Transitional arrangements for Regulation (EU) 2019/6 for Veterinary Medicinal Products

On 19/July/2021 the CMDv released document EMA/CMDv/181154/2021 entitled “Transitional arrangements for the entry into application of Regulation (EU) 2019/6 for veterinary medicinal products registered under national, mutual recognition and decentralised procedures”. CMDv has prepared this document to assist Marketing Authorisation Holders (MAHs) as well as National Competent Authorities (NCAs) in the management of the transition …

EMA’s new veterinary product information template

To be able to support the new veterinary regulations coming into effect in January 2022, the EMA updated the product information template that can be accessed here . The new template includes a new section on restrictions on the use of antimicrobials and antiparasitic veterinary products in an attempt to reduce resistance. The other thing …

EMA electronic Product Information (ePI) Consultation

Expert and public comments sought on ePI, open until 31/July/2021. The EMA has opened a public consultation on the draft EU common standard for electronic product information or ePI. The consultation period is open until end of July 2021 so there is little time left to give feedback. Comments should be provided via an online …

EU pilot project ‘Market Launch of Centrally Authorised Medicinal Products’

Action required: Pilot started 25/March/2021. In March 2021 the European Commission, together with the EMA and Member States, committed to initiate a pilot to better understand the root causes of deferred market launches for centrally authorised products. The initiative has been launched with the engagement of future Marketing Authorisation Holders (MAHs). The pilot’s overall objective …

EMA introduces additional measures to streamline assessments

Published by the EMA 11/May/2021. In the process of streamlining assessment for medicinal products during the COVID-19 pandemic, the EMA is implementing additional temporary measures in the European medicines regulatory network . This should allow assessors to concentrate on the ever-increasing volume of COVID-19-related applications, whether vaccines or treatments. The focus will be on vaccines …

EMA’s PRIME draft toolbox: Consultation ends July 2021

Action required: Consultation for the EMA PRIority MEdicine (PRIME) draft toolbox guidance closes 31st July 2021. What is PRIME about? The European Medicines Agency (EMA) launched the PRIority MEdicines (PRIME) scheme in March 2016. The scheme was launched to provide early and enhanced scientific and regulatory support for medicines that target an unmet medical need. …

EMA’s Union Product Database user research

Union Product Database: EMA’s Veterinary Medicines Division released user research. In January 2021, the EMA released some interesting findings about how stakeholders might want to make use of the Union Product Database (UPD). What is the UPD? According to the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain …

EMA’s Union Product Database implementation guide updated (again!)

Action required: Union Product Database implementation guide is available for consultation until 21/March/2021. Today, I shall look at three of the many changes proposed. The first important update. Under the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain a Union Product Database (UPD). In previous blogs we looked …

UPDated – EMA updated Union Product Database implementation guide

According to the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain a Union Product Database (UPD). In July 2020 the EMA published the UPD access policy (EMA/198149/2020), which outlines who gets access to which data stored in the UPD. It outlines how all parties can meet their obligations …

EMA provides latest on Article 57

Action required before end of January 2021. Since 1 February 2020, when the United Kingdom withdrew from the European Union (EU), the UK has become a ‘third country’ as far as the EU is concerned. A withdrawal agreement has provided direction for the transition period, ending 31 December 2020 (European Commission, Notice to Stakeholders, 13 …