In a recent (and totally unscientific) straw poll of a number of veterinary surgeons in practice, not one was able to provide any details of the VMDs proposals for changes to the Veterinary Medicines Regulations this year.
Not one person said he or she was intending to make any comments on the proposals – “that’s up to the BVA” was a common response – and hardly anyone could recall what changes had been made last year. As it happens none of the changes proposed will have much impact upon the vast majority of vets in practice.
A summary of the changes on which the VMD is currently consulting is on the VMD’s website; it reads:
Summary of the proposed changes to VMRs:
- Remove permission for antimicrobial veterinary medicinal products to be advertised to farmers.
- Allow dispensing of prescriptions from EEA veterinarians by UK pharmacists and veterinarians.
- Introduction of controls on internet retailing of veterinary medicinal products with an associated fee.
- Implementation of Article 8 of EU Regulation 767/2009 on the placing on the market and use of feed.
- Revision of the exemptions relating to animals kept on domestic premises – ceiling on weight of medicated feeding stuffs that can be manufactured from the pre-mixture.
- Revision of the exemptions relating to animals kept on domestic premises – extension to veterinary surgeons and pharmacists of the derogation allowing registered SQP retailers to supply pre-mixtures and medicated feed intended for domestic use without the additional need to be approved as a distributor.
- Simplification of the procedure for variations to national marketing authorisations (implementation of Commission Regulation 1234/09 regarding variations to national authorisations) and associated fee changes.
- Removal of the “5% rule” permitting the supply of products between retailers.
- Introduction of a procedure and fee for giving formal advice as to whether a product requires a Marketing Authorisation.
- Introduction of a procedure and fee to change the distribution category for a centralised product.
- Change to the method of recharging travel and subsistence costs for inspections of UK sites.
- Correction of the fees for inspections relating to more than one authorisation.
- Introduction of a waiver for fees for variations to remove or reduce animal testing.
- Correction of the fees for decentralised extensions applying to multiple species where the UK is reference member state.
- Introduction of a fee to assess equivalence data for parallel imports.
- Removal of the additional fees for late payment of annual fees for marketing authorisations, retailers of feeding stuffs and SQP premises.
- Reduction of fees for some categories of wholesale dealers’ authorisations.
- Application of a below inflation increase to existing fees.
- Application of a below inflation increase in the Graded Annual Fee as a percentage of industry turnover.
Comments can be made to the VMD by 10th September and the new regulations are expected to come into force on 1st December.
The first item, removing permission for antimicrobials to be advertised to farmers, represents a u-turn by the VMD which allowed POM-Vs to be advertised to farmers because they were “professional keepers of animals”.
The VMD now believes that advertising to farmers of these products, particularly new ones, could lead to pressure being put on veterinary surgeons to prescribe them and this could in turn hasten the development of resistance.
Strangely, the VMD has produced no evidence to support this.