{"id":16797,"date":"2025-04-14T18:22:48","date_gmt":"2025-04-14T16:22:48","guid":{"rendered":"https:\/\/www.pharmanutra.it\/?page_id=16797"},"modified":"2025-04-14T19:19:16","modified_gmt":"2025-04-14T17:19:16","slug":"reporting-form-for-adverse-reactions-information-and-consent","status":"publish","type":"page","link":"https:\/\/www.pharmanutra.it\/en\/reporting-form-for-adverse-reactions-information-and-consent\/","title":{"rendered":"Reporting form for adverse reactions \u2013 Information and consent"},"content":{"rendered":"\n<p>Disclosure pursuant to art. 13 of Legislative decree 196\/2003<\/p>\n\n\n\n<p>Dear Sir\/Madam,<br>in accordance with article 13 of Legislative Decree no. 196 of 30 June 2003 (hereinafter the \u201cDecree\u201d), we hereby inform you about the processing of your personal data by PHARMANUTRA S.p.A. (hereinafter referred to as \u2018PHARMANUTRA\u2019).<\/p>\n\n\n\n<p><strong>1 Purpose of processing<\/strong><br>Your personal and possibly sensitive data (such as name, surname, address, telephone numbers, e-mail, event description \u2026), directly provided by you and collected through the registration form on this website, will be collected and processed exclusively for the proper implementation of activities related to and instrumental to the purposes of pharmacovigilance such as, for example: identification of any unknown adverse reactions; improvement and enhancement of the information on suspected adverse reactions already known; assessment of the causal link between the administration of the medicinal product and the observed adverse reaction; notification to the competent authority of such information to ensure that the medicinal products used have a favourable risk\/benefit ratio for the population.<\/p>\n\n\n\n<p><strong>2 Methods of processing<\/strong><br>The personal data you provide will be processed both through the use of paper tools and computer and telematic tools.<\/p>\n\n\n\n<p><strong>3 Provision of data<\/strong><br>The provision of data is optional, although any refusal involves the impossibility for the owner to follow up on its reports or requests.<\/p>\n\n\n\n<p><strong>4 Communication and dissemination<\/strong><br>The data will be processed by employees and collaborators of Pharmanutra spa and its associated companies as persons in charge and \/ or responsible for processing. In order to achieve the purposes indicated above, your personal data will be organized in special databases at PHARMANUTRA and will be made available, again for the purposes indicated above, to subjects who access the National Pharmacovigilance Network as well as to subjects obliged to perform pharmacovigilance activities (AIFA, marketing authorization holders of medicines, Italian Regions, Local Health Authorities, Pharmacovigilance offices of hospitals or Clinical Research Hospitals). The personal data provided may also be communicated, for the purposes indicated above, to the following categories of persons: persons, companies, associations that provide services or activities relating to assistance and advice on legal matters and pharmacovigilance towards the company Junia Pharma with which the same has entered into special confidentiality agreements under the law 196\/2003. The data may also be communicated to the competent authorities, according to the terms of the law. Personal data will not be disclosed.<\/p>\n\n\n\n<p><strong>5 Rights of the interested party<\/strong><br>In relation to the processing of their personal data you have the right to exercise the rights referred to in Article 7 of Legislative Decree 196\/2003, reproduced in full\u00a0<a href=\"https:\/\/www.pharmanutra.it\/en\/rights\/\">here<\/a>, by sending a communication to the following e-mail address: info@pharmanutra.it<\/p>\n\n\n\n<p><strong>6 Duration of storage&nbsp;<\/strong><br>The data will be kept for the time strictly necessary for the above purposes and in accordance with the terms of the law and in any case for a period not exceeding one year if in the meantime the right of opposition is not exercised by the person concerned.<\/p>\n\n\n\n<p><strong>7 Data controller&nbsp;<\/strong>The data controller is PHARMANUTRA S.p.A, via Campodavela n\u00b01 56122 PISA \u2013 P.IVA 01679440501.<br>Latest update: 30\/07\/2024<\/p>\n\n\n\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f16799-o1\" lang=\"it-IT\" dir=\"ltr\" data-wpcf7-id=\"16799\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/en\/wp-json\/wp\/v2\/pages\/16797#wpcf7-f16799-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Modulo di contatto\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"16799\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.2\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"it_IT\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f16799-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><input type=\"hidden\" name=\"_uacf7_hidden_conditional_fields\" value=\"\" \/>\n<\/fieldset>\n<div class=\"uacf7-form-wrapper-container uacf7-form-16799  \"><span class=\"wpcf7-form-control-wrap\" data-name=\"radio-347\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first last\"><label><input type=\"radio\" name=\"radio-347\" value=\"I have read the information\" \/><span class=\"wpcf7-list-item-label\">I have read the information<\/span><\/label><\/span><\/span><\/span>\n\n<label>I give my consent for the processing of any sensitive data necessary to carry out the purposes indicated in the information.<\/label>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"radio-910\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"radio-910\" value=\"I agree\" \/><span class=\"wpcf7-list-item-label\">I agree<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"radio-910\" value=\"I deny consent\" \/><span class=\"wpcf7-list-item-label\">I deny consent<\/span><\/label><\/span><\/span><\/span>\n\n<div class=\"uacf7_conditional conditional-107\">\n\n<br>\n\n<label> Your Name\n    <span class=\"wpcf7-form-control-wrap\" data-name=\"your-name\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" autocomplete=\"name\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-name\" \/><\/span> <\/label>\n\n<label> Your Surname\n    <span class=\"wpcf7-form-control-wrap\" data-name=\"your-surname\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" autocomplete=\"surname\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-surname\" \/><\/span> <\/label>\n\n<label> Your e-mail\n    <span class=\"wpcf7-form-control-wrap\" data-name=\"your-email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" autocomplete=\"email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"your-email\" \/><\/span> <\/label>\n\n<span class=\"wpcf7-form-control-wrap\" data-name=\"select-683\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"select-683\"><option value=\"Doctor\">Doctor<\/option><option value=\"Pharmacist\">Pharmacist<\/option><option value=\"Nurse\">Nurse<\/option><option value=\"Other\">Other<\/option><\/select><\/span>\n\n\n<label> Data on the person who has experienced the adverse reaction: <\/label>\n\n<label> First and last name initials\n    <span class=\"wpcf7-form-control-wrap\" data-name=\"iniziali\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" autocomplete=\"name\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"iniziali\" \/><\/span> <\/label>\n\n<span class=\"wpcf7-form-control-wrap\" data-name=\"select-448\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"select-448\"><option value=\"F\">F<\/option><option value=\"M\">M<\/option><\/select><\/span>\n<label> Age\n<span class=\"wpcf7-form-control-wrap\" data-name=\"number-404\"><input class=\"wpcf7-form-control wpcf7-number wpcf7-validates-as-number\" aria-invalid=\"false\" value=\"\" type=\"number\" name=\"number-404\" \/><\/span><\/label>\n\n<label>City\n<span class=\"wpcf7-form-control-wrap\" data-name=\"residenza\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"residenza\" \/><\/span><\/label>\n\n<label>PharmaNutra product name\n<span class=\"wpcf7-form-control-wrap\" data-name=\"farmaco\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"farmaco\" \/><\/span><\/label>\n\n<label>Adverse reaction description\n<span class=\"wpcf7-form-control-wrap\" data-name=\"avversa\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"avversa\" \/><\/span><\/label>\n\n<label>Daily dose\n<span class=\"wpcf7-form-control-wrap\" data-name=\"dose\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"dose\" \/><\/span><\/label>\n\n<label>Treatment start date\n<span class=\"wpcf7-form-control-wrap\" data-name=\"data-inizio\"><input class=\"wpcf7-form-control wpcf7-date wpcf7-validates-as-date\" aria-invalid=\"false\" value=\"\" type=\"date\" name=\"data-inizio\" \/><\/span><\/label>\n\n<label>Treatment end date\n<span class=\"wpcf7-form-control-wrap\" data-name=\"data-fine\"><input class=\"wpcf7-form-control wpcf7-date wpcf7-validates-as-date\" aria-invalid=\"false\" value=\"\" type=\"date\" name=\"data-fine\" \/><\/span><\/label>\n\n<input class=\"wpcf7-form-control wpcf7-submit has-spinner\" type=\"submit\" value=\"Submit\" \/>\n\n<\/div><\/div><div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Disclosure pursuant to art. 13 of Legislative decree 196\/2003 Dear Sir\/Madam,in accordance with article 13 of Legislative Decree no. 196 of 30 June 2003 (hereinafter the \u201cDecree\u201d), we hereby inform you about the processing of your personal data by PHARMANUTRA S.p.A. (hereinafter referred to as \u2018PHARMANUTRA\u2019). 1 Purpose of processingYour personal and possibly sensitive data [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-16797","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Reporting form for adverse reactions \u2013 Information and consent - pharmanutra.it<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.pharmanutra.it\/en\/reporting-form-for-adverse-reactions-information-and-consent\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Reporting form for adverse reactions \u2013 Information and consent - pharmanutra.it\" \/>\n<meta property=\"og:description\" content=\"Disclosure pursuant to art. 13 of Legislative decree 196\/2003 Dear Sir\/Madam,in accordance with article 13 of Legislative Decree no. 196 of 30 June 2003 (hereinafter the \u201cDecree\u201d), we hereby inform you about the processing of your personal data by PHARMANUTRA S.p.A. 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