Regulation (EU) 2019/5 amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use

Summary:

In September 2014 the European Commission presented a proposal to amend Regulation (EC) No 726/2004 on the authorisation and supervision of medicinal products for human and veterinary use. The European Parliament and the Council of the European Union adopted the new Regulation on 11 December 2018.

Further information:

Following a proposal to repeal and replace Directive 2001/82/EC on veterinary medicinal products, Regulation (EC) No 726/2004 must be amended to take account of the fact that centralised marketing authorisation for veterinary products is being decoupled from that for medicines for humans.

The draft law was adopted as part of a package of proposals aiming to improve animal and human health.

Official

EUR-Lex: COM(2014)557: Proposal to amend Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use https://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2014:557:FIN

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