Definitions
Article 2
For the purposes of this Regulation, the following definitions apply: (1) ‘chargeable unit in relation to medicinal products for human use’ means a unit defined by a unique combination of the following dataset derived from information on all medicinal products authorised in the Union, held by the Agency, and consistent with the obligation of marketing authorisation holders referred to in Article 57(2), points (b) and (c), of Regulation (EC) No 726/2004 to submit such information to the database referred to in Article 57(1), second subparagraph, point (l), of that Regulation: (a) the name of the medicinal product, as defined in Article 1, point (20), of Directive 2001/83/EC; (b) the marketing authorisation holder; (c) the Member State in which the marketing authorisation is valid; (d) the active substance or combination of active substances, except in the case of homeopathic medicinal products or herbal medicinal products, as defined in Article 1, points 5 and 30, respectively, of Directive 2001/83/EC; (e) the pharmaceutical form; (2) ‘chargeable unit in relation to veterinary medicinal products’ means a unit defined by the unique combination of the following data fields contained in the Union product database established pursuant to Article 55(1) of Regulation (EU) 2019/6: (a) the Permanent Identifier referred to under Data Field ID 3.1 in Annex III to Implementing Regulation (EU) 2021/16; (b) the Product Identifier referred to under Data Field ID 3.2 in Annex III to Implementing Regulation (EU) 2021/16; (3) ‘medium-sized enterprise’ means a medium-sized enterprise within the meaning of Recommendation 2003/361/EC; (4) ‘small enterprise’ means a small enterprise within the meaning of Recommendation 2003/361/EC; (5) ‘microenterprise’ means a microenterprise within the meaning of Recommendation 2003/361/EC; (6) ‘public health emergency’ means a situation of public health emergency recognised by the Commission in accordance with Article 23(1) of Regulation (EU) 2022/2371 of the European Parliament and of the Council ( 25 ) .