Pharmacovigilance

1. Data Controller and Data Protection Officer
the Data Controller is the Data Controller is Laboratorio Chimico Farmaceutico "A. Sella" S.r.l. (hereinafter also referred to as the "Controller") P. Iva 00161860242, with registered office in Via Vicenza n. 67 36015 Schio (VI). The Controller may be contacted through:
- Email at the addresses privacy@sellafarmaceutici.it (Ordinary mail) or sellafarmaceutici@cert.assind.vi.it (Certified mail);
- Telephone at no. 0445 670088;
- Ordinary mail at the address Via Vicenza n. 67 36015 Schio (VI)
The Controller has not appointed a data protection officer (RPD, or Data Protection Officer, DPO).

2. Data processed and processing methods
The Data Controller will carry out the processing of the following data: A) for the reporter: identification data including first name, surname and contact details (including address, email address, telephone or fax number); B) for the person to whom the report refers: - name and/or initials of the patient; - date of birth / age range, sex, weight, height; - information on health, race or ethnic origin and sexual life; - medical history and health conditions, which might include for example: - details of the Sella product suspected of causing the adverse event, including the dosage taken or prescribed, the reason it was taken or prescribed, and any subsequent change to the usual regimen; - details of other medicines or remedies that are or were being taken at the time of the adverse event, including the dosage taken or prescribed, the duration and reason for taking such medicine and any subsequent change to the regimen; - details of the adverse event that occurred, the treatment received for that event and any potential long-term effect that the adverse event caused to the person's health; other information regarding the medical history deemed relevant by the reporter, including documents such as laboratory reports, medicines taken in the past and previous pathologies. The data may be processed both in paper and digital form using IT tools

3. Purposes of data processing and legal basis
Your data are processed on the basis of the legal bases and for the Purposes indicated below: Reasons of public interest in the field of public health and fulfilment of the legal obligation relating to the collection, analysis and reporting to the competent authorities of adverse reactions to the medicines produced (EU Reg. 1235/2010 and subsequent amendments and additions): A. monitor the safety profile of the products manufactured. B. identification of any known and unknown adverse reactions, also identifying their frequency and impact; C. improvement and enhancement of information on suspected adverse reactions already known; D. assessment of the causal link between administration of the medicine and the observed adverse reaction; E. notification to the competent authority of such information to ensure that the medicines used present a favourable benefit/risk ratio for the population. F. maintain the registers and archives of the documentation relating to Pharmacovigilance, also in view of possible Pharmacovigilance Audit activities; Contractual relationship: G. management and handling of liability charges and claims for compensation, including in court

4. Consequences of failure to provide personal data
The provision of data is necessary; refusal makes it impossible for the Controller to act on the request made, as well as to comply with the legal obligations concerning Pharmacovigilance. The processing of data is lawful as it is based on the fulfilment of a legal obligation (for personal data) and on reasons of public interest in the field of public health (for special data) as indicated in the previous point.

5. Data retention
Starting from their receipt and/or update, the data will be kept for a period appropriate to the purposes of the processing and in any case within the terms of the law. Specifically, personal data will be anonymised within six months of the closure of the case and in any case no later than two years from the date on which the first report was made. The data relating to the pharmacovigilance report in anonymous form will be kept for as long as the product is authorised and for ten years from the expiry or revocation of the marketing authorisation of the product in the last country of marketing, save for any defensive needs of the Controller. In relation to purpose G, retention will take place for the duration of the relationship with the data subject and the limitation period of the rights connected to it.

6. Access and communication of data
The data being processed will not be disseminated; they may instead be made available in anonymous form, for the purposes indicated above, to the parties who access the National Pharmacovigilance Network as well as to parties obliged to carry out Pharmacovigilance activities (AIFA, EMA, holders of the marketing authorisation of medicines, Italian Regions, Local Health Units, the pharmacovigilance office of hospitals or of the Scientific Institutes for Research, Hospitalisation and Healthcare). Your personal data may be processed for the purposes indicated above by: 1. employees and collaborators of the Controller as persons in charge of the processing; 2. Third parties such as professionals, consultants and parties who process data and provide services functional to the purposes indicated above (e.g. IT service providers, IT systems maintainers, financing companies, etc.) in the capacity of data processors or autonomous controllers on whom the Controller relies for the management of the systems or the execution of part of the data processing. The updated list of such parties is available at the company's registered office.

7. Data transfers to third countries
The Controller will not transfer your data outside the European Union.

8. Profiling and dissemination of data
Your personal data are not subject to dissemination nor to any entirely automated decision-making process, including profiling.

9. Your Rights
Among the rights recognised to you, subject to legal limitations, are those to: ask the Controller for access to your personal data, confirmation of their existence and the information relating to their processing including the updated list of data processors; the rectification of inaccurate data or the integration of incomplete data. - obtain the erasure of the data and the restriction of the processing where the legal requirements are met. - Receive in a structured format commonly used and machine-readable the personal data concerning you, where the processing is carried out by automated means, in order to transmit them to another Controller or - if technically feasible - to obtain the direct transmission by the Controller to another controller. - revoke at any time the consents given to the processing of personal data. - object, in whole or in part, to the processing where the legal requirements are met - lodge a complaint with a supervisory authority and in particular with the Italian Data Protection Authority (Autorità Garante per la Protezione dei Dati Personali). The rights may be exercised by sending a written request indicating in the subject "Privacy – exercise of the data subject's rights" by registered letter with return receipt or e-mail to the Controller's addresses indicated above. The full text of EU Reg. 2016/679 – General Data Protection Regulation – may be consulted on the website of the Data Protection Authority and in particular Chapter III – Rights of the data subject – arts. 12 – 23.