Regulation 2019/6 - Veterinary medicinal products - Main contents
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official 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| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2019/6 |
| Original proposal | COM(2014)558  |
| CELEX number i | 32019R0006 |
| Document | 11-12-2018; Date of signature |
|---|---|
| Publication in Official Journal | 07-01-2019; OJ L 4 p. 43-167 |
| Signature | 11-12-2018 |
| Effect | 27-01-2019; Entry into force Date pub. +20 See Art 160 28-01-2022; Application See Art 160 |
| Deadline | 27-01-2019; See Art 153.5 27-01-2021; At the latest See Art 153.3 27-09-2021; At the latest See Art 153.2 28-01-2022; At the latest See Art 154 And 155 28-01-2022; At the earliest See Art 153.4 28-01-2022; See Art 153.1 And 153.2 And 153.3 And 153.5 And 156 29-01-2025; At the latest See Art 153.4 And 158 29-01-2027; See Art 157 |
| End of validity | 31-12-9999 |
7.1.2019 |
EN |
Official Journal of the European Union |
L 4/43 |
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)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168(4)(b) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1) |
Directive 2001/82/EC of the European Parliament and of the Council (3) and Regulation (EC) No 726/2004 of the European Parliament and of the Council (4) constituted the Union regulatory framework for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and the use of veterinary medicinal products. |
(2) |
In the light of experience and following the assessment by the Commission on the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products should be adapted to scientific progress, the current market conditions and economic reality, while continuing to ensure a high level of protection of animal health, animal welfare and environment and safeguarding public health. |
(3) |
The regulatory framework for veterinary medicinal products should take into account the needs of the businesses in the veterinary pharmaceutical sector and trade in veterinary medicinal products within the Union. It should also integrate the major policy objectives set out in the Communication from the Commission of 3 March 2010 entitled ‘Europe 2020 A Strategy for smart, sustainable and inclusive growth’. |
(4) |
Experience has shown that the needs of the veterinary sector differ substantially from those of the human sector in relation to medicinal products. In particular, the drivers for investment in markets for medicinal products for human use and veterinary medicinal products are different. For example, in the veterinary sector there are many different animal species, which creates both a fragmented market and the need for major investments in order to extend the authorisation of veterinary medicinal products existing for one animal species to another. Moreover, the price-setting mechanisms in the veterinary sector follow a completely different logic. Consequently, prices for veterinary medicinal products are typically substantially lower than for medicinal products for human use. The size of the animal pharmaceutical industry is only a small fraction of the size of the pharmaceutical industry for medicinal products for human use. It is therefore appropriate to develop a regulatory framework addressing the characteristics and specificities of the veterinary sector, which cannot be considered as a model for the market for medicinal products for human use. |
(5) |
This Regulation aims to reduce the administrative burden, enhance the internal market and increase the availability of veterinary medicinal products, while guaranteeing the highest level of public and animal health and environmental protection. |
(6) |
The identification of packs of veterinary medicinal products via identification codes is common practice in several Member States. Those Member States have developed integrated electronic systems at national level for the proper functioning of such codes, linked to national databases. The introduction of a harmonised Union-wide system has not been the subject of any assessment as to costs and... |
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