Classification of variations
Article 3
1. In relation to any variation which is not an extension the classification laid down in Annex II shall apply. 2. A variation which is not an extension and whose classification is undetermined after application of the rules provided for in this Regulation, taking into account the guidelines referred to in point (a) of Article 4(1) and, where relevant, any recommendations delivered pursuant to Article 5, shall by default be considered a minor variation of type IB. 3. By way of derogation from paragraph 2, a variation which is not an extension and whose classification is undetermined after application of the rules provided for in this Regulation shall be considered a major variation of type II in the following cases: (a) upon request from the holder when submitting the variation; (b) where the competent authority of the reference Member State as referred to in Article 32 of Directive 2001/82/EC and Article 28 of Directive 2001/83/EC (hereinafter the reference Member State), in consultation with the other Member States concerned or, in the case of a centralised marketing authorisation, the Agency concludes, following the assessment of validity of a notification in accordance with Article 9(1) or Article 15(1) and taking into account the recommendations delivered pursuant to Article 5, that the variation may have a significant impact on the quality, safety or efficacy of the medicinal product concerned.