The State Expert Center of the Ministry of Health (the Center) is reviewing and updating the Periodicity of submission of periodic safety update reports for medicinal products, vaccines and tuberculin by the international nonproprietary name (INN) of the active pharmaceutical ingredient (API) or combinations of APIs.
We ask applicants for medicinal products to provide the Center with information on the INNs of APIs for which data are absent from Appendix 10 to the Procedure for Pharmacovigilance, approved by order of the Ministry of Health of Ukraine of 27 December 2006 No. 898, registered with the Ministry of Justice of Ukraine on 29 January 2007 under No. 73/13340 (as amended by order of the Ministry of Health of Ukraine of 26 September 2016 No. 996).
Provide information to the e-mail address vigilance@dec.gov.ua
