Information notice pursuant to Section 13 of the Italian Legislative Decree No. 196/2003
A. Menarini I.F.R. takes the requestor’s (“Data Subject”) privacy very seriously and commits to respect it to the best of its ability. This information notice is provided pursuant to Section 13 of the Italian Legislative Decree No. 196/2003, as amended (the “Italian PDPA”) and applies to personal data voluntarily provided by the requestor (“Data Subject”).
The Data Controller is A. Menarini Industrie Farmaceutiche Riunite s.r.l. (“Menarini or “Company” ), with registered offices in Florence (Italy) via dei Sette Santi 1/3 50131. The Data Processor is the Director in charge of the Corporate Medical Department of the Company
Purpose and Methods of Data Processing
The Menarini Group fully support responsible sharing of clinical trial data for legitimate, proofed scientific research purposes. Consistently with the Principles for Responsible Clinical Trial Data Sharing, upon request from qualified scientists and medical researchers, the Menarini Group is committed to share with such researchers clinical trial data from its sponsored trials in patients regarding medicines and indications approved in Europe and US. The Company shall process personal data that the requestor has provided for the sole purpose of processing his/her request to access to the information on the clinical studies sponsored by the Menarini Group according to the principles set forth in the “Principles for Responsible Clinical Trial Data Sharing” (“Purpose”).
Requestor’s personal data shall be processed in both paper and electronic form. Data are entered into the Company information system in compliance with the Italian PDPA and according to profiles of security and confidentiality. To confirm requestor’s identity, requestor will receive an email including username and password as soon as the registration has been processed. Pursuant to Section 11 of the Italian PDPA, data are retained for the time strictly necessary to achieve the Purpose.
Types of Data Processed
Providing all the data requested, fax number excluded, is essential for the Company to process / follow up Data Subject’s requests: Data Subject’s refusal to provide such data will not allow the Company to process / follow up his/her request. Moreover, if the requestor provide Menarini with personal data of third party individuals (“3rd Party Individual Data”), the requestor declares and warrants that: (i) any 3rd Party Individual Data which he/she may provide to Menarini, is legitimate and accurate, (ii) the requestor is validly acting on behalf of the 3rd party individual and (iii) the requestor have the authority of the 3rd party individual to provide the 3rd Party Individual’s Data to Menarini and for Menarini to collect, use, disclose and process such personal data for the Purpose described above.
Access to Data Subject’s Personal Data
Data Subject’s personal data will be accessible only to the personnel in charge of data processing to follow up your request within the Company, including the members of the Independent Review Committee.. Data may be disclosed to other employees of the Company as well as of the other companies of the Menarini Group for the same purposes as stated above and/or for administrative purposes, pursuant to Section 34, Paragraph 1-ter, of the Italian PDPA. Data Subjects’ request and or personal data may be communicated to Company’s Licensor/Licensee which may be entitled/interested to know/follow up/reply to the Data Subject’s request. Without prejudice for the provisions of the above paragraph, Data Subject’s personal data are not communicated to third parties, be it natural or legal persons, and they will not be disseminated in any other manner or form.
Rights of Data Subject
Data Subject may at any times exercise the rights foreseen by Section 7 of the Italian PDPA, including the right to receive confirmation of the existence of his/her personal data within the Company, the right to check the content, the source and the accuracy of the data, and/or to request that personal data are updated, erased and/or de-identified, if unlawfully processed, as well as the right to stop the processing of data for any legitimate reasons. At any times, Data Subject may apply the Data Controller via registered letter to be sent to the above address, as well as via email to ScientificSecretariat@menarini.it to receive information on the processing of personal data by the Company, to exercise the rights as established by the Italian PDPA, as well as to receive the updated list of personnel to whom data are accessible.