OTC Hybrid Art. 10(3) UK MA

Supplier landscaping identified a number of flexible options for the client to partner with in the short/immediate term.

A hybrid 10(3) submission was agreed, identifying the appropriate reference product for locally acting products. Full E2E management of the dossier conversion to eCTD standards involving the complete Module 1, Module 2 summaries and overviews (using Regulink non-clinical and clinical experts), Module 3 review and update to EU requirements and Module 4/5 literature based updates.

The immediate resource requirement was met by a Regulink PM and a senior regulatory & CMC partner.

Regulink provided support for PV, PL user testing, scientific services and non-clinical and clinical experts for the MAA itself and for the client in the long term to meet its MAH obligations.

The MAH was connected with trusted partners to be able to act as a MAH for a UK licensed medicine, including MIA holder, QP and eCTD publishers.

Regulink acted as applicant for the MAH and took complete responsibility for authoring/compiling the entire Module 1, together with external providers, as required. All liaison with the UK health authority was undertaken by Regulink’s project manager and team.

The MAA eCTD dossier (Module 2 – 5) was compiled using this experienced team with close involvement and support from the client’s technical experts, when necessary. Submission was made within the desired timeframe and the application is following standard timelines with no major requests for further information.

A particularly tight launch window for this seasonal product will therefore be met.