Legal Background of the Identification of Medicinal Products (IDMP)
Current regulations in the US and Europe require substantially different technologies, terminologies and vocabularies for registration of medicinal products. In the US, the FDA requires a “Structured Product Labeling” (SPL). In Europe, the European Medical Agency (EMA) initiated a new standard called IDentification of Medicinal Products (IDMP). It is most likely that the FDA will take-over these standards in the near future.
Regulation (EU) No 520/2012
Article 25 : Use of internationally agreed terminology
For the classification, retrieval, presentation, risk-benefit evaluation and assessment, electronic exchange and communication of pharmacovigilance and medicinal product information, Member States, marketing authorisation holders and the Agency shall apply the following terminology: IDMP ISO/FDIS norms 11615, 11616, 11238, 11239 and 11240
Article 40 : Transitional Provisions
1. The obligation on the part of marketing authorisation holders, national competent
authorities and the Agency to use the terminology provided for in points (c) to (g) of
Article 25 shall apply from 1 July 2016.
2. Article 26(2) shall apply from 1 July 2016.