Is it necessary to submit the PSUR for medicinal products with marketing authorisation based on a combination of generic and hybrid applications (e.g. one strength has been authorised as generic, the other one as hybrid)?, State Institute for Drug Control

Is it necessary to submit the PSUR for medicinal products with marketing authorisation based on a combination of generic and hybrid applications (e.g. one strength has been authorised as generic, the other one as hybrid)?

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.

State Institute for Drug Control

Is it necessary to submit the PSUR for medicinal products with marketing authorisation based on a combination of generic and hybrid applications (e.g. one strength has been authorised as generic, the other one as hybrid)?

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