Article 57 xEVMPD to IDMP/SPOR: PMS Data Migration

EMA’s webinar “DADI-PMS Webinar Agenda – ‘Variations Form for Human Medicinal Products – What will happen at Go-Live’” made it more than clear: data quality [in PMS] is dependent on xEVMPD. In our previous blog on PMS Data Migration we highlighted some of the challenges faced by Marketing Authorisation Holders (MAHs) already and these challenges …

Article 57 xEVMPD to IDMP/SPOR PMS Data Migration: are you ready?

The situation All Marketing Authorisation Holders (MAHs) in the European Union (EU) and the European Economic Area are required to submit information on their authorised medicinal products to the Article 57 database of the European Medicine Agency (EMA) in accordance with Article 57(2) of Regulation (EC) No. 726/2004. It is a legally binding requirement from …

A first glimpse of the UPD Public Portal

Although still under development, the UPD Public Portal offers a first glimpse of what will come: better access to medicinal product information for the public. Let’s have a look at what is on offer. The homepage mainly gives access to the substance and medicine index as well as the search functionality. As expected, under the …

Union Product Database – EMA’s Agile Approach?

With the pressure mounting to implement the New Veterinary Regulations (NVR) which came into force 28th January 2022, releases of the Union Product Database (UPD) to be implemented under the NVR are getting more frequent. In true software development fashion, is the EMA using the Agile approach to get solutions out more frequently and much …

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. …