In European pharmaceutical law, a local representative is the representative designated by the holder of a marketing authorization in the respective Member State. Directive 2001\/83\/EC refers to them as the representative of the marketing authorization holder and explains that this person is usually called local representative. The designation does not transfer the legal responsibility of the marketing authorization holder.<\/p>\n
Directive 2001\/83\/EC defines the representative of the marketing authorization holder as the person designated by the marketing authorization holder to represent him in the Member State concerned. The role is thus tied to an already authorized human medicinal product and to the marketing authorization holder. It is not the designation for every local service or contact function in the context of a clinical trial.<\/p>\n
The marketing authorization holder remains responsible for the marketing of the medicinal product. The designation of a local representative does not change this responsibility. Which tasks the representative actually performs, for example communication in the Member State or support in national activities, results from the designation, the applicable law and the respective agreements. The definition itself does not imply a transfer of all legal obligations and no relief for the marketing authorization holder.<\/p>\n
The authorized representative according to Article 11 of Regulation (EU) 2017\/745, also called Bevollm\u00e4chtigter in German, is a different role of medical device law. A manufacturer of medical devices who is not established in the Union must designate a single authorized representative in the Union. This person performs specified tasks on behalf of the manufacturer and must be available to the competent authorities. Their designation is therefore linked to the manufacturer’s establishment outside the Union and to the conformity assessment of medical devices.<\/p>\n
The MDR authorized representative is not the local representative of a pharmaceutical marketing authorization holder. The terms may appear similar in general parlance, but refer to different products, legal acts and chains of responsibility. For a medical device, it is decisive whether the requirements of Article 11 MDR are met. For a human medicinal product, the local representative is based on the definition of Directive 2001\/83\/EC. A person can contractually offer multiple services, but does not automatically act in both legal roles as a result.<\/p>\n
A further distinction must be made with the legal representative of the sponsor of a clinical trial according to Regulation (EU) No 536\/2014. If a sponsor is not established in the Union, they must designate a legal representative in the Union. This representative ensures compliance with the sponsor’s obligations under the regulation. The role thus concerns the sponsor and the conduct of a clinical trial, not the marketing authorization holder of an already authorized medicinal product.<\/p>\n
The legal representative of the sponsor is also not to be equated with the MDR authorized representative. The Clinical Trials Regulation regulates research processes involving investigational medicinal products, while the MDR organizes manufacturer obligations for medical devices. The local representative under pharmaceutical law, on the other hand, stands for the representation of the marketing authorization holder in the Member State. The correct classification determines which person is to be designated, what duties they bear and which authority or communication interface is concerned.<\/p>\n
In cross-border projects, confusion arises above all when the marketing authorization holder, manufacturer and sponsor are not the same legal entity. A role matrix should therefore indicate the product type, legal act, establishment of the responsible organization, subject of the designation and specific communication channels. It must also make it clear whether it involves a marketed medicinal product, a medical device or a clinical trial. Contracts and contact data alone do not replace an examination of the legal role description.<\/p>\n
The local representative can administratively facilitate local communication, but within the pharmaceutical role remains bound by the designation by the marketing authorization holder. In the event of changes to the marketing authorization holder, product responsibility or the markets concerned, the designation should be reviewed and the product information checked for current contact data. This clear separation facilitates inspections, official inquiries and the handling of safety or quality information.<\/p>\n
In clinical trials, the correct role designation is essential because sponsor, marketing authorization holder and medical device manufacturer can have different obligations. Particularly in combined development programs, the designation of a local representative must not be treated as a substitute for a legal representative of the sponsor according to Regulation (EU) No 536\/2014. Authorities and trial sites need clear contact persons, but the operational contact function must match the respectively required legal role.<\/p>\n
Full-service CROs such as Mediconomics support the creation of role and communication plans, regulatory affairs management, preparation of trial documents, trial site management, monitoring, safety processes and the documentation of official communication. In doing so, they can transparently structure the interfaces between sponsor, marketing authorization holder, legal representative and other service providers, without replacing the legal responsibility of the respectively designated party.<\/p>\n
Does the local representative bear the responsibility of the marketing authorization holder?<\/strong><\/p>\n No. Directive 2001\/83\/EC makes it clear that the designation of a representative does not relieve the marketing authorization holder of their legal responsibility.<\/p>\n Is the local representative the MDR authorized representative?<\/strong><\/p>\n No. The MDR authorized representative represents a medical device manufacturer established outside the Union according to Article 11 MDR.<\/p>\n Can the local representative replace the legal representative of a sponsor?<\/strong><\/p>\n No. The legal representative according to the Clinical Trials Regulation concerns the sponsor established outside the Union and has a different legal purpose.<\/p>\n In European pharmaceutical law, a local representative is the representative designated by the holder of a marketing authorization in the respective Member State. Directive 2001\/83\/EC refers to them as the representative of the marketing authorization holder and explains that this person is usually called local representative. The designation does not transfer the legal responsibility of […]<\/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":[],"class_list":["post-6681","glossary","type-glossary","status-publish","hentry"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6681","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":1,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6681\/revisions"}],"predecessor-version":[{"id":7469,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6681\/revisions\/7469"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6681"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6681"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory references<\/h2>\n
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