Changes to submission and assessment of maximum residue limits of veterinary medicines in foods

News 07/06/2018

Three new implementing regulations replace current guidance

A set of three implementing measures will help strengthen the assessment of maximum residue limits (MRLs) of veterinary medicines in food-producing animals. They will also serve as key reference documents for companies who apply for the establishment of MRLs for their respective medicine.

An MRL establishes how much residue of a veterinary medicine in the food obtained from a treated animal is safe for human consumption. The European Union requires by law that foodstuffs such as meat, milk or eggs must not contain residue levels of veterinary medicines or biocidal products that might represent a hazard to the health of the consumer.

The first measure, adopted in January 2017 with Commission Implementing Regulation (EU) 2017/12, 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 (Chapter 3). It also changes the position in the dossier of the so-called detailed and critical summaries (DACS) — a summary report provided by experts. The safety DACS will be included in the Safety file (Part 2) and the residues DACS will be included in the Residues file (Part 3). The updated application form will be available on the European Medicines Agency's (EMA) website as of 1 September 2018, and the new dossier structure will be accepted in e-submission thereafter. EMA will provide further updates on the implementation.

The second measure was adopted in May 2017 with Commission Regulation 2017/880 with the aim to increase the availability of veterinary medicines. It sets out 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. When finalising an MRL evaluation EMA's Committee for Medicinal Products for Veterinary Use (CVMP) will routinely consider if its conclusions can be extrapolated to additional species and foodstuffs, regardless of whether the applicant has specifically requested this. The guideline on safety and residues data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market will be revised to make it consistent with the provisions of this new regulation.

The latest of the three measures, adopted in May 2018 with Commission Regulation 2018/782, 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.

The CVMP is EMA's committee responsible for veterinary medicines. The CVMP recommends safe limits (MRLs) for residues of veterinary medicines used in food-producing animals and biocidal products used in animal husbandry which, when adopted by the European Commission, become legally binding food safety standards.

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