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Home / Medicines / Pharmacovigilance / Documents for pharmacovigilance branch / Questions and answers on the amended Act on... / PSUR – Periodic Safety Update Reports / Is it necessary to apply for the MA variation...

Is it necessary to apply for the MA variation to discharge the obligation submitting of the PSUR for MPs authorised according to Section 27, Sub-sect. 1 or 7, homeopathics products or trad. herbal MP according to Sect. 30 of AoP?

It is not necessary to apply for the marketing authorisation variation in relation to these medicinal products, the Amendment to the Act on Pharmaceuticals itself has nullified the obligation to submit the PSUR, specified in the marketing authorisation of these medicinal products.

 

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