Update on the new Veterinary Medicines Regulation (Regulation (EU) 2019/6)

The new veterinary medicines regulation (Regulation (EU) 2019/6) will come into force in January 2022.  It will modernise the existing rules on the authorisation and use of veterinary medicines in the European Union. The new regulation seeks to simplify the regulatory environment and reduce the administrative burden for pharmaceutical companies developing veterinary medicines.

The current requirements and procedures for granting a marketing authorisation for veterinary medicinal products are laid down primarily in Directive 2001/82/EC and in Regulation (EC) No 726/2004. The new Regulation (EU) 2019/6 on veterinary medicinal products (VMPs) has been published on January 7th, 2019, to come into force on January 28th, 2022. The main aim of the new legislation is to increase the availability of VMPs in the EU, to improve the function of the EU market, reduce the administrative burdens, and strengthen innovation.  It contains new measures for increasing the availability and safety of veterinary medicines and enhances EU action against antimicrobial resistance. This new Regulation has a new short Article 9 dedicated to veterinary clinical trials.

Simplified Marketing Authorisation Assessment

The new regulation brings a simplified marketing authorisation application assessment with respect to veterinary medicinal products of major interest, in particular in terms of animal health and therapeutic innovation.  Further, the new legislation provides for an extended data protection period of technical documentation of 10, 14, or 18 years, depending on the type of VMP.  These measures intend to stimulate the development of new VMPs, for example for rare diseases.

Approaches to Veterinary Clinical Trials

There are several ways to approach and perform veterinary clinical trials. By having multiple investigational sites, the potential bias can be largely overcome. In addition, it is preferable to “blind” a study such that those involved cannot distinguish the identity of treatments (or controls) being administered. In veterinary clinical trials blinding by function is often used – where the diagnosing and evaluating investigator is not involved in treatment administration, and this methodology is well accepted by veterinary regulators. Performing a trial that recruits patients from different regulatory jurisdictions can have major regulatory and economic advantages.

Talk To Us About Veterinary Clinical Trials

The Acorn Regulatory clinical team monitors the development closely and is available to advise you on possible implications for your business.  Call us on 00353 52 61 76 706, email: info@acornregulatory.com, or complete the form below.

Further Reading

Acorn Regulatory Secures Manufacturer’s/Importer’s Authorisation Licence for Veterinary Use

Acorn Regulatory has obtained a Manufacturer’s / Importer’s Authorisation (MIA) licence  (otherwise known as an MIA Licence) for Batch Certification of Imported Medicinal Products for Veterinary Use. Read more here.