Category Archives: PL section 4

QRD Appendix V – the Finnish wording for “Reporting of side effects”

Recently I did some small jobs where the the phrases in the section 4.8 of SPC  , under the heading “Reporting of suspect adverse reactions” (Epäillyistä haittavaikutuksista ilmoittaminen)  and in the section 4 of the PL, under the heading “Reporting of side effects” (Haittavaikutuksista ilmoittaminen), were amended to include the contact information of the national authority.

Adding the address requires some wording changes in the template phrases (at least for Finnish).  The phrases to be used can be found in the Fimea document “The national translations, QRD Appendix V“.