BEBAC  Ing. Helmut Schütz


Draft guidelines on oral modified release products and transdermal patches (Section I: quality)

On 14 Sep 2012 the EMA’s Quality Working Party (QWP) published two drafted guidelines for a six-month public consultation period (i.e., until 15 March 2013).

This section I documents cover the various parts of the application for Marketing Authorization releated to quality and should be read in conjuction with section II of this NfG relating to clinical aspects (see here). Furthermore, it is clear that this NfG cross-references to other quality guidelines and to official compendia.

These guidelines will replace the Note for Guidance on Modified Release Products:
A. Oral Dosage Forms and B: Transdermal Dosage Forms. Part I (Quality).

Comments should be provided using this template and sent to [email protected].


The final Guideline on quality of oral modified release products (EMA/CHMP/QWP/428693/2013) was adopted by the CHMP in March 2014, published on 31 July 2014, and is effective with 1 February 2015.