The European Medicines Agency (“EMA”) has issued a new submission form in order to help marketing authorisation holders to submit the post-approval data that is generated to satisfy post-authorisation measures related to centrally authorised medicinal products.
Market Authorisation Holders (MAHs) may need to fulfil post-authorisation measures by providing additional data on safety, efficacy and quality of the medicinal product after authorisation. Post-authorisation measures fall into several categories in relation to their legal basis and the nature of data to be generated. For example, post-authorisation measures can fall into categories such as the specific obligations (SOB) category imposed only on marketing authorisations granted under exceptional circumstances or on conditional marketing authorisations. Another category may concern conditions to the marketing authorisation included in Annex-II (ANX) of the marketing authorisation.
EMA’s Committees, such as the Committee for Medicinal Products for Human Use (“CHMP”), the Committee for Advanced Therapies (“CAT”) and the Pharmacovigilance Risk Assessment Committee (“PRAC”) may agree that MAHs should be required to provide additional data in the post-authorisation period.
The new form will be available for use in submitting the post-authorisation additional data in a manner that is more simplified as compared to the current procedure. The submission form will ensure the correct classification of the submission and MAHs will automatically receive information in relation to the category of the post-authorisation measure. Additionally, MAHs will receive procedural information such as the assessment timetables, the EMA’s Committees involved and the resources assigned.
EMA provides useful guidance on the submission of post-authorisation data on the questions and answers (“Q&A”) published in EMA’s website. EMA has recently revised a part of these Q&A concerning the procedure under which MAHs should submit post-authorisation measures and how they should structure the submission dossier.
According to the Q&A, the procedure under which post-authorisation measures should be submitted will depend on the content and the type of information submitted as part of the post-authorisation measure. Additionally, the EMA highlights that it will check post-authorisation submissions with respect to the Guidelines on Variations to ensure that it does not fall within one of the classification. The EMA will reject any post-authorisation submission that should be filed as a variation implication.
The use of the new form will become mandatory from 1 September 2017 and it will make part of module 1.0 of the Electronic Common Technical Document submission.