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Type 1B variations in the European Union/UK

Commission Regulation (EC) No 1234/2008 ('the Variations Regulation') defines a minor variation of type IB as a variation that is neither a type-IA variation nor a type-II variation nor an extension. Such minor variations must be notified to the national competent authority or the European Medicines Agency by the MAH before implementation, but do not require a formal approval. Upon acknowledgement of receipt of a valid notification, the MAH must wait a period of 30 days to ensure that the notification is deemed acceptable by the national competent authority or the Agency before implementing the change ('tell, wait and do' procedure).

The European Commission guidelines on the details of the various categories of variations, on the operation of the procedures laid down in chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 and on the documentation to be submitted pursuant to those procedures (the Variations Guideline) contains examples of changes that are considered as type-IB variations. In addition, any change that is not an extension and whose classification is not determined taking into account the Classification Guideline and the recommendations delivered pursuant to Article 5 of the Variations Regulation is considered a type-IB variation by default.

When one or more of the conditions established in the Classification Guideline for a type-IA variation are not met, the concerned change may be submitted as a type-IB variation unless the change is specifically classified as a major variation of type II.

For changes which are submitted as default type-IB variations, the Agency will determine during validation whether the proposed classification as type-IB variation is appropriate before the start of the evaluation procedure

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