(a)the introductory wording is replaced by the following:‘For the purposes of this Regulation, the definitions in Article 1 of Directive 2001/83/EC shall apply.The following definitions shall also apply:’;
(b)paragraph 1 is deleted;
(c)the following paragraph (6a) is inserted:‘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;’