limited sale (Vet only)

6. Why the need for two acts
Allow farmers access to certain drugs
Act 36/47 promulgated under agriculture
Only 3000 vets in SA, with 100 practices dedicated to productions animals
Medicines Act promulgated later
Vet POMs 1983 (Old Medicines)
Under Department of Health
Problems controlling an Act in another department

7. Further Control
Food Safety: Foodstuffs, Cosmetics and Disinfectants Act
Vaccines: Animals Diseases Act
Environmental Protection: Hazardous Substances Act
Professional Acts: Veterinary Act, Pharmacy Act, Health Professions Act
Consumer Protections Act
Advertising Standards Authority
Animal Ethics: SA National Standard 10386

8. Pillars of control
All products are evaluated. No mutual recognition on registration (Except Manufacture)
Safety
Preclinical, clinical and environmental
Quality
Manufacture quality
Efficacy
Target species
Target indication

9. Safety Preclinical Safety Laboratory animal toxicity testing OECD GLP
Accept OECD guidelines (SANAS)
Companion animals Vs Production Animals
Food safety, ADI and MRLs
Accept CODEX MRLs

10. Quality Agriculture Health GMP approval: Major Regulator’s Approval
In-house evaluations
Health
Inspectorate evaluates all manufacture facilities
Internal or via PICs (WHO cGMP)
Frequent monitoring
Wholesale and storage sites
Vaccine quality laboratory (Medical)
No analytical laboratory (pending)
Batch release (ISO17025 Accredited labs)

11. Efficacy Quality Control: GCP (MCC or SANAS)
Statistical designed studies
VICH guidelines
WAAVP protocols
Bioequivalence acceptable
AUC (80 to 125%); Cmax (75 to 133%)
Local Studies
Parasiticides, Mastitis Remedies
Require regulatory and ethics approval

12. Food safety Compulsory for all products
Except pharmacokinetic bioequivalence
Depletion study or single time point
Per species and route
At maximum recommended dose
Evaluated against CODEX or EU MRLs
Law does allow for setting of MRLs
Not commonly undertaken except pesticides
National and commercial residue laboratories

13. Pharmaceutical Full technical dossier required
All manufacturing information
All ingredients
Quality (Chemical/Biological)
Mixing process
GMP compliance
Stability: Accelerated and actual
Zone II and some in Zone III
Packaging

14. Package inserts/Packaging
Major attention to editing PI
Veterinary Medicines
Based on the clinical and tolerance data submitted
Template PIs considered
Owner Information Leaflets (In discussions)
Stock Remedies
Emphasis on language
No complicated instructions or information
Well designed packaging

15. Pharmacovigilance Spontaneous Reporting
Comprehensive guidelines
Veterinarians and applicants obliged to submit
No vet pharmacovigilance centre
Controlled by each Department
Applicants
Have to have a technical expert on staff (Vet)
PSUR evaluations requested on concern
NSAIDs
Antimicrobials

16. Inspectorate Both Departments
Hospital and practice inspections (Health)
Monitor all ports of entry (Via customs)
Border Control Agency (To be set up)
Stricter control on chemical imports
Monitor internet sites (Health)
Illegal products
Assisted by local pharmaceutical industry
National labs: Jockey club, Forensics, SABS, Doping, Residue, WHO reference lab
Non-compliance with certificate of registration
Illegal marketing/Sale
Complaints/Pharmacovigilance

17. Sa legislation: differences
Minor species, minor use
Still in process (e.g. fish)
Used for wildlife immobilisation agent
Mastitis Guidelines (Done)
Unique SA bacteria
Unique conditions of use
Complementary and alternative medicines
Controlled by health
Strict control on manufacture
No specific claims allowed

18. SA deficiencies Insufficient experts Insufficient Inspectorate
Not training new experts
Insufficient Inspectorate
Insufficient Quality assurance laboratories
Compounding of veterinary medicines
Meant for limited use
Control as pharmacy and not manufacture
No clause in law to restrict quantity
Dual regulatory system?
Difficult to maintain uniformity in process
Plans: Harmonise guidelines/implementation

19. Conclusion Future Plans to assist in VMPs activities
Streamline process/ Uniformity
Control of all VMPs under/by one Authority?
New Authority which replaced MCC
SA Health Products Regulatory Authority (SAHPRA)
Control human foods, medicines, medical devices, complementary medicines, Vet POMs
Inclusion of OTC: Stock remedies: Under discussion
Mutual recognition in SADC
SA experts involved (Health and Agriculture)
Proper Standard
Proper Evaluator Qualification
VICH Involvement