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Identification of Medicinal Products (IDMP)

The consultancy for global, pharmaceutical regulatory affairs

We support pharmaceutical companies to comply with the Identification of Medicinal Products (IDMP), EU legislation.

As mandated by EU legislation, Identification of Medicinal Products (IDMP) was implemented in July 2016. The main purpose is to standardise the way the pharmaceutical industry refers to medicinal products, providing a universal identification for drugs that can be referenced in individual case safety reports. IDMP is much more comprehensive than, and replaces the eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) as the submission standard. The scope of IDMP is much larger than XEVMPD, requiring more information, with higher levels of granularity and new controlled vocabularies.

Devised by the International Organization for Standardisation (ISO), the IDMP is comprised of five information management standards on the use, consumption and packaging of drugs. The standards specify ‘definitions in terms for all data elements required to uniquely and with certainty identify medical products for human use’.

The 5 standards are:

ISO 11615:2012– defines the product as per the marketing authorization, whether that is many pack configurations or one. This will be a new identification system that allows a product to be identified internationally. It is equivalent to the ‘authorized product’ in XEVMPD although more extensive and will require additional details such as: manufacturers, clinical information (indications, contraindications and side effects) and marketing authorization information.

ISO 11616:2012 –defines the pharmaceutical product in the administrable dosage form. Quite often a repeat of the information within ISO 11615:2012 but not necessarily.

ISO 11238:2012 –covers the data required for uniquely identifying substances, including active ingredients, excipients, adjuvants and primary packaging materials. It will include the ability to define between grades of material and manufacturers.

ISO 11239:2012 –defines the controlled vocabularies that will be used to ensure a standard global approach. These will cover pharmaceutical dose forms, units of presentation and routes of administration with some matching those used in XEVMPD.

ISO 11240:2012 –confirms the Unified Code for Units of Measurement (UCUM) standard which will be applied as the reference vocabulary for the strength of medicinal products. This standard is already used in XEVMPD and no further guidance will be released.

Tips to address your IDMP implementation concerns