V.B.4. RMP part I “Product(s) overview”

This should provide the administrative information on the RMP and an overview of the product(s). The information presented should be current and accurate in relation to the ongoing application as it is anticipated to appear in the marketing authorisation.

The information should include: Active substance information:

• active substance(s);
• pharmacotherapeutic group(s) (ATC code);
• name of the:
  • marketing authorisation applicant – for initial marketing authorisation applications;

or

• • marketing authorisation holder – for RMPs submitted with post-authorisation procedures;
• for mutual recognition/ decentralised procedures applications: the name(s) of the expected future marketing authorisation holder(s) in the reference Member State, if known at the time of the application;
• medicinal product(s) to which this RMP refers.
• authorisation procedure(s) (centralised, mutual recognition, decentralised, national);
• invented name(s) in the European Economic Area (EEA);
• brief description of the product including:
  • chemical class;
  • summary of mode of action;
  • important information about its composition (e.g. origin of active substance of biologicals, relevant adjuvants or residues for vaccines);

• eCTD link to the proposed product information, as appropriate;
• indications: approved and proposed (if RMP submitted with an extension/restriction of indication);
• dosage (summary information – only related to main population; not a duplication of SmPC section 4.2);
• pharmaceutical forms and strengths;
• whether the product is subject to additional monitoring in the EU (at initial marketing authorisation application conclusion or with RMP updates).