For products with hybrid marketing authorisation it is necessary to submit the PSUR. If for example it concerns a product which has two different strengths, where one has hybrid marketing authorisation and the other one generic, the PSUR will relate to hybrid strength, plus cases when it is not certain what strength is concerned.
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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 for...