From 1 July 2016, the European Medicines Agency ("EMA") will implement the International Organization for Standardization ("ISO") Identification of Medicinal Products ("IDMP") standards for the submission of information on medicinal products. In order to smoothen the move to the ISO IDMP standards, the EMA:
- has amended the requirements as to what information marketing authorisation holders must submit to it in relation to authorised medicinal products; and
- is requiring marketing authorisation holders to ensure that all information previously submitted by them to the EMA in connection with an authorised product is up-to-date, complete and of high quality. This activity must be completed by marketing authorisation holders by the end of 2014.
Marketing authorisation holders have been submitting product information to the EMA electronically since July 2012. As of July of this year, the EMA expects marketing authorisation holders to submit more detailed information on their products including more robust supporting scientific data. These new requirements are the result of changes to pharmacovigilance legislation and they move towards ISO IDMP standards. The EMA has published updated guidance documents on what revised information it expects marketing authorisation holders to submit to it (see here, here and here).
Pharmaceutical companies have until the end of the year to update documentation submitted to the EMA for eachof their authorised products or could face sanctions. This is likely to be a daunting task for companies which have a large number of pharmaceutical products in their portfolio. Companies should ensure that they have begun to take all necessary actions to update historic submissions to the EMA.