DCP Archives | European Regulatory Affairs Specialists

Back to Basics – The Decentralised Procedure (DCP)

17th June 2024

We continue our back to basics series for those who may be new to Regulatory Affairs (If you need help with the jargon visit our A-Z Glossary of Regulatory abbreviations).

In the EU, there are two different procedures available to apply for a marketing authorisation application (MAA) for the same medicinal product in more than one Member State at a time:

the Decentralised Procedure (DCP)
the Mutual Recognition Procedure (MRP).

This Article focuses the Decentralised Procedure (DCP).

The DCP is only applicable if no marketing authorisation has previously existed in the EU/EEA, as per Directive 2004/27/EC and if an identical dossier is submitted simultaneously in all selected Member States.

To prepare for a DCP submission:

Establish a Reference Member State (RMS).
- One Member State called the RMS will be selected by the Applicant to lead the assessment of the MAA.
- To do this, complete a “Request for RMS in a Decentralised Procedure” Form and send it to your preferred RMS at least 2 months before the planned date of submission of the marketing authorisation application.
- Only one RMS request can be submitted at a time. It is advisable to establish an RMS as soon as possible as DCP slots get booked up very quickly.
- The guidance, Decentralised Procedure – Requests to act as RMS, provides an overview of the booking system & links to the various National Competent Authorities who act as RMS
Prepare a dossier in accordance with the current legislation and EU guidelines.
Check that the requirements for submissions for new Marketing Authorisations are met for the various Member States to avoid validation comments (at Day -14) and also for any additional requirements to determine if any wet/original/notarised signatures are required
Ensure the correct fee amount has been paid.
Check the dossier for common validation issues raised by the RMS and the CMSs in DCP procedures to prevent them being requested during the validation of your application.
The applicant then simultaneously submits an identical dossier to the RMS and all CMS by the agreed submission date booked with RMS.
The application will be submitted via CESP portal, according to eCTD Guidelines, & then applicant will send any hard copies/original documents required by various Member States as per national requirements.

Assessment Reports (Day 70, D120, Day160, D210):
- The RMS is responsible for preparing an Assessment Report (AR) which summarises the dossier presented by the applicant. The AR characterises and critically evaluates the medicinal product concerned with regard to its quality, safety and efficacy.
- This AR will be made available to all Concerned Member States (CMS) together with SmPC, PL and labelling by the RMS and forms the basis for the evaluation by CMS.
- In the case a Member State concerned by the procedure is unable to accept the AR or draft AR on the basis of a “potential serious risk to public health”, the application will be sent to the CHMP for arbitration.
End of Procedure can be in 90-210 days after validation phase is closed.
It is advisable to plan the national translations in time. It is critical that the translation service used is reliable and technically competent to translate medical text.
Seven calendar days after end of procedure the Applicant should send high quality national translations of SmPC, PL and labelling and mock-ups to individual CMSs.
There is usually a 30-day National assessment before of the granting of the MA, however the timelines differ in each MS.
If consensus is not reached at the end of the procedure, a pre-arbitration (CMDH) and arbitration (CHMP) phase may take place.

We can help you to do all of the above or even better we can do it for you – to save you time and money let our experienced team take the pain out of it for you.

Written by

Marian Winder

Brexit… it’s getting closer…

16th January 2019

Ivowen have provided some practical guidance and documents below, which may help you prepare for Brexit for products authorised by the DCP and MRP procedures.

Take our Brexit quiz to see if you are ready.

Do you still need to change your MAH(s) in any of the EU Member States because of Brexit?

If so, refer to the following updated guidance issued in January 2019 which details the documentation and requirements to submit a Marketing Authorisation Holder transfer:

CMDh guidance on Brexit, Jan 2019

If you need any clarification or support to complete a Marketing Authorisation Holder transfer, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.

Is the UK your current RMS?

If so, you need to initiate an RMS switch as soon as possible. The guidance issued in July 2018 along with the template issued in June 2018 is required to complete this process. This template needs to be completed and sent to a specific e-mail address at the proposed new RMS. The list of contacts points to send the completed template is provided below:

Guidance:

CMDh guidance on changing RMS

Template for RMS change

List of RMS contacts can be found in the excel spread sheet in the link Contact Points, which can be found here:

MS contact points

If you need any clarification or support a RMS switch, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.

Do you need to change your UK batch release site, etc., if it currently within the UK?

If so, you can refer to the updated guidance document issued in December 2018, which provides information on the type of variation that is required to change functions such as batch release site(s), QC testing site(s), packaging site(s), deletion of site(s) for batch release and changes to the QP for Pharmacovigilance (QPPV) and PSMF where these functions still reside within the UK:

CMDh practical guidance for Brexit & DCP/MRP

If you need any clarification or support to complete variations to support changes needed as a result of Brexit, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.

Do you supply product to Cyprus?

If so, the Cypriot Competent Authority has issued a newsletter to Stakeholders on the 14 January 2019 which lists 105 products authorised via an exceptional marketing authorisation affected by Brexit which are considered critical. The Drugs Council in Cyprus recommends that pharmaceutical companies register these products via an exceptional marketing authorisation using another reference state other that the UK.

If you need any clarification or support to complete an Exceptional Marketing Authorisation to avoid no supply of these critical products on the Cypriot market, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.

Written by Marian Winder

2018 02 eSubmission Roadmap final slide v2.0 Feb 2017.

eCTD is coming…

7th February 2018

All good (and bad) things, must come to an end. The NeeS (Non-eCTD electronic submissions) submission format, will no longer be accepted for any Marketing Authorisation applications (MAAs) or submissions in MRP or DCP from 1^st January 2018. Centralised Procedure (CP) submissions have been mandatory in eCTD since 2010. All new MAAs submitted using either the Decentralised Procedure (DCP) or the Mutual Recognition Procedure (MRP), have had to be in eCTD format since the middle of 2015. As of 1^st January 2018, all MRP submissions must be submitted in eCTD. Therefore, if your application/product is not in eCTD format and you need to submit an MRP variation, you have to transition to eCTD for the next submission.

What is the timetable?

Starting from 1^st January 2018 it is mandatory for all CP, DCP and MRP submissions to be in eCTD format. For national procedures (NP) the deadline is currently set at 1^st July 2018 for new MAAs.

Following quickly behind these requirements, all submissions in CP, DCP, MRP and NP will have to be in eCTD from January 2019. At this stage, the exact date is not confirmed, but you need to be ready.

We can help…

Ivowen can create a baseline dossier for any submission based on currently approved information. Currently, baselines are not mandatory but some Member States are requesting them. In addition, it is best practise to get your dossier into a baseline for all future submissions.

Ivowen can transition your application to eCTD at the next regulatory activity (variation, renewal, Article 61.3, etc.).

Ivowen can manage the eCTD lifecycle for you in-house and provide you with fully valid, submission-ready sequences.

Contact us for more information or for help with building your eCTD now.

New EU MA Applications will require eCTD Submissions by Q3 2015

21st April 2015

Marketing Authorisation Applications for human use submitted using the Decentralised Procedure (DCP) will need to be provided electronically as eCTD by Q3 2015. Submission in eCTD for Mutual Recognition Procedures (MRP) will also be required by the start of 2017, and finally National Procedures by the start of 2018. eCTD is already required for Centralised Procedures.

The EMA also announced at the end of 2014 that Veterinary Drugs must be filed electronically starting in 2016 for CP/DCP, and all submissions by 2017 by VNeeS (Veterinary Non-eCTD Electronic Submissions).

Plans are also underway to replace the Microsoft Word-formatted application form with the eAF (Electronic Application Form) and the deadline will be Q1 2016. Further detailed guidance can be found under the following links:

European Medicines Regulatory Network eSubmission Roadmap

eSubmission Roadmap flow chart

Ivowen are fully eCTD-ready and compliant. Please contact us for more information and for support of your electronic applications.

Written by Laura Oakey

Points to note on the eAF

3rd February 2016

General

The eAF is mandatory for all procedures from 01/01/2016 (CP, MR, DC, National in eCTD/NeeS/Paper). However, Presubmission Meeting Requests, Article 61(3) & MAT forms remain the outside scope and can be submitted as paper or PDFs.

Please contact us if you require any assistance with any of the forms or any advice on any of the above procedures. For your convenience, the following is a summary of the important aspects of using the eAF.

Always check the e-submission website for the latest version of the eAF (http://esubmission.ema.europa.eu/eaf/)
- Word versions will be removed from Notice to Applicants in January 2016
- After 11/01/2016 only version 1.19 will be acceptable for new procedures
- eAF should be printed for Paper submissions
- Version 1.20 is planned for April 2016 (unless hotfixes are required before then)
- It is important to note, and welcome news, that there is no need to update to a newer version of the eAF in the middle of a procedure
- See the guidelines (update planned in January 2016) and release notes (lists the changes made to newer versions) for further information
- In line with the proposed move towards a Single Submission Portal (SSP) in place of CESP and the EMA Gateway, there are plans to reformat the eAF into a data capture system that can be submitted directly through CESP. This is in a very preliminary stage.

Technical queries should be sent to EMA Service Desk via IT service portal (login)
- Q&A documents should be consulted first
- Fast web view warning in the dossier validation report for the eAF can be ignored

Procedural queries should be directed to the National Competent Authority (NCA) (and response sent to EMA Service Desk). Complicated queries should be sent to both parties.

Webinars are available for the NCAs (to try to reduce the requests for MS specific national requirements)

Using the eAF

Technical Validation of the form (internal):
- Once signature is added and form validated, it is now locked. Locked forms cannot be amended. Therefore, the signature should be the last thing added to the form.
- Always keep a copy of the unlocked form so that amendments can be made (e.g. during preparation or for requests from NCA for updated forms during a procedure)
- Do not use bookmarks as these may cause invalidation issues

Annexes to the form should be filed separately in module 1.2 (do not use the PDF function to insert them into the eAF)
- Form should be named; cc-form-eaf-var
- Annex should be named; cc-form-annex-var (e.g. cc-form-5-19 or cc-form-proofpayment)

Electronic signature can be an image of a real signature (e.g. jpeg file – a scanned copy of wet signature. This however is not an electronic signature and is only used to close/lock the form) or can also be a line of text which states that signature is on file internally (e.g. “This form was authorised following company policies by Majella Ryan, Regulatory Affairs Manager of Ivowen with authorisation to sign. The signature is on file”)
- The eAF does not accommodate multiple signatures at present. A separate annex should be provided if multiple signatures are mandatory for a particular NCA. Multiple name sections will be incorporated into version 2.0 but no mention of whether multiple signatures will also be accommodated.
- The signature should be provided by the responsible MAH or can be provided by any authorised deputy
- Please also check national requirements for signatures.
- See Q&A guidance for further information

Workaround solutions (e.g. Annex B for multiple MAH or Product names) should always be mentioned in your cover letter
- Some unforeseen variations (category z) are not adequately accounted for yet. Details of such changes should be outlined in the scope section of form and in the cover letter.
- Duplicate sections only if products differ with regard to API or Pharmaceutical Form
- Annex A or Annex B can be used for multiple MAH or Product names. Click on Annex A/B button in form and add the annex as a separate file in Module 1.2
- Detailed instructions on how to use workaround solutions is available in the eAF Q&A document and the eAF Technical Guidance documents – both are published on the eAF webpage – if you need more advice contact EMA Service Desk.

No translations of the eAF are available, nor should they be requested.

Drug substances can be entered from controlled vocabulary lists or free text, and these each have different EV codes.
- The focus should be on using substance, product, organisation and referential (SPOR)

Request for New Terms:
- EUDRACT terminology used
- Use eAF Term Request form to request new terms
- Send it to mdms@ema.europa.eu only
- Response should be received within 5 working days

Strikethrough text function is not available in eAF but text can be copied and pasted (with text struck through) from Word or Outlook

In MRP/DCP one common application form is highly recommended, one per pharmaceutical form or strength for all member states in case of new MAA and one eAF for all involved products for all member states in case of variations and renewals.

Written by Majella Ryan

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