Renewals

Renewal of marketing authorisations, including (MR and DC) - main points:

It is recommended to apply for concurrent renewal of all pharmaceutical forms and strengths, even though individual authorisations have not expired. It is also permitted to request a changed date for the renewal in order to coordinate the dates of the authorisations within the EEA (harmonised birthday).

The IMA must receive a consolidated file on quality, safety and efficacy of the medicine, including all approved variations/extensions from the original marketing authorisation, within six months from the foreseen expiry of the marketing authorisation. Included in a consolidated file are, inter alia:

  • A list of all changes of preconditions for marketing authorisations (type variations/ new forms/new strengths), which have been approved from the date of issuing of the marketing authorisation
  • A list of Periodic Safety Update Reports (PSURs) and a report and an expert statement on a current assessment of benefit/risk of using the medicine.
  • Updated expert reports or updated overviews and summaries. Expert statements accompanying applications for variations can be regarded as a supplement to the original expert reports.
  • If a revised SPC, labelling and/or package leaflet (PL) is proposed to take account of issues raised by the expert (e.g. after evaluation of the PSURs), the precise present and proposed wording should be specified on the form. Alternatively such listing may be provided as a separate document attached to the application form under a tabular format (indicating the current and proposed texts). Any changes not listed will not be considered as part of the renewal application.

Further details on the regulatory requirements can be found in “CMD(h) Guidelines on the processing of renewals in the mutual recognition and decentralised procedures”, which appears on the HMA website (http://www.hma.eu/).

Application form: Application for Renewal of a Marketing Authorisation.