extensionmeans a variation which is listed in Annex I and fulfils the conditions laid down therein;
Major variation of type IImeans 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;
Member State concernedmeans a Member State whose competent authority has granted a marketing authorisation for the medicinal product in question;
Minor variation of type IAmeans a variation which has only a minimal impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
Minor variation of type IBmeans a variation which is neither a minor variation of type IA nor a major variation of type II nor an extension;
Purely national marketing authorisationmeans 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.
reference authorityshall mean one of the following:
Urgent safety restrictionmeans 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;