EMA Publishes New Versions of EudraVigilance Controlled Vocabularies for Article 57(2) Compliance
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EMA Publishes New Versions of EudraVigilance Controlled Vocabularies for Article 57(2) Compliance

EMA Publishes New Versions of EudraVigilance Controlled Vocabularies for Article 57(2) Compliance

Medicinal ProductsJust about two months before the deadline of July 2, 2012, by which Marketing Authorization Holders (MAHs) are required to electronically submit to the EMA information on all medicinal products for human used authorized in the European Union, using the new electronic exchange format XEVPRM, the agency released a set of updated versions of their controlled vocabularies.

As part of this release, the European Medicines Agency (EMA) published updated lists of organizations, pharmaceutical dose forms, substances (including their translations where applicable), and units of presentations and measurement. The previous versions were originally published on March 5, 2012, along with eight other controlled vocabularies, which remain unchanged.

Two months is not a long time, and the current deadline, which seems legally set in stone, has many pharmaceutical organizations scrambling to get their electronic submissions ready in the updated eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) format, to meet the deadline.

Partly in response to the feedback from the pharmaceutical industry, the Agency also recently published an updated (= reduced) set of mandatory requirements related to this Article 57(2) compliance, citing the “practical challenges of compliance”. The expectations are that these measures will significantly reduce the administrative burden for MAHs, in view of helping them meet the deadline.

The Agency will no longer require several data sets to be submitted by July 2012, among them the structured substance information (SSI). In addition, the language requirements specific to the authorization procedure used have been clarified by the following:

The rule is that substance names should be specified as reflected in the Summary of Product Characteristics (SmPC) and in accordance with the national language(s) as applicable, while adhering to the controlled vocabularies. For centrally authorized products, substance names should be specified in all official EU languages. In Member States with more than one official language, the information needs to be provided in each of the official languages. For products authorized through the mutual recognition (MRP) or decentralized procedure (DCP), substance names should be given in the national language of the country of authorization, along with English translation.

The electronic submissions as part of this Article 57(2) compliance also require the respective SmPC to be attached. For centrally authorized medicinal products, the SmPC is to be provided in English only (while the other languages are available via the EMA). For medicinal products authorized through the MRP or DCP procedures, the SmPC is provided in the national language of the country of authorization.  However, the harmonized English text of the SmPC is now also acceptable.

The good news is that while the update of the controlled vocabularies comes quite close to the deadline (and they will continue to be updated regularly), if an MAH has already submitted medicine information to the EMA using the previous version of the vocabularies, they are not required to resubmit this information.

Submitting information to the EMA and need to add translations into the equation? Download our article Finding the Ideal Process for Pharmaceutical Translations, which reviews some of the current issues in pharmaceutical translations related to marketing authorization.