Deadlock in Pharmaceutical law

On the 1st of January 2017 new regulations of Pharmaceutical law regarding reporting to the Integrated System of Monitoring Trade of Medical Products entered into force. Because the system has not been launched yet, entities obliged to report are unable to fulfill their duties and risk being fined.

At the end of last year the Ministry of Health published a communication on developments of the system and informed, that legislative proceedings in order to suspend provisions imposing reporting duties till the end of June 2017 are pending. In accordance with the project penalty proceedings during the above period will not be initiated and already initiated proceedings will be ceased. However, the project envisions to prolong previously applicable reporting duties in respect of made transactions, stock levels, stock changes and release of series. The project is currently subject to public consultations.

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