Information pursuant to Regulation (EU) 679/2016
We inform you, pursuant to Regulation (EU) 679/2016 on the protection of personal data, that your data will be processed in compliance with the aforementioned legislation and the confidentiality obligations which inspire the activity of our company , referred to in Art. 6(1.a), 9 (2.i) and considering the Art. 54.
The Data Controller of personal data is ABC Farmaceutici S.p.A., with registered office in Corso Vittorio Emanuele II, 72 – 10121 Turin, Italy. ABC Farmaceutici S.p.A. has appointed the company Spaziottantotto S.r.l. as Personal Data Protection Officer (DPO). with registered office in Turin (TO), C.so Ferrucci 77/9 – CAP 10138. The DPO can be contacted at the following email address: email@example.com
Purpose of the processing
The personal data that you provide will be collected and processed exclusively in relation to pharmacovigilance activities, which the company is required to undertake in compliance with European Regulation 1235/2010 and Directive 2010/84/EU.
The processing of personal data will take place on the basis of compliance with a legal obligation (art. 6, par. 1, letter c) of the GDPR) and on the fulfillment of a task of public interest (art. 6, par. 1 , letter e) of the GDPR) found in the circulation of safe and reliable medicines.
The report may contain information relating to the state of health.
These particular categories of personal data will be processed by the Data Controller to guarantee the public interest in the public health sector and guarantee the safety of medicines, pursuant to article 9, par. 2, letter. i) of the GDPR.
The processing is also based on the granting of consent by the interested party to the processing of personal data pursuant to article 6, par.1, letter. a) of the GDPR for the purposes of recontact by the designated personnel of ABC Farmaceutici S.p.A. with the aim of investigating any elements of the report provided. The provision of personal data is optional, but failure to provide it will jeopardize the possibility of proceeding with the recontact.
The data will be collected and processed exclusively for the adequate implementation of pharmacovigilance activities such as, for example:
- Identification of any adverse reactions;
- Improvement and strengthening of information on suspected adverse reactions already known;
- Evaluation of the causal link between drug administration and the adverse reaction observed;
- Notify the competent authority of this information to ensure that the medicine used continues to present a favorable benefit/risk balance for the population.
The quality and completeness of the information collected as part of the spontaneous reporting are fundamental for the proper functioning of the pharmacovigilance system.
The data is collected by adopting security measures to guarantee maximum confidentiality.
No processing operations involving automated decision-making (e.g. profiling) will be carried out.
Communication of data to third parties
The data provided could be made available, in pseudonymized form, for the purposes indicated above, to the subjects responsible for carrying out pharmacovigilance activities (AIFA, companies holding the marketing authorization for the medicinal product, companies responsible for the quality of the medicinal product or that manage the pharmacovigilance system of the medicinal product, Italian regions, local healthcare companies, pharmacovigilance offices of hospitals or scientific research and treatment institutes).
Transfer of data outside the European Union
It is specified that, in relation to pharmacovigilance activity, personal data in pseudonymized form could be transferred to competent authorities outside the European Union, to fulfill legal obligations.
Data retention period
The data collected for the purposes covered by this information will be kept for up to ten years from the disposal of the medicinal product, in accordance with legal obligations regarding pharmacovigilance.
Rights of interested parties
The subjects to whom the personal data refer have the right, at any time, to obtain confirmation of the existence or otherwise of the same data and to know its content and origin, verify its accuracy or request its integration or update, or rectification (from Art. 15 to Art. 20).
The interested party also has the right to obtain, pursuant to Regulation (EU) 679/2016:
- The updating, rectification or, when interested, integration of the data;
- The cancellation, transformation into anonymous form or blocking of data processed in violation of the law, including those whose retention is not necessary in relation to the purposes for which the data were collected or subsequently processed. It is specified that, in accordance with Art. 17 (3), deletion cannot apply to pseudonymised data, the processing of which takes place for reasons of public interest in the public health sector, in order to fulfill regulatory obligations;
- The certification that the operations referred to in points 1) and 2) have been brought to the attention, also with regard to their content, of those to whom the data have been communicated or disseminated, except in the case in which this fulfillment proves impossible or involves a use of means that is manifestly disproportionate to the protected right.
The interested party has the right to object, in whole or in part, for legitimate reasons, to the processing of personal data concerning him, even if pertinent to the purpose of the collection. The interested party also has the right to request the portability of their data pursuant to Art. 13 of the Regulation.
How to exercise your rights
Requests should be sent via e-mail to the address firstname.lastname@example.org