8. Post-Approval

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2. Variations

2.1. Variation procedures

  • Definition:      
    ‘Variation’ means any amendment to the terms of the marketing authorisation, and any conditions, obligations, or restrictions affecting the marketing authorisation, including the SmPC or changes to the labelling or the package leaflet
  • Variations are classified in different categories depending on the level of risk to public health and the potential impact on the quality, safety and efficacy of the medicine concerned.
  • Regardless of the legal basis of the initial MA, a MAH can submit an application in relation to further developments or uses of its medicinal product, including new therapeutic indications, in accordance with the provisions and requirements set out in Regulation (EC) No 1234/2008
  • Any application by the MAH to vary a MA which has been granted in accordance with the legislation needs to be submitted to all relevant authorities*.

*‘Relevant authority’ hereinafter means:

Legal basis:      

Regulation (EC) No 1234/2008 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02008R1234-20210513)‘concerning the examination of variations to the terms of marketing authorisations for medicines for human use and veterinary medicines and on the documentation to be submitted pursuant to those procedures’ (the ‘Variation Regulation’)

Of note: The following text refers to the Variation Regulation as legal basis unless otherwise noted