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(fra kommisjonsforordningen) (1) In accordance with Regulation (EU) 2019/6, holders of a manufacturing authorisation (‘manufacturers’) are required to comply with good manufacturing practice. Compliance with good manufacturing practice is required for the …

(fra kommisjonsforordningen) (1) Pharmacologically active substances are classified on the basis of opinions on maximum residue limits (MRLs) issued by the European Medicines Agency (EMA).  (2) An application for an opinion to establish the MRL is …

(fra kommisjonsforordningen) (1) In accordance with Regulation (EU) 2019/6, veterinary medicinal products manufactured in the Union, including veterinary medicinal products intended for export as well as veterinary medicinal products imported into the …

(fra kommisjonsforordningen) (1)    Regulation (EU) 2024/903 introduced the interoperability regulatory sandboxes as an innovation support measure to enhance the development of innovative interoperability solutions and the cross-border interoperability of …

(fra kommisjonsforordningen) (1) Regulation (EC) No 273/2004 lays down measures for monitoring trade in drug precursors within the Union, while Regulation (EC) No 111/2005 governs trade in drug precursors between the Union and third countries. Annex I to …