Manufacture of the finished dosage form
| Keywords | Veterinary, manufacture, finished dosage form, dosage form |
| Description | This document provides clarification on the type and level of information that should be included in the marketing authorisation application dossier with respect to the manufacturing process description. It applies to veterinary medicinal products. Read together with the annex on start of shelf-lif of the finished dosage form. |
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Draft guideline on manufacture of the veterinary finished dosage form - Revision 1 (PDF/160.69 KB)
Draft: consultation open
First published: 23/04/2018
Last updated: 07/01/2019
Consultation dates: 23/04/2018 to 31/08/2019
EMA/CVMP/QWP/798401/2015 -
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Concept paper on the need for revision of the note of guidance on manufacture of the finished dosage form (PDF/74.2 KB)
Draft: consultation closed
First published: 17/07/2015
Last updated: 17/07/2015
Consultation dates: 17/07/2015 to 17/10/2015
EMA/CVMP/QWP/360463/2015