The Decentralised Procedure is a coordinated European marketing authorisation route for a medicinal product that is not authorised in any Member State. The application is submitted simultaneously in a proposed Reference Member State and in the other Concerned Member States. The Reference Member State prepares the initial assessment, on the basis of which the participating states each grant national marketing authorisations. <\/p>\n
The Decentralised Procedure, usually referred to as DCP, is intended for medicinal products without an existing marketing authorisation in any Member State. The applicant selects the states in which it seeks authorisation and proposes one of them as the Reference Member State. The remaining participating states are Concerned Member States. All receive the same scientific basis for their decisions within the procedure. <\/p>\n
The Reference Member State conducts the first scientific assessment of the dossier and prepares a draft assessment report. The Concerned Member States review this assessment, raise questions or submit reasoned objections. If the outstanding issues can be resolved, each participating state grants its own national marketing authorisation. The result is therefore not a central EU authorisation, but a bundle of harmonised national authorisations. <\/p>\n
The DCP may be used where no centralised procedure is required and the applicant does not use that route. It is therefore an important pathway for medicinal products intended to be introduced in several Member States without having been authorised in any one state beforehand. The choice of Reference Member State should take into account its experience with the product class, the dossier and the proposed timetable. <\/p>\n
The procedure combines joint scientific work with the responsibility of national authorities for the actual authorisation. The Reference Member State coordinates the assessment and exchange; the Concerned Member States do not accept the assessment uncritically, but review it as well. In the event of disagreements, European coordination mechanisms are available. The aim is a consistent decision on the assessment report, SmPC, labelling and package leaflet. <\/p>\n
Directive 2001\/83\/EC sets fixed timelines for this process. As no authorisation yet exists, under Article 28(3) the Reference Member State, within 120 days of receipt of a valid application, prepares the draft assessment report as well as drafts of the SmPC, labelling and package leaflet and forwards them to the Concerned Member States and the applicant. Under paragraph 4, these approve the documents within 90 days; once consensus is established, the Reference Member State closes the procedure and each participating state issues its national decision within 30 days. <\/p>\n
If a Member State cannot agree within this period due to a potential serious risk to public health, it sets out its reasons in detail under Article 29, and the points of dispute are referred to the Coordination Group. If the participating states reach agreement there within 60 days, the procedure is concluded as usual. Otherwise, the European Medicines Agency is involved and the arbitration procedure under Articles 32 to 34 is carried out; states that have agreed may, at the applicant\u2019s request, authorise the medicinal product earlier. <\/p>\n
For applicants, the procedure is only robust if the dossier, product information and responses remain consistent across all states. National requirements, such as language or administrative documents, may need to be addressed in addition. The DCP therefore does not replace country-specific implementation work, but it creates a coordinated regulatory core for the markets applied for simultaneously. <\/p>\n
The Decentralised Procedure must be distinguished from the Mutual Recognition Procedure. The MRP requires that the medicinal product is already nationally authorised in at least one Member State; that authority then acts as the Reference Member State. In the DCP, this initial authorisation does not exist. Here, the Reference Member State first prepares the initial assessment for all participating states. <\/p>\n
Likewise, the Decentralised Procedure is not a decentralised clinical trial. Decentralised clinical trials describe a study design using, for example, digital methods, remote visits or local measures for participants. The DCP, by contrast, is an authorisation procedure between the applicant and the medicines authorities. The entry on decentralised clinical trials therefore addresses the conduct of clinical research, not the route to a marketing authorisation. <\/p>\n
The almost identical word formation should not obscure the different regulatory objectives. In the DCP, the focus is the regulatory assessment of a marketing authorisation dossier and the coordination of multiple national decisions. In decentralised clinical trials, the focus is participant protection, data collection and the practical organisation of trials. The terms therefore belong to different phases and legal frameworks of medicinal product development. <\/p>\n
The later requirements of the DCP feed back into clinical development because the data must be presented coherently for all Member States applied for. Relevant study populations, endpoints, safety data and the comparability of investigational medicinal products should therefore be integrated early into an overarching marketing authorisation strategy. Particular attention is required for consistent documentation and for aligning the clinical evidence with the SmPC and risk management. <\/p>\n
Full-service CROs such as Mediconomics support the planning of multinational studies, the selection and management of trial sites, monitoring, data management, biostatistics and medical writing. They can translate regulatory requirements from the target countries into workflows and ensure that clinical reports, safety data and responses to authority questions fit together coherently in a DCP dossier. <\/p>\n
When is the Decentralised Procedure possible?<\/strong><\/p>\n It may be considered for a medicinal product that is not yet authorised in any Member State and does not have to be, or is not intended to be, authorised via the centralised procedure.<\/p>\n Does the Reference Member State grant an EU marketing authorisation?<\/strong><\/p>\n No. It conducts the assessment. After successful alignment, the participating states each grant national marketing authorisations. <\/p>\n Is a DCP a decentralised clinical trial?<\/strong><\/p>\n No. The DCP is a medicinal product marketing authorisation pathway; decentralised clinical trials are a form of study organisation and conduct. <\/p>\n The Decentralised Procedure is a coordinated European marketing authorisation route for a medicinal product that is not authorised in any Member State. The application is submitted simultaneously in a proposed Reference Member State and in the other Concerned Member States. The Reference Member State prepares the initial assessment, on the basis of which the participating […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[20],"class_list":["post-7830","glossary","type-glossary","status-publish","hentry","glossary-cat-regulatory-affairs-zulassung"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7830","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7830\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7830"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7830"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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