Where a Certificate of Suitability is referred to, the manufacturer shall give an assurance in writing to the applicant that the manufacturing process has not been modified since the granting of the certificate of suitability by the European Directorate for the Quality of Medicines and HealthCare.
I gcás ina ndéantar tagairt do Dheimhniúchán Oiriúnachta, tabharfaidh an monaróir dearbhú i scríbhinn don iarratasóir nár athraíodh an próiseas monaraíochta ó dheonaigh an Stiúrthóireacht Eorpach um Cháilíocht Leigheasra agus Cúraim Sláinte an Deimhniúchán Oiriúnachta.