All Veterinary medicinal products articles
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EditorialVeterinary medicines: the challenges of new regulation
Regulatory Rapporteur October 2023 | Volume 20 | No.9 The October 2023 edition of TOPRA’s journal – Regulatory Rapporteur – focuses on topics and developments specific for veterinary medicines: From the challenging aspects arising ...
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Meeting ReportVM5: CVMP Guidelines Update:
Data protection (Article 40.5),
prescription status (Article.34) and benefit-riskThe secondary legislation and guidelines are as critical as Regulation 2019/6 itself in defining the future landscape for animal health in the EU. The concept and definitions of benefit-risk affect many different aspects of veterinary medicines regulation, as per the legislation.
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FocusProcedure withdrawals within Europe: past trends, impact and communication recommendations
When an application for a new veterinary medicinal product (VMP) is submitted through a MR/DCP, the Applicant has the option to prematurely withdraw their application in the reference member state (RMS) or in one or several of the concerned member states (CMS). This would result in a total or partial withdrawal of the procedure. The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Veterinary (CMDv) sent a questionnaire to all national competent authorities…
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FocusTerrestrial ecotoxicological studies for veterinary pharmaceuticals in livestock dung in the field: Phase II Tier A and beyond
The environmental risk from veterinary pharmaceuticals (VPs), which are usually called veterinary medical products (VMPs) must be assessed according to European legislation: in particular, parasiticides that are used for pastured animals (eg, sheep, cattle etc). This is especially true regarding the non-target effects of faecal residues on dung-dwelling organisms. Focusing ...