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EMA Concept paper for the revision of scientific guidelines on limited market for veterinary medicinal products.

10th December 2019

The European Medicines Agency has released for public consultation the concept paper for the revision of scientific guidelines on limited market for veterinary medicinal products.

With the aim of promoting availability of veterinary medicines, the Agency established in 2009 (revised in 2014) a policy, complemented by supporting guidance, for Minor Uses/Minor Species which defined a procedure for classification of products as MUMS as well as the support provided to companies submitting marketing authorisation applications for veterinary medicinal products that have been classified as MUMS/Limited markets. This support includes financial incentives (fee waivers and fee reductions) and reduced data requirements.  

The CVMP developed specific guidelines detailing reduced data requirements for products classified as MUMS in relation to quality, efficacy and safety of pharmaceutical veterinary medicinal products also in relation to immunological veterinary medicinal products. The guidelines were initially developed in 2006 and 2007 and subsequently revised in 2016.

The current guidelines were developed with the aim of reducing data requirements, where possible, for products classified as MUMS/Limited markets, according to the Agency’s policy, while still providing assurance of appropriate quality, safety, and efficacy, and complying with the legislation in place, leading to an overall positive benefit-risk balance for the product.

The draft guideline is available by clicking here.

Comments should be provided using this template and sent to Vet-Guidelines@ema.europa.eu by 31 January 2020.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.

For more information on the European regulatory system for medicines, please click here (brochure available in all languages).

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