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Posted Fri, 10 Jan 2025 12:04:25 GMT by Victor Cagérus Mr
In preparation of a PIP submission and Scientific Advice submission, should a new RPI be created for a combination product where each component already has an existing RPIs today? 
Posted Fri, 10 Jan 2025 17:20:21 GMT by Paolo Tomasi EMA
Yes. A fixed dose combination product is a different product from any of its components. 
Posted Tue, 14 Jan 2025 07:00:07 GMT by Victor Cagérus Mr
Can I create this RPI myself the normal way or do I need to send an email to request a form to create a "special RPI" as mentioned in the guidance below:

Note 2: if your RPI is not for a single medicinal product, but for a group of products or technology or methodology (as is often the case for Innovation Task Force (ITF) briefing meeting, for example, or occasionally for Scientific Advice / Qualification procedures), the steps below do not apply as the RPI needs to be created by EMA. In such cases you need to seek assistance by referring to Innovation in medicines (for ITF), or by writing to the Scientific Advice office directly, at ScientificAdvice@ema.europa.eu (for human Scientific Advice, Protocol Assistance, or Qualification Advice/Opinion) or VetScientificAdvice@ema.europa.eu (for veterinary scientific advice procedures). You will be sent a specific form to request one of these “special” RPIs.  8.3 Transfer a Research Product Identifier (RPI) 
Posted Tue, 14 Jan 2025 08:37:52 GMT by Paolo Tomasi EMA
For a fixed-dose combination (FDC) product, the RPI should be asked in the normal way, in the IRIS portal, simply adding two or more SMS substances in the submission request. "Special RPIs" are not intended for FDCs, they are intended to model situations in which an applicant is requesting an ITF briefing meeting, scientific advice or biomarker qualification procedure in instances where the request is not for a single medicinal product (single substance or FDC), but rather for a methodology, technology, or (for ITF) an initial pipeline of multiple substances/products where it is not known yet which one will be developed. 

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