Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of New Active Substance (NAS) status of chemical substances - Draft

Oct 26, 2026

Reflection paper from the Committee for Medicinal Products for Veterinary Use (CVMP), reflecting Quality Working Party (QWP) and CMDv experience, on how to define New Active Substance (NAS) for veterinary chemical medicinal products in marketing authorisation procedures. It clarifies chemical structure and properties criteria used to qualify a chemical active substance as NAS and lists required documentation elements applicants must submit to substantiate NAS claims. It also explains scope limits and how assessments relate to eligibility and later marketing authorisation evaluation.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages7

Reading Time18 min

AccessFree to download

Executive Summary

1. Introduction

1.1. Scope

1.2. Legal basis and relevant guidelines

2. Discussion and guidance

2.1. Isomers

2.2. Mixtures of isomers

2.3. Complexes

2.4. Derivative

2.5. Esters and ethers

2.6. Salts

2.7. Solid state forms and NAS status

2.8. Documentation

3. References

10 November 2016 EMA/CVMP/QWP/3629/2016 Committee for Medicinal Products for Veterinary Use (CVMP) Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of New Active Substance (NAS) status of chemical substances Draft | Draft agreed by the QWP | June 2016 | | --- | --- | | Draft adopted by the CVMP for release for consultation | July 2016 | | Draft endorsed by the CMD(v) | June 2016 | | Start of public consultation | 17 November 2016 | | End of consultation (deadline for comments) | 17 February 2016 | Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu | Keywords | New Active Substance, NAS, salts, complexes, isomers, mixtures of isomers, derivative, esters and ethers | | --- | --- | Table of contents Executive Summary..................................................................................... 3 1. Introduction ............................................................................................ 3 1.1. Scope .................................................................................................................3 1.2. Legal basis and relevant guidelines .........................................................................3 2. Discussion and guidance ......................................................................... 4 2.1. Isomers ..............................................................................................................4 2.2. Mixtures of isomers ..............................................................................................4 2.3. Complexes .......................................................................................................... 5 2.4. Derivative ........................................................................................................... 5 2.5. Esters and ethers .................................................................................................6 2.6. Salts ...................................................................................................................6 2.7. Solid state forms and NAS status ...........................................................................6 2.8. Documentation ....................................................................................................6 3. References .............................................................................................. 7 1 Executive Summary 2 This reflection paper is intended to reflect the current experience of the Quality Working Party (QWP), 3 of the Committee for Medicinal Products for Veterinary Use (CVMP) and the Co-ordination Group for 4 Mutual Recognition and Decentralised Procedures-Veterinary (CMDv) concerning the definition of a 5 New Active Substance (NAS) in the context of preparation of dossiers and submissions of applications 6 for Marketing Authorisation (MAA) in the Centralised Procedure (CP), the Mutual Recognition Procedure 7 (MRP)/Decentralised Procedure (DCP) and purely national procedures for chemical medicinal products 8 for veterinary use under Article 12(3) of Directive 2001/82/EC as amended. 9 The paper describes the chemical structure and properties criteria to be taken into account by the 10 CVMP to qualify a chemical active substance as NAS, as well as the required elements to be submitted 11 by applicants to substantiate their claims. 12 1. Introduction 13 This reflection paper intends to provide clarifications for applicants on the elements that need to be 14 substantiated in relation to a claim of considering an active substance as NAS. Assessment of the NAS 15 status will be performed in light of principles defined in Article 13.2b of Directive 2001/82/EC and the 16 Chapter I-Volume 6A of Notice to Applicants, as well as the evidence required to substantiate the 17 claim of NAS in a MAA. However it c

FAQs

What is the purpose of this reflection paper regarding NAS status?

It provides clarifications on the chemical structure and properties criteria used to qualify a chemical active substance as New Active Substance (NAS) and on what applicants must substantiate in NAS claims.

Which substances are in scope and which are excluded?

The paper applies to marketing authorisation applications for solely chemical active substance(s) under centralised, MRP/DCP, and purely national procedures. Biological and biotechnological active substances are excluded.

How is NAS status assessment handled across procedures?

The eligibility assessment for procedures is without prejudice to the later evaluation of scientific data supporting the NAS claim during marketing authorisation evaluation. A designation as a NAS is made only after detailed assessment of the application.

Oct 26, 2026

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