In recent months, several legislative acts have been adopted that significantly affect the regulation of medicinal products, specifically: A ban on advertising information on the labeling and information about persons other than the Manufacturer and MAH (marketing authorization holder), which comes into effect on January 18, 2025; Parallel import of medicines purchased by an authority […]
COVID-19: quarantine impact and BCP
Due to the rapid development of COVID-19 coronavirus infection, considering the safety and well-being of our colleagues and partners, we inform about the plans of our organization for the duration of the pandemic.
From March 16, 2020, for an indefinite period of time, Cratia has activated the Business Continuity Plan (BCP) aimed at minimizing risks for customers and employees and maintaining all critical business processes. BCP has been developed taking into account ISO 22301:2012 and EU GPvP.
Quarantines are being introduced in the countries in which we operate to ensure the safety of citizens and prevent the spread of coronavirus. Most competent authorities and expert organizations have switched to a limited access mode, in some cases submission of hard documents has been restricted, procedures of signing and legalization of manufacturer’s documentation became complicated.
Most of our employees have been transferred to remote work and continue absolutely all current tasks in the standard working schedule. A special epidemiological regime is implemented in our central office, negotiations with partners are conducted by phone or other means of telecommunication, mail and parcels are received uninterruptedly.
Communication with representatives of the competent authorities is mainly switched to the telephone mode, where possible the receipt and submission of documentation is carried out electronically. We do our best to postpone the signing and legalization of administrative documents by our clients, coordinating temporary measures with experts.
In general, all ongoing processes are performed on time, at the expected quality and expertise level. Our entire team is available by e-mail, for quick communication we recommend using the mobile phones indicated in the signature of each person
In case of an emergency, please send an e-mail to key@cratia.ua or call +38 067 238-31-37.