№ lp_1_2_29937
Policy document defining statutory responsibilities, conditions, procedures, and liabilities governing the authorization, use, monitoring, and withdrawal of unregistered medicines by the South African Health Products Regulatory Authority under Section 21 of Act 101 of 1965.
Year: 1965
Jurisdiction: Republic of South Africa
Legal basis: Medicines and Related Substances Act 101 of 1965, Section 21
Subject area: Regulation of medicines and medical devices
Document type: Regulatory policy and authorization framework
Regulatory authority: South African Health Products Regulatory Authority
Scope: Unregistered orthodox, complementary, veterinary medicines and medical devices
Authorization period: Up to six months per authorization
Approval requirements: Written authorization by the Authority
Applicable parties: Medical practitioners, applicants, importers, suppliers, patients
Consent requirements: Informed consent from patient or guardian
Reporting obligations: Adverse events and final case reports
Source document: Section 21 of Act 101 of 1965
Administrative responsibility: Delegated to qualified officers including Clinical Pharmacologists or Medicine Control Officers
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

Don’t have cryptocurrency yet?

You can still complete your purchase in a few minutes:
  1. Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
  2. In the app, tap Send.
  3. Select network, paste our wallet address.
  4. Send the exact amount shown above.
After sending, paste your TXID (transaction ID) and your email to receive the download link. Need help? Contact support and we’ll guide you step by step.