Frequently asked Questions (FAQ)
The information in this website is intended to increase predictability
to all stakeholders and to facilitate communication with them. A number
of Frequently Asked
Questions have been
prepared to help stakeholders understand more the requirements in this
area.
European Union Regulations on Veterinary Medicinal Product and on
Medicated Feed.
The following Regulations were published in the Official Journal of the
European Union on 7th January 2019 and were applied on 28th January 2022.
Regulation (EU) 2019/4 of the European Parliament and of the Council of
11 December 2018 on manufacture, placing on the market and use of medicated
feed, amending Regulation (EC) No 183/2005 and repealing Council Directive
90/167/EEC
and
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
The purpose of these revisions in the EU Legislation is to
increase the availability of veterinary medicinal products and Medicated
Feeds , to reduce the administrative burden on enterprises, to improve the
functioning of the internal market for veterinary medicinal products and
Medicated Feeds and to assess the possibilities to have an improved response to
antimicrobial resistance.
A video on some important aspects regarding veterinary medicinal
products can be found here.
Information in this website
The information in this website is regularly reviewed and updated in
line with the rapidly evolving legislative, regulatory and technical
areas.
The Veterinary Medicines Unit does not take responsibility of the
concepts as understood, or misunderstood, by the reader.
The information present in this website is not to be considered as professional
consultancy material. Stakeholders are responsible for their own decisions in
accordance with the existent legislation and Department's requirements.
The information and instructions contained in this website has
guidelines prepared by the Veterinary Medicines Unit for the benefits of its
stakeholders. Interested parties are encouraged to refer to the legislation
proper, i.e. Subsidiary legislation 437.47, Veterinary Medicinal Products Regulation as amended by LN 179/2021 published on 23rd April 2021 and LN 470/2021 published on 7th December 2021. As regard Medicated feed, the national legislation is Subsidiary Legislation 437.73. S.L 437.47 and S.L 437.73 are under Chapter 437, Veterinary Services Act as amended by ACT No. XIV of 2022 published on the 28th October 2022.
The amendments added the necessary vires to the minister to enact
important legislation related with anything related with veterinary medicinal
products. Amongst other important changes there are those related with
enforcement action, collection of data on sales, penalties, the application for
licences for veterinary pharmacies, managing pharmacist for veterinary pharmaciesand alignment with
regulation (EU) 2019/6 of the European Parliament and of the Council of
11th December 2018. Amendments have also been carried out in relation to the
functions of the National Veterinary Laboratory, the responsibilities of the
Director of Veterinary Services and the slaughter of food-producing
animals.
Interested parties can read more about the amended CAP 437 by referring
to the User Guidelines on ACT No. XIV
All interested parties can find a list of all authorised veterinary
products in the EU in the Union Product Database (UPD). More information on this can be found here .
This website was last updated on the: 10/07/2023