Attention applicants!
On the information fund of the State Register of Medicinal Products of Ukraine at the link: http://www.drlz.com.ua/ a working version (beta version) of the Information Resource “Frequency of Submission of Periodic Safety Update Reports for Medicinal Products, Vaccines, and Tuberculin by International Nonproprietary Name of the Active Pharmaceutical Ingredient or Combinations of Active Pharmaceutical Ingredients” (the Information Resource) is currently posted.
The beta version format provides for productive interaction between pharmacovigilance experts of the State Expert Center of the Ministry of Health of Ukraine (the Center) and applicants regarding the submission to the Center of information on the absence / change in the Information Resource of data on the international nonproprietary name (INN) of the active pharmaceutical ingredient (API) or API combinations, and on the deadlines for submission of regularly updated safety reports for medicinal products, vaccines, tuberculin by the international nonproprietary name of the active pharmaceutical ingredient or combinations of active pharmaceutical ingredients (PSUR).
The Center is currently working on updating and improving the Information Resource, and at this stage of development the Information Resource may contain errors and cannot be used by the applicant to determine the frequency of PSUR submission.
Information on the approval of the Information Resource will be published on the Center's website.
Currently, the frequency of submission of the PSUR is regulated by the deadlines specified in the Pharmacovigilance Procedure approved by the order of the Ministry of Health of Ukraine of 27 December 2006 No. 898, registered with the Ministry of Justice of Ukraine on 19 December 2016 under No. 1649/29779 (as amended by the order of the Ministry of Health of Ukraine of 26 September 2016 No. 996) (hereinafter, the Pharmacovigilance Procedure), and Annex 10 to the Pharmacovigilance Procedure.
The frequency of PSUR submission specified in Annex 10 to the Pharmacovigilance Procedure is published on the Center’s website at this link.
In order to achieve international harmonization and in accordance with the requirements of the Procedure for Conducting Expert Evaluation of Registration Materials for Medicinal Products Submitted for State Registration (Re-registration), and of Materials on Amendments to Registration Materials during the Validity of the Registration Certificate, approved by Order of the Ministry of Health of Ukraine of 26 August 2005 No. 426 (as amended by Order of the Ministry of Health of Ukraine of 23 July 2015 No. 460), registered with the Ministry of Justice of Ukraine on 07 October 2015 under No. 1210/27655, the applicant has the opportunity to change the frequency of PSUR submission to the Center by making variation B.1.10. “Change in the frequency and/or dates of submission of periodic safety update reports for medicinal products”.
Current information on the change in the frequency of submission of PSURs is available on the Center’s website at the link
