Europa Component Library

EMA content page template

{#
  This is an example and should not be used as it is.
#}

{% include '@ec-europa/ecl-skip-links' with {
    'href': '#main-content',
    'label': 'Skip to main content'
} %}

{% include '@ec-europa/ema-headers' with header %}

{% include '@ec-europa/ema-navigation-menus' with menu %}

{% include '@ec-europa/ema-context-banners' with banner %}
<style>

/* Define accordion custom style. */
.ecl-accordion__header:active,
.ecl-accordion__header:focus,
.ecl-accordion__header:hover,
.ecl-accordion__header[aria-expanded=true] {
  background-color: #efefef;
}

.ecl-accordion__header {
  font-weight: normal;
}

.ecl-accordion__header[aria-expanded=true] .ecl-icon--up,
.ecl-accordion__header[aria-expanded=false] .ecl-icon--down {
  display: block;
}

.ecl-accordion__header[aria-expanded=false] .ecl-icon--up,
.ecl-accordion__header[aria-expanded=true] .ecl-icon--down {
  display: none;
}
</style>
<main class="ecl-u-mv-l">
  <div class="ecl-container">
  <div class="ecl-row ecl-u-mb-lg-l">
    <section class="ecl-col-lg-8">
      <h2 class="ecl-heading ecl-heading--ema-h2 ecl-u-d-inline">Zydelig</h2>
      <button class="ecl-button ecl-button--ema-small ecl-u-fs-xs ecl-u-ml-lg-xxs ecl-u-pa-xxxs"><span class="ecl-icon ecl-icon--share"></span> Share</button>
      <p class="ecl-u-mv-lg-m"><em>active substance 1 / active substance 2 / active substance 3</em></p>
      {% include '@ec-europa/ema-status-referral' with referral_status %}
    </section>
    <section class="ecl-col-lg-4">
      {% include '@ec-europa/ema-status' with status %}
      {% include '@ec-europa/ema-status' with safety %}
    </section>
   </div>

    <div class="ecl-row">
      <section class="ecl-col-lg-12">

        <p class="ecl-paragraph ecl-paragraph--ema"><strong>A transfer of the orphan designation is the procedure by which the orphan designation is transferred from the currently approved sponsor (orphan designation holder) to a new sponsor which is a different person/legal entity.</strong></p>

        {% include '@ec-europa/ema-separator' with {
          title: 'Overview',
        } %}

        <dl class="ecl-accordion" role="presentation" id="qa-60">
          <div class="ecl-u-d-flex ecl-u-justify-content-end">
            <button onclick="expandAll('#qa-60', true)" class="ecl-button ecl-button--ema-small ecl-u-mr-xs">Expand all</button>
            <button onclick="expandAll('#qa-60', false)" class="ecl-button ecl-button--ema-small">Collapse all</button>
          </div>
          <dl class="ecl-accordion" role="presentation">

            <dt role="heading">
              <button aria-controls="ecl-accordion-panel-pan2" aria-expanded="false" class="ecl-accordion__header ema-u-bg-light-grey-3" id="ecl-accordion-header-pan2" tabindex="0">
                <span class="ecl-accordion__header-icon ecl-icon ecl-icon--rounded ecl-icon--down ecl-u-bg-secondary ema-u-bg-primary ecl-u-color-white"></span>
                <span class="ecl-accordion__header-icon ecl-icon ecl-icon--rounded ecl-icon--up ecl-u-bg-secondary ema-u-bg-primary ecl-u-color-white"></span> Question 1      </button>
            </dt>
            <dd aria-hidden="true" aria-labelledby="ecl-accordion-header-pan2" class="ecl-accordion__panel" id="ecl-accordion-panel-pan2" role="region">
                  <div class="ecl-editor ecl-u-fs-m first last"><p>Answer 1</p></div>
            </dd>
          </dl>
        </dl>

        {% include '@ec-europa/ema-separator' with {
          icon: 'related-documents',
          modifier: 'secondary',
          title: 'Related documents',
        } %}

        {% include '@ec-europa/ema-listings' with items %}

        {% include '@ec-europa/ema-separator' with {
          icon: 'related-links',
          modifier: 'secondary',
          title: 'Related links',
        } %}

        <ul class="ecl-list ecl-list--unstyled ema-listings">
          <li>
            <a class="ecl-link--ema-default" href="#">
              Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designation from one sponsor to another
            </a>
          </li>
        </ul>

        <div class="ecl-u-mr-md-l ecl-u-mv-l">
          {% include '@ec-europa/ema-rating-form' with ratingForm %}
        </div>
      </section>
    </div>
  </div>
</main>

{% include '@ec-europa/ema-footers' with footer %}
{
  "header": {
    "logo": {
      "src": "../../framework/images/logo_ema.jpg",
      "alt": "EMA logo"
    },
    "links": []
  },
  "footer": {
    "sections": [
      {
        "title": "About",
        "links": [
          {
            "label": "Who we are",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "What's new on the site",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "Expert blog",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "Human regulation",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "Veterinary regulation",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "Commitees",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          }
        ]
      },
      {
        "title": "Ask EMA",
        "links": [
          {
            "label": "Public enquiries",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "FAQs",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "Access to documents",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          }
        ]
      },
      {
        "title": "Links",
        "links": [
          {
            "label": "Legal",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "Privacy",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "Complaints",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "Browser compatibility",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "Contacts",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "Business hours and holidays",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "Website help",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          }
        ]
      },
      {
        "title": "Contact",
        "links": [
          {
            "label": "EMA<br />30 Churchill Place<br />Canary Whaf<br />London E14 5EU<br />United Kingdom",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "Tel: +44 (0)20 3660 6000",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "Fax: +44 (0)20 3660 5550",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted"
          },
          {
            "label": "Send a question",
            "href": "#",
            "extra_classes": "ecl-link--ema-inverted ecl-link--ema-external"
          }
        ]
      }
    ],
    "hotline": {
      "href": "#",
      "title": "Product emergency hotline",
      "description": "outside working hours"
    },
    "social": [
      {
        "label": "RSS",
        "href": "#",
        "icon": "rss",
        "extra_classes": "ecl-link--ema-inverted ecl-u-mr-xs"
      },
      {
        "label": "Twitter",
        "href": "#",
        "icon": "twitter",
        "extra_classes": "ecl-link--ema-inverted ecl-u-mr-xs"
      }
    ],
    "copyright": "&copy; 1995-2016 European Medicines Agency",
    "description": "An agency of the European Union",
    "logo": {
      "src": "../../framework/images/eu.png",
      "alt": "European Union flag"
    },
    "logo_network": {
      "src": "../../framework/images/euan.png",
      "alt": "European Union agencies network"
    }
  },
  "menu": {
    "menu_label": "Menu",
    "menu_aria_label": "Main Navigation",
    "extra_classes": "ecl-navigation-menu--ema",
    "links": [
      {
        "label": "Home",
        "href": "#home"
      },
      {
        "label": "Human regulatory",
        "href": "#item1",
        "title": "Human regulatory",
        "description": "This section of the website provides information on the regulation of medicines for human use in the European Union (EU). It particularly concerns the centralised procedure, where the European Medicines Agency (EMA) plays a key role.",
        "is_active": true,
        "children_links": [
          {
            "label": "Overview",
            "href": "#item1-1"
          },
          {
            "label": "Marketing authorisation",
            "href": "#item1-4"
          },
          {
            "label": "Research and development",
            "href": "#item1-2",
            "is_active": true
          },
          {
            "label": "Post authorisation",
            "href": "#item1-5"
          },
          {
            "label": "Herbal products",
            "href": "#item1-3"
          }
        ]
      },
      {
        "label": "Item 2",
        "href": "#item2",
        "title": "Section title",
        "description": "Lorem ipsum dolor sit amet, consectetur adipiscing elit. Pellentesque efficitur cursus varius. Ut id leo sed libero placerat feugiat eu eget mi. In hac habitasse platea dictumst. Etiam eleifend justo nec ex lacinia blandit. Aenean pellentesque mauris ut malesuada ultricies. Vestibulum blandit arcu et metus semper porta.",
        "children_links": [
          {
            "label": "Item 2.1",
            "href": "#item2-1"
          },
          {
            "label": "Item 2.2",
            "href": "#item2-2"
          },
          {
            "label": "Item 2.3",
            "href": "#item2-3"
          },
          {
            "label": "Item 2.4",
            "href": "#item2-4"
          },
          {
            "label": "Item 2.5",
            "href": "#item2-5"
          },
          {
            "label": "Item 2.6",
            "href": "#item2-6"
          }
        ]
      },
      {
        "label": "Item 3",
        "href": "#item3"
      }
    ]
  },
  "banner": {
    "extra_classes": "ema-context-banner--standalone",
    "title": "Medicines",
    "description": "This section of the website provides information on the regulation of medicines for human use in the European Union (EU). It particularly concerns the centralised procedure, where the European Medicines Agency (EMA) plays a key role."
  },
  "status": {
    "variant": "authorised",
    "status": "Authorised",
    "description": "This medicine is authorised for use in the European Union"
  },
  "referral_status": {
    "items": [
      {
        "title": "Procedure started"
      },
      {
        "title": "Under evaluation"
      },
      {
        "title": "PRAC recommendation"
      },
      {
        "title": "CHMP opinion",
        "active": true
      },
      {
        "title": "European Commission final decision"
      }
    ]
  },
  "accordion1": {
    "panels": [
      {
        "id": "pan1",
        "isExpanded": true,
        "heading": {
          "title": "Jobs, Growth, Investment and Competitiveness with an additional quite long string",
          "icon": "growth",
          "level": 2
        },
        "body": "<p>Bullfights. Bull hockey. Do you like this? The bull is stabbed, prodded, beaten. The bull is wounded. The bull is tired before the matador ever steps into the ring. Now, is that victory? Of course it is. Wanna know the secret to winning? Creative sportsmanship. In other words, one has to rig the game.</p>"
      },
      {
        "id": "pan2",
        "heading": {
          "title": "Energy Union",
          "icon": "energy",
          "level": 2
        },
        "body": "<p>Bullfights. Bull hockey. Do you like this? The bull is stabbed, prodded, beaten. The bull is wounded. The bull is tired before the matador ever steps into the ring. Now, is that victory? Of course it is. Wanna know the secret to winning? Creative sportsmanship. In other words, one has to rig the game.</p>"
      }
    ]
  },
  "safety": {
    "variant": "patient-safety",
    "status": "Patient safety",
    "description": "Patient safety informations"
  },
  "ratingForm": {
    "message": "Tell us more",
    "ratings": [
      {
        "feedback": [
          "Unhelpful",
          "Not very helpful",
          "Fairly helpful",
          "Helpful",
          "Very helpful"
        ],
        "title": "Add your rating",
        "name": "ema-rating1"
      },
      {
        "title": "Average",
        "name": "ema-rating2",
        "default_rating": 3,
        "disabled": true
      }
    ]
  },
  "items": [
    {
      "title": "Checklist for sponsors applying for the transfer of orphan medicinal product designation <small class=\"ema-u-color-grey-2\">(PDF - 230kb)</small>",
      "detail": "<div class=\"ema-u-color-grey-2\"><small>Published 15/01/2009<br />Updated 13/11/2017</small></div>",
      "icon": "pdf",
      "extra_classes": "ema-list-item--file",
      "translations": [
        {
          "title": "French",
          "meta": "230 kB - PDF"
        },
        {
          "title": "German",
          "meta": "230 kB - PDF"
        },
        {
          "title": "Spanish",
          "meta": "230 kB - PDF"
        }
      ],
      "translations_label": "Available languages (3)",
      "translations_tooltip": "Click to see translations"
    },
    {
      "title": "Template 1 - Orphan designation transfer form <small class=\"ema-u-color-grey-2\">(DOC - 512kb)</small>",
      "detail": "<div class=\"ema-u-color-grey-2\"><small>Published 13/04/2016<br />Updated 13/12/2016</small></div>",
      "icon": "word",
      "extra_classes": "ema-list-item--file"
    },
    {
      "title": "Template 2 - Translations of the active ingredient and indication for transfer of orphan-medicinal-product designation <small class=\"ema-u-color-grey-2\">(DOCX - 132kb)</small>",
      "detail": "<div class=\"ema-u-color-grey-2\"><small>Published 24/11/2008<br />Updated 04/07/2013</small></div>",
      "icon": "word",
      "extra_classes": "ema-list-item--file"
    }
  ],
  "_demo": {
    "scripts": "document.addEventListener('DOMContentLoaded', function () {\n        ECL.megamenu();\n        ECL.ratingForm(\"ema-rating-form__review\");\n        ECL.initExpandables('.ecl-file__translations-toggle');\n        ECL.accordions();\n      });\n      /* ECL Accordion Components expand/collapse all */\n      function expandAll(selector,action) {\n        var i;\n        var collection = document.querySelector(selector);\n        var collection_aria_hidden = collection.querySelectorAll('[aria-hidden]');\n        var collection_aria_expanded = collection.querySelectorAll('[aria-expanded]');\n        for (i = 0; i < collection_aria_hidden.length; ++i) {\n          collection_aria_hidden[i].setAttribute('aria-hidden',!action);\n        }\n        for (i = 0; i < collection_aria_expanded.length; ++i) {\n          collection_aria_expanded[i].setAttribute('aria-expanded',action);\n        }\n      }"
  }
}
<div class="ecl-skip-link__wrapper" id="skip-link">
  <a href="#main-content" class="ecl-skip-link">Skip to main content</a>
</div>

<header class="ema-header">
  <div class="ecl-container ema-header__extra">
    <div class="ema-header__links">
    </div>
  </div>

  <div class="ecl-container ema-header__banner">
    <div class="ema-header__logo"><img src="../../framework/images/logo_ema.jpg" alt="EMA logo" /></div>

    <form class="ecl-search-form ecl-site-header__search ecl-search-form--ema">
      <label class="ecl-search-form__textfield-wrapper">
    <span class="ecl-u-sr-only">Search this website</span>
    






  

  


<input
  type="search"
  class="ecl-text-input ecl-search-form__textfield ecl-text-input--ema"
  id="global-search"
  name="default-name"
  
/>
  </label>

      <button class="ecl-button ecl-button--form ecl-search-form__button ecl-button--primary ecl-button--ema-primary" type="submit">Search</button>
    </form>
  </div>
</header>

<nav class="ecl-navigation-menu ecl-navigation-menu--ema" aria-label="Main Navigation">
  <div class="ecl-container">
    <button class="ecl-navigation-menu__toggle ecl-navigation-menu__hamburger ecl-navigation-menu__hamburger--squeeze" aria-controls="nav-menu-expandable-root" aria-expanded="false">
      <span class="ecl-navigation-menu__hamburger-box">
        <span class="ecl-navigation-menu__hamburger-inner"></span>
      </span>
      <span class="ecl-navigation-menu__hamburger-label">Menu</span>
    </button>
    <ul class="ecl-navigation-menu__root" id="nav-menu-expandable-root" aria-hidden="true">
      <li class="ecl-navigation-menu__item">
        <a href="#home" class="ecl-navigation-menu__link">Home</a>
      </li>
      <li class="ecl-navigation-menu__item ecl-navigation-menu__item--active">
        <a href="#item1" class="ecl-navigation-menu__link">Human regulatory</a>
      </li>
      <li class="ecl-navigation-menu__item">
        <a href="#item2" class="ecl-navigation-menu__link" aria-controls="nav-menu-expandable-group-3" aria-expanded="false" aria-haspopup="true">Item 2</a>

        <div class="ecl-navigation-menu__group" id="nav-menu-expandable-group-3">

          <div class="ema-context-banner">
            <div class="ecl-container">
              <div class="ema-context-banner__wrapper">
                <a href="#" class="ema-context-banner__title">Section title</a>

                <p class="ecl-paragraph ecl-paragraph--ema ecl-paragraph--l">Lorem ipsum dolor sit amet, consectetur adipiscing elit. Pellentesque efficitur cursus varius. Ut id leo sed libero placerat feugiat eu eget mi. In hac habitasse platea dictumst. Etiam eleifend justo nec ex lacinia blandit. Aenean pellentesque
                  mauris ut malesuada ultricies. Vestibulum blandit arcu et metus semper porta.</p>

                <ul class="ema-context-banner__links">
                  <li class="ema-context-banner__item">
                    <a href="#item2-1" class="ema-context-banner__link">Item 2.1</a>
                  </li>
                  <li class="ema-context-banner__item">
                    <a href="#item2-2" class="ema-context-banner__link">Item 2.2</a>
                  </li>
                  <li class="ema-context-banner__item">
                    <a href="#item2-3" class="ema-context-banner__link">Item 2.3</a>
                  </li>
                  <li class="ema-context-banner__item">
                    <a href="#item2-4" class="ema-context-banner__link">Item 2.4</a>
                  </li>
                  <li class="ema-context-banner__item">
                    <a href="#item2-5" class="ema-context-banner__link">Item 2.5</a>
                  </li>
                  <li class="ema-context-banner__item">
                    <a href="#item2-6" class="ema-context-banner__link">Item 2.6</a>
                  </li>
                </ul>
              </div>
            </div>
          </div>
        </div>
      </li>
      <li class="ecl-navigation-menu__item">
        <a href="#item3" class="ecl-navigation-menu__link">Item 3</a>
      </li>
    </ul>
  </div>
</nav>

<div class="ema-context-banner">
  <div class="ecl-container">
    <div class="ema-context-banner__wrapper">
      <a href="#" class="ema-context-banner__title">Medicines</a>

      <p class="ecl-paragraph ecl-paragraph--ema ecl-paragraph--l">This section of the website provides information on the regulation of medicines for human use in the European Union (EU). It particularly concerns the centralised procedure, where the European Medicines Agency (EMA) plays a key role.</p>

      <ul class="ema-context-banner__links">
      </ul>
    </div>
  </div>
</div>
<style>
  /* Define accordion custom style. */

  .ecl-accordion__header:active,
  .ecl-accordion__header:focus,
  .ecl-accordion__header:hover,
  .ecl-accordion__header[aria-expanded=true] {
    background-color: #efefef;
  }

  .ecl-accordion__header {
    font-weight: normal;
  }

  .ecl-accordion__header[aria-expanded=true] .ecl-icon--up,
  .ecl-accordion__header[aria-expanded=false] .ecl-icon--down {
    display: block;
  }

  .ecl-accordion__header[aria-expanded=false] .ecl-icon--up,
  .ecl-accordion__header[aria-expanded=true] .ecl-icon--down {
    display: none;
  }
</style>
<main class="ecl-u-mv-l">
  <div class="ecl-container">
    <div class="ecl-row ecl-u-mb-lg-l">
      <section class="ecl-col-lg-8">
        <h2 class="ecl-heading ecl-heading--ema-h2 ecl-u-d-inline">Zydelig</h2>
        <button class="ecl-button ecl-button--ema-small ecl-u-fs-xs ecl-u-ml-lg-xxs ecl-u-pa-xxxs"><span class="ecl-icon ecl-icon--share"></span> Share</button>
        <p class="ecl-u-mv-lg-m"><em>active substance 1 / active substance 2 / active substance 3</em></p>

        <ul class="ema-status-referral" ">
  
            <li class="ema-status-referral__step ">Procedure started</li>

  
            <li class="ema-status-referral__step ">Under evaluation</li>

  
            <li class="ema-status-referral__step ">PRAC recommendation</li>

  
                      <li class="ema-status-referral__step ema-status-referral__step--active ">CHMP opinion</li>

  
            <li class="ema-status-referral__step ">European Commission final decision</li>

  </ul>
    </section>
    <section class="ecl-col-lg-4 ">
      









          





<div class="ema-status ema-status--authorised " ">
          <svg class="ema-icon ema-icon--xl ecl-u-fs-xxl ecl-u-mr-xs ema-status-icon">
    <use xlink:href="../../framework/images/icons/ema-icons.svg#ema-icon-set_select" />
  </svg>
          <span>
    <div class="ema-status-title">Authorised</div>
    <div class="ema-status-desc">This medicine is authorised for use in the European Union</div>
  </span>
    </div>

    <div class="ema-status ema-status--patient-safety" ">
  <svg class="ema-icon ema-icon--xl ecl-u-fs-xxl ecl-u-mr-xs ema-status-icon " >
    <use xlink:href="../../framework/images/icons/ema-icons.svg#ema-icon-set_info " />
  </svg>
  <span>
    <div class="ema-status-title ">Patient safety</div>
    <div class="ema-status-desc ">Patient safety informations</div>
  </span>
</div>
    </section>
   </div>

    <div class="ecl-row ">
      <section class="ecl-col-lg-12 ">

        <p class="ecl-paragraph ecl-paragraph--ema "><strong>A transfer of the orphan designation is the procedure by which the orphan designation is transferred from the currently approved sponsor (orphan designation holder) to a new sponsor which is a different person/legal entity.</strong></p>

        







<div class="ema-separator ">
  <div class="ema-separator__heading ">
    <h3 class="ema-separator__heading--title ecl-heading ecl-heading--ema-h3 ">
      Overview
    </h3>

    






  



<svg class="ema-icon ema-separator__heading--icon " >
  <use xlink:href="../../framework/images/icons/ema-icons.svg#ema-icon-set_ " />
</svg>
  </div>
</div>

        <dl class="ecl-accordion " role="presentation " id="qa-60 ">
          <div class="ecl-u-d-flex ecl-u-justify-content-end ">
            <button onclick="expandAll( '#qa-60', true) " class="ecl-button ecl-button--ema-small ecl-u-mr-xs ">Expand all</button>
            <button onclick="expandAll( '#qa-60', false) " class="ecl-button ecl-button--ema-small ">Collapse all</button>
          </div>
          <dl class="ecl-accordion " role="presentation ">

            <dt role="heading ">
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                <span class="ecl-accordion__header-icon ecl-icon ecl-icon--rounded ecl-icon--up ecl-u-bg-secondary ema-u-bg-primary ecl-u-color-white "></span> Question 1      </button>
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      <h3 class="ecl-list-item__title ecl-heading ecl-heading--h3 ">Checklist for sponsors applying for the transfer of orphan medicinal product designation <small class="ema-u-color-grey-2 ">(PDF - 230kb)</small></h3>

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                  <div class="ema-u-color-grey-2 "><small>Published 15/01/2009<br />Updated 13/11/2017</small></div>
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      <h3 class="ecl-list-item__title ecl-heading ecl-heading--h3 ">Template 1 - Orphan designation transfer form <small class="ema-u-color-grey-2 ">(DOC - 512kb)</small></h3>

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                  <div class="ema-u-color-grey-2 "><small>Published 13/04/2016<br />Updated 13/12/2016</small></div>
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      <h3 class="ecl-list-item__title ecl-heading ecl-heading--h3 ">Template 2 - Translations of the active ingredient and indication for transfer of orphan-medicinal-product designation <small class="ema-u-color-grey-2 ">(DOCX - 132kb)</small></h3>

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                  <div class="ema-u-color-grey-2 "><small>Published 24/11/2008<br />Updated 04/07/2013</small></div>
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              Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designation from one sponsor to another
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