Since 1st of January 2017, an e-CTD became an obligatory format and method of submission and e-CTD software became indispensable tool for each MAH in the EU. Also, many non-EU health and regulatory authorities follow this path closely [e.g. Health Canada]. Therefore we have decided to expand our range of services.
Suspected ADR can be, as of now, reported via mobile application of Croatian Medicinal Products and Medical Devices Agency (HALMED), intended to the patients, health care professionals, caregivers and other citizens.
Serialization process is not a new one in other industries on global level. Automotive and banking indutry have already implemented it. No, pharmaceutical industry must do the same.