If an Addendum to the clinical data review is provided as part of the re-registration materials, information about an independent clinical expert must also be provided.
Regulatory references: Annex 15 to the Procedure for expert evaluation of registration materials for medicinal products submitted for state registration (re-registration), as well as expert evaluation of materials on amendments to registration materials during the validity of the registration certificate, approved by order of the Ministry of Health of Ukraine dated 26 August 2005 No. 426 (as amended by order of the Ministry of Health of Ukraine dated 23 July 2015 No. 460).
