Practical information

• The CZMVO can continue to close alerts in the AMS that concern a batch or medicinal product exempted in Section 11 (r)) of the Pharmaceuticals Act. Closing alerts with exception can be done by MAH as well.

 

• The quarantine starts as soon as the first alert for a given medicinal product and serial number is generated, even if several consecutive alerts are generated for one pack of the medicinal product, i.e. the same serial number.

 

• Requested medicinal products dispensed by a hospital pharmacy cannot be returned to the pharmacy. If a hospital pharmacy dispensed a medicinal product requested by a healthcare provider and the unique identifier was decommissioned, the medicinal product would be considered to be dispensed to the public, even though it was dispensed to the healthcare facility and not to a patient.

 

• Once a month, the CZMVO provides to the State Institute for Drug control a list of marketing authorization holders (MAHs) who do not investigate alerts as well as the list of end users who do not respond to MAHs’ repeated requests for additional information about alerts.

 

• The end user may only verificate a medicinal product if the medicinal product is physically available. Articles 20 and 25 of Delegated Regulation (EU) 2016/161 of 2 October 2015 refer to the verifications carried out for packaging physically held by the end user (wholesaler or pharmacist).