Fixe-dose combination, combination pack, co-administration: when are separate RPIs needed?

A combination product has separate RPIs.
When making a submission in IRIS do I have to make a separate submission for each RPI?

There are three possibilities:
1) fixed dose combination: must be a single RPI
2) combination pack (two or more separate formulations in different immediate containers, but co-packaged in the same presentation): must be a single RPI
3) co-administration treatment: (two separate products, in different formulations and separate presentations, but administered together in the same clinical trial): these must be separate RPIs. For Orphan designations and Paediatric Investigation plans, only one RPI should be provided per application, and separate submissions should be done for the two products (if desired). For Scientific Advice, it is necessary to specify the main RPI, but it is possible to mention separate RPIs for co-administration product(s) in the submission; these RPIs must also be "owned" by the applicant.

Thank you this is useful, so for a combination product (two RPIs), when making a submission for a Paediatric Investigational Plan, would this be one submission or two (co packaged in the same presentation, different immediate containers), they are administered one after the other in the clinical trial but not together.  

Dear Daniel Sargon, what you describe is a "combination pack". In such case, a single RPI is sufficient. However, please be aware that combination packs are only exceptionally acceptable in the centralised procedures and are subjected to special rules. Please see section 1.11 of European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. If the Request for Acceptability is not approved, this may have consequences on the RPI, which could be split, and for any related Regulatory Entitlement.