Equine Plasma in European Law

Under European law, horse (equine) plasma is classified as an Immunological Veterinary Medicine.

This means it must be produced in full compliance with the European rules for the manufacture of veterinary medicines which in turn means the manufacturer must have a Manufacturing Licence granted.

Veterinary Immunogenics was granted a Manufacturing licence in September 2002 - ML/19513/1

The Manufacturing License is granted only after site visits and documentation have satisfied the regulatory authority that production methods and Quality Control are of a sufficiently high standard to comply with Good Manufacturing Practice.

Veterinary Immunogenics current Certificate of Good Manufacturing Practice

However the plasma manufactured can not be sold until all data relating to its quality, safety and efficacy has been approved by the regulatory authority at which time a Marketing Authorisation is granted.

Veterinary Immunogenics was granted a Marketing Authorisation for Hypermune in January 2003 - Vm 18513/4000

Under new European laws which came into force in October 2005 governing the use of authorised veterinary medicines in different countries in Europe it is permitted, provided there is no similar authorised product in a country, for a product to be used which is authorised in a different European country under the Prescribing Cascade.

Hypermune is a licenced product in the UK and therefore can be legally considered for use in any country in Europe under the prescribing cascade as managed by that country's regulatory authority.

A veterinary surgeon wishing to use Hypermune should enquire from his or her national regulatory authority governing the use of immunological veterinary medicines.

Thomas John Barr BVMS MRCVS Director January 2006