CRED Managing Variations Effectively

Chapter C – 2 nd example cont.

C. Safety, Efficacy, Pharmacovigilance changes I. Human and Veterinary medicinal products 1 Change(s) in the SmPC, Labelling or Package Leaflet to implement a Union referral procedure 2 Change(s) in the SmPC, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product 3 Change(s) in the SmPC, Labelling or Package Leaflet of human medicinal products intended to implement PSUR or PASS outcome, or following assessment under Articles 45 or 46 of Reg 1901/2006 4 Change(s) in the SmPC, Labelling or Package Leaflet due to new quality, (pre-)clinical, or PhV data. 5 Change in the legal status of a medicinal product for centrally authorised products 6 Change(s) to therapeutic indication(s) 7 Deletion of a pharmaceutical form or strength

8 Introduction of, or changes to, a summary of PhV system for medicinal products for human use 9 Change(s) to an existing PhV system as described in the detailed description of the PhV system (DDPS) 10 Change in the frequency and/or date of submission of PSUR for human medicinal products 11 Introduction of, or change(s) to, the obligations/conditions of a marketing authorisation, incl the RMP 12 Inclusion/deletion of black symbol & explanatory statements for products subject to additional monitoring 13 Other variations not specifically covered elsewhere in this Annex which involve the submission of studies 73

Introduction to Classification of CMC (Quality) / Clinical / PhV Variations