Must the applicant submit to the Center notifications of cases of lack of efficacy of a medicinal product if they were recorded in the territory of another country and became known to the applicant?

108

Information on identified cases of lack of efficacy of a medicinal product, if they were recorded in the territory of another country and became known to the applicant, must be provided by the applicant as part of the next periodically updated safety report of the medicinal product authorized for medical use.

Regulatory references: subparagraphs 7 of paragraph 1 of chapter 2 of section V of 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 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).

Must the applicant submit to the Center notifications of cases of lack of efficacy of a medicinal product if they were recorded in the territory of another country and became known to the applicant?

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