Procedural advice on the accelerated assessment of marketing authorisation applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6
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Committee for Veterinary Medicinal Products (CVMP)Procedural advice on the accelerated assessment of
marketing authorisation applications pursuant to Article
44 (3) of Regulation (EU) No 2019/6Table of contents
1. - Accelerated assessment of the marketing authorisation application ....... 5
6.1. - It only applies to marketing authorisation applications and does not cover any postauthorisation procedure.
- The document replaces the ?Guideline on the procedure for accelerated
assessment pursuant to Article 39(8) of Regulation (EC) No 726/2004' (EMEA/CVMP/32995/2006). - General considerations
The accelerated assessment procedure is applicable to marketing authorisation applications for
veterinary medicinal products falling within the scope of Article 44(3) of Regulation (EU) 2019/6. - An accelerated assessment request has to be agreed by the CVMP before submission of
a marketing authorisation application as it introduces changes in the operation of the CVMP and
procedure timelines. - A
decision on accelerated assessment will be taken without prejudice to the (future) CVMP opinion
(positive or negative) on the granting of a marketing authorisation. - It forms the basis for requesting an accelerated assessment and should be
followed unless otherwise justified. - Procedural advice on the accelerated assessment of marketing authorisation
applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6
EMA/CVMP/32995/2006 ? Rev.2Page 3/8
5.3.
- Request for an accelerated assessment procedure
The formal request for an accelerated assessment should be submitted approximately 3-2 months prior
to the actual submission of the marketing authorisation application. - Applicants are also reminded that evaluation under accelerated assessment is subject to
the same evidence requirements for marketing authorisation as an evaluation under standard
timetable. - Procedural advice on the accelerated assessment of marketing authorisation
applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6
EMA/CVMP/32995/2006 ? Rev.2Page 5/8
6.2.
- ** The timing of the documents should be at least 11 working days in advance of the CVMP plenary meeting
Procedural advice on the accelerated assessment of marketing authorisation
applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6
EMA/CVMP/32995/2006 ? Rev.2Page 6/8
7.2.
- Procedural advice on the accelerated assessment of marketing authorisation
applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6
EMA/CVMP/32995/2006 ? Rev.2Page 8/8