Article 14: Notification procedure for minor variations of type IA

Location:

Chapter III

Source:

1. Where a minor variation of type IA is made, the holder shall submit to the Agency a notification containing the elements listed in Annex IV. This notification shall be submitted within 12 months following implementation of the variation as an annual update for all minor variations of type IA or be submitted as part of grouping in accordance with Article 7(2), first subparagraph, points (b) and (c), or as part of super-grouping of variations in accordance with Article 7a.

The notification shall be submitted immediately after the implementation of the variation in the case of minor variations requiring immediate notification for the continuous supervision of the medicinal product concerned.

By way of derogation from the first subparagraph, in justified cases, the Agency may accept the immediate submission of the notification of the variation.

2. Within 30 days following receipt of the notification, the measures provided for in Article 17 shall be taken.