Notification to end-users about message or requirement from MAH for additional info during alert investigation

Notification in the Alert Management System (AMS NOOL) was established for all end users of Czech Medicines Verification System (CZMVS-NSOL) - ie primarily pharmacists and distribution staff, from whom the MAH requires co-operation in the form of additional information to the package that was not sucessfully verified; alert was caused during verification. These are alerts created at the CZMVS-NSOL end user's premises, to which the notification is sent via e-mail to the address specified during registration as a "contact for FMD".

If the request for additional information necessary for the examination and closure of the alert has not been fulfiled within 48 hours, a first notification shall be sent to end-users; after 5 days from the origin the requirement for additional info, the 2nd notification request.

If the pharmacist or distributor does not respond even after 30 days from the request for additional information, the information is forwarded to the State Institute for Drug Control (SÚKL). All subjects that may be involved in the development of an allergy (MAH, pharmacy, distribution, NOOL) should work together to determine the cause and close the allergy that arose after an unsuccessful attempt to validate a medicinal product according to the requirements of "anti-counterfeiting legislation".