Revision of Veterinary Medicines Legislation

Movement towards a single EU-wide authorisation

Veterinary MedicineIt was announced at the TOPRA 7th Annual Veterinary Medicines Symposium in Dublin in 2012 that significant changes would be made to the current Veterinary Medicines legislation (Veterinary Medicines Directive).

Four main problems were identified by industry:

  • High administrative burdens
  • Lack of availability of veterinary medicines
  • Risk of antimicrobial resistance
  • Deficient operation of single market

The Battle against Falsified Medicines

EU legislation to combat an increasingly significant problem

Regulatory Affairs - Falsified MedicinesThe most commonly used definition for Falsified Medicines, describes them as deliberately and fraudulently mislabelled medicines with respect to identity and/or source. Falsified medicines do not meet the legal prerequisite quality or safety standards, and subsequently put at risk the health of millions of patients who take for granted safe and effective prescription drugs.

Pharmaceutical falsification of medicines is a lucrative and sophisticated business, and it is gradually becoming a significant global problem. The success of the business can be attributed to increased commercial use of the internet. Rogue internet drug websites are the most frequent way that people purchase falsified drugs. These websites bypass the regulatory safeguards that store-based pharmacies must follow, for example the need for a prescription. These websites also appeal to the customers as they offer cheaper medications, and there is also a sense of anonymity when making a purchase online.