{"id":274,"date":"2020-04-25T19:35:48","date_gmt":"2020-04-25T19:35:48","guid":{"rendered":"http:\/\/letsfightcorona.net\/?p=274"},"modified":"2020-05-21T15:31:36","modified_gmt":"2020-05-21T15:31:36","slug":"certification-process-is-difficult-ask-for-compassionate-use","status":"publish","type":"post","link":"http:\/\/letsfightcorona.net\/?p=274","title":{"rendered":"Certification process is difficult? Ask for Compassionate Use"},"content":{"rendered":"\n<p>From European Medicines Agency (EMA): <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compassionate-use\">https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compassionate-use<\/a><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><strong><a rel=\"noreferrer noopener\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/compassionate-use\" target=\"_blank\">Compassionate use<\/a> is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter <a rel=\"noreferrer noopener\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/clinical-trial\" target=\"_blank\">clinical trials<\/a>.<\/strong><\/p>\n\n\n\n<p>The European Medicines Agency (EMA) <strong>provides recommendations<\/strong> through the <a href=\"https:\/\/www.ema.europa.eu\/en\/committes\/committee-medicinal-products-human-use-chmp\">Committee for Medicinal Products for Human Use (CHMP)<\/a>, but these do not create a legal framework. <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/compassionate-use\" target=\"_blank\" rel=\"noreferrer noopener\">Compassionate use<\/a> programmes are coordinated and implemented by Member States, which set their own rules and procedures.<\/p>\n\n\n\n<p>These programmes are only put in place if the medicine is expected to help patients with <strong>life-threatening, long-lasting or seriously debilitating illnesses<\/strong>, which cannot be treated satisfactorily with any currently authorised medicine.<\/p>\n\n\n\n<p>The medicine must be undergoing <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/clinical-trial\" target=\"_blank\" rel=\"noreferrer noopener\">clinical trials<\/a> or have entered the marketing-authorisation application process and while early studies will generally have been completed, its safety profile and dosage <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/guideline\" target=\"_blank\" rel=\"noreferrer noopener\">guidelines<\/a> may not be fully established.<\/p>\n\n\n\n<p><strong>Regulations\/Law and Contact points in your country:<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/www.hma.eu\/fileadmin\/dateien\/HMA_joint\/02-_HMA_Strategy_Annual_Reports\/08_HMA_Publications\/2016_04_HMA_Compassionate_use_program.pdf\">https:\/\/www.hma.eu\/fileadmin\/dateien\/HMA_joint\/02-_HMA_Strategy_Annual_Reports\/08_HMA_Publications\/2016_04_HMA_Compassionate_use_program.pdf<\/a><\/p>\n\n\n\n<p><a href=\"javascript:void(0)\">Share<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Table of contents<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compassionate-use#how-to-request-an-opinion-section\">How to request an opinion<\/a><\/li><li><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compassionate-use#comparison-to-individual-basis-treatment-section\">Comparison to individual basis treatment<\/a><\/li><li><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compassionate-use#compassionate-use-opinions-section\">Compassionate use opinions<\/a><\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">How to request an opinion<\/h3>\n\n\n\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/national-competent-authority\" target=\"_blank\" rel=\"noreferrer noopener\">National competent authorities<\/a> can ask EMA for an opinion on how to administer, distribute and use certain medicines for <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/compassionate-use\" target=\"_blank\" rel=\"noreferrer noopener\">compassionate use<\/a>. The <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/chmp\" target=\"_blank\" rel=\"noreferrer noopener\">CHMP<\/a> also identifies which patients would benefit, and Member States should take note of these recommendations when making decisions.<\/p>\n\n\n\n<p>Manufacturers and marketing-authorisation applicants should not contact EMA to request an opinion, but they may wish to inform the Agency of applications underway at national level. <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/national-competent-authority\" target=\"_blank\" rel=\"noreferrer noopener\">National competent authorities<\/a> <strong>will inform the Agency<\/strong> if they are making a product available to a group of patients for <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/compassionate-use\" target=\"_blank\" rel=\"noreferrer noopener\">compassionate use<\/a>.<\/p>\n\n\n\n<p>Established by Article 83 of <a href=\"http:\/\/ec.europa.eu\/health\/files\/eudralex\/vol-1\/reg_2004_726\/reg_2004_726_en.pdf\">Regulation (EC) No 726\/2004<\/a>, this tool is designed to:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>facilitate and improve access to <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/compassionate-use\" target=\"_blank\" rel=\"noreferrer noopener\">compassionate use<\/a> programmes by patients in the EU;<\/li><li>favour a common approach regarding the conditions of use, the conditions for distribution and the patients targeted for the <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/compassionate-use\" target=\"_blank\" rel=\"noreferrer noopener\">compassionate use<\/a> of unauthorised new medicines;<\/li><li>increase transparency between Member States in terms of treatment availability.<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Comparison to individual basis treatment<\/h3>\n\n\n\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/compassionate-use\" target=\"_blank\" rel=\"noreferrer noopener\">Compassionate use<\/a> should not be confused with &#8216;named-patient basis&#8217; treatments, which see doctors obtain medicines <strong>directly from manufacturers<\/strong> before authorisation. This is done on an individual basis under the direct responsibility of the doctor, and the Agency does not need to be informed.<\/p>\n\n\n\n<p>In general, medicines that are not yet authorised are first made available through <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/clinical-trial\" target=\"_blank\" rel=\"noreferrer noopener\">clinical trials<\/a> and patients should always be considered for inclusion in trials <strong>before<\/strong> being offered <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/compassionate-use\" target=\"_blank\" rel=\"noreferrer noopener\">compassionate use<\/a> programmes.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Compassionate use opinions<\/h3>\n\n\n\n<p>The list of <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/compassionate-use\" target=\"_blank\" rel=\"noreferrer noopener\">compassionate use<\/a> opinions includes the <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/chmp\" target=\"_blank\" rel=\"noreferrer noopener\">CHMP<\/a>&#8216;s recommendations on how a medicine should be used, and the type of patient who should be eligible.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Name of medicine<\/strong><\/td><td>Remdesivir&nbsp;Gilead<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/active-substance\" target=\"_blank\" rel=\"noreferrer noopener\">Active substance<\/a><\/td><td>remdesivir<\/td><\/tr><tr><td>Dosage<\/td><td>100 mg<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/pharmaceutical-form\" target=\"_blank\" rel=\"noreferrer noopener\">Pharmaceutical form<\/a><\/td><td>Concentrate for solution for infusion<br>Powder for concentrate for solution for infusion<\/td><\/tr><tr><td>Member State notifying the Agency<\/td><td>Estonia, Romania, The Netherlands and Greece<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/chmp\" target=\"_blank\" rel=\"noreferrer noopener\">CHMP<\/a> opinion documents<\/td><td><a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/conditions-use-conditions-distribution-patients-targeted-conditions-safety-monitoring-adressed_en-2.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring<\/a> <a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/summary-compassionate-use-remdesivir-gilead_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Summary on compassionate use<\/a><\/td><\/tr><tr><td>Date of opinion<\/td><td>02\/04\/2020<\/td><\/tr><tr><td>Company contact information<\/td><td>Gilead Sciences Ireland UC<br>Carrigtohill<br>County Cork, T45 DP77<br>Ireland<br>Tel: +353 1 686 1890<br>Fax: +353 (0) 214825518<br>Email: <a href=\"mailto:MAH.Gilead@gilead.com\">MAH.Gilead@gilead.com<\/a><\/td><\/tr><tr><td>Status<\/td><td>Ongoing<\/td><\/tr><tr><td>Related documents<\/td><td>&#8211;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Name of medicine<\/strong><\/td><td>Ledipasvir\/Sofosbuvir<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/active-substance\" target=\"_blank\" rel=\"noreferrer noopener\">Active substance<\/a><\/td><td>ledipasvir, sofosbuvir<\/td><\/tr><tr><td>Dosage<\/td><td>90 mg \/ 400 mg<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/pharmaceutical-form\" target=\"_blank\" rel=\"noreferrer noopener\">Pharmaceutical form<\/a><\/td><td>Film coated tablet<\/td><\/tr><tr><td>Member State notifying the Agency<\/td><td>Ireland<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/chmp\" target=\"_blank\" rel=\"noreferrer noopener\">CHMP<\/a> opinion documents<\/td><td><a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/conditions-use-conditions-distribution-patients-targeted-conditions-safety-monitoring-adressed\/sofosbuvir-available-compassionate-use_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring<\/a> <a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/summary-compassionate-use-ledipasvir\/sofosbuvir_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Summary on compassionate use<\/a><\/td><\/tr><tr><td>Date of opinion<\/td><td>20\/02\/2014<\/td><\/tr><tr><td>Company contact information<\/td><td>Gilead Sciences Limited<br>Granta Park<br>Abington<br>Cambridgeshire<br>CB21 6GT<br>United Kingdom<br>Tel. +44 (0)208 5872206<br>Fax +44 (0)1223 897233<br>E-mail: <a href=\"mailto:eamemed.info@gilead.com\">eamemed.info@gilead.com<\/a><\/td><\/tr><tr><td>Status<\/td><td>Ongoing<\/td><\/tr><tr><td>Related documents<\/td><td>&#8211;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Name of medicine<\/strong><\/td><td>Daclatasvir<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/active-substance\" target=\"_blank\" rel=\"noreferrer noopener\">Active substance<\/a><\/td><td>daclatasvir<\/td><\/tr><tr><td>Dosage<\/td><td>30 and 60 mg<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/pharmaceutical-form\" target=\"_blank\" rel=\"noreferrer noopener\">Pharmaceutical form<\/a><\/td><td>Film coated tablet<\/td><\/tr><tr><td>Member State notifying the Agency<\/td><td>Sweden<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/chmp\" target=\"_blank\" rel=\"noreferrer noopener\">CHMP<\/a> opinion documents<\/td><td><a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/conditions-use-conditions-distribution-patients-targeted-conditions-safety-monitoring-adressed_en-0.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring<\/a> <a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/summary-compassionate-use-daclatasvir_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Summary on compassionate use<\/a><\/td><\/tr><tr><td>Date of opinion<\/td><td>21\/11\/2013<\/td><\/tr><tr><td>Company contact information<\/td><td>Bristol-Myers Squibb Pharma EEIG<br>Uxbridge Business Park<br>Sanderson Road<br>Uxbridge UB8 1DH<br>United Kingdom<br>Tel. +44 (0)1895 523 740<br>Fax +44 (0)1895 523 677<br>E-mail: <a href=\"mailto:medical.information@bms.com\">medical.information@bms.com<\/a><\/td><\/tr><tr><td>Status<\/td><td>Ongoing<\/td><\/tr><tr><td>Related documents<\/td><td>&#8211;&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Name of medicine<\/strong><\/td><td>Sofosbuvir Gilead<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/active-substance\" target=\"_blank\" rel=\"noreferrer noopener\">Active substance<\/a><\/td><td>sofosbuvir<\/td><\/tr><tr><td>Dosage<\/td><td>400 mg<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/pharmaceutical-form\" target=\"_blank\" rel=\"noreferrer noopener\">Pharmaceutical form<\/a><\/td><td>Film-coated tablet<\/td><\/tr><tr><td>Member State notifying the Agency<\/td><td>Sweden<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/chmp\" target=\"_blank\" rel=\"noreferrer noopener\">CHMP<\/a> opinion documents<\/td><td><a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/conditions-use-conditions-distribution-patients-targeted-conditions-safety-monitoring-adressed_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring<\/a> <a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/summary-compassionate-use-sofosbuvir-gilead_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Summary on compassionate use<\/a><\/td><\/tr><tr><td>Date of opinion<\/td><td>24\/10\/2013<\/td><\/tr><tr><td>Company contact information<\/td><td>Gilead Sciences International Ltd<br>Granta Park, Abington<br>Cambridgeshire CB21 6GT<br>United Kingdom<br>Tel. +44 (0)1223 897496<br>Fax +44 (0)1223 897233<br>E-mail: <a href=\"mailto:eamemed.info@gilead.com\">eamemed.info@gilead.com<\/a><\/td><\/tr><tr><td>Status<\/td><td>Ongoing<\/td><\/tr><tr><td>Related documents<\/td><td>&#8211;&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Name of medicine<\/strong><\/td><td>IV Zanamivir<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/active-substance\" target=\"_blank\" rel=\"noreferrer noopener\">Active substance<\/a><\/td><td>Zanamivir<\/td><\/tr><tr><td>Dosage<\/td><td>10 mg\/ml<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/pharmaceutical-form\" target=\"_blank\" rel=\"noreferrer noopener\">Pharmaceutical form<\/a><\/td><td>Solution for infusion<\/td><\/tr><tr><td>Member State notifying the Agency<\/td><td>Sweden<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/chmp\" target=\"_blank\" rel=\"noreferrer noopener\">CHMP<\/a> opinion documents<\/td><td><a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/summary-compassionate-use-iv-zanamivir-rev-1_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring<\/a> <a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/summary-compassionate-use-iv-zanamivir-rev-1_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Summary on compassionate use<\/a><\/td><\/tr><tr><td>Date of opinion<\/td><td>18\/02\/2010<\/td><\/tr><tr><td>Company contact information<\/td><td>GlaxoSmithKline Research &amp; Development Limited<br>980 Great West Road, Brentford<br>Middlesex, TW8 9GS<br>United Kingdom<br>Telephone: 00800 2468 3579 free phone<br>or +44(0)2089904855<br>E-Mail: <a href=\"mailto:GSKClinicalSupportHD@gsk.com\">GSKClinicalSupportHD@gsk.com<\/a><\/td><\/tr><tr><td>Status<\/td><td>Ongoing<\/td><\/tr><tr><td>Related documents<\/td><td>&#8211;&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Name of medicine<\/strong><\/td><td>Tamiflu IV<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/active-substance\" target=\"_blank\" rel=\"noreferrer noopener\">Active substance<\/a><\/td><td>Oseltamivir phosphate<\/td><\/tr><tr><td>Dosage<\/td><td>100 mg<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/pharmaceutical-form\" target=\"_blank\" rel=\"noreferrer noopener\">Pharmaceutical form<\/a><\/td><td>Powder for solution for infusion<\/td><\/tr><tr><td>Member State notifying the Agency<\/td><td>Finland<\/td><\/tr><tr><td><a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/chmp\" target=\"_blank\" rel=\"noreferrer noopener\">CHMP<\/a> opinion documents<\/td><td><a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/conditions-use-conditions-distribution-patients-targeted-conditions-safety-monitoring-addressed_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring<\/a> <a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/summary-compassionate-use-tamiflu-iv_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Summary on compassionate use<\/a><\/td><\/tr><tr><td>Date of opinion<\/td><td>20\/01\/2010<\/td><\/tr><tr><td>Company contact information<\/td><td>F. Hoffmann-La Roche Ltd.<br>Pharmaceuticals Division<br>PBMV Bldg 74\/3O 104<br>CH-4070, Basel<br>Switzerland<br>Tel. +41 61 688 5522<br>Fax +41 61 687 2239<br>E-mail: <a href=\"mailto:basel.tamifluquestions@roche.com\">basel.tamifluquestions@roche.com<\/a><\/td><\/tr><tr><td>Status<\/td><td>Closed<\/td><\/tr><tr><td>Related documents<\/td><td><a href=\"https:\/\/www.ema.europa.eu\/documents\/public-statement\/public-statement-tamiflu-iv-closure-compassionate-use-programme-european-union_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Public statement on Tamiflu IV: Closure of compassionate-use programme in the EU<\/a> <a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/tamiflu-iv-compassionate-use-programme-closure-programme-emea\/h\/k\/002287_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Tamiflu IV compassionate-use programme EMEA\/H\/K\/002287 &#8211; Closure of programme<\/a><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">Related content<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/support-early-access\">Support for early access<\/a><\/li><li><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/prime-priority-medicines\">PRIME<\/a><\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Related EU legislation<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li><a href=\"http:\/\/ec.europa.eu\/health\/files\/eudralex\/vol-1\/reg_2004_726\/reg_2004_726_en.pdf\">Regulation (EC) No 726\/2004<\/a><\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Related documents<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li><a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/questions-answers-compassionate-use-medicines-european-union_en-0.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">List item<\/a><ul><\/ul><a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/questions-answers-compassionate-use-medicines-european-union_en-0.pdf\" target=\"_blank\" rel=\"noreferrer noopener\"><br>First published: 21\/01\/2010<br>Last updated: 21\/01\/2010<br>EMEA\/72144\/2006 (rev)<\/a><\/li><li><a href=\"https:\/\/www.ema.europa.eu\/documents\/regulatory-procedural-guideline\/guideline-compassionate-use-medicinal-products-pursuant-article-83-regulation-ec-no-726\/2004_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">List item<\/a><ul><\/ul><a href=\"https:\/\/www.ema.europa.eu\/documents\/regulatory-procedural-guideline\/guideline-compassionate-use-medicinal-products-pursuant-article-83-regulation-ec-no-726\/2004_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Adopted<br><br>First published: 19\/07\/2007<br>Last updated: 19\/07\/2007<br>EMEA\/27170\/2006<\/a><\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">External links<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li><a href=\"http:\/\/www.hma.eu\/fileadmin\/dateien\/HMA_joint\/02-_HMA_Strategy_Annual_Reports\/08_HMA_Publications\/2016_04_HMA_Compassionate_use_program.pdf\">Heads of Medicines Agencies: List of national competent authorities providing guidance on compassionate use programs within their Member States<\/a><\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Contact point<\/h3>\n\n\n\n<p><a href=\"mailto:compassionateuse@ema.europa.eu\">compassionateuse@ema.europa.eu<\/a><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>About EMA<\/strong><\/p>\n\n\n\n<p><strong>The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU). It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.EMA serves a market of over 500 million people living in the EU.<\/strong><\/p>\n\n\n\n<p>EMA protects public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>From European Medicines Agency (EMA): https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compassionate-use Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in&hellip; <\/p>\n","protected":false},"author":1,"featured_media":276,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[32],"tags":[],"class_list":["post-274","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-alternatives-certification"],"_links":{"self":[{"href":"http:\/\/letsfightcorona.net\/index.php?rest_route=\/wp\/v2\/posts\/274","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/letsfightcorona.net\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/letsfightcorona.net\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/letsfightcorona.net\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/letsfightcorona.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=274"}],"version-history":[{"count":3,"href":"http:\/\/letsfightcorona.net\/index.php?rest_route=\/wp\/v2\/posts\/274\/revisions"}],"predecessor-version":[{"id":279,"href":"http:\/\/letsfightcorona.net\/index.php?rest_route=\/wp\/v2\/posts\/274\/revisions\/279"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/letsfightcorona.net\/index.php?rest_route=\/wp\/v2\/media\/276"}],"wp:attachment":[{"href":"http:\/\/letsfightcorona.net\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=274"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/letsfightcorona.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=274"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/letsfightcorona.net\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=274"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}