- Latest available (Revised)
- Original (As adopted by EU)
Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)
You are here:
What Version
More Resources
Legislation originating from the EU
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
This item of legislation originated from the EU
Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).
Status:
This is the original version as it was originally adopted in the EU.
This legislation may since have been updated - see the latest available (revised) version
1. Immunological veterinary medicinal products
A.VACCINE ANTIGEN MASTER FILE
For particular immunological veterinary medicinal products and by derogation from the provisions of Title II, Part 2 Section C on active substances, the concept of a Vaccine Antigen Master File is introduced.
For the purpose of this Annex, a Vaccine Antigen Master File means a stand-alone part of the marketing authorisation application dossier for a vaccine, which contains all relevant information on quality concerning each of the active substances, which are part of this veterinary medicinal product. The stand-alone part may be common to one or more monovalent and/or combined vaccines presented by the same applicant or marketing authorisation holder.
Scientific guidelines for the submission and evaluation of a vaccine antigen master file shall be adopted by the Agency. The procedure for the submission and evaluation of a vaccine antigen master file shall follow the guidance published by the Commission in The rules governing medicinal products in the European Union, Volume 6B, Notice to Applicants.
B.MULTI-STRAIN DOSSIER
For certain immunological veterinary medicinal products (foot-and-mouth disease, avian influenza and bluetongue) and by derogation from the provisions of Title II, Part 2 Section C on active substances the concept of the use of a multi-strain dossier is introduced.
A multi-strain dossier means a single dossier containing the relevant data for a unique and thorough scientific assessment of the different options of strains/combinations of strains permitting the authorisation of vaccines against antigenically variable viruses.
Scientific guidelines for the submission and evaluation of multi-strain dossiers shall be adopted by the Agency. The procedure for the submission and evaluation of multi-strain dossiers shall follow the guidance published by the Commission in The rules governing medicinal products in the European Union, Volume 6B, Notice to Applicants.
(1)
This Annex will be amended by the Commission in accordance with Articles 146 and 153. All references to Articles or to ‘this Directive’ in this Annex, unless otherwise specified, are to be understood as references to Directive 2001/82/EC.
Options/Help
Print Options
PrintThe Whole Regulation
PrintThe Whole Annex
PrintThe Whole Title
PrintThis Division only
You have chosen to open the Whole Regulation
The Whole Regulation you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
You have chosen to open Schedules only
The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the EU Official Journal
- lists of changes made by and/or affecting this legislation item
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.