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Changes to assessment of maximum residue limits
An MRL is the highest level of residue from a veterinary medicine that is legally allowed in food for human consumption.
New EMA measures to replace current guidance

Three new regulations to strengthen the assessment of maximum residue limits (MRLs) of veterinary medicines in food-producing animals have been implemented by the European Medicines Agency.

The measures will also serve as key reference documents for companies who apply for the establishment of MRLs for their respective medicine.

An MRL is the highest level of residue from a veterinary medicine that is legally allowed in food for human consumption. Under EU law, food from animals must not contain levels of veterinary medicine that might represent a hazard to the health of the consumer.

The first measure, adopted in January 2017, changes the structure of the documentation to be included in the application dossier for an MRL application by including a new chapter on risk management considerations. It also changes the position in the dossier of the so-called detailed and critical summaries - a summary report provided by experts.  

Measure two, adopted in May 2017, aims to increase the availability of veterinary medicines. It outlines the principles and minimum criteria for the extrapolation of an MRL to either another foodstuff from the same species, or to the same foodstuff from another species.

The third measure, adopted in May 2018, describes the methodology to be used in the scientific risk assessment and establishment of risk management recommendations relevant to MRL applications. The new rules will replace the existing guidance on MRLs in Volume 8 of “The rules governing medicinal products in the European Union" as of 19 June 2018. 

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New single-dose RHD-2 vaccine launched

News Story 1
 The first monovalent vaccine to be registered in Europe for the prevention of rabbit hemorrhagic disease type 2 (RHD-2) has been launched by animal health firm HIPRA.

ERAVAC is a single-dose injectable emulsion that can be administered without the need for reconstitution beforehand. The new presentation contains 10 vials with individual doses that can be given to companion rabbits from 30 days of age. 

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News Shorts
New canine and feline dentistry manual announced

A new canine and feline dentistry and oral surgery manual has been published by the BSAVA. Announcing the news on its website, the BSAVA said this latest edition contains new step-by-step operative techniques, together with full-colour illustrations and photographs.

‘This is a timely publication; veterinary dentistry is a field that continues to grow in importance for the general veterinary practitioner,’ the BSAVA said. ‘The manual has been fully revised and updated to include the most relevant, evidence-based techniques.’

The BSAVA Manual of Canine and Feline Dentistry and Oral Surgery, 4th edition is available to purchase from www.bsava.com/shop