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The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

Environmental sustainability: the EIPG perspective


Piero Iamartino Although the impact of medicines on the environment has been highlighted since the 70s of the last century with the emergence of the first reports of pollution in surface waters, it is only since the beginning of the Read more

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Draft Guideline on the acceptability of names for human medicinal products

January 7, 2022 , , , , , , , , , , ,

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