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

Advanced Therapy Medicinal Products (ATMPs)

medicinal products for human useEmergence of biotechnology has brought along tremendous technological advancement in innovative therapies which are based on genes, cells and engineered tissues. These new medicinal products, termed as Advanced Therapy Medicinal Products (ATMPs) are defined and categorised in the legislation (Part IV – Annex 1 to Directive 2001/83/EC) as Gene Therapy, Somatic cell therapy and Tissue engineered products.

These ATMPs have revolutionised the treatments for a number of diseases or injuries such as skin burns, Alzheimer’s, cancer and muscular dystrophy to name a few.

The changing face of the Iranian market?

Iranian Market

Iranian Market

The historic deal announced recently between Iran and P5+1 Countries (US, UK, France, China, Russia and Germany) regarding the suspension of international economic sanctions could potentially have a major impact on the Iranian Pharmaceutical industry.In recent years, Iran has faced severe sanctions on foreign trade and banking. Whilst international powers have ensured that there are exemptions in the sanctions for medicines, anecdotal evidence suggests that those exemptions are not working. Many big companies have tended to err on the side of caution when dealing with Iran, for fear of violating the sanctions. The risk of fines and potential for bad publicity means doing business with Iranian companies was often not worthwhile.

Paediatric Investigation Plans

Paediatric Investigation Plans

Paediatric Investigation Plans

Historically, there have been relatively few clinical studies on how medicines affected children in Europe and what the prescribing dose should be. This was in part due to children making up a smaller percentage of the patient population as well as it being seen as unethical to conduct clinical trials on children.

With no clear guidance for the pharmaceutical industry, this resulted in fewer medicines being available for children who required treatment; therefore children were often prescribed medicinal products off-label i.e. being given medicines for unapproved indications or age groups. Recognised by the industry as unsuitable and unsafe, new regulations and guidelines were brought out to help address this issue.