NRG Archives - European Industrial Pharmacists Group (EIPG)

EMA, new features for the PRIority Medicines (PRIME) scheme


By Giuliana Miglierini Based on the review of results obtained in the first five years of implementation of the PRIority Medicines (PRIME) scheme, the European Medicines Agency has launched a set of new features to further enhance the support to Read more

The proposals of the EU Commission for the revision of the IP legislation


By Giuliana Miglierini In parallel to the new pharmaceutical legislation, on 27 April 2023 the EU Commission issued the proposal for the new framework protecting intellectual property (IP). The reform package impacts on the pharmaceutical industry, as it contains proposals Read more

Webinar: Pharmacovigilance as a specialization and the role of the Pharmacovigilance Risk Assessment Committee (PRAC)


EIPG webinar Next EIPG webinar is to be held on Wednesday 31st of May 2023 at 17.00 CEST (16.00 BST) in conjunction with PIER and University College Cork. Sofia Trantza, a pharmacist with long experience as a Qualified Person for Pharmacovigilance Read more

Draft Guideline on the acceptability of names for human medicinal products

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The scope of this guideline is to provide information on the overall procedure for submitting and reviewing the acceptability of proposed (invented) names for human medicinal products processed through the centralised procedure, as well as detailed guidance on the criteria applied by the Name Review Group (NRG) when reviewing the acceptability of names. The main aim is to promote patient safety as an essential principle.

Based on the experience gathered by the NRG since the last revision of the guideline in May 2014, it became apparent that some areas of the guideline would benefit from further clarifications, in particular with regards to the requirements for acceptability of proposed (invented)1 names of medicinal products processed through the centralised procedure.

This 7th update of the guideline further clarifies specific aspects of the criteria applied to address safety and public health concerns, international non-proprietary names issues and product-specific concerns in proposed (invented) names. This update also provides further information on the conditional acceptability of invented names and the process for bilateral negotiations and proposes changes to the duration of the validity of an (invented) name and the review process of the NRG.

Consultation dates: 16/12/2021 to 16/03/2022

Reference number: EMA/CHMP/287710/2014 Rev. 7