Legal

Information on the processing of personal data

The purpose of the following privacy policy of Pierrel S.p.A. (“Pierrel” or, also, the “Company”)Ā Ā is to describe the management methods of the website with particular reference to the purposes and methods by which the personal data of the users who consult it are collected, recorded and used; this document refers exclusively to the websiteĀ www.orabloc.com,Ā Ā (hereinafter also the “Orabloc website”) and not to other websites that may be consulted by the user through links on the pages of the aforementioned website.

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The Pierrel website is controlled and managed by Pierrel, the Data Controller of the personal data collected there, with headquarters in Strada Statale Appia 7bis, 46/48, 81043 Capua (CE) – Italy. This privacy policy, aimed at those who interact with Pierrel website, has the objective to meet the requirements of EU Regulation no. 679/2016 concerning the protection of individuals with regard to the processing of personal data, as well as the free circulation of such dataĀ (the “Regulation”) and Legislative Decree n. 196/2003 (“Privacy Code”) and is also inspired by Recommendation no. 2/2001 that the European authorities for the protection of personal data, gathered in the Group established by art. 29 of the Directive n. 95/46 / EC, adopted on May 17, 2001, in order to identify some minimum requirements for the collection of personal data online; in particular, the methods, timing and nature of the information that the data controllers must provide to users when they connect to web pages, regardless of the purpose of the connection.

The Regulation sets out a series of requirements aimed at ensuring that the processing of personal data is carried out in compliance with the rights, fundamental freedoms and dignity of individuals, with particular reference to confidentiality and personal identity.

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Types of data processed

Navigation data

The computer systems and software procedures used to operate the Orabloc website acquire, during their normal operation, some personal data whose transmission is implicit in the use of Internet communication protocols.

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This is information that is not collected to be associated with identified interested parties, but which by their very nature could, through processing and association with other data, allow users to be identified.

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This category of data includes the IP addresses or domain names of the computers used by users who connect to the Orabloc website, the URI (Uniform Resource Identifier) addresses of the requested resources, the time of the request, the method used to submit the request to the server, the size of the file obtained in response, the numerical code indicating the status of the response given by the server (successful, error, etc.) and other parameters relating to the operating system and the user’s IT environment.

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Finally, the navigation data may possibly be used to ascertain illegal activities, such as in cases of computer crimes, to the detriment of the Orabloc website.

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Ā Data voluntarily provided by the user

The optional, explicit and voluntary sending of e-mails to the addresses indicated on the Orabloc website in order to obtain informative material or submit a job application to Pierrel or receive the Company’s newsletters, entails the subsequent acquisition of the sender’s address, necessary to respond to requests, as well as any other personal data included in the message. These data will be processed and used by Pierrel, in compliance with the provisions of the Regulations and the applicable Italian legislation on the protection of personal data, for the time strictly necessary to provide the requested information and/or the requested service or evaluate the applications. presented, the latter as specified below. Finally, we specify that, without prejudice to the optional nature of providing data, not providing them has the consequence of not allowing Pierrel to provide the services requested by the user.

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D)Ā  Data provided voluntarily by health professionals and distributors for complaints related to the use of a Pierrel product

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The processing of personal data of healthcare professionals and distributors provided voluntarily for complaints related to the use of a Pierrel product, finds legal basis: (i) in the performance of the pharmacovigilance and safety oversight of medical devices, to which Pierrel is bound by law; (ii) in the pursuit of its own or third-party “legitimate interests”, for example for the purposes of handling any disputes, disputes, complaints, as well as the protection of its information systems, as well as to comply with the provisions of applicable law and regulations.

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The data will be collected and processed exclusively for the proper implementation of activities related and instrumental to the purposes of pharmacovigilance and supervision of the safety of medical devices, such as: (i) identification of any adverse reactions/side effects not known; (ii) improvement and enhancement of information on suspected adverse reactions/side effects already known; (iii) notification to the competent authority; and (iv) monitor the benefit/risk ratio and ensure that it is favourable for the population.

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As required by law, Pierrel will make available, for the purposes indicated above, personal data provided by health professionals and distributors to persons accessing the European Pharmacovigilance Network and to persons obliged to carry out pharmacovigilance activities or supervision on the safety of medical devices (National Drug Agencies, Competent Authorities, Marketing Authorisation Holders, Regional Pharmacovigilance Centres, Manufacturers, Distributors) that process the data in full autonomy.

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The provision of data is optional and any refusal to provide such data has no consequence.

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Third party data

If the user provides personal data of third parties, such as those of family members or friends, they must be sure that these subjects have been adequately informed and have consented to its processing in the manner described in this privacy policy.

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Data of minors under the age of 16

If the user is under the age of 16, they cannot provide any personal data nor can they register on the Pierrel website, and in any case the Company assumes no responsibility for any false statements provided by the user. If Pierrel becomes aware of the existence of untruthful statements, it will proceed with the immediate cancellation of any personal data acquired.

Further information

  1. The user’s personal data will be accessible to natural persons designated by the Company in charge of processing, as well as to people who perform certain services for the Company specifically appointed as data processors pursuant to art. 28 of the Regulation. The data may be disclosed to subsidiaries and/or affiliates and/or companies that are part to the same group as Pierrel and the same will not be used by the Company for other purposes, even located outside the European Union in compliance with the Regulations and applicable legislation.
  2. As required by law, Pierrel will make available, for the purposes indicated above in the previous letter D), Your personal data to subjects who access the European Pharmacovigilance Network as well as to Subjects obliged to carry out pharmacovigilance activities or supervision on the safety of medical devices (National Drug Agencies, Competent Authorities, Marketing Authorisation Holders of Medicinal Products, Regional Pharmacovigilance Centres, Manufacturers, Distributors) which process the data in full autonomy.
  3. The user’s personal data will be processed in compliance with the security measures imposed by the Regulations and by the applicable Italian legislation in order, in particular, to guarantee their security and to prevent data loss, illicit or unauthorized use, meaning unauthorized access.
  4. If Pierrel decides to change this privacy policy, these changes will be published on the Orabloc website so that the user can always have access to the updated version of the same.
  5. The user can contact the Data Controller to assert the rights listed below by sending a communication to the following email address [privacy@pierrelgroup.com].

Rights of interested parties

Pursuant to the Regulation, the subjects to whom the data that will eventually be processed refers have the right to obtain access to their personal data and the following information at any time:

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  1. the purposes of the processing;
  2. the categories of personal data in question;
  3. the recipients or categories of recipients to whom the personal data have been or will be communicated, in particular if they are recipients of third countries or international organizations;
  4. when possible, the retention period of the personal data envisaged or, if not possible, the criteria used to determine this period;
  5. the existence of the right of the interested party to ask the data controller to rectify or delete personal data or limit the processing of personal data concerning him or to oppose their treatment;
  6. the right to lodge a complaint with the Guarantor for the Protection of Personal Data to assert their rights;
  7. if the data are not collected from the data subject, all available information on their origin;
  8. the existence of an automated decision-making process, including profiling referred to in Article 22, paragraphs 1 and 4, of the Regulation and, at least in such cases, significant information on the logic used, as well as the importance and expected consequences of this treatment for the interested party;
  9. the portability of personal data.

Requests can be sent to the e-mail address:Ā [privacy@pierrelgroup.com].

Data Protection Officer

The contact details of the Data Protection Officer (“DPO”) of Pierrel, based in [Capua (CE), Strada Statale Appia 7bis, 46/48],: tel. [0823626111] – email [dpo@pierrelgroup.com].