Order of the Ministry of Health of Ukraine No 1349 dated 09.06.2020 outlines revised rules of the submission and expertise of the documents for GMP certification and recognition of the foreign GMP certificates, including:
• priority consideration for some categories medicinal products
• qupdated list of the documents submitted for certification and recognition
in the event of pandemics and other force-majeure:
• the possibility of remote auditing for new applications
• the possibility of extension of validity of the existing certificates up to 1,5 year based on the risk management plan
• electronic submission and communication through the SMDC portal
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