Various clarifications, including:
- Section 5.6 Combination products:
- Information only required if changes are made through a variation or authorisation extension
- A.100: additional condition: “The SA number of the type IB variation (1st pack with new design) is specified under “Scope / justification for the change”.”
- A.101: Documentation requirement no. 1 expanded.
- A.106: 2 documentation requirements expanded:
- “Confirmation that the documentation submitted is identical to that for the basic product (including any additional material that was approved in the meantime)” and
- “Confirmation that the authorisation holder has at its disposal all the documents it requires to fulfil its healthcare-related responsibilities, and accepts all the obligations associated with the authorisation of a stand-alone medicinal product.”
- C.I.6: -Preclinical documentation requirement expanded for additional indications:
- “An Environmental Risk Assessment (ERA) must be submitted, as an additional indication is likely to have a substantial impact on the environment. If no ERA is submitted, reasons for this must be stated.”
- C.I.102: Adaptation of formulation in connection with document protection:
- New: use “expansion” rather than “extension”.
The new version of the affected document takes immediate effect.