Adaptation of the form Variations and extensions HMV4


New variation A.100, type IAIN:
Implementation of the design change can be notified as of the second pack in the form of an A.100, type IAIN. This should be done after the first pack in the new design (corporate identity) has been submitted as a regulatory change A.100 type IB and approved.

“It must not be an essential medicinal product” no longer a condition for regulatory change A.104 conversion of a main authorisation to an export licence.

Various clarifications, including:

  • Applications for (an) additional indication(s) and extensions must always state the active substance(s) and the area of application being requested.
  • If clinical trials (including bioequivalence trials) are enclosed with the application, a completed EMA “GCP inspections template” must always be sent to Swissmedic.
  • When applying for extensions, applicants must specify whether or not they are also applying for extended 10-year document protection.
  • Where applications involve co-marketing medicinal products and the Information for healthcare professionals and Patient information are affected, applicants have to confirm that these match the texts for the basic product.
  • What information Swissmedic expects for “Currently approved – Requested” when medicinal product information has been changed (sections A.100, A.109, C.I.1, C.I.3, C.I.4, C.I.13. C.I.100 and C.I.z, date of revision: A.101 and C.I.2)
  • A.106 and A.107: Condition associated with “No scientific data are submitted” specified in greater detail.
  • Linguistic clarification egarding the submission of the form Status of authorisation applications abroad HMV4
  • New chapter 5.5 and 5.6 inserted

The new version of the affected document enter into force as of 12.08.2019.