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Variations / Renewals / PSURs

Regulatory Maintenance - Variations/Renewals/PSURs

Variations

Changes to the registered dossier are necessary throughout the life-cycle of your medicine.  Changes can administrative medical or technical. Companies are always making (albeit small) improvements to the product and occasionally they want to add indications or patient groups.  Some revisions are imposed by updates in guidelines monographs etc.

Any such change will mean that a variation application will need to be submitted to the relevant Health authorities.

We can:

  • Prepare and submit the necessary documentation (Type I, II, line extensions etc)
  • Suggest the optimum variation strategy encompassing required changes (type of variation, timing, grouping options etc)
  • Discuss and advise on forthcoming variations / PI revisions required due to product changes (e.g. SmPC, CMC changes etc)

Renewals

EU Marketing Authorisations have an initial life of five years. After five years, the MA may be renewed on the basis of a re-evaluation of the risk-benefit balance. To this end, the MA Holder needs to submit a renewal application. Once renewed, the MA is valid for an unlimited period unless the regulators decide that one additional five-year renewal is required (based on justified grounds relating to pharmacovigilance).

Therefore, as an MA Holder, you will need to submit at least one renewal application during the lifetime of your product.

We can:

  • Prepare and submit the renewal application
  • Advise on setting the optimum renewal date (common renewal, early renewal etc)
  • Provide expert input to prepare requisite expert statements

Periodic Safety Update Reports (PSURs)

In conjunction with the above, a PSUR is usually required at the time of renewal.  A PSUR is intended to provide an update of the worldwide safety experience of a medicinal product to Competent Authorities at defined time points post-authorisation. At these times, MA Holders are expected to provide succinct summary information together with a critical evaluation of the risk-benefit balance of the product in the light of new or changing information.

Thus, PSURs are an important part of your post-licencing Pharmacovigilance obligations.

We can:

  • Author, review and submit your PSURs
  • Harmonise your PSUR cycles
  • Advise on PSUR Bridging Summaries and Addenda