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Assessment procedure

Applicants should review the Operational Procedure for the Generic Medicines Work-Sharing Initiative (GMWSI) which outlines the operational steps, target milestones and recommendations for the planning and the filing of the application .

Applicantsshould first express interest in the initiative by using the GMWSI Expression of Interest (EOI) form. This should be done 3 - 6 months before the target submission date.

The applicant must then submit identical dossiers (while taking country-specific aspects into account) to the relevant authorities

The application to the MHRA must be in eCTD format and in accordance with UK regulatory requirements. Modules 2-5 do not have to be identical across countries, but it is preferable that the same dossier is submitted to all the participating regulators. Where there are differences, the Summary of Differences between dossiers (included in the EOI form) should be completed outlining the differences in information provided to each regulator. It is preferable that Modules 2-5 of the application contain common information.

However, any differences in Modules 2-5 should be clearly identified by the applicant on the Expression of Interest form. In addition, the application submitted to each of the identified regulatory authorities would include the country-specific Module 1 for the respective agency.

The lead agency, designated as the Reference Regulatory Agency (RRA), will prepare the assessment reports following the full review of the dossier. The other participating agencies, acting as the Concerned Regulatory Agencies (CRAs), will perform a peer review of the assessment reports and the application and provide supplementary comments (as needed). The RRA prepares the consolidated List of Questions (LOQ) on Modules 2?5. The RRA and the CRAs forward the consolidated LOQ on Modules 2?5 and their respective LOQ on Module 1 (including questions on product information and labelling) to the local affiliate.

Each agency makes its own sovereign decision based on the recommendations contained in the assessment reports. Marketing authorisation approval or refusal by one regulator may not affect the decision or the timing of the decision of the remaining participating regulators. Although not anticipated, if during the process, it becomes apparent that there are insurmountable issues with the data that the participating agencies are unable to reconcile, the agencies have the option to seek additional information and undertake further review. National procedures still apply for posting an external summary of the application e.g. UK Public Assessment Report (PAR), AusPAR, Canadian Summary Basis of Decision, SwissPAR.

Fees

National fees apply. Fees vary depending on the type of application. For full details see MHRA fees.

How to apply

Interested applicants are invited to participate by contacting their regional regulatory authority using the Expression of Interest form.

• United Kingdom: access-mhra@mhra.gov.uk
• Australia: PCSInbox@tga.gov.au / tga.international@tga.gov.au
• Canada: hc.bps.enquiries.sc@canada.ca
• Singapore: HSA_TP_Enquiry@hsa.gov.sg
• Switzerland: Networking@swissmedic.ch

Communication via email should include Access Consortium - GMWSI in the subject line.Guidance for UK requirements on submissions