For the purposes of this Regulation, the definitions in Article 1 of Directive 2001/83/EC shall apply.
The following definitions shall also apply:
2. ‘Minor variation of type IA’ means a variation which has only a minimal impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
3. ‘Major variation of type II’ means a variation which is not an extension and which may have a significant impact on the quality, safety or efficacy of the medicinal product concerned;
4. ‘Extension of a marketing authorisation’ or ‘extension’ means a variation which is listed in Annex I and fulfils the conditions laid down therein;
5. ‘Minor variation of type IB’ means a variation which is neither a minor variation of type IA nor a major variation of type II nor an extension;
6. ‘Member State concerned’ means a Member State whose competent authority has granted a marketing authorisation for the medicinal product in question;
6a. ‘Reference authority’ means:
(a) the Agency where at least one of the marketing authorisations concerned is a centralised marketing authorisation;
(b) the competent authority of the Member State chosen by the holder and accepted by that competent authority, or chosen by the coordination group referred to in
Article 27 of Directive 2001/83/EC if none of the competent authorities of the Member States agrees to act as the reference authority, in the other cases;
7. ‘Relevant authority’ means:
(a) the competent authority of each Member State concerned;
(b) in the case of centralised marketing authorisations, the Agency;
8. ‘Urgent safety restriction’ means an interim change in the terms of the marketing authorisation due to new information having a bearing on the safe use of the medicinal product;
9. ‘Purely national marketing authorisation’ means any marketing authorisation granted by a Member State in accordance with the acquis outside the mutual recognition or decentralised procedure and that has not been subject to a complete harmonisation following a referral procedure.