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” (hereinafter – the Information Resource) is currently being improved, which provides for streamlining the frequency of PSUR submission and determining the data lock point for inclusion of data in a PSUR for a given period.
We ask that, if the Information Resource contains no data in the columns “PSUR submission frequency”, “Final date for inclusion of data in the PSUR for a given period” and “PSUR submission date” ( http://www.drlz.com.ua/) for the INN of the API or API combinations corresponding to the medicinal products that you represent in the territory of Ukraine, you provide to the State Expert Center of the Ministry of Health of Ukraine (hereinafter, the Center) information on:
- International birth date of the medicinal product (IBD)
- The approximate birth date of the API or combinations of APIs
If data are missing in the column “INN of API or API combinations,” please provide the name of the active pharmaceutical ingredient or their combinations. The language of submission is English; for herbal medicinal products, Latin (clarification in the Help section of the Information Resource http://www.drlz.com.ua/ibp/tpsite.nsf/all/tp_help?opendocument).
To implement the planned changes to the requirements for submitting PSURs, we ask applicants of original medicinal products registered in Ukraine to provide the Center with information on the date of registration in Ukraine.
We await responses at the email address PSUR@dec.gov.ua
We also inform you that during the quarantine period, PSURs should be submitted to the Center in electronic form to the e-mail PSUR@dec.gov.ua
