• Regulatory House

Important information for MAHs of the medicinal products

An amendment to the registration Decree no. 27/2022 Coll. came into force on 8. March 2022. What does it mean for all current and future MAHs that have already registered or plan to register their medicinal products in Czech Republic?

According to this Decree the name of the active substance(s) in Czech langulage shall be provided in the product information (SmPC, PIL and packaging).

State Institute for Drug Control provides to all marketing authorisation holders a basic information on how to proceed in order to meet the requirements of this Decree. Also provides a link to catalogue which lists the preffered Czech names of medicinal substances. The good news is that a period of 7 years has been set for registered products from the date of entry into force of this decree.

Do you need more information? Not sure about something? Contact us!

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