S.L. 458.35 ст. 41Single assessment of periodic safety update reports.

A single assessment of periodic safety update reports shall be performed for medicinal products authorised in more than one

Member State and, in the cases of paragraphs 4 to 6 of Article 107c of Directive 2001/83/EC, for all medicinal products containing the same active substance or the same combination of active substances and for which a Community reference date and frequency of periodic safety update reports has been established.