The Veterinary Medicines Directorate (VMD) has given a preview of the likely changes to the Veterinary Medicinal Products Directive 2001/82/EC at an information day.
A review of the existing directive has been ongoing since 2010. Reports had found a “serious failure” with regards to availability of medicines.
As a result, the objectives set out for reform included reducing the administrative burden, encouraging innovation and investment, improving availability and tackling antimicrobial resistance (AMR).
The European Commission is expected to publish proposals for the draft legislation in autumn. It will shape the regulatory framework for the research, development and authorisation of new medicines and control how they are distributed to those administering them.
The National Office of Animal Health would like marketing authorisations (MA) to be streamlined, according to technical director Donal Murphy. “Commission data estimates a directive can add one-third to the administrative burden, as opposed to a regulation.
“This is due to uneven implementation of legislation in member states and extra national requirements, potentially affecting animal health and welfare, public health through zoonotic disease, as well as sustainable agriculture and EU competitiveness,” he added.
“We would like to see a bridging procedure to convert national MAs that an organisation might have into a single European MA.”
According to VMD director of operations, Paul Green, the final proposals should not come as a surprise. “We haven’t seen them yet, but the commission is being very open about what the specifics might be,” he said.
“We’ve sat down with commission officials and have a very clear indication about what the proposals will cover.
“The Coordination Group for Mutual Recognition and Decentralised Procedures Veterinary has been working on this and the industry has been involved in these discussions, so I don’t think there will be any surprises in terms of reducing requirements and introducing further pictogram use.”
Mr Green outlined likely changes, such as the rationalisation of packaging and labelling requirements and exemptions for minor use and minor species.
“The key point is if a company wants a product to have pan-Euro MA, there will be more scope to go down the centralised procedure,” said Mr Green.
Further analysis of the changes to the directive can be found in the latest edition of Veterinary Times.