{"id":52183,"date":"2015-01-06T12:06:00","date_gmt":"2015-01-06T12:06:00","guid":{"rendered":"http:\/\/mostafa.openonline.co.uk\/?guid=21f40f4dcb140f127bd5e19ebbc17eb9"},"modified":"2015-01-06T12:06:00","modified_gmt":"2015-01-06T12:06:00","slug":"press-release-new-essential-orange-and-green-guides-2015-out-now","status":"publish","type":"post","link":"https:\/\/mostafa.openonline.co.uk\/?p=52183","title":{"rendered":"Press release: New essential Orange and Green Guides 2015 \u2013 out now!"},"content":{"rendered":"<div class=\"govspeak\">\n<p>The latest UK pharmaceutical regulations, EU directives and guidance for manufacturers and distributors of human medicines, known as the Orange and Green Guides, compiled by the Medicines and Healthcare products Regulatory Agency (<abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr>), are available to buy now. These are an essential purchase for anyone subject to good manufacturing practice (<abbr title=\"good manufacturing practice\">GMP<\/abbr>) and good distribution practice (<abbr title=\"good distribution practice\">GDP<\/abbr>) in Europe.<\/p>\n<p>The <a rel=\"external\" href=\"http:\/\/www.pharmpress.com\/product\/9780857111715\/orangeguide?utm_source=mhra_pressrelease&amp;utm_medium=email&amp;utm_campaign=orangeguide15\">Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors)<\/a> contains information and legislation relating to the manufacture and distribution of human medicines. The <a rel=\"external\" href=\"http:\/\/www.pharmpress.com\/product\/9780857111722\/green?utm_source=mhra_pressrelease&amp;utm_medium=email&amp;utm_campaign=greenguide15\">Green Guide  (Rules and Guidance for Pharmaceutical Distributors)<\/a> provides information on the broader distribution. <\/p>\n<p>Mark Birse, <abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr> GMDP Group Manager, IE&amp;S said:<\/p>\n<blockquote>\n<p>The Orange and Green Guides are essential tools in helping companies understand the regulatory environment in which they operate, follow good practice and stay compliant with the law.<\/p>\n<p class=\"last-child\">This is key to ensuring that safe and high quality medicines for people are being made and distributed, providing the trust needed by patients and healthcare professionals to use them.<\/p>\n<\/blockquote>\n<p>The new 2015 edition of the Orange Guide includes changes made to European Community guidelines on <abbr title=\"good manufacturing practice\">GMP<\/abbr> and the revised EU Guidelines on <abbr title=\"good distribution practice\">GDP<\/abbr>.  <\/p>\n<p>There are new sections on: <\/p>\n<ul>\n<li>\n<abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr> Innovation Office<\/li>\n<li>\n<abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr> Compliance Management and Inspection Action Group <\/li>\n<li>\n<abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr>\u2019s risk-based inspection programme naming Contract Quality Control laboratories on a manufacturer\u2019s licence<\/li>\n<li>the gold standard for Responsible Persons<\/li>\n<li>the application and inspection process for new licences &#8211; what to expect<\/li>\n<\/ul>\n<p>The new Green Guide has been updated to incorporate the revised EU Guidelines on <abbr title=\"good distribution practice\">GDP<\/abbr>. In addition there are new sections on: <\/p>\n<ul>\n<li>\n<abbr title=\"good distribution practice\">GDP<\/abbr> quality systems<\/li>\n<li>the European  Commission Q&amp;A on <abbr title=\"good distribution practice\">GDP<\/abbr> guidelines <\/li>\n<li>the Gold Standard for Responsible Persons <\/li>\n<li>a list of persons who can be supplied with medicines by way of wholesale dealing  (Human Medicines Regulations 2012) <\/li>\n<li>controls on certain medicinal products <\/li>\n<li>Compliance Management and Inspection Action Group <\/li>\n<li>the application and inspection process for new licences &#8211; what to expect<\/li>\n<li>sales representative samples <\/li>\n<li>handling returns of non-defective medicinal products <\/li>\n<li>\n<abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr>\u2019s risk-based inspection programme <\/li>\n<li>reporting adverse reactions <\/li>\n<li>short-term storage of ambient and refrigerated medicinal products \u2013 requirements for a wholesale Dealers Authorisation<\/li>\n<li>\n<abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr> Innovation Office <\/li>\n<\/ul>\n<p>Both publications provide a new flow chart on registration requirements for UK companies involved in the sourcing and supply of active substances (ASs) to be used in the manufacture of licensed human medicines.<\/p>\n<h2 id=\"background\">Background<\/h2>\n<p>The Orange and Green Guides are published by Pharmaceutical Press, and are available to order in print at www.pharmpress.com. They are also both available online via <a rel=\"external\" href=\"http:\/\/www.medicinescomplete.com\">MedicinesComplete<\/a>.<\/p>\n<p>Pharmaceutical Press is the publishing division of the Royal Pharmaceutical Society. We produce the most comprehensive and trustworthy range of independent pharmaceutical information in the world, including reference works, textbooks, digital products and services, professional titles and journals. <\/p>\n<p>The <a href=\"https:\/\/www.gov.uk\/government\/groups\/mhra-innovation-office\"><abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr> Innovation Office<\/a> <\/p>\n<p><abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr> is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). <abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr> is an executive agency of the Department of Health.<\/p>\n<div class=\"contact postal-address\" id=\"contact_2345\">\n<div class=\"content\">\n<h3>Media enquiries<\/h3>\n<div class=\"vcard contact-inner\">\n<p class=\"adr\">\n<span class=\"fn\">Press office<\/span><br \/><span class=\"street-address\">4 T<br \/>\n<br \/>\n151 Buckingham Palace Road<br \/>\n<br \/>\nVictoria<\/span><br \/><span class=\"locality\">London<\/span><br \/><span class=\"postal-code\">SW1W 9SZ<\/span>\n<\/p>\n<div class=\"email-url-number\">\n<p class=\"email\">\n              <span class=\"type\">Email<\/span><br \/>\n              <a class=\"email\" href=\"mailto:press.office@mhra.gsi.gov.uk\">press.office@mhra.gsi.gov.uk<\/a>\n            <\/p>\n<p class=\"tel\">\n              <span class=\"type\">During office hours:<\/span><br \/>\n              020 3080 7651\n            <\/p>\n<p class=\"tel\">\n              <span class=\"type\">Out of office hours:<\/span><br \/>\n              07770 446 189\n            <\/p>\n<\/p><\/div>\n<p class=\"comments\">Office hours are Monday to Friday, 9am to 5pm. For real-time updates including the latest press releases and news statements, see our Twitter channel at twitter.com\/mhrapress<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Latest UK pharmaceutical regulations, EU directives and guidance for manufacturers and distributors of human medicines available to buy now.<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"_links":{"self":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/52183"}],"collection":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=52183"}],"version-history":[{"count":0,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/52183\/revisions"}],"wp:attachment":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=52183"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=52183"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=52183"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}