Regulation (EU) 2019/6
E553847
Regulation (EU) 2019/6 is a key EU law that modernizes and harmonizes the rules governing the authorization, use, and monitoring of veterinary medicinal products across Member States.
Statements (52)
| Predicate | Object |
|---|---|
| instanceOf |
EU veterinary medicinal products legislation
ⓘ
European Union regulation ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| adoptionDate | 2018-12-11 ⓘ |
| appliesTo | European Union Member States NERFINISHED ⓘ |
| basedOn | Article 114 of the Treaty on the Functioning of the European Union ⓘ |
| concerns | veterinary medicinal products placed on the EU market ⓘ |
| dateOfApplication | 2022-01-28 ⓘ |
| entryIntoForceDate | 2019-01-28 ⓘ |
| establishes |
rules for marketing authorization of veterinary medicinal products
ⓘ
rules for pharmacovigilance systems for veterinary medicinal products ⓘ rules for renewal and variation of marketing authorizations ⓘ rules on collection and reporting of adverse events in animals ⓘ rules on good distribution practice for veterinary medicinal products ⓘ rules on good manufacturing practice for veterinary medicinal products ⓘ rules on internet retailing of veterinary medicinal products ⓘ rules on labelling and package leaflet of veterinary medicinal products ⓘ rules on manufacturing authorizations for veterinary medicinal products ⓘ |
| geographicalScope | European Union NERFINISHED ⓘ |
| hasSubjectMatter |
measures to address antimicrobial resistance in veterinary medicine
ⓘ
rules for the authorization, supervision and pharmacovigilance of veterinary medicinal products ⓘ |
| language | all official languages of the European Union ⓘ |
| legalForm | regulation ⓘ |
| objective |
combat antimicrobial resistance related to veterinary medicinal products
ⓘ
ensure high level of protection of animal health ⓘ ensure high level of protection of public health ⓘ harmonize authorization procedures for veterinary medicinal products across Member States ⓘ improve functioning of the internal market for veterinary medicinal products ⓘ modernize the rules on veterinary medicinal products in the EU ⓘ reduce administrative burden for companies and authorities ⓘ |
| officialTitle | 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 NERFINISHED ⓘ |
| OJReference | OJ L 4, 7.1.2019, p. 43–167 ⓘ |
| policyArea |
animal health
ⓘ
internal market ⓘ public health ⓘ veterinary medicinal products ⓘ |
| publicationDate | 2019-01-07 ⓘ |
| publishedIn | Official Journal of the European Union NERFINISHED ⓘ |
| regulates |
advertising of veterinary medicinal products
ⓘ
authorization of veterinary medicinal products ⓘ distribution of veterinary medicinal products ⓘ export of veterinary medicinal products ⓘ import of veterinary medicinal products ⓘ manufacture of veterinary medicinal products ⓘ pharmacovigilance of veterinary medicinal products ⓘ retail supply of veterinary medicinal products ⓘ use of veterinary medicinal products in animals ⓘ wholesale distribution of veterinary medicinal products ⓘ |
| relevanceDate | 2022-01-28 ⓘ |
| repeals | Directive 2001/82/EC NERFINISHED ⓘ |
| shortTitle | Veterinary Medicinal Products Regulation NERFINISHED ⓘ |
Referenced by (1)
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