If the active substance is not included in the EURD list, a MAH is still obliged to keep submitting the PSUR in accordance with the frequency, specified in the marketing authorisation or if it is not specified therein, then in compliance with law (6-month, annual, 3-year frequency).
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Documents for pharmacovigilance branch
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Questions and answers on the amended Act on...
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PSUR – Periodic Safety Update Reports
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Shall PSURs be submitted, if the active...