Changes to marketing authorisation documentation: memorandum
Duplication of information identified following a review of authorisation documentation issued to the authorisation holder.
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鈥檚 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鈥檚 post authorisation assessment (PAA) document. This document is published in the .
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