From 1st September 2017 the use of a new form is mandatory for the submission of a PAM.
EMA has launched the new form to help MAHs to 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.
Asphalion has large experience in post-authorisation activities and can assist you with the submission of the PAM. For more information, please contact us at firstname.lastname@example.org