Grouping of changes
Article 4
1. Where several changes of products are sought, a separate notification or application shall be submitted in respect of each change sought. 2. By way of derogation from paragraph 1, the following rules shall apply: (a) a single notification may cover a series of proposed administrative changes affecting different products in the same manner; (b) a single notification may cover a series of proposed administrative changes affecting the same product; (c) a single application may cover more than one proposed change of the same product in the following cases: (1) one of the proposed changes in the group is a major change of the product; all other proposed changes in the group are a direct consequence of that change; (2) one of the proposed changes in the group is a minor change; all other proposed changes in the group are a direct consequence of that change; (3) all changes in the group are a direct consequence of a new classification of the active substance(s) or non-active substance(s) contained in the product or of the product itself; (4) all changes in the group are a direct consequence of a specific condition of the authorisation; (d) a single application may cover more than one proposed change if the Member State evaluating the application in accordance with Article 7(4) or 8(4), or, in the case of a change of a Union authorisation, the Agency, confirms that it is practically feasible to handle those changes in the same procedure. The single applications referred to in points (c) and (d) of the first subparagraph shall be made in accordance with Article 7 or 12 where at least one of the proposed changes is a minor change of the product and none of the proposed changes is a major change of the product, and with Article 8 or 13 where at least one of the proposed changes is a major change of the product.