CRED Managing Variations Effectively

Regulation Structure (1234/2008) Chapter Article Content I: General provisions 2 Definitions 3

Classification of variations (also see Annex II)

4 5 7

Guidelines

Procedure for unforeseen variations Grouping (also see Annex III)

II: Variations to Marketing Authorisations IIa: Variations to Marketing Authorisations - National III: Centralized Marketing Authorisations IV: Section 1 Special Procedures Section 2: Amendment to decisions

8-13 Variation Procedures covering

MRP/DCP/Centralised (also see Annex VI)

13a-f

Variation Procedures covering National (also see Annex VI)

14-18

19 20 22 24

Extensions (also see Annex I)

Worksharing

Urgent Safety Restriction Implementation of Variations

IV: Final provisions

25-28