Talk:RPS R2 Iteration 2 - Multi-Regulator Submissions

To understand whether the requirements can be addressed adequately it might be necessary to explain the more or less complex process of the so called decentralised procedure (DCP) for authorising human medicinal products in Europe.

1. One applicant (RI Company A) will submit one dossier / submission / submission unit to more than one Regulating Authority (RA A, RA B, RA C etc.). The RI Company A may be technically supported by an affiliate, e.g RI Company AA, taking perhaps the role of future Marketing Authorisation Holder. But this is not necessarily the case.

2. The first phase of assessment is the validation. The Reference Member State (RMS), e.g. RA B, will lead the process and will monitor whether other RA A or RA C (so called Concerned Member States, CMS) will have concerns due to an invalid application. This status will be sent by each RA back to RI Company A.. Responses (new submission unit) will be sent to the respective RA answering the validation questions. This is a bi-directional communication.

3. Once all validation issues have been solved, the RMS (RA B) will start the procedure. A communication to all concerned RA (e.g. RA A and RA C) as well as to the RI Company A. A multi regulator and one RI Company A communication.

4. The preliminary assessment will again be sent by RA B (RMS) to all concerned Member States (CMS: RA A and RA C) and RI Company A. RA A and RA C will sent comments to all CMS and RMS and RI Company A. Again a multi regulator and one RI Company A communication.

5. RI Company A will prepare their response document. The submission <response document> will be sent to all RA. The step 4 will be repeated afterwards. There may happen two or three more iterations, but they all will follow the same principle of a multi regulator and one RI Company A communication.

6. Finally the harmonised text for product information and the “end of procedure letter” will be sent by the RMS RA B to all CMS (RA A and RA C) as well as to RI Company A.

7. Next step is the national translations of the harmonised product information text documents. This will be a bi-lateral communication between RI Company A or their affiliates AA and AC and the respective RA A or RA C.

Following requirements need to be supported:

1. One RA must be able to sent a set of documents to the attention of a number of other RAs and the sender of the submission where these regulatory documents relate to. The status of the procedure might change. The regulatory documents will have a status of <preliminary; draft; final>.

2. All RAs must be able to sent a set of documents to the attention of all concerned RAs and the sender of the submission where the regulatory documents relate to as an reaction of / comment on those set of documents. The status of the procedure will not change. The comments will have the status <final> in every case.

3. A RI Company must be able to submit a submission unit to one or many RAs. The initial submission will not have a relationship to a former submission. Any further submission will be a related submission to the former within the same regulatory activity / procedure (e.g. new application, variation, renewal, commitment). In all cases a second relationship to the regulatory “response” exists and must be mentioned.

To my understanding these requirements will cover the needs for all procedures in the same way and – assumably – for all regulated products, not only human medicinal products. Please add comments or feel free to correct me.