Better identification of medicinal products

News 28/07/2016

Webinar on new ISO standards to take place on 4 August 2016

The European Medicines Agency (EMA) is currently implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). To help all interested stakeholders prepare for the new requirements linked to IDMP, the Agency is organising a webinar on Thursday 4 August 2016, from 09:30 to 12:30 (UK time).

The webinar is open to all interested stakeholders. It can be followed under the multimedia tab on the event page, without the need for prior registration.

The ISO IDMP standards provide data elements, formats and terminologies to identify medicines and exchange information on medicines. Following a phased implementation process, pharmaceutical companies will be required to submit data to EMA in accordance with the new formats and terminologies.

To facilitate the implementation of these ISO IDMP standards, EMA is delivering a set of master data management services (a comprehensive method that focuses on the management and interlinking of information that is considered to play a key role in the core operation of a business and is reused for multiple purposes) for the four key domains of substances, products, organisations and referentials (SPOR):

  • substance data describes the ingredients of a medicine;
  • products data describes the marketing authorisation, packaging and medicinal information relating to a product;
  • organisations data encompasses names and location addresses for organisations such as marketing authorisation holders, sponsors, regulatory authority and manufacturers;
  • referential data provides controlled vocabularies (e.g. dosage, pharmaceutical forms, country codes, package codes, weight codes) for a medicine, which are explicitly defined for use in Europe.

EMA's webinar will help industry stakeholders to better understand:

  • why the ISO IDMP standards are needed and how they link to SPOR;
  • SPOR data services timelines, engagement approach and plan;
  • common processes for registering the data and keeping it up to date.

For further details, see Implementation of the ISO IDMP standards.

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