EudraVigilance: Obtaining EDQM terms from SPOR

On 3 February 2022 the EMA published the EudraVigilance guidance on obtaining EDQM terms from SPOR.

The Routes of Administration and Dosage Form terms in the EDQM Standard Terms database comply with the ISO 11239 standard. The content of the EDQM Standard Terms database is updated on a continuous basis, with new or revised terms available to users as soon as they are available (see https://standardterms.edqm.eu/). The EudraVigilance system synchronizes the EDQM code lists every Sunday night with the SPOR RMS system so that the following Monday new terms are added and updates to pre-existing terms are made. Organizations should also aim to regularly update their systems with EDQM changes to ensure that they are exchanging up-to-date terms, and they are able to process ICSRs downloaded/routed from EudraVigilance correctly and to avoid rejections of submissions of ICSRs if terms are marked as non-current by EDQM.

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