The centralised procedure is an EU authorisation pathway where a medicinal product can be assessed with a single application and authorised with a single decision for the entire European Union. The scientific assessment is carried out by the European Medicines Agency, while the European Commission grants the legally binding marketing authorisation. For medicinal products within its scope, this pathway replaces individual national marketing authorisation applications. <\/p>\n
In the centralised procedure, the applicant submits the marketing authorisation application to the EMA. The Committee for Medicinal Products for Human Use assesses quality, safety, and efficacy and issues a scientific opinion. Based on this, the European Commission decides on the marketing authorisation. The EMA therefore recommends, but does not itself grant, the authorisation. <\/p>\n
The Commission’s decision applies in all member states of the European Union and in the European Economic Area. It thus creates a uniform authorisation status and harmonised product information. The approved text of the summary of product characteristics, package leaflet, and labelling is part of the outcome; different national scientific assessments of the same centrally authorised medicinal product do not take its place. <\/p>\n
Annex I of Regulation (EC) No 726\/2004 specifies which medicinal products must be authorised by the Union. These include medicinal products developed using biotechnological processes, namely recombinant DNA technology, controlled expression of genes for biologically active proteins in prokaryotes and eukaryotes, or hybridoma and monoclonal antibody methods. Also covered are advanced therapy medicinal products within the meaning of Regulation (EC) No 1394\/2007, products designated as orphan medicinal products, and human medicinal products containing a new active substance whose therapeutic indication is the treatment of acquired immunodeficiency syndrome, cancer, neurodegenerative diseases, diabetes, autoimmune diseases and other immune dysfunctions, or viral diseases. <\/p>\n
Outside this Annex, the Union may grant an authorisation under Article 3(2) if the medicinal product contains an active substance not yet authorised in the Union on 20 May 2004, or if the applicant demonstrates that it represents a significant therapeutic, scientific, or technical innovation, or that authorisation at Union level is in the interest of patients’ health. Conversely, a generic of a reference medicinal product authorised by the Union may be authorised nationally under the conditions specified in Article 3(3). <\/p>\n
A central application bundles the marketing authorisation dossier and the scientific assessment at EU level. The Committee works with rapporteurs, expert working groups, and, if necessary, other scientific committees. Questions regarding quality, preclinical and clinical data, benefit-risk balance, or risk management are addressed within this assessment. The Commission then takes the legal decision in an act binding on all states. <\/p>\n
Uniformity does not mean that no national tasks remain after authorisation. Member States are involved, for example, in market surveillance, pharmacovigilance, and reimbursement. Actual availability may also depend on national decisions regarding price, reimbursement, supply, and distribution. The authorisation pathway therefore concerns the marketing authorisation, not all subsequent decisions in the healthcare system. <\/p>\n
The centralised procedure is not the only pathway for medicinal product authorisation in Europe. Medicinal products outside its mandatory or chosen scope can be authorised via the national procedure, the decentralised procedure, or the mutual recognition procedure. These pathways lead to national authorisations in the respective participating states, even if their assessments are coordinated in the DCP or MRP. <\/p>\n
In the decentralised procedure, a medicinal product not yet authorised in any Member State is applied for simultaneously in several states. In contrast, the mutual recognition procedure involves an existing national authorisation that other states are to recognise. Both pathways work with a reference Member State and concerned Member States. Such roles do not exist in the centralised procedure because the EMA assessment and the Commission’s decision form the Union-wide framework. <\/p>\n
The choice of procedure is therefore a strategic decision before submission, not a subsequent formality. It determines which authority receives the application, how the scientific assessment is organised, and what type of authorisation results. A single application in the centralised procedure also does not mean that national requirements outside of authorisation, such as for reimbursement, dispensing, or use, would be harmonised. <\/p>\n
For clinical development programs, the targeted centralised authorisation pathway determines early on what evidence, product information, and risk management plan must be brought together in a coherent dossier. Study protocols, endpoints, comparator therapies, safety data, and the description of the target population should therefore be planned to support the subsequent EU-wide benefit-risk assessment. Especially for complex or innovative products, the traceability of transitions from development, manufacturing, and clinical evidence is crucial. <\/p>\n
Full-service CROs like Mediconomics support regulatory development planning, preparation of scientific advice, clinical project management, monitoring, data management, biostatistics, and medical writing. They also help to coordinate clinical reports, safety evaluations, and dossier components so that queries from the authorisation assessment can be answered based on robust study data. <\/p>\n
Who grants authorisation in the centralised procedure?<\/strong><\/p>\n The European Commission grants the legally binding marketing authorisation based on the EMA’s scientific opinion.<\/p>\n Does a centralised authorisation automatically apply in Germany?<\/strong><\/p>\n Yes. The Commission’s decision applies in all EU Member States and additionally in the EEA states of Iceland, Liechtenstein, and Norway. <\/p>\n Can every medicinal product be centrally authorised?<\/strong><\/p>\n No. For certain categories, the procedure is mandatory; for other medicinal products, it is only possible under the specified conditions. Otherwise, national or coordinated national pathways may be considered. <\/p>\n The centralised procedure is an EU authorisation pathway where a medicinal product can be assessed with a single application and authorised with a single decision for the entire European Union. The scientific assessment is carried out by the European Medicines Agency, while the European Commission grants the legally binding marketing authorisation. For medicinal products within […]<\/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-7841","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\/7841","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\/7841\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7841"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7841"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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