We draw applicants' attention to the fact that, within the framework of the pharmacovigilance obligations defined by the Pharmacovigilance Procedure approved by the order of the Ministry of Health of Ukraine of December 27, 2006 No. 898, registered with the Ministry of Justice of Ukraine on December 19, 2016 under No. 1649/29779 (as amended by the order of the Ministry of Health of Ukraine of September 26, 2016 No. 996) (the Pharmacovigilance Procedure), the applicant submits to the Center a periodic safety update report (PSUR) for the medicinal product, vaccine, or tuberculin by the international nonproprietary name (INN) of the active pharmaceutical ingredient (API) or combinations of APIs.
The frequency and submission dates of PSURs are currently regulated by the Pharmacovigilance Procedure and its Annex 10.
If the terms for submitting PSURs for an INN are not specified in Annex 10, the applicant should follow the information specified in subparagraph 1 of paragraph 2 of Chapter 3 of Section V of the Procedure for Pharmacovigilance, namely:
– for a medicinal product registered in Ukraine as the first country in the world or for the first time in any other country in the world – every 6 months during the first two years (regardless of whether the medicinal product is on the market), once a year during the following two years and thereafter – 1 time every three years, starting from the date of registration of the medicinal product.
In order to achieve international harmonization, the applicant may change the frequency and/or submission date of the PSUR by introducing changes in the manner prescribed by law. To do this, the applicant submits an application to change the frequency and/or timing of submission of periodic safety update reports for medicinal products (B.I.10) in accordance with Annex 25 to the Procedure for Conducting 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 MoH order of 26.08.2005 No. 426 (as amended).
The template for completing the registration form is available at the linkhttps://www.dec.gov.ua/applicant/shablony/?role=applicant
