As part of the documents for the re-registration procedure, the Addendum to the Clinical Data Review must be submitted. Submission of this document is mandatory, since the transitional period provided for by the Procedure for conducting expert evaluation of registration materials for medicinal products (order of the Ministry of Health No. 460) has expired.
More information: order of the Ministry of Health of Ukraine dated 26 August 2005 No. 426 (as amended by the order of the Ministry of Health of Ukraine dated 23 July 2015 No. 460) http://zakon2.rada.gov.ua/laws/show/z1210-15
