Post-Submission Activities

Applying for and being granted a Marketing Authorisation is a complex and detailed task; however, its life cycle management can be a far greater undertaking. CPS can perform any of the following to ensure your Marketing Authorisation stays valid.

Variations – From classification to filing, CPS can assist with Type IA, IB or Type II variations.

Renewals – CPS can assist compiling the condensed renewal dossier application or file on your behalf.

Sunset Clause assistance – Certain justifications for an extension or complete exemption from the Sunset Clause are possible in some EU countries – CPS can provide you with the needed advice and assistance.