RPS R2 Iteration 2 - Multi-Regulator Submissions

Multiple Regulator Submissions

Formalised Processes several RAs involved

One RA will sent a <List of Out-standing Issues, (Draft) Assessment Report, question or answer to inform about the composition, former decision etc.> to one or several other concerned RAs involved into the formalized process

At least within the EU we have a number of well defined processes involving Member States in the role of Rapporteur, Co-Rapporteur, Peer Reviewing MS or Reference MS sending out draft documents on List of Out-Standing Issues, List of Questions Preliminary, Draft or Final Assessment Reports to other RAs (Member States and / or EMEA) to reach a consensus about those documents before sending them to the applicant. Therefore, answers might be sent back, but silence is possible and means consent (see below). In addition, several messages / correspondence can be exchanged bilateral between European RA (questions and answers about facts or as negotiation to reach a finally agreed position).

Several RAs will sent back their position to one applicant or / and all RAs involved during an authorisation procedure. Based on the case above the RAs involved may sent back their position to all RA involved and possibly to the applicant directly. In some procedures the applicant will receive the final position from the one RA leading the procedure. After the agreement on the pivotal language product information texts during the translation phase RAs a bilateral exchange about their linguistic comments between applicant and RA will occur. So several RAs will sent back comments to one applicant.

Formalised processes one RA involved

One RA will sent a <request, questionnaire, decision> to one or plenty of Marketing Authorisation Holders Based on a risk situation the RA will sent a questionnaire requesting more detailed information about the risk or will sent the request for updated product information texts or will sent the decision on withdrawal from the market to all Marketing Authorisation Holders of medicinal products with the component in question.

Non-formalised process

One RA will sent information about a former decision, a risk situation etc. to one or several other RA not within a formalised process For example, the information about the withdrawal of a marketing authorization can be announced publicly but can also be sent directly to all MS.