Policy on treatment of personal data for pharmacovigilance purposes
Pharmacovigilance includes a series of activities in which different parties are involved: Competent Authorities, Marketing Authorization Holders (MAHs) of medicinal products, any Third Party involved in the management of pharmacovigilance or in the promotion and/or distribution and/or sale of medicinal products, health facilities, healthcare professionals and individual citizens and patients. The contribution of citizens and patients in reporting adverse reactions to a medicinal product is essential to ensure the functioning of pharmacovigilance activities.
This Policy is aimed at clarifying the type of processing of the personal data sent by you as well as the rights and duties deriving from the processing. In summary, any personal data will be processed solely to fulfill the legal obligations relating to pharmacovigilance, ensuring that the processing will take place, where possible, anonymously.
Di Renzo, as pharmacovigilance Provider, acts as Data Processor in charge of the processing of personal data for pharmacovigilance purposes on behalf of various Companies, which in turn act as Data Controllers. Di Renzo processes the personal data in accordance with the GDPR, the Agreements in place with such Companies, the present Policy on processing of personal data and applicable Standard Operating Procedures on the topic.
PURPOSE
The personal data received will be processed for all obligations related to pharmacovigilance, that is, the collection, evaluation and analysis of reports of adverse reactions or any other drug-related safety problem, and the preparation of pharmacovigilance documents required by the legislation.
RECIPIENTS
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, MAHs of medicinal products, Third Parties involved in the management of pharmacovigilance or in the promotion and/or distribution and/or sale of medicinal products, health facilities, etc.).
In some circumstances, for the purposes indicated above, personal data may be shared with subjects located outside Italy or the European Union. In these situations, taking into account the Agreements with the Companies, every agreed measure will be adopted in order to guarantee an adequate level of protection of personal data.
There are no automated treatments but only traditional treatment, based on technological means and tools.
LEGAL BASIS OF THE PROCESSING
Pharmacovigilance is a necessary activity for the protection of public health and is therefore provided for by the legislation (in particular: DL 30 April 2015, EU Directive 2010/84, EU Directive 2012/26, Regulation (EC) 726/2004, EU Regulation 1235/2010, EU Implementing Regulation 520/2012, Good Pharmacovigilance Practices), 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 is not mandatory, but represents an act of civility and responsibility.
RIGHTS
Within the limits and under the conditions set out in Articles 15 – 23 of EU Regulation 679/2016 and of the applicable Italian 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.
Di Renzo collaborates with the Companies for which act as Data Processor for pharmacovigilance purposes, in order to guarantee the aforementioned rights.
STORAGE
The retention of personal data for the purpose of managing pharmacovigilance obligations is guaranteed for the period of collaboration between Di Renzo and the Companies for which acts Data Processor for pharmacovigilance purposes, and in accordance with the Agreements in place with such Companies.
CONSENT
Pursuant to art. 9, paragraph 2 lett. i) of EU Regulation 679/2016, the personal data provided can be processed without consent.
COMPLAINT
If you wish, you can consult the Privacy Guarantor (http://www.garanteprivacy.it/) to propose a formal complaint.
