RPS R2 Iteration 2 - Multi-Regulator Submissions

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Regulated Product Submissions | Multi-Regulator Submissions

==Multiple Regulator Submissions== UPDATED

Storyboard: Multi-Regulator submission and Withdraw of the Application from one MS

Initial Submission

Cure-All Pharmaceuticals has submitted a marketing application via the Decentralised Procedure to Germany (Reference Member State) plus 15 other Concerned Member States (including the UK) for the product PainVanish 100mg tablets to be marketed in all countries. The initial application included the following information

1. Country and Language specific documents

• All labelling documents (Summary of Product Characteristics, Package Leaflet, etc.) - Module 1.3.1

2. Country specific documents

• Cover Letters and attachments - Module 1.0

• Application Forms and attachments - Module 1.2

• Mockups - Module 1.3.2

• Specimens - Module 1.3.3

• Product Information Already Approved in Member States - Module 1.3.5

• Additional country specific requirements documents - Additional Data

3. Documents common to all countries

• Information about documents in braille - Module 1.3.6

• Information about the experts - Modules 1.4.1, 1.4.2 and 1.4.3

• Specific requirements for different application types - Modules 1.5.1 to 1.5.5

• The environmental risk assessment - Module 1.6

• Information about orphan drug status - Module 1.7.1 and 1.7.2

• Information about pharmacovigilance - Modules 1.8.1 and 1.8.2

• Information about clinical trials - Module 1.9

• Information about paediatrics - Module 1.10

• All content in Modules 2, 3, 4 and 5 is considered common for all countries

Review of the Submission

Member States review the submission and provide initial feedback to the applicant. There are several steps to consider:

1. The RMS will prepare a preliminary assessment report. This will be sent to all CMS for commenting and to the applicant for information.

2. The CMS will sent their comments to the RMS, all other CMS and the applicant.

A clock-off period is started by the RMS meanwhile the applicant is active:

3. The applicant will prepare the response document.

4. This draft response will be checked by the RMS, and

5. then be sent to all CMS and RMS for information.

The RMS will re-start the procedure.

6. The draft Assessment Report will be the next step. Any withdrawal must be done before that day).

Cure-All Pharmaceuticals assess the comments and come to the conclusion that the issues being raised by the UK could jeopardise approval in other member states and decides that they will withdraw UK as part of the procedure before restart.

Withdrawal Submission

Cure-All Pharmaceuticals sends a submission unit to the RMS and CMS to indicate that the UK is being withdrawn from the procedure.

Subsequent Submissions

The procedure progresses as normal, with Germany as Reference Member States plus the 14 other Concerned Member States, now excluding the UK.

Storyboard: Repeat use (add other CMS to an application)

Initial Submission

Cure-All Pharmaceuticals compiles all variations made from first authorisation up to planned start of repeat use. The submission will contain all former submission units and will be sent to the RMS as well (serving as a new baseline so to say).

Review of the Submission

The new CMS have to accept in principal the current status. Comments the new CMS may have can be addressed during a new variation just to take on board their concerns and to align old CMS and new CMS. (Note: not sure whether this variation will need a relationship to the repeat use procedure.)

The "new" baseline at RMS will not get a "0000" but contains all data operated as "new".

Formalised Processes several RAs involved (extracted from the scenario above)

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.

Multi-Regulator without initial submission unit

Note - need to discuss if this should be handled with content for this iteration.

Regulator A sends a question to Company A. This is a submission unit not sent to any other regulator.

Company A responds to the question from Regulator A. However, they also think that this is also information that every other regulator should receive so they send it to them as well (Regulators B-Z). In the current eCTD world there is no way for Regulators B-Z to see the content sent by Regulator A to Company A. So, unless Company A copies the content of the question from Regulator A into their response, then for Regulators B-Z there could be an answer to a non-existent question (note: there is no central repository for the MRP/DCP procedures in the EU, so every Regulator receives the submission unit separately). This may be a business process issue, much more than a technical one.