The definitions laid down in Article 1 of Directive 2001/83/EC shall apply for the purposes of this Regulation.
As a consequence, in this Regulation, the terms, medicinal product and medicinal product for human use mean a medicinal product as defined in point (2) of Article 1 of Directive 2001/83/EC.
In addition, the following definitions shall apply for the purposes of this Regulation:
veterinary medicinal product means a medicinal product as defined in point (1) of Article 4 of Regulation (EU) 2019/6 of the European Parliament and of the Council ;
antimicrobial means an antimicrobial as defined in point (12) of Article 4 of Regulation (EU) 2019/6.
The holder of a marketing authorisation for medicinal products covered by this Regulation must be established in the ►M8 Union◄. The holder shall be responsible for the placing on the market of those medicinal products, whether he does it himself or via one or more persons designated to that effect.