News story

Changes to marketing authorisation documentation: memorandum

Duplication of information identified following a review of authorisation documentation issued to the authorisation holder.

Memorandum

Changes to be introduced on all memorandum documents issued after 9 February 2015

The memorandum document (memo-doc) unofficially forms part of a medicinal product’s marketing authorisation (MA).

The memo-doc is not a public document and is only shared with the MA holder of the product concerned.

Information is being duplicated with a list of completed applications at the end of the memo-doc which is also provided in the product’s post authorisation assessment (PAA) document. This document is published in the Product Information Database.

The level of information in the PAA is not as detailed as that provided in the memo-doc, but the extra detail in the memo-doc, mostly in relation to variations, is included on the approval certificate issued to the MA holder at the end of an application procedure.

Changes to be introduced:

  • tidying up of wording in the opening paragraphs
  • removing the date of original authorisation which is on the SPC
  • removing the history table which lists completed applications
  • removing the reference to who it was prepared by, authorised and date sections
  • introducing the version control procedure used for SPCs and mock-ups
  • only issuing an updated memo-doc following completion of an application procedure that results in changes to the content
Published 2 February 2015