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European Medicines Agency (EMA)
Article 2

Article 2

▼M8

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:

(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.

▼B

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.