{"id":1119,"date":"2022-03-28T09:28:34","date_gmt":"2022-03-28T09:28:34","guid":{"rendered":"https:\/\/www.customs-declarations.uk\/?p=1119"},"modified":"2022-03-28T11:52:22","modified_gmt":"2022-03-28T11:52:22","slug":"a-quick-guide-to-importing-a-human-medicine-to-the-uk","status":"publish","type":"post","link":"https:\/\/www.customs-declarations.uk\/a-quick-guide-to-importing-a-human-medicine-to-the-uk\/","title":{"rendered":"A Quick Guide to Importing a human medicine to the UK"},"content":{"rendered":"<p>[vc_row][vc_column][vc_column_text]<\/p>\n<hr \/>\n<h3><b>Introduction<\/b><\/h3>\n<hr \/>\n<p><span data-preserver-spaces=\"true\">You&#8217;ll need to apply for one or more licences if you want to import a licenced medicine:<\/span><\/p>\n<ul>\n<li><span data-preserver-spaces=\"true\">Wholesale Licence (also known as a wholesale dealer licence or wholesaler distribution authorisation)<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">Manufacturer Licence\u00a0<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">Marketing Authorisation licence\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-preserver-spaces=\"true\">Wholesale and manufacturing licences are issued by the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA aims to complete all applications within 90 days.<\/span><\/p>\n<p>[\/vc_column_text][vc_video link=&#8221;https:\/\/www.youtube.com\/watch?v=1-oJcwQM6zE&#8221;][vc_column_text]<\/p>\n<hr \/>\n<h3><span data-preserver-spaces=\"true\">Apply for a wholesaler licence<\/span><\/h3>\n<hr \/>\n<p><span data-preserver-spaces=\"true\">If you plan to import medicine from the following countries, you&#8217;ll need to apply for a wholesaler licence.<\/span><\/p>\n<ul>\n<li><span data-preserver-spaces=\"true\">A country on an approved country for import list, or a country in the European Economic Area if you&#8217;re in Northern Ireland, and then supplying it to another country, including the UK.<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">A country that isn&#8217;t approved for import and exports it to a country that isn&#8217;t approved for import, or if you&#8217;re in Northern Ireland, an EEA country that exports to a non-EEA country.<\/span><\/li>\n<\/ul>\n<p><span data-preserver-spaces=\"true\">The type of application determines the amount you pay, the number of sites, and the total amount of money you make selling licenced human medicines.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">Once you are ready with your licences and other documentation, you can use Customs-Declarations.UK&#8217;s platform for filing your customs declaration swiftly and effortlessly.\u00a0<\/span><\/p>\n<p>[\/vc_column_text][vc_gallery interval=&#8221;3&#8243; images=&#8221;1120,1121,1122,1123,1144&#8243; img_size=&#8221;full&#8221;][vc_column_text]<\/p>\n<hr \/>\n<h3><span data-preserver-spaces=\"true\">Apply for a manufacturer licence<\/span><\/h3>\n<hr \/>\n<p>If you want to import medicine from a country that isn&#8217;t on the approved country for import list for use in the UK or supply it to a country on the approved country for import list, you&#8217;ll need to apply for a manufacturer licence.<\/p>\n<p>If you import medicine from outside the EEA for use in the UK or to supply to another EEA country, you&#8217;ll need to apply for a manufacturing licence in Northern Ireland.<\/p>\n<p>[\/vc_column_text][vc_gallery interval=&#8221;3&#8243; images=&#8221;1125,1126,1127&#8243; img_size=&#8221;full&#8221;][vc_column_text]<\/p>\n<hr \/>\n<h3><span data-preserver-spaces=\"true\">Apply for a marketing authorisation (MA) licence<\/span><\/h3>\n<hr \/>\n<p>Before you may sell human medicine, you must first obtain an MA licence. Because there are many different sorts of MA licences, the procedure you must take is determined by the type of MA licence you require.<\/p>\n<p>A Qualified Person (QP) listed in the manufacturer\/importer licence must certify that a drug has been prepared and tested according to good manufacturing practice before being supplied to the market.<\/p>\n<p>Customs-Declarations.UK makes it easy for you to maintain and track your authorisations on a single platform and easily link those with your customs declaration.<\/p>\n<p>[\/vc_column_text][vc_gallery interval=&#8221;3&#8243; images=&#8221;1128,1129,1130,1145&#8243; img_size=&#8221;full&#8221;][vc_column_text]<\/p>\n<hr \/>\n<h3><strong><span data-preserver-spaces=\"true\">Import an unlicensed medicine<\/span><\/strong><\/h3>\n<hr \/>\n<p><span data-preserver-spaces=\"true\">You can import an unlicensed medicine if you meet the following criteria:<\/span><\/p>\n<ul>\n<li><span data-preserver-spaces=\"true\">You import it from a country that isn&#8217;t approved for import and then export it to a country that isn&#8217;t approved for import (called an introduced product).<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">You are in Northern Ireland, and you are importing it from a non-EEA country to export it to another non-EEA country (called an introduced product).<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">Licensed medicines do not work for a patient&#8217;s unique clinical needs (called a special product).<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">No licenced medication are available to meet a patient&#8217;s clinical demands (also called a special product).<\/span><\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_gallery interval=&#8221;3&#8243; images=&#8221;1132,1133,1134,1135&#8243; img_size=&#8221;full&#8221;][vc_column_text]<\/p>\n<hr \/>\n<h3><span data-preserver-spaces=\"true\">Import an introduced product<\/span><\/h3>\n<hr \/>\n<p>To import an introduced product into the UK, you must be a licenced wholesale dealer.<\/p>\n<p>Only a person authorised to import or supply medicinal items through wholesale distribution in a country other than an approved country or in Northern Ireland in a non-EEA country may receive an introduced medicine.<\/p>\n<p>[\/vc_column_text][vc_gallery interval=&#8221;3&#8243; images=&#8221;1136,1137,1138&#8243; img_size=&#8221;full&#8221;][vc_column_text]<\/p>\n<hr \/>\n<h3><span data-preserver-spaces=\"true\">Import a special product<\/span><\/h3>\n<hr \/>\n<p>If you&#8217;re importing medicine from a country that isn&#8217;t on the list of recognised countries for import, or if you&#8217;re in Northern Ireland from outside the EEA, you&#8217;ll need to apply for a manufacturer &#8216;specials&#8217; licence. You will also need to make a notification of intent to import an unlicensed medicine 28 days before you do so.<\/p>\n<p>[\/vc_column_text][vc_gallery interval=&#8221;3&#8243; images=&#8221;1139,1140&#8243; img_size=&#8221;full&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_separator][vc_column_text]<\/p>\n<p><span style=\"color: #999999;\"><em><span style=\"font-weight: 400;\"><b><i>We value your feedback, and if you have any comments, suggestions or anything else that you would like to highlight to us, we will be delighted to hear from you and incorporate your feedback into our content. <\/i><\/b><\/span><\/em><\/span><\/p>\n<p><em>Note: While we have made every attempt to ensure that the information contained in this Site has been obtained from reliable sources, Customs Declarations UK is not responsible for any errors or omissions, or for the results obtained from the use of this information. All information in this Site is provided &#8220;as is&#8221;, with no guarantee of completeness, accuracy, timeliness or of the results obtained from the use of this information, and without warranty of any kind, express or implied, including, but not limited to warranties of performance, merchantability and fitness for a particular purpose. Nothing herein shall to any extent substitute for the independent investigations and the sound technical and business judgment of the reader. In no event will Customs Declarations UK, or its partners, employees or agents, be liable to you or anyone else for any decision made or action taken in reliance on the information in this Site or for any consequential, special or similar damages, even if advised of the possibility of such damages. Certain links in this Site connect to other Web Sites maintained by third parties over whom Customs Declarations UK has no control. Customs Declarations UK makes no representations as to the accuracy or any other aspect of information contained in other Web Sites.<br \/><\/em><\/p>\n<p>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_column_text] Introduction You&#8217;ll need to apply for one or more licences if you want to import a licenced medicine: Wholesale Licence (also known as a wholesale dealer licence or wholesaler distribution authorisation) Manufacturer Licence\u00a0 Marketing Authorisation licence\u00a0 Wholesale and manufacturing licences are issued by the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA aims [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1141,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[17,18],"tags":[111,109,19,137,135,136,110,35],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v16.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<meta name=\"description\" content=\"At Custom-Declarations.com, we believe that considering the end-to-end workflow is crucial to cross-border trading. 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