Therapeutic Products Law
This article was originally published in SRA
Executive Summary
More in the series of guidelines issued
More in the series of guidelines issued
The Swiss Ministry of Health (Bundesamt für Gesundheit - BAG) has issued draft versions of a number of guidelines, which form part of the series intended to assist manufacturers and sponsors in complying with the requirements of the Therapeutic Products Law (Heilmittelgesetz ), which came into effect in January 2002. The guidelines cover a variety of topics including:
- veterinary medicinal products;
- advertising and price comparisons;
- information policy and data protection;
- import and export; and
- special requirements for medical devices.
The deadline for comments was 15 October 2003.
Guidelines have been previously issued on: the registration of generics and new active substances, homeopathic medicines and anthroposophic medicines, veterinary products, minimising the risk of TSE transfer, marketing authorisation transfers and changes, throat and cough lozengers, and establishment licences1,2.
ALAN CHALMERS
References
1. The Regulatory Affairs Journal , 2002, 13 (4), 342-343
2. The Regulatory Affairs Journal - Pharma , 2003, 14 (1), 64