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class="breadcrumb-item d-none d-md-block active" aria-current="page" >Access to documents</li></ol></nav></div></div></header><main id="main-content" class="main-content-wrapper" role="main" aria-label="Main content"><div class="container mt-3"><div class="row"><div class="col-12"><div data-drupal-messages-fallback class="hidden"></div><div id="block-ema-content-banner--2"><div class="node ema-general content-banner ema-general--content-banner mb-4-75 bcl-content-banner ema-light-blue"><div class="container px-0"><div class="row"><div class="col-12"><article class="bg-transparent border-0 card container"><div class="row"><div class="left-col col-12 col-md-3 col-lg-2"><div class="img-wrapper format-svg"><img src="https://www.ema.europa.eu/sites/default/files/2024-07/Document_magnify-glass_lines.svg" alt="icon document with lines and magnifying glass" class="card-img-top rounded-1" /></div></div><div class="right-col col-12 col-md-9 col-lg-10"><div class="card-body container"><div class="row"><div class="col"><div class="heading-title"><h1 class="content-banner-title card-title bcl-heading"><span>Access to documents</span></h1></div><div class="heading-actions align-self-stretch d-flex justify-content-end"><div class="action-bar"><div class="ema-social-media-share button"><script type="application/json">{"service":"share","version":"2.0","more":["email","linkedin","bluesky","facebook","whatsapp","blogger","digg","gmail","netvibes","pinterest","pocket","printfriendly","qzone","reddit","threads","tumblr","typepad","viadeo","weibo","yahoomail","yammer"],"selection":false,"stats":true,"target":"_blank"}</script></div></div></div><div class="card-content-block"><div class="card-content-wrapper"><div class="content"><div class="field string-long ema-general__field-ema-summary">In accordance with European Union (EU) law, the European Medicines Agency (EMA) is committed to ensuring the widest possible access to its documents following requests from the public. It is also committed to increasing its level of openness and transparency over its decision-making processes. </div></div></div><div class="d-flex flex-column flex-lg-row justify-content-between gap-3"><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-3 align-items-start"><span class="ema-bg-category badge rounded-pill badge-outline-primary" title="Corporate"><span class="label">Corporate</span></span></div></div></div></div></div></div></div></div></article></div></div></div></div></div></div><div class="col-12 "><div class="row"><div class="col-12"><div id="block-system-main-block" class="main-content"><article class="content-with-sidebar node ema-general ema-general--full container"><div class="row"><div class="bcl-sidebar col-md-3"><nav class="bcl-inpage-navigation position-sticky" id="bcl-inpage-navigation"><h2 class="mb-0 dropdown-toggle bcl-heading" aria-expanded="false" type="button" id="bcl-inpage-navigation-dropdown" data-bs-toggle="dropdown"> Page contents<svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#chevron-down"/></svg></h2><div class="dropdown-menu" role="navigation" aria-labelledby="bcl-inpage-navigation-dropdown"><ul class="nav nav-pills flex-column" ><li class="nav-item" ><a class="nav-link" href="#policy-on-access-to-documents-12177">Policy on access to documents</a></li><li class="nav-item" ><a class="nav-link" href="#who-can-request-access-to-documents-12178">Who can request access to documents</a></li><li class="nav-item" ><a class="nav-link" href="#how-to-submit-a-request-12179">How to submit a request</a></li><li class="nav-item" ><a class="nav-link" href="#definitions-used-in-access-to-documents-12180">Definitions used in access to documents</a></li><li class="nav-item" ><a class="nav-link" href="#public-documents-12181">Public documents</a></li><li class="nav-item" ><a class="nav-link" href="#policies-and-guidance-documents-9000">Policies and guidance documents</a></li><li class="nav-item" ><a class="nav-link" href="#public-consultation-documents-9001">Public consultation documents</a></li><li class="nav-item" ><a class="nav-link" href="#archive-9002">Archive</a></li><li class="nav-item" ><a class="nav-link" href="#related-content-18579">Related content</a></li></ul></div></nav></div><div class="col-md-9"><div class="ema-node-content-wrapper node-sections"><div class="item"><div id="ema-inpage-item-12176" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div class="ecl-editor"><p>At the same time, the Agency must guarantee that it continues to protect information held on individuals and the commercial interests of the organisations and individuals that it works with.</p><p>The Agency reserves the right to charge applicants for the <strong>cost</strong> of producing and sending copies of documents. This is in accordance with:</p><ul><li>Article 10 of <a href="http://www.europarl.europa.eu/RegData/PDF/r1049_en.pdf">Regulation (EC) No 1049/2001</a> of 30 May 2001 regarding public access to European Parliament, Council and Commission documents;</li><li>Section 6.1 of the Annex to EMA's <a xmlns:xlink="http://www.w3.org/1999/xlink" href="/en/documents/other/policy-43-european-medicines-agency-policy-access-documents_en.pdf" target="_blank" hreflang="en"><svg class="me-2-5 bi icon--s"><use xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"></use></svg>Policy 43: European Medicines Agency policy on access to documents</a>.</li></ul></div></div></div><div class="item"><div id="ema-inpage-item-12177" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div id="policy-on-access-to-documents-12177"><h2 class="mb-4 rounded-title"> Policy on access to documents </h2></div><div class="ecl-editor"><p>EMA's policy on access to documents describes the rules the Agency applies to grant access to the documents it holds on <strong>human and veterinary medicines</strong> and <strong>documents not related to medicines</strong>.</p><p>EMA revised the policy in October 2018 based on its experience implementing the policy since it was introduced in 2010. The revisions update the provisions for medicines-related documents and also extend the policy's scope to documents that are not related to medicines:</p><ul><li><a xmlns:xlink="http://www.w3.org/1999/xlink" href="/en/documents/other/policy-43-european-medicines-agency-policy-access-documents_en.pdf" target="_blank" hreflang="en"><svg class="me-2-5 bi icon--s"><use xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"></use></svg>Policy 43: European Medicines Agency policy on access to documents</a></li></ul><p>The policy is accompanied by two output tables outlining access rules for <strong>specific document types</strong>:</p><ul><li><a xmlns:xlink="http://www.w3.org/1999/xlink" href="/en/documents/regulatory-procedural-guideline/output-european-medicines-agency-policy-access-documents-related-medicinal-products-human-and-veterinary-use_en.pdf" target="_blank" hreflang="en"><svg class="me-2-5 bi icon--s"><use xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"></use></svg>Output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use</a></li><li><a xmlns:xlink="http://www.w3.org/1999/xlink" href="/en/documents/other/output-european-medicines-agency-policy-access-documents-non-related-medicinal-products-human-and-veterinary-use_en.pdf" target="_blank" hreflang="en"><svg class="me-2-5 bi icon--s"><use xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"></use></svg>Output of the European Medicines Agency policy on access to documents non-related to medicinal products for human and veterinary use</a></li></ul><p>The revised policy takes into account stakeholder recommendations provided during a public consultation held in 2017:</p><ul><li><a xmlns:xlink="http://www.w3.org/1999/xlink" href="/en/documents/comments/overview-comments-received-draft-policy0043-european-medicines-agency-policy-access-documents_en.pdf" target="_blank" hreflang="en"><svg class="me-2-5 bi icon--s"><use xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"></use></svg>Overview of comments received on the draft policy/0043: European Medicines Agency policy on access to documents</a></li><li><a xmlns:xlink="http://www.w3.org/1999/xlink" href="/en/documents/comments/overview-comments-received-output-european-medicines-agency-policy-access-documents-related-medicinal-products-human-and-veterinary-use_en.pdf" target="_blank" hreflang="en"><svg class="me-2-5 bi icon--s"><use xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"></use></svg>Overview of comments received on the output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use</a></li><li><a xmlns:xlink="http://www.w3.org/1999/xlink" href="/en/documents/comments/overview-comments-output-european-medicines-agency-policy-access-documents-non-related-medicinal-products-human-and-veterinary-use_en.pdf" target="_blank" hreflang="en"><svg class="me-2-5 bi icon--s"><use xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"></use></svg>Overview of comments on the output of the European Medicines Agency policy on access to documents non-related to medicinal products for human and veterinary use</a></li></ul></div></div></div><div class="item"><div id="ema-inpage-item-12178" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div id="who-can-request-access-to-documents-12178"><h2 class="mb-4 rounded-title"> Who can request access to documents </h2></div><div class="ecl-editor"><p><strong>Citizens of the EU</strong> and natural or legal persons residing or having their registered office <strong>in an EU Member State</strong> have the right of access to EMA documents under Article 2(1) of <a href="http://www.europarl.europa.eu/RegData/PDF/r1049_en.pdf">Regulation (EC) No 1049/2001</a>. This right to access concerns documents held by EMA (that is to say, documents drawn up or received by EMA and in its possession).</p><p>The Agency is no longer in a position to process access to documents requests issued from <strong>outside the EU</strong>. This is due to a high volume of requests resulting in an excessive workload and in order to avoid EMA's core business tasks and performance being jeopardised by the administrative workload related to activities under Regulation (EC) 1049/2001 regarding public access to documents.</p></div></div></div><div class="item"><div id="ema-inpage-item-12179" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div id="how-to-submit-a-request-12179"><h2 class="mb-4 rounded-title"> How to submit a request </h2></div><div class="ecl-editor"><p>Access-to-documents requests should be submitted by completing the <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="8a6304b7-2831-4cd4-91be-7c1d0595239c" href="/en/about-us/contacts-european-medicines-agency/send-question-european-medicines-agency" title="Send a question to the European Medicines Agency">online form</a>.</p><p>For further information, see the <a xmlns:xlink="http://www.w3.org/1999/xlink" href="/en/documents/other/guide-access-unpublished-documents_en.pdf" target="_blank" hreflang="en"><svg class="me-2-5 bi icon--s"><use xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"></use></svg>Guide on access to unpublished documents</a>.</p></div></div></div><div class="item"><div id="ema-inpage-item-12180" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div id="definitions-used-in-access-to-documents-12180"><h2 class="mb-4 rounded-title"> Definitions used in access to documents </h2></div><div class="ecl-editor"><ul><li>'Document' means any content regardless of its medium (a written document stored electronically or on paper, or an audio, video or audio-visual recording) concerning a matter relating to the policies, activities and decisions falling within the Agency's area of responsibility.</li><li>Documents are classified as: <ul><li>'Restricted': information whose unauthorised disclosure at the time of an access-to-documents request could be disadvantageous to the interests of the EU Institutions, the Member States and/or the Agency, but which may be made available to the public in the future. Documents are classified 'restricted' if they fall into any of the categories listed Article 3 of the <a xmlns:xlink="http://www.w3.org/1999/xlink" href="/en/documents/other/rules-implementation-regulation-ec-no-10492001-access-emea-documents_en.pdf" target="_blank" hreflang="en"><svg class="me-2-5 bi icon--s"><use xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"></use></svg>Rules for the implementation of Regulation (EC) No 1049/2001 on access to EMEA documents</a> and their premature disclosure might be prejudicial to the interests of the Agency;</li><li>'Confidential': information whose unauthorised disclosure could harm the essential interests of the EU Institutions, the Member States and/or the Agency. Documents are classified 'confidential' if they fall under any of the exceptions laid down in Article 3 of the <a xmlns:xlink="http://www.w3.org/1999/xlink" href="/en/documents/other/rules-implementation-regulation-ec-no-10492001-access-emea-documents_en.pdf" target="_blank" hreflang="en"><svg class="me-2-5 bi icon--s"><use xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"></use></svg>Rules for the implementation of Regulation (EC) No 1049/2001 on access to EMEA documents</a>;</li><li>'Public': information that is not classified as either restricted or confidential.</li></ul></li><li>'Commercially Confidential Information' (CCI) refers to the safeguarding of the privacy of sensitive information.</li><li>'Protected Personal Data' (PPD) refers to protected data related to a living individual who can be identified from that data.</li><li>'Redacted documents' are documents that, in their original form, contain sensitive information (such as CCI or PPD) and which information must be blacked out before access to these documents may be granted.</li><li>'Third party' refers to any natural or legal person, or any entity outside the Agency, including the Member States, other Community or non-Community institutions and bodies and third countries.</li></ul></div></div></div><div class="item"><div id="ema-inpage-item-12181" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div id="public-documents-12181"><h2 class="mb-4 rounded-title"> Public documents </h2></div><div class="ecl-editor"><p>All our public documents are made available on the EMA website. If you cannot find a particular public document on our website, you can ask the EMA to provide it to you by <a href="/en/about-us/contact/send-question-european-medicines-agency">sending a question to the European Medicines Agency</a>.</p><p>Your request will not be processed as a request for access to documents, but as a request for information in accordance with the <a xmlns:xlink="http://www.w3.org/1999/xlink" href="/en/documents/other/european-medicines-agency-code-good-administrative-behaviour_en.pdf" target="_blank" hreflang="en"><svg class="me-2-5 bi icon--s"><use xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"></use></svg>The European Medicines Agency code of good administrative behaviour</a>.</p></div></div></div><div class="item"><div class="paragraph paragraph--type--ema-documents paragraph--view-mode--default" id="ema-inpage-item-9000"><div id="policies-and-guidance-documents-9000"><h2 class="mb-4 rounded-title documents-title"> Policies and guidance documents </h2></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="other" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Heads of Medicines Agencies / European Medicines Agency guidance document on the identification of commercially confidential information and personal data within the structure of the marketing-authorisation application: ...</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Adopted</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (704.94 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2012-03-27T10:00:00Z">27/03/2012</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2024-12-18T09:59:00Z">18/12/2024</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/other/heads-medicines-agencies-european-medicines-agency-guidance-document-identification-commercially-confidential-information-personal-data-within-structure-marketing-authorisation-application_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="other" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Guide on access to unpublished documents</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/304162/2014 Rev.6</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (307.05 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2014-11-24T15:00:00Z">24/11/2014</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2024-04-25T14:05:00Z">25/04/2024</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/other/guide-access-unpublished-documents_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="other" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Policy 43: European Medicines Agency policy on access to documents</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Adopted</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/729522/2016</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row legal-effective-date fw-normal text-muted"><span class="label">Legal effective date: </span><span class="value"><time datetime="2010-12-01T12:00:00Z">01/12/2010</time></span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (150.42 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2010-11-30T00:00:00Z">30/11/2010</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2018-11-23T12:00:00Z">23/11/2018</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/other/policy-43-european-medicines-agency-policy-access-documents_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="comments" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Overview of comments received on the draft policy/0043: European Medicines Agency policy on access to documents</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/768660/2018</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (505.49 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2018-12-06T10:18:00Z">06/12/2018</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/comments/overview-comments-received-draft-policy0043-european-medicines-agency-policy-access-documents_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="regulatory-procedural-guideline" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/127362/2006 Rev. 1</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row summary fw-normal text-muted"><span class="label">Summary: </span><span class="value"><p>Output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use</p></span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (449.27 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2010-11-30T00:00:00Z">30/11/2010</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2018-11-23T12:00:00Z">23/11/2018</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/regulatory-procedural-guideline/output-european-medicines-agency-policy-access-documents-related-medicinal-products-human-and-veterinary-use_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="comments" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Overview of comments received on the output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/770027/2018</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (184.38 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2018-12-06T10:34:00Z">06/12/2018</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/comments/overview-comments-received-output-european-medicines-agency-policy-access-documents-related-medicinal-products-human-and-veterinary-use_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="other" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Output of the European Medicines Agency policy on access to documents non-related to medicinal products for human and veterinary use</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/183710/2016</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row summary fw-normal text-muted"><span class="label">Summary: </span><span class="value"><p>Output of the European Medicines Agency policy on access to documents non-related to medicinal products for human and veterinary use</p></span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (178.46 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2017-02-17T13:30:00Z">17/02/2017</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2018-11-23T12:00:00Z">23/11/2018</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/other/output-european-medicines-agency-policy-access-documents-non-related-medicinal-products-human-and-veterinary-use_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="comments" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Overview of comments on the output of the European Medicines Agency policy on access to documents non-related to medicinal products for human and veterinary use</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/770394/2018</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (98.24 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2018-12-06T10:36:00Z">06/12/2018</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/comments/overview-comments-output-european-medicines-agency-policy-access-documents-non-related-medicinal-products-human-and-veterinary-use_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="regulatory-procedural-guideline" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Draft EMEA policy on the practical operation of access to EMEA documents</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMEA/110196/2006/Final</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (53.44 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2008-12-17T23:00:00Z">18/12/2008</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2008-12-17T23:00:00Z">18/12/2008</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/regulatory-procedural-guideline/draft-emea-policy-practical-operation-access-emea-documents_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="regulatory-procedural-guideline" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Output of the draft EMEA policy on the practical operation of access to EMEA documents in the context of the authorisation and supervision of medicinal products for human and veterinary use</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMEA/659316/2008/Final</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (179.65 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2008-12-17T23:00:00Z">18/12/2008</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2008-12-17T23:00:00Z">18/12/2008</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/regulatory-procedural-guideline/output-draft-emea-policy-practical-operation-access-emea-documents-context-authorisation-and-supervision-medicinal-products-human-and-veterinary-use_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></div></div><div class="item"><div class="paragraph paragraph--type--ema-documents paragraph--view-mode--default" id="ema-inpage-item-9001"><div id="public-consultation-documents-9001"><h2 class="mb-4 rounded-title documents-title"> Public consultation documents </h2></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="other" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation closed</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row consultation-dates fw-normal text-muted"><span class="label">Consultation dates: </span><span class="value"><time datetime="2024-04-12T12:00:00Z">12/04/2024</time> to <time datetime="2024-06-28T12:00:00Z">28/06/2024</time></span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row summary fw-normal text-muted"><span class="label">Summary: </span><span class="value"><p>This guidance document is intended to be applicable to information/documents pertaining to the initial and variation of marketing authorisation application (MAA) dossiers of medicinal products for human use for which the regulatory procedure has been finalised, under the national, mutual recognition, decentralised and centralised procedures. “Finalised” shall mean that the marketing authorisation (MA) has been granted or refused or that the MAA has been withdrawn.</p><p>By extension, the principles laid down in this guidance can be considered for other types of finalised procedures such as orphan designations, Paediatric Investigation Plans (PIPs)/waivers or scientific advice. The application of the general principles laid down in this guidance is without prejudice to national rules on transparency. The guidance should be read in conjunction with the relevant applicable legislation and case law on transparency and data protection.</p><p>Comments should be provided using this <a href="https://ec.europa.eu/eusurvey/runner/HMAEMApublicstakeholdersurvey">EUSurvey form</a>. For any technical issues, please contact the <a href="https://ec.europa.eu/eusurvey/home/support?assistance=1">EUSurvey Support</a>.</p></span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (625.03 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2024-04-12T07:28:07Z">12/04/2024</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/other/draft-revised-heads-medicines-agency-european-medicines-agency-guidance-document-identification-personal-data-commercially-confidential-information-within-structure-marketing-authorisation-application_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="other" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Draft policy/0043: European Medicines Agency policy on access to documents</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Draft: consultation closed</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/729522/2016</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row summary fw-normal text-muted"><span class="label">Summary: </span><span class="value"><p>European Medicines Agency policy on access to documents - Draft policy/0043</p></span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (141.87 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2017-02-17T13:30:00Z">17/02/2017</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/other/draft-policy0043-european-medicines-agency-policy-access-documents_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="regulatory-procedural-guideline" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Data protection statement for the public consultation on European Medicines Agency policy on access to documents</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/108062/2017</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row summary fw-normal text-muted"><span class="label">Summary: </span><span class="value"><p>The objective of this consultation is to receive the views of stakeholder and/or concerned individuals on the revised European Medicines Agency policy on access to documents, the output table on corporate documents and the output table for documents related to medicines for human and veterinary use.</p></span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (91.25 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2017-03-15T12:25:00Z">15/03/2017</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2017-03-15T12:25:00Z">15/03/2017</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/regulatory-procedural-guideline/data-protection-statement-public-consultation-european-medicines-agency-policy-access-documents_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="other" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-word"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Submission of comments form</p></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (166.5 KB - DOC)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2017-02-17T13:30:00Z">17/02/2017</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2017-02-17T13:30:00Z">17/02/2017</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/other/submission-comments-form_en.doc">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></div></div><div class="item"><div class="paragraph paragraph--type--ema-documents paragraph--view-mode--default" id="ema-inpage-item-9002"><div id="archive-9002"><h2 class="mb-4 rounded-title documents-title"> Archive </h2></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="other" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Rules for the implementation of Regulation (EC) No 1049/2001 on access to EMEA documents</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Adopted</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMEA/MB/203359/2006 Rev 1 Adopted</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (37.93 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2007-01-10T23:09:21Z">11/01/2007</time></span></small><small 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