Publishing and Submission of a grouped application of Type IAIN Variations (IA-Supergroup)

Case studies - 15 October 2020

BlueReg Group Case studies Publishing and Submission of a grouped application of Type IAIN Variations (IA-Supergroup)

Publishing and Submission of a grouped application of Type IAIN Variations (IA-Supergroup)

A global specialty-driven biopharmaceutical group focused on innovation and specialty care entrusted BlueReg to co-ordinate the publishing and submission of a grouped application of Type
IAIN variations. This impacted several different products from the same Marketing Authorisation Holder, with different Reference Member States (IA Supergroup).

In parallel, to publish and submit the same variation dossiers as a grouped application of Type IAIN variations for nationally registered products.

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