Article 2
Location:
Title I
Source:
Eur-LexThe 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:e
(1) ‘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 ( 1 ) ;
(2) ‘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 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.