The MOH Order No.1730 dated 22 December 2017 brought amendments to the format and the description of the registration certificate for medical drugs. On 30 March 2018 the MOH Order came into force. Hence the reporting period for PSURs (safety report updates) shall not be indicated now in the registration certificates for medical drugs.
Throughout 2017 the Association’s Health Care Committee (Association’s Committee) highlighted the necessity to remove information on PSURs’ submission from the registration certificate’s format as such a requirement is unavailable in relevant EU practices. In addition, the PSUR’s reporting information is indicated in current registration certificates for medical drugs differently adding extra difficulties for the pharmaceutical companies’ operation.
Association’s Committee welcomes the already adopted amendments, which were previously elaborated by the SEC experts. We expect no problems or delays during the further organization and implementation of the effective registration certificates’ interchange with the new ones as according to the new format standard.