{"id":13580,"date":"2022-09-07T18:55:14","date_gmt":"2022-09-07T18:55:14","guid":{"rendered":"http:\/\/legalblog.ie\/?p=13580"},"modified":"2022-09-25T07:17:06","modified_gmt":"2022-09-25T07:17:06","slug":"good-practice","status":"publish","type":"post","link":"https:\/\/legalblog.ie\/good-practice\/","title":{"rendered":"Good Practice [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\/good-practice\/#Good_clinical_practice\" title=\"Good clinical practice\">Good clinical practice<\/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\/good-practice\/#Summary\" title=\"Summary\">Summary<\/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\/good-practice\/#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-4\" href=\"https:\/\/legalblog.ie\/good-practice\/#Inspection_and_verification_of_laboratory_studies_on_all_chemicals\" title=\"Inspection and verification of laboratory studies on all chemicals\">Inspection and verification of laboratory studies on all chemicals<\/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\/good-practice\/#Summary-2\" title=\"Summary\">Summary<\/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\/good-practice\/#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-7\" href=\"https:\/\/legalblog.ie\/good-practice\/#Tests_on_chemical_substances\" title=\"Tests on chemical substances\">Tests on chemical substances<\/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\/good-practice\/#Summary-3\" title=\"Summary\">Summary<\/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\/good-practice\/#References-3\" title=\"References\">References<\/a><\/li><\/ul><\/nav><\/div>\n<h3><span class=\"ez-toc-section\" id=\"Good_clinical_practice\"><\/span>Good clinical practice<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Under this Directive, the European Parliament and the Council are defining the principles and guidelines of good clinical practice (GCP) in line with the principles enunciated in the 1964 Helsinki Declaration.<\/p>\n<p>Directive 2001\/20\/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Summary\"><\/span>Summary<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>This Directive concerns clinical trials of medicinal products as defined in Article 1 of Directive 65\/65\/EEC, including multi-centre trials.<br \/>\nThe Directive does not apply to non-interventional clinical trials.<\/p>\n<p>All clinical trials, including bioavailability and bioequivalence studies, are to be designed, conducted and reported in accordance with the standard of good clinical practice.<\/p>\n<p>The trial subjects are protected. On the one hand, a clinical trial may only be undertaken if the risks to the subject are not disproportionate to the potential benefits of the medical research. On the other hand, the right of the subject to physical and mental integrity must be respected, as well as the right to privacy.<\/p>\n<p>The medical care given to the subjects and medical decisions made on their behalf are the responsibility of an appropriately qualified physician.<\/p>\n<p>Trial subjects are to be provided with a contact point, where further information can be obtained.<\/p>\n<p>In preparing its opinion on clinical trials, the ethics committee must take into consideration a certain number of elements, in particular:<\/p>\n<ul>\n<li>the relevance of the trial and the trial design;<\/li>\n<li>the protocol;<\/li>\n<li>the suitability of the investigator (i.e. the person responsible for performing the clinical trials on a site) and his supporting staff;<\/li>\n<li>the quality of the facilities.<\/li>\n<\/ul>\n<p>The ethics committee\u2019s opinion must be delivered before the start of the clinical trials.<br \/>\nMember States must establish a procedure by which a single ethics committee opinion must be delivered for each Member State, including the case of multi-centre clinical trials.<\/p>\n<p>The Directive describes the conditions and time limits to be respected in order to begin a clinical trial.<\/p>\n<p>The sponsor (i.e. the person, firm, institution or body responsible for mounting, managing and\/or funding the clinical trial) must, within 90 days of completion of the clinical trial, duly inform the Member States.<\/p>\n<p>Member States on whose territory the clinical trial is performed must enter data extracted from the initial request, amendments as appropriate and the notification at the end of the clinical trial, into a database accessible only to:<\/p>\n<ul>\n<li>the Member States;<\/li>\n<li>the European Medicines Evaluation Agency;<\/li>\n<li>the Commission.<\/li>\n<\/ul>\n<p>The European Medicines Evaluation Agency can, by derogation, make part of the information entered in this database available to the public.<\/p>\n<p>A Member State must immediately inform the other Member States and the Commission whenever:<\/p>\n<ul>\n<li>it suspends or prohibits the trial because the conditions set out in the application cease to be met or because doubts arise as to the safety or scientific justification of the trial;<\/li>\n<li>it is of the opinion that the sponsor or investigator is no longer fulfilling his obligations.<\/li>\n<\/ul>\n<p>The manufacture and import of investigational medicinal products is subject to the authorisation referred to in Article 16 of Council Directive 75\/319\/EC. The particulars to appear on the outer packaging or, where there is no outer packaging, on the immediate packaging of investigational medicinal products, must be published by the Commission in the good manufacturing practice guideline on investigational medicinal products to be adopted.<\/p>\n<p>The Member States must appoint Community inspectors. These inspectors carry out inspections on behalf of the Community at relevant sites, notably trial sites and manufacturing sites, in order to check compliance with the provisions of good clinical practice. An inspection report must be prepared.<\/p>\n<p>The European Medicines Evaluation Agency is responsible for coordinating inspections.<\/p>\n<p>Inspections may be carried out in a third country, where there are agreements between the Community and the third country.<\/p>\n<p>The investigator must immediately report all serious adverse events to the sponsor, except for those listed in the protocol or in the investigator\u2019s brochure as not requiring immediate reporting.<\/p>\n<p>Adverse events and abnormalities identified in the protocol as critical to safety evaluations must be reported to the ethics committee and the sponsor. In the event of the death of a participant in a clinical trial, the investigator must supply the sponsor and the ethics committee with any additional requested information.<\/p>\n<p>The sponsor:<\/p>\n<ul>\n<li>must ensure that all the relevant information about adverse events are reported to the Member State concerned within the time limits;<\/li>\n<li>must maintain detailed records of all suspected adverse events, which must be submitted to the Member States in whose territory the clinical trial is being conducted.<\/li>\n<\/ul>\n<p>In the event of suspected serious unexpected adverse reactions to an investigational medicinal product occurring on its territory, the Member State must ensure that this event is reported to the European Medicines Evaluation Agency, which must inform the competent authorities of the other Member States.<\/p>\n<p>The Directive is without prejudice to the general civil and criminal liability of the sponsor or the investigator.<\/p>\n<p>Medicinal products used in the course of clinical trials may not be sold, other than in exceptional circumstances.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"References\"><\/span>References<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<table width=\"100%\">\n<tbody>\n<tr>\n<td>Act<\/td>\n<td>Entry into force &#8211; Date of expiry<\/td>\n<td>Deadline for transposition in the Member States<\/td>\n<td>Official Journal<\/td>\n<\/tr>\n<tr>\n<td>Directive 2001\/20\/EC<\/td>\n<td>01.05.2001<\/td>\n<td>&#8211;<\/td>\n<td>OJ L 121 of 01.05.2001<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<table width=\"100%\">\n<tbody>\n<tr>\n<td>Amending act(s)<\/td>\n<td>Entry into force<\/td>\n<td>Deadline for transposition in the Member States<\/td>\n<td>Official Journal<\/td>\n<\/tr>\n<tr>\n<td>Regulation (EC) No 1901\/2006<\/td>\n<td>Thirty days following publication in the Official Journal<\/td>\n<td>&#8211;<\/td>\n<td>OJ L 378 of 27.12.2006<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Good laboratory practice:<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Inspection_and_verification_of_laboratory_studies_on_all_chemicals\"><\/span>Inspection and verification of laboratory studies on all chemicals<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>This directive makes provision for a verification procedure for laboratories claiming to use Good Laboratory Practice (GLP) in conducting tests on chemicals.<\/p>\n<p>Directive 2004\/9\/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) .<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Summary-2\"><\/span>Summary<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>This Directive amends and repeals Directive 88\/320\/EEC on the inspection and verification of Good Laboratory Practice.<\/p>\n<p>It applies to the inspection and verification of the organisational processes and the conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing, carried out in accordance with the rules and regulations, of all chemicals (e.g. cosmetics, industrial chemicals, medicinal products, food additives, animal feed additives, pesticides) in order to assess the effect of such products on man, animals and the environment.<\/p>\n<p>Each Member State designates the authorities responsible for the inspection of laboratories within its territory.<\/p>\n<p>Each year, the Member States forward to the Commission and to a Committee set up by the Directive a report listing the laboratories inspected, the date of the inspection and the conclusions of the inspection.<\/p>\n<p>If the inspection is positive, the Member State is the guarantor that the laboratory is GLP-compliant and this decision is binding in the other Member States.<\/p>\n<p>If a Member State considers that a laboratory within its territory claiming GLP compliance does not in fact comply, it shall inform the Commission, which shall inform the other Member States. Similarly, a Member State may also request a study audit, possibly in conjunction with a new inspection, of laboratories located in another Member State.<\/p>\n<p>The Annexes to the Directive include a detailed description of the procedures to be followed in monitoring GLP compliance in order to ensure that these are internationally acceptable.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"References-2\"><\/span>References<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<table width=\"100%\">\n<thead>\n<tr>\n<td width=\"25%\">Act<\/td>\n<td width=\"25%\">Entry into force<\/td>\n<td width=\"25%\">Deadline for transposition in the Member States<\/td>\n<td width=\"25%\">Official Journal<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Directive 2004\/9\/EC<\/td>\n<td>11.03.2004<\/td>\n<td>&#8211;<\/td>\n<td>OJ L 50 of 20.02.2004<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<table width=\"100%\">\n<thead>\n<tr>\n<td width=\"25%\">Amending act(s)<\/td>\n<td width=\"25%\">Entry into force<\/td>\n<td width=\"25%\">Deadline for transposition in the Member States<\/td>\n<td width=\"25%\">Official Journal<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Regulation (EC) No 219\/2009<\/td>\n<td>20.4.2009<\/td>\n<td>&#8211;<\/td>\n<td>OJ L 87 of 31.3.2009<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Successive amendments and corrections to Directive 219\/2009 have been incorporated in the basic text. This consolidated version is for reference purpose only.<\/p>\n<p>RELATED ACTS<\/p>\n<p>Regulation (EC) No 1907\/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999\/45\/EC and repealing Council Regulation (EEC) No 793\/93 and Commission Regulation (EC) No 1488\/94 as well as Council Directive 76\/769\/EEC and Commission Directives 91\/155\/EEC, 93\/67\/EEC, 93\/105\/EC and 2000\/21\/EC\u00a0[Official Journal L 396 of 30.12.2006].<br \/>\nSee consolidated version<\/p>\n<p>Good laboratory practice:<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Tests_on_chemical_substances\"><\/span>Tests on chemical substances<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>By means of this Directive, the European Union guarantees the quality of tests on chemical products, avoids the repetition of tests caused by divergent laboratory practices in the different Member States and protects animals by limiting the number of animal experiments through the mutual recognition of results obtained on the basis of standard methods.<\/p>\n<p>Directive 2004\/10\/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version).<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Summary-3\"><\/span>Summary<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>This directive substantially amends and repeals Directive 87\/18\/EEC on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice (GLP) and the verification of their applications for tests on chemical substances.<\/p>\n<p>The purpose of this Directive is to take over all the provisions from the existing Directives in this field. This measure forms part of the project to codify Community legislation in order to make it clearer.<\/p>\n<p>The Directive requires Member States to take all measures necessary to ensure that laboratories carrying out tests on chemical products, in accordance with Directive 67\/548\/EEC, comply with the principles of good laboratory practice (GLP) as laid down in Annex I to this Directive.<\/p>\n<p>It also applies where other Community provisions provide for the application of the principles of GLP to tests on chemical products to evaluate their safety for man and\/or the environment.<\/p>\n<p>The tests conducted on these different elements seek to obtain data on their properties and their safety with regard to human health and the environment.<\/p>\n<p>When submitting results, laboratories must certify that the tests were carried out in accordance with the principles of good laboratory practice.<\/p>\n<p>Member States must adopt the measures necessary for verification of compliance with the principles of good laboratory practice including, in particular, inspections and checks conducted in accordance with the recommendations of the Organisation for Economic Cooperation and Development (OECD) in this area.<\/p>\n<p>Member States may not, on grounds relating to the principles of GLP, prohibit, restrict or impede the placing on the market of chemical products if the principles applied are in conformity with this directive.<\/p>\n<p>Should a Member State establish that the application of the principles of GLP and the verification of their application for tests on chemical substances show that, although a chemical substance has been examined in accordance with the requirements of this Directive, it presents a danger to man or the environment, the Member State may provisionally prohibit or make subject to special conditions the marketing of that product on its territory.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"References-3\"><\/span>References<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<table width=\"100%\">\n<thead>\n<tr>\n<td width=\"25%\">Act<\/td>\n<td width=\"25%\">Entry into force<\/td>\n<td width=\"25%\">Deadline for transposition in the Member States<\/td>\n<td width=\"25%\">Official Journal<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"25%\">Directive 2004\/10\/EC [adoption: codecision COD\/2002\/233]<\/td>\n<td width=\"25%\">11.03.2004<\/td>\n<td width=\"25%\">&#8211;<\/td>\n<td width=\"25%\">OJ L 50 of 20.02.2004<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>RELATED ACTS<\/p>\n<p>Regulation (EC) No 1907\/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999\/45\/EC and repealing Council Regulation (EEC) No 793\/93 and Commission Regulation (EC) No 1488\/94 as well as Council Directive 76\/769\/EEC and Commission Directives 91\/155\/EEC, 93\/67\/EEC, 93\/105\/EC and 2000\/21\/EC [Official Journal L 396 of 30.12.2006].<\/p>\n<!--themify_builder_content-->\n<div id=\"themify_builder_content-13580\" data-postid=\"13580\" class=\"themify_builder_content themify_builder_content-13580 themify_builder tf_clear\">\n    <\/div>\n<!--\/themify_builder_content-->\n","protected":false},"excerpt":{"rendered":"<p>Good clinical practice Under this Directive, the European Parliament and the Council are defining the principles and guidelines of good clinical practice (GCP) in line with the principles enunciated in the 1964 Helsinki Declaration. Directive 2001\/20\/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations [&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":[213],"tags":[],"_links":{"self":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/13580"}],"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=13580"}],"version-history":[{"count":4,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/13580\/revisions"}],"predecessor-version":[{"id":18571,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/13580\/revisions\/18571"}],"wp:attachment":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/media?parent=13580"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/categories?post=13580"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/tags?post=13580"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}