{"id":17404,"date":"2022-09-14T07:04:45","date_gmt":"2022-09-14T07:04:45","guid":{"rendered":"http:\/\/legalblog.ie\/?p=17404"},"modified":"2022-09-24T22:05:39","modified_gmt":"2022-09-24T22:05:39","slug":"medicines","status":"publish","type":"post","link":"https:\/\/legalblog.ie\/medicines\/","title":{"rendered":"Medicines I [EU]"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_63 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title \" >Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/legalblog.ie\/medicines\/#EU_rules_on_the_authorisation_import_and_production_of_medicines_for_humans\" title=\"EU rules on the authorisation, import and production of medicines for humans\">EU rules on the authorisation, import and production of medicines for humans<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/legalblog.ie\/medicines\/#Key_Points\" title=\"Key Points\">Key Points<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/legalblog.ie\/medicines\/#Application_Background\" title=\"Application &amp; Background\">Application &amp; Background<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/legalblog.ie\/medicines\/#References\" title=\"References\">References<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/legalblog.ie\/medicines\/#Medicines_and_investigational_medicines_for_human_use_%E2%80%94_safe_production\" title=\"Medicines and investigational medicines for human use \u2014 safe production\">Medicines and investigational medicines for human use \u2014 safe production<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/legalblog.ie\/medicines\/#Key_Points-2\" title=\"Key Points\">Key Points<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/legalblog.ie\/medicines\/#Application_Background-2\" title=\"Application &amp; Background\">Application &amp; Background<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/legalblog.ie\/medicines\/#ACT\" title=\"ACT\">ACT<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/legalblog.ie\/medicines\/#Colouring_matters_for_medicinal_products_recast\" title=\"Colouring matters for medicinal products (recast)\">Colouring matters for medicinal products (recast)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/legalblog.ie\/medicines\/#References-2\" title=\"References\">References<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/legalblog.ie\/medicines\/#European_Pharmacopoeia\" title=\"European Pharmacopoeia\">European Pharmacopoeia<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/legalblog.ie\/medicines\/#References-3\" title=\"References\">References<\/a><\/li><\/ul><\/nav><\/div>\n<h3><span class=\"ez-toc-section\" id=\"EU_rules_on_the_authorisation_import_and_production_of_medicines_for_humans\"><\/span>EU rules on the authorisation, import and production of medicines for humans<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Medicines for human use must satisfy strict authorisation procedures to prove they meet high quality and safety standards. Different national provisions must also be removed to ensure they are available throughout the European Union (EU).<\/p>\n<p>Directive 2001\/83\/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use<\/p>\n<p>It brings together all the existing provisions in force on the sale, production, labelling, classification, distribution and advertising of medicinal products for human use in the EU.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Key_Points\"><\/span>Key Points<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>All medicines offered for sale in the EU must have prior authorisation from either a national authority or the European Medicines Agency. To receive the authorisation, manufacturers must provide a range of detailed therapeutic information about the product, including any possible side-effects.<\/p>\n<p>Authorisation may be refused if a medicine\u2019s risk-benefit ratio is not considered favourable or its therapeutic effect is insufficiently substantiated.<\/p>\n<p>National authorities should make every effort to complete the authorisation procedure within 210 days from the submission of a valid application. Authorisation is valid for 5 years and is renewable.<\/p>\n<p>A mutual recognition procedure exists to enable medicines already authorised in 1 EU country to be sold in another.<\/p>\n<p>The legislation sets out in detail the information, such as storage precautions, expiry date and batch number, which must be given on the outer packaging.<\/p>\n<p>Medicines are classified according to whether they require a medical prescription or not.<\/p>\n<p>Strict controls are laid down for advertising medical products to the general public. The information must be presented objectively, not exaggerate an item\u2019s properties and not be misleading.<\/p>\n<p>National pharmacovigilance systems* are in place to collect information, particularly on adverse reactions in human beings, potentially useful for monitoring medicinal products.<\/p>\n<p>Specific provisions apply to homeopathic products*. These may be subject to a simplified registration procedure if they are taken orally or applied externally.<\/p>\n<p>The legislation does not apply to whole blood, plasma or certain medicinal products, such as those prepared in a pharmacy or used for research and development.<\/p>\n<p>The European Commission has also issued guidelines for good practices in the manufacture and distribution of medicinal products.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Application_Background\"><\/span>Application &amp; Background<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>From 18 December 2001.<\/p>\n<p>For more information, see the medicinal products for human use page of the European Commission\u2019s website.<\/p>\n<p>KEY TERMS<\/p>\n<p>Pharmacovigilance systems: systems set in place to monitor the effects of medicines and, in particular, to identify and assess adverse reactions.<\/p>\n<p>Homeopathic products: remedies based on the idea that the body has the ability to heal itself, i.e. a substance that causes the symptoms of a disease in healthy people can cure similar symptoms in sick people.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"References\"><\/span>References<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Directive 2001\/83\/EC<\/p>\n<p>18.12.2001<\/p>\n<p>OJ L 311 of 28.11.2001, pp. 67-128<\/p>\n<p>Successive amendments and corrections to Directive 2001\/83\/EC have been incorporated into the basic text. This consolidated version is for information only.<\/p>\n<p>RELATED ACTS<\/p>\n<p>Commission Directive 2003\/94\/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (Official Journal L 262 of 14.10.2003, pp. 22-26).<\/p>\n<p>Guidelines of 5 November 2013 on good distribution practice of medicinal products for human use (Official Journal C 343 of 23.11.2013, pp. 1-14)<\/p>\n<p>Guidelines of 19 March 2015 on principles of good distribution practice of active substances for medicinal products for human use (Official Journal C 95 of 21.3.2015, pp. 1-9).<\/p>\n<p>Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (Official Journal C 95 of 21.3.2015, pp. 10-13).<\/p>\n<p>&nbsp;<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Medicines_and_investigational_medicines_for_human_use_%E2%80%94_safe_production\"><\/span>Medicines and investigational medicines for human use \u2014 safe production<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>SUMMARY OF:<\/p>\n<p>Commission Directive 2003\/94\/EC \u2014 good manufacturing practice for medicines and investigational medicines for human use<\/p>\n<p>It sets out the principles and guidelines of good manufacturing practice for medicines and investigational medicines* for human use.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Key_Points-2\"><\/span>Key Points<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>National authorities must organise inspections to ensure manufacturers comply with the principles and guidelines set out in the legislation.<\/p>\n<p>Manufacturers must:<br \/>\nensure that their activities are properly authorised and respect good manufacturing practice;<br \/>\nregularly review their manufacturing methods in the light of scientific and technical progress;<br \/>\nestablish and implement an effective pharmaceutical quality assurance system, involving management and staff;<br \/>\nhave enough competent and qualified staff to ensure quality standards are met;<br \/>\ndefine the duties of the managerial and supervisory staff and provide them with appropriate training;<br \/>\nestablish and maintain documentation records, a quality control system under a suitably qualified person and hygiene programmes;<br \/>\nconduct frequent inspections of their operations and take any necessary corrective action;<br \/>\nimplement a system to respond to, and investigate, complaints and have measures in place to promptly recall any medicines if necessary, while informing the competent authorities of their action.<\/p>\n<p>The premises and equipment used must be located, designed, constructed, adapted and maintained to suit their intended purpose, minimise the risk of error and allow effective cleaning and maintenance.<\/p>\n<p>The documentation system must contain details of each batch of products and kept for at least a year after their expiry date for medicines; and for investigational medicines, at least 5 years after the end of the clinical trial in which they were used. Electronic data must be protected against any loss or damage.<\/p>\n<p>Different production operations must comply with pre-established instructions and procedures.<\/p>\n<p>The quality control system includes access to quality control laboratories and must retain samples of each batch of products for at least a year after their expiry date for medicines; and for investigational medicines, at least 2 years after the end of the clinical trial in which they were used.<br \/>\nAny work contracted out must be authorised by a written contract setting out the responsibilities of both parties in complying with good manufacturing practice.<br \/>\nImporters must ensure that imported products have been manufactured according to standards that are at least equivalent to those in the EU.<br \/>\nSeparate legislation (Regulation (EU) No 536\/2014) sets out the conditions that clinical trials must meet.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Application_Background-2\"><\/span>Application &amp; Background<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>It has applied since 3 November 2003. EU countries had to incorporate it into national law by 30 April 2004.<\/p>\n<p>For more information, see:<\/p>\n<p>\u2018Quality of medicines and Good Manufacturing Practices (GMP)\u2019 on the European Commission\u2019s website<br \/>\n\u2018Good-manufacturing-practice and good-distribution-practice compliance\u2019 on the European Medicines Agency\u2019s website<br \/>\nKEY TERM<\/p>\n<p>* Investigational medicine: a pharmaceutical form of an active substance or placebo that is being tested or used as a reference in a clinical trial.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"ACT\"><\/span>ACT<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Commission Directive 2003\/94\/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, pp. 22\u201326)<\/p>\n<p>RELATED ACTS<\/p>\n<p>Regulation (EC) No 726\/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, pp. 1\u201333).<\/p>\n<p>Subsequent amendments to Regulation (EC) No 726\/2004 have been incorporated into the basic text. This consolidated version is of documentary value only.<\/p>\n<p>Directive 2004\/27\/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001\/83\/EC on the Community code relating to medicinal products for human use (OJ L 136, 30.4.2004, pp. 34\u201357)<\/p>\n<p>Directive 2001\/83\/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, pp. 67\u2013128). See consolidated version.<\/p>\n<p>Regulation (EU) No 536\/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001\/20\/EC (OJ L 158, 27.5.2014, pp. 1\u201376)<\/p>\n<p>&nbsp;<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Colouring_matters_for_medicinal_products_recast\"><\/span>Colouring matters for medicinal products (recast)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>In the light of the many disparities between Member States\u2019 legislation on colouring matters for medicinal products, the European Commission considered it necessary to recast Directive 78\/25\/EC. It is important not to hamper the development of the pharmaceutical industry or trade in medicinal products within the Community.<\/p>\n<p>Directive 2009\/35\/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (recast) (Text with EEA relevance).<\/p>\n<p>This Directive gives specifications on colouring matters for medicinal products.<\/p>\n<p>Only the colouring matters listed in Annex I to Directive 94\/36\/EC may be used to colour medicinal products for human and veterinary use.<\/p>\n<p>The colouring matters referred to in Annex I must meet the general specifications for aluminium lakes of colours and the specific criteria of purity laid down in Annex I to Directive 95\/45\/EC. The methods of analysis needed to verify these criteria are framed by Directive 81\/712\/EC.<\/p>\n<p>When a colouring matter is deleted from Annex I to Directive 94\/36\/EC, but the marketing of foodstuffs containing this colouring matter is permitted to continue for a limited period, this additional period of use also extends to medicinal products. However, the Commission may amend the duration of this additional period.<\/p>\n<p>The Commission shall be assisted by a committee for the adjustment to technical progress of the Directives composed of representatives from Member States and chaired by a Commission representative.<\/p>\n<p>This Directive repeals Directive 78\/25\/EC.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"References-2\"><\/span>References<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Directive 2009\/35\/EC<\/p>\n<h3><span class=\"ez-toc-section\" id=\"European_Pharmacopoeia\"><\/span>European Pharmacopoeia<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The European Union supports the European Pharmacopoeia, which was drawn up by the Council of Europe. The objective of this institution is to harmonise national laws on the manufacture, circulation and distribution of medicines in Europe.<\/p>\n<p>Council Decision 94\/358\/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia.<\/p>\n<p>On 22 July 1964, Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Switzerland and the United Kingdom (1) signed a Convention, drawn up under the aegis of the Council of Europe, on the elaboration of a European Pharmacopoeia.<\/p>\n<p>The objectives are to harmonise specifications for medicinal substances of general interest to the population of Europe and to hasten the drawing-up of specifications for the growing number of new medicinal substances appearing on the market.<\/p>\n<p>These objectives are met by creating a European Pharmacopoeia comprising monographs which become official standards applicable in the territories of the countries which are Contracting Parties to the Convention.<\/p>\n<p>On 16 November 1989 a Protocol to this Convention was signed in order to enable the European Community to accede to it. It entered into force on 1 November 1992.<\/p>\n<p>The European Pharmacopoeia currently has 38 European members, including the European Union (EU). The 37 member countries are:<\/p>\n<p>the EU-15, namely Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom (1);<br \/>\nthree of the European Free Trade Association (EFTA) countries, namely Iceland, Norway and Switzerland;<br \/>\nthe thirteen most recent Member States of the EU, namely Croatia, Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, the Slovak Republic, Slovenia, Bulgaria and Romania;<br \/>\nthe four EU candidate countries, namely the former Yugoslav Republic of Macedonia (FYROM), Montenegro, Serbia and Turkey;<br \/>\nBosnia and Herzegovina, and Ukraine.<br \/>\nThe European Pharmacopoeia also has 26 observers, including the World Health Organisation (WHO). The 25 observer countries are:<\/p>\n<p>six European countries, namely Albania, Republic of Belarus, Georgia, Kazakhstan, Moldova and the Russian Federation;<br \/>\nnineteen non-European countries, namely Algeria, Argentina, Australia, Azerbaijan, Brazil, Canada, China, Israel, Madagascar, Malaysia, Morocco, Republic of Guinea, Senegal, Singapore, South Africa, Syria, the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare, Tunisia and the United States.<br \/>\nThe elaboration of the European Pharmacopoeia is undertaken by two bodies:<\/p>\n<p>the European Pharmacopoeia Commission, which prepares and adopts the technical decisions relating to monographs. It comprises eminent scientists appointed by each Contracting Party and chosen for their competence in certain fields;<br \/>\nthe Public Health Committee of the Council of Europe, which exercises administrative authority over the Commission&#8217;s activities and sets the date of application of the monographs but cannot interfere with their technical content.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"References-3\"><\/span>References<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Official Journal<\/p>\n<p>Decision 94\/358\/EC<\/p>\n<p>RELATED ACTS<\/p>\n<p>Directive 2001\/83\/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (l21230) [Official Journal L 311 of 28.11.2001].<\/p>\n<p>Directive 2001\/82\/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (l21231) [Official Journal L 311 of 28.11.2001].<\/p>\n<p>Directive 2011\/62\/EU of the European Parliament and of the Council amending Directive 2001\/83\/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products [OJ L 174 of 1.7.2011].<\/p>\n<!--themify_builder_content-->\n<div id=\"themify_builder_content-17404\" data-postid=\"17404\" class=\"themify_builder_content themify_builder_content-17404 themify_builder tf_clear\">\n    <\/div>\n<!--\/themify_builder_content-->\n","protected":false},"excerpt":{"rendered":"<p>EU rules on the authorisation, import and production of medicines for humans Medicines for human use must satisfy strict authorisation procedures to prove they meet high quality and safety standards. Different national provisions must also be removed to ensure they are available throughout the European Union (EU). Directive 2001\/83\/EC of the European Parliament and of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[210],"tags":[],"_links":{"self":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/17404"}],"collection":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/comments?post=17404"}],"version-history":[{"count":7,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/17404\/revisions"}],"predecessor-version":[{"id":18464,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/17404\/revisions\/18464"}],"wp:attachment":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/media?parent=17404"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/categories?post=17404"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/tags?post=17404"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}