chargeable unit in relation to medicinal products for human usemeans 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:
chargeable unit in relation to veterinary medicinal productsmeans 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:
medium-sized enterprisemeans a medium-sized enterprise within the meaning of Recommendation 2003/361/EC;
microenterprisemeans a microenterprise within the meaning of Recommendation 2003/361/EC;
public health emergencymeans 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.
small enterprisemeans a small enterprise within the meaning of Recommendation 2003/361/EC;