Directive 2001/82/EC
E555032
Directive 2001/82/EC is a key European Union law that sets out the rules for the authorization, supervision, and pharmacovigilance of veterinary medicinal products across EU member states.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Directive 2001/82/EC canonical | 1 |
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
EU veterinary medicinal products legislation
ⓘ
European Union directive ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| aimsTo |
ensure a high level of protection of animal health
ⓘ
ensure a high level of protection of public health ⓘ facilitate the free movement of veterinary medicinal products within the EU ⓘ harmonize rules on veterinary medicinal products in the EU ⓘ |
| amendedBy | Directive 2004/28/EC NERFINISHED ⓘ |
| appliesTo | EU Member States NERFINISHED ⓘ |
| contains |
rules on pharmacovigilance reporting obligations
ⓘ
rules on prescribing and dispensing of veterinary medicinal products ⓘ rules on retail supply of veterinary medicinal products ⓘ rules on wholesale distribution of veterinary medicinal products ⓘ |
| defines |
homeopathic veterinary medicinal product
ⓘ
immunological veterinary medicinal product ⓘ veterinary medicinal product ⓘ |
| establishes | Community code relating to veterinary medicinal products NERFINISHED ⓘ |
| fullTitle | Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products NERFINISHED ⓘ |
| jurisdiction | European Union ⓘ |
| languageVersions | all official languages of the European Union ⓘ |
| legalBasis | Treaty establishing the European Community NERFINISHED ⓘ |
| policyArea |
animal health
ⓘ
internal market ⓘ public health ⓘ |
| regulates |
advertising of veterinary medicinal products
ⓘ
distribution of veterinary medicinal products ⓘ import of veterinary medicinal products ⓘ labelling of veterinary medicinal products ⓘ manufacture of veterinary medicinal products ⓘ marketing authorization of veterinary medicinal products ⓘ package leaflets for veterinary medicinal products ⓘ pharmacovigilance systems for veterinary medicinal products ⓘ |
| repealedBy | Regulation (EU) 2019/6 ⓘ |
| repealEffectiveDate | 28 January 2022 ⓘ |
| replacedBy | Regulation (EU) 2019/6 on veterinary medicinal products NERFINISHED ⓘ |
| requires |
Member States to establish pharmacovigilance systems for veterinary medicinal products
NERFINISHED
ⓘ
assessment of quality, safety and efficacy of veterinary medicinal products ⓘ good distribution practice for veterinary medicinal products ⓘ good manufacturing practice for veterinary medicinal products ⓘ manufacturing authorization for producers of veterinary medicinal products ⓘ marketing authorization before placing veterinary medicinal products on the market ⓘ qualified person responsible for pharmacovigilance ⓘ recording and reporting of adverse reactions to veterinary medicinal products ⓘ |
| sector | veterinary medicine ⓘ |
| subjectMatter |
authorization of veterinary medicinal products
ⓘ
pharmacovigilance of veterinary medicinal products ⓘ supervision of veterinary medicinal products ⓘ veterinary medicinal products ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.