Notification of the commencement of distribution activities within the territory of the Czech Republic based upon distribution authorization for medicinal products issued by another EU member state - after Brexit

State Institute for Drug Control hereby informs UK WDL holders providing distribution activities within the territory of the Czech Republic upon distribution authorization for medicinal products issued by Medicines & Healthcare products Regulatory Agency, UK about changes of conditions after Brexit.  

Since UK has left the EU, all UK distributors authorized in the Czech Republic via the procedure of notification can be no more registered, as they are third country distributors.

Therefore, in compliance with European Commission´s guidance, State Institute for Drug Control kindly asks all UK WDL holders providing distribution activities within the territory of the Czech Republic upon distribution authorization for medicinal products issued by Medicines & Healthcare products Regulatory Agency, UK to apply either for a notification of a change in information on the distributor performing distribution activities within the territory of the Czech Republic or for its annulment (https://www.sukl.eu/medicines/dis-10-verze-3).

Notification of a change in information on the distributor performing distribution activities within the territory of the Czech Republic based upon distribution authorization for medicinal products issued by another EU member state may be requested if the distribution activity will be continuously provided by entity established within EU (organizational unit, branch office, …) with its valid WDA license.

Otherwise, should be sent notification annulment of the commencement of distribution activities within the territory of the Czech Republic based upon distribution authorization for medicinal products issued by another EU member state.

State Institute for Drug Control hereby informs, that all UK distributors who don´t meet the above conditions will be removed from the list of authorized distributors.

For any questions, please contact us on gabriela.vaculova@sukl_cz.