Facilitating submission of post-approval data

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01/09/2017

Facilitating submission of post-approval data

EMA implements new submission form for post-authorisation measures

The European Medicines Agency (EMA) has launched a new form to help marketing authorisation holders submit data generated to satisfy post-authorisation measures (PAMs) for centrally authorised products.

PAMs require marketing authorisation holders (MAHs) to provide additional data on the safety, efficacy or quality of the medicine once it is authorised. They fall into several categories, depending on their legal basis and the type of data to be generated. PAMs can be agreed by the Committee for Medicinal Products for Human Use (CHMP), the Committee for Advanced Therapies (CAT) and the Pharmacovigilance Risk Assessment Committee’s (PRAC).

The new form helps to simplify the submission process for PAMs. Upon completing the form, the MAH is automatically informed of the category of PAM and the submission type and code for the eSubmission Gateway. The MAH also receives useful procedural information, including the timetable, the EMA committees involved and the EMA resources assigned.

The easy-to-use form is an integral part of the regulatory submission package and its use is mandatory from 1 September 2017. The form will be part of module 1.0 of the electronic common technical document (eCTD) submission.

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