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Review of Directive 2001/82/EC


EU Commission releases proposals on revised law on veterinary medicines and medicated feeds which are available here.

Workshops to discuss the European proposals for revised law on veterinary medicines and medicated feeds.


Due to unforeseen circumstances, The Medicated feeds workshop to be held on 18 November has been cancelled. The workshop will now be held on Tuesday 16 December at 10am.
I apologise for any inconvenience that this may cause. For more information please contact Lea Reynolds (l.reynolds@vmd.defra.gsi.gov.uk)


Further to our invitation to register interest in attending workshops to discuss the European proposals for revised law on veterinary medicines and medicated feed, please find below details of three workshops:

  1. Marketing Authorisations, including approval and post authorisation actions
    To be held on Monday 10 November 2014
  2. Medicated Feed
    To be held on Tuesday 16 December 2014
  3. Prescribing, supply and use of Veterinary Medicines, including advertising
    To be held on Monday 24 November 2014 - NOW FULLY BOOKED

Each workshop will be held on the VMD site and start at 10am with tea and coffee available from 9:30. These meetings will now close at 13:00 and delegates should make their own arrangements for lunch.

For further information please contact Jo Cawthorne j.cawthorne@vmd.defra.gsi.gov.uk or Lea Reynolds l.reynolds@vmd.defra.gsi.gov.uk


Invitation to register interest to discuss European proposals for revised law on veterinary medicines and medicated Feed

We understand the European Commission intends to publish its proposals to replace the existing Directives on veterinary medicines and medicated feed in September.

Following the publication of the proposals we plan to run stakeholder workshops to seek and understand the industries views on the impact of the proposals to inform the negotiation position.

Due to the broad scope of the provisions it may not be feasible to hold a single workshop. We anticipate that if there is enough interest several workshops of groups with similar interests may be required.

If you would like to register your interest to take part, please send the name of the representative(s), the name of the organisation and the specific area(s) of interest to Lorna Shelley (l.shelley@vmd.defra.gsi.gov.uk) by Friday 19 September. Due to the space required places will be limited to 2 people per organisation.

Once the proposals have been published, we will include a link to them on our website and will publish the dates for the stakeholder workshops(s).

For more information please contact Jo Cawthorne (j.cawthorne@vmd.defra.gsi.gov.uk) or Lea Reynolds (l.reynolds@vmd.defra.gsi.gov.uk)


Survey of veterinary surgeons cascade prescribing practices - Summary of responses

From April to July of 2013 the VMD sought veterinary surgeon's views on how they use the cascade in practice through a questionnaire posted on the VMD's website. We are grateful to the 230 veterinary surgeons who responded to the survey.

The summary report is now available here.

The responses have given some interesting information and will be very useful in helping to inform the development of future policy.

Also highlighted were a number of areas where additional guidance could be beneficial, for example when setting withdrawal periods or using medicines for poultry kept as domestic pets. As a result we are considering where we can improve our guidance or provide links to other sources of information.

We also remind veterinary surgeons that our website has a thematic area dedicated to veterinary professionals, which is updated regularly and we recommend checking "what's new" and signing up to our RSS feed to stay up date.

For more information please contact Lea Reynolds, Legislation team (01932 338321 or l.reynolds@vmd.defra.gsi.gov.uk).


Background:

The Veterinary Medicinal Products Directive 2001/82/EC (as amended) sets out the controls on the manufacture, authorisation, marketing, distribution and post-authorisation surveillance of veterinary medicines applicable in all Member States. The Directive provides the basis for the UK controls on veterinary medicines, which are set out nationally in the Veterinary Medicines Regulations. This legislation impacts on the UK veterinary sector (including the pharmaceutical industry, animal keepers, farmers, veterinary surgeons, pharmacists and Suitably Qualified Persons (SQPs). The review is, therefore, very important to the UK and we plan to be actively involved in ensuring that our stakeholders' views are heard. The Commission is aware of concerns expressed by members of the public, veterinarians, regulatory bodies and the animal health industry relating to Directive 2001/82 as amended. The main concerns related to limited availability of veterinary medicinal products, lack of incentives for innovation, high administrative burdens and limited benefits of the Common Market in the area of veterinary medicines. During 2010 the European Commission launched a public consultation on the legal framework for veterinary medicinal products: Better regulation of veterinary pharmaceuticals: how to put in place a simpler legal framework, safeguarding public and animal health while increasing the competitiveness of companies. The aim of the public consultation was to provide sufficient information for the Commission to produce an Impact Assessment on a revision of the legal framework for veterinary medicinal products.

The key issues that the Commission's consultation covered were:

  1. Data exclusivity
  2. Authorisation procedure
  3. Packaging and labelling
  4. Pharmacovigilance
  5. The distribution channel
  6. The use of drugs not in accordance with the summary of the product characteristics (off-label use)
  7. Harmonisation of already authorised veterinary products
  8. New needs, new challenges

An open stakeholder meeting was held at the VMD on Wednesday 13 January to discuss the European Commission's review of Directive 2001/82/EC (as amended).

During the meeting John FitzGerald presented some of the VMD's initial thoughts for amendment of the Directive based on information gathered throughout the years in which the Directive has been in force.

Martinus Nagtzaam from the European Commission also gave a presentation on the Commission's intentions. Copies of the presentations and an associated information sheet are available on the links below:

For more information on the European Commission's review of Directive 2001/82/EC please contact Lea Reynolds (VMD 01932 338321, email: l.reynolds@vmd.defra.gsi.gov.uk).

Last Updated: 16 October 2014

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