Other chemicals data submitted or generated under Union legal acts on medicinal products could also be of relevance to chemicals regulatory areas, such as data related to other active substances contained in medicinal products, clinical data and data related to other substances contained in medicinal products besides active substances. Moreover, a relevant part of the medicinal data is held by the competent authorities of the Member States. No later than 6 years after the entry into force of this Regulation, the Commission should therefore assess, in consultation with Member States and the Agencies, whether such additional data should be included in the common data platform. That assessment should also take into account the relevance, the anticipated added value and the cost-benefit balance of incorporating the additional data.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
