2021/0136/D
EC/EFTA
DE Allemagne
  • C10P - Produits pharmaceutiques
2021-06-07
2021-03-15

Veterinary medicinal products in accordance with Regulation (EU) 2019/6 and other veterinary medicinal products not covered by the Regulation.

Law on the enactment of a Veterinary Medicinal Products Act and on the modification of regulations under medicinal products law and other regulations.

Introduction of a Veterinary Medicinal Products Act and amendment of other legal provisions relating to medicinal products

The national provisions of veterinary medicinal products legislation must be adapted to new provisions of Union law with effect from 28 January 2022.
To date, Directive 2001/82/EC and Regulation (EC) No 726/2004 constitute the Union legal framework for the placing on the market, manufacture, import, export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products. The provisions of Directive 2001/82/EC have been implemented in particular by the Medicines Act and other pharmaceutical regulations. From 28 January 2022, the new 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 (OJ L 4, 7/1/2019, p 43; L 163, 20/6/2019, p 112; L 326, 8/10/2020, p 15), which repeals Directive 2001/82/EC, will apply in particular to veterinary medicinal products in the European Union.
In addition, some legislative amendment orders of Article 2 of the Fourth Act amending pharmaceutical and other regulations of 20 December 2016 Federal Law Gazette I p 3048), which was last amended by Article 19 of the Second Data Protection Adaptation and Implementation Act EU of 20 November 2019 (Federal Law Gazette I p 1626), require correction due to amendments to the Pharmaceutical Act that have been made in the meantime.