Updated rules of GMP certification and recognition of foreign GMP certificates in Ukraine

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

Contact us for further information and regulatory support on the Ukrainian market: info@smart-pharma.group