Manufacture of the finished dosage form (veterinary) - Scientific guideline

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.

Keywords: Veterinary, manufacture, finished dosage form, dosage form

Current effective version

Guideline on Manufacture of the veterinary finished dosage form

Adopted Legal effective date: 28/01/2022

Document history

Guideline on Manufacture of the veterinary finished dosage form

Adopted Legal effective date: 28/01/2022

Overview of comments received on the draft guideline on manufacture of the veterinary finished dosage form

Reference Number: EMA/CVMP/QWP/485008/2019

Draft guideline on manufacture of the veterinary finished dosage form

Draft: consultation closed Consultation dates: 23/04/2018 to 31/08/2019 Reference Number: EMA/CVMP/QWP/798401/2015

Concept paper on the need for revision of the note of guidance on manufacture of the finished dosage form

Draft: consultation closed Consultation dates: 17/07/2015 to 17/10/2015 Reference Number: EMA/CVMP/QWP/360463/2015 Summary:

This concept paper addresses the need to update and revise the veterinary Note for Guidance on Manufacture of the Finished Dosage Form (EMEA/CVMP/126/95) (Ref 1). This guideline was originally adopted in December 1995 and came into operation in June 1996. Since then, the references to directives applicable to veterinary medicinal products have changed, revised Annex I to the Directive 2001/82/EC (i.e. Directive 2009/9/EC) was introduced and several aspects described in the current guideline were further elaborated within other regulatory documents. Also the manufacture of finished dosage forms has spread worldwide and terms like holding time and bulk product are now important parts of the description of the manufacturing process. The guideline therefore needs to be revised to be in line with all these changes.

Note for guidance: Manufacture of the finished dosage form

Adopted Reference Number: EMEA/CVMP/126/95 Legal effective date: 01/06/1996