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FOI Guidelines- Guidelines issued by the Australian Information Commissioner under s 93A of the Freedom of Information Act 1982  

Medicines | Australia

The Guidelines are divided into the following parts:

 Part 1 – Introduction
 Part 2 – Scope of application of the FOI Act
 Part 3 – Processing and deciding on requests for access
 Part 4 – Charges for providing access
 Part 5 – Exemptions
 Part 6 – Conditional exemptions
 Part 7 – Amendment and annotation of personal records
 Part 9 – Internal agency review of decisions
 Part 10 – Review by the Information Commissioner
 Part 11 – Complaints and investigations
 Part 12 – Vexatious applicant declarations
 Part 13 – Information publication scheme
 Part 14 – Disclosure log
 Part 15 – Reporting

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Guideline on Completing Veterinary Clinical Trial Applications  

Medicines | South Africa

This document is to guide applicants on the information to submit on the design and conduct of all clinical studies for veterinary products. It is intended to ensure that such studies are conducted and documented in accordance with good clinical practice. Any person who needs to conduct a clinical trial with an unregistered veterinary medicine, a new indication, or new dosage regimen of a registered veterinary medicine requires approval from the South African Health Products Regulatory Authority.

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Access to Unregistered Veterinary Medicines  

Medicines | South Africa

This document provides guidance on access to unregistered medicines for animal use through the provisions of Section 21 of the Medicines and Related Substances Act, 1965.

The SAHPRA is mandated to regulate the quality, safety, and efficacy of all registered medicines. Prior to
registration of a medicine, access is limited to clinical trials authorized by the Authority and may in certain
circumstances, and in accordance with Section 21 of the Act, authorize the sale of an unregistered medicine for
such purposes and in such manner and during such period as the Authority may determine. Authorization of the
importation and use of unregistered medicines used in clinical trials is also covered by this document. However,
another set of guidelines that accompanies the use of unregistered medicines together with the protocol is provided as a separate document.

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