If the EURD list does not specify a fixed combination and the product does not fall under the category of products exempt from the submission of the PSURs, a MAH should continue submitting the PSUR according to the frequency and the DLP, specified in the marketing authorisation, or if it is not stipulated therein, then in compliance with law.
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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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Is it necessary to submit the PSUR, if the EURD...