FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Reminds Companies to Submit Type I Variations by Nov. 30

Nov. 28, 2017
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Drugmakers should submit type I variations for 2017 to the European Medicines Agency by the end of November.

All marketing authorization holders should submit any type IAIN and type IA variations for the year by Nov. 30 to give the agency time to acknowledge them between Dec. 23 and Jan. 2, 2018. They should also submit any type IB variations or groupings of type IBs and type IAs by Dec. 8.

Type IB variations must be notified to the relevant national authorities or the EMA prior to implementation but they are not subject to formal approval.

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