Worksharing: one assessment of a variation across several authorisations
Worksharing lets one authority assess the same Type IB or Type II variation for several marketing authorisations of the same holder in a single procedure.
Worksharing is set out in Article 20 of Commission Regulation (EC) No 1234/2008. Where the same variation, or the same group of variations, affects several marketing authorisations held by the same holder, the holder can ask for a single assessment by one reference authority instead of parallel assessments in every procedure. The authorisations can be nationally authorised, authorised through the mutual recognition or decentralised procedure, centrally authorised, or a mixture, which is what makes worksharing useful for holders with the same change across a whole portfolio.
If any centrally authorised product is involved, EMA is the reference authority and the CHMP gives the opinion. Otherwise the CMDh chooses a reference authority, normally one of the reference member states involved, and that authority's assessment is recognised by all the others. The holder asks for worksharing before submission, with a letter of intent that lists the products, the change and the proposed reference authority, so the authorities can agree the arrangement and the submission date. Type IA notifications cannot use worksharing, because they are notified rather than assessed.
What goes wrong: packages where the change is not truly identical across products, so the reference authority refuses or splits the procedure; different dossier content in different Member States that the single assessment then exposes; and forgetting that each authority still charges its own fee and may still require national implementation steps after the opinion. Holders also underestimate the preparation, because the dossiers of every product in the scope have to be brought to the same state before the shared submission can be validated.
Worksharing suits safety updates to the product information for a substance across many products, manufacturing changes at a shared site, and consequential updates after a referral or PSUR single assessment. Where a change is identical but the products belong to different holders in the same group, the holders must still meet the same-holder condition or file separately.
Under the new pharma package (not yet in force), the conditions for one application covering several changes or several authorisations will be set by Commission delegated acts rather than the current Regulation; see variations changes.
Timing
The reference authority assesses on the standard variation timetable: 60 days for a Type II change, 90 days for a new indication or other changes that the Regulation allows to be extended, and 30 days for a Type IB. Requests for supplementary information stop the clock. Once the opinion is adopted, the other authorities have 30 days to recognise it, after which each updates its own authorisation. For centrally authorised products a Commission decision follows.
Used in
Teams plan a worksharing submission alongside the other changes due on the same products in the lifecycle planning workflow.
Related terms
- Grouping of variations: several changes in one submissionGrouping of variations is the filing of several changes to one or more marketing authorisations in one submission under Article 7 of Regulation 1234/2008.
- Type II variation: major change requiring prior approvalA Type II variation is a major change that may significantly affect a medicine's quality, safety or efficacy and needs approval before implementation.
- Type IB variation: minor change notified before implementationA Type IB variation is a minor change that is neither Type IA nor Type II and must be notified to the authority before it is implemented.
- CMDh: Co-ordination Group for Mutual Recognition and Decentralised ProceduresThe CMDh is the group of national authority representatives that resolves disagreements in MRP and DCP and coordinates nationally authorised medicines.
- PSUSA: PSUR single assessmentA PSUSA is the single EU assessment of all periodic safety update reports for one active substance, led by the PRAC and binding on every holder.
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