Pursuant to art. 13 of Legislative Decree 196/03 and ex art. 13 of EU Reg. 679/2016
Pharmacovigilance consists of specific activities involving the Authorities, the Marketing Authorization Holders of medicinal products, potential distributors and partners, local health units, healthcare professionals, patients and citizens. The citizen’s contribution is essential to ensure the functioning of the pharmacovigilance system, based on the reporting of adverse reactions of medicinal products that the Marketing Authorization Holders have the obligation to register.
This Policy is aimed at clarifying the type of processing of personal data you may send us as well as the rights and duties that derive from such processing. The Data Controller will process personal data only to fulfill the legal obligations relating to pharmacovigilance, ensuring that the treatment will take place, where possible, anonymously.
The purpose of the treatment is the protection of public health and public knowledge of the adverse effects related to medicinal products.
Data Controller: Offhealth S.p.A
Address: Via G. Paisiello 10 – 50144 Firenze, Italy
Contact details: (+39) 055 016 1771 / email@example.com
Data Protection Officer: Maurizio Ghignone
Data Processor: Di Renzo s.r.l.
The personal data received will be processed for all obligations related to pharmacovigilance, namely the detection, evaluation, understanding and prevention of adverse reactions or any other drug-related problem.
The personal data provided may be made available, for the purposes indicated above, to some of the subjects obliged to carry out pharmacovigilance activities (e.g. AIFA, EMA and other competent Authorities, Marketing Authorization Holders, potential distributors and partners, Italian Regions, local health units, pharmacovigilance offices of hospitals or of scientific research and treatment institutes). The personal data collected, associated to an individual, may be processed only for the purpose of verifying the information and recording adverse reaction reports by internal staff of the Data Controller or by partners appointed as Data Processors.
In some circumstances, personal data may be shared with (i) other companies belonging to the same group both in Italy and out of Italy (also outside the EU) in particular for the management of the pharmacovigilance reporting system and for the notification to the regulatory authority in different countries; (ii) subjects to whom the right to access personal data is expressly recognized by legal provisions and / or orders from public authorities (e.g. judicial and / or regulatory authority). In this case, the subjects involved will process your data as independent data controllers, relieving Offhealth S.p.A. of any responsibility.
Such data, only after being made anonymous, will be subsequently shared with the scientific world and all the subjects interested in pharmacovigilance.
There are no automated treatments but only traditional treatment, based on technological means and tools.
LEGAL BASIS OF THE PROCESSING:
For Offhealth S.p.A., pharmacovigilance is first of all an ethical and scientific duty, it is also a precise legal obligation (DL 30 April 2015 – EU Directive 2010/84 – EU Directive 2012/26 – Regulation (EC) n.726 / 2004 – EU Regulation 1235/2010 – EU Implementing Regulation 520/2012), therefore the processing of personal data provided spontaneously is based on the pursuit of purposes of public interest in the health sector.
The provision of personal data for pharmacovigilance purposes on medicines is not mandatory, but represents an act of civilization and responsibility. Failure to provide data could jeopardize the correct functioning of the pharmacovigilance system.
Within the limits and under the conditions set out in articles 15 – 23 of EU Regulation 679/2016 and of the applicable national legislation, you may exercise the following rights:
- Right of access;
- Right to rectification, updating and cancellation;
- Right to object to the processing for legitimate and specific reasons;
- Right to obtain the correction of inaccurate personal data without undue delay;
- Right to obtain the limitation of treatment pursuant to art. 18, paragraph 1 of EU Regulation 679/2016;
- Right to data portability within the limits and in the ways provided for by art. 20 of EU Regulation 679/2016 and the guidelines on data portability;
- Right to lodge complaints with the competent authority.
The retention of personal data for the purposes of internal management of pharmacovigilance obligations is guaranteed for the entire duration of the marketing authorization of the medicinal product concerned by the report and for the following ten years from the moment the authorization lapses. . This time limit is extended indefinitely for scientific and research purposes only.
Pursuant to art. 9, paragraph 2 lett. i) of EU Regulation 679/2016, the personal data provided can be processed without consent.
If you wish, you can consult the Privacy Guarantor (http://www.garanteprivacy.it/) to propose a formal complaint.
Dr. Milad Espahbodinia(firstname.lastname@example.org)
Dott.ssa. Chiara Empiri (email@example.com)
Tel. 06 77209020 Fax. 06 70474067