When transitioning to the PBRER, how should the MAH handle medicinal products whose current DLP is not synchronised to the new definition of the IBD?

The definition of IBD in the Guideline refers to the date of the first marketing approval for any product containing the active substance granted to any company in any country in the world. Provisions are available in many countries, whether through formal regulation or informal guidance, for the MAH to synchronise the PBRER DLP with the IBD. The MAH should consult the relevant local/regional regulations for further information. It should also contact the appropriate regulatory authority and request adjustment of the PBRER DLP to the IBD, as necessary. Granting these requests is at the discretion of each regulatory authority; experience has shown that most regulatory authorities are willing to do so, in the interest of international harmonisation.