New XEVMPD controlled vocabularies published by EMA

The European Medicines Agency (EMA) has published new versions 2.0 of some of the controlled vocabularies required to comply with the requirements on submission of information on medicines as set forth in Art. 57 (2) of Regulation (EC) 726/2004.

The following controlled vocabularies have been updated:

• Organisation (WC500123647), version 2.0 (166 added)
• Pharmaceutical Dose Forms (WC500123648), version 2.0 (48 deleted)
• Substances (WC500123652), version 2.0  (2364 entries were added, furthermore additional colums "Name Type" and "Language" have been introduced. Whereas the name type specifies whether an entry reflects a substance name or a translation the corresponding language of a translation (if name type = "translation") is stated in column "Language)
• Units of Measurement (WC500123653), version 2.0 (1 XEVMP Numerator Unit added: "[FFU] = Fluorescent Focus-Forming Unit")
• Units of Presentation (WC500123654), version 2.0 (3 added: "Actuation", "Pessary", "Puff")

Note: The controlled vocabularies will be updated by EMA regularly. Marketing authorisation holders are required to use the latest version of the controlled vocabularies for XEVPRM submissions of medicinal product information as soon as they are published on the Agency's website.

[Source: EMA website]

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