Guideline on the acceptability of names for human medicinal products processed through the centralised procedure - Scientific guideline

This 7^th 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.

Keywords: NRG, acceptability of names

Current version

Guideline on the acceptability of names for human medicinal products processed through the centralised procedure - revision 7

Reference Number: EMA/CHMP/287710/2014

Overview of comments received on draft ‘Guideline on the acceptability of names for human medicinal products processed through the centralised procedure’

Document history

Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure

Draft: consultation closedConsultation dates: 16/12/2021 to 16/03/2022Reference Number: EMA/CHMP/287710/2014 Rev. 7Summary:

This 7^th 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.

Comments should be provided using this template. The completed comments form should be sent to [e-mail].

Guideline on the acceptability of names for human medicinal products processed through the centralised procedure

AdoptedReference Number: EMA/CHMP/287710/2014 Rev. 6Legal effective date: 01/01/2015Summary:

Based on the experience gathered by the Name Review Group (NRG) since the last revision of the guideline in December 2007, it became apparent that some areas of the guideline would benefit from further clarifications, in particular with regards to the requirements for acceptability and submission of proposed (invented)1 names of medicinal products processed through the centralised procedure.

Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure

Draft: consultation closedConsultation dates: 16/12/2021 to 16/03/2022Reference Number: EMA/CHMP/287710/2014 Rev. 7Summary:

This 7^th 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.

Comments should be provided using this template. The completed comments form should be sent to [e-mail].

Guideline on the acceptability of names for human medicinal products processed through the centralised procedure

AdoptedReference Number: EMA/CHMP/287710/2014 Rev. 6Legal effective date: 01/01/2015Summary:

Based on the experience gathered by the Name Review Group (NRG) since the last revision of the guideline in December 2007, it became apparent that some areas of the guideline would benefit from further clarifications, in particular with regards to the requirements for acceptability and submission of proposed (invented)1 names of medicinal products processed through the centralised procedure.

Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure

Draft: consultation closedConsultation dates: 07/06/2013 to 30/08/2013Reference Number: CPMP/328/98 Revision 6Summary:

The current update of this guideline provides further recommendations on the requirements for acceptability and submission of proposed (invented) names of medicinal products processed through the centralised procedure. Specific aspects of the criteria applied to address safety and public-health concerns, international-non-proprietary-name issues, product-specific concerns and the procedure for submission of proposed (invented) names requests are further clarified.