INFORMATION NOTE pursuant to art. 13 of L. Decree 196/03 and art. 13 of EU Reg. 679/2016

Pharmacovigilance includes a series of activities which involve the competent Authorities, the Holders of the marketing authorisation for medical products, any dealer and distributor, local health facilities, health personnel and individual citizens. The citizen's contribution is essential to ensure the functioning of the pharmacovigilance system linked to the reporting of adverse reactions of a medicinal product that the Marketing Authorisation Holder of the medicinal product is required to record.

This information note seeks to clarify the type of personal data collected and the way in which it is processed. In summary, the Data Controller will process the data only to fulfil the legal obligations concerning the pharmacovigilance, assuring you that the processing will take place, where possible, anonymously.

The purpose of the processing is the protection of public health and the public knowledge of adverse effects related to medicinal products.

Data Controller: Pharmacare S.r.l.

Processor: Di Renzo s.r.l.

PURPOSE OF PROCESSING

The personal data sent will be processed for the sole purpose of fulfilling the obligations concerning the pharmacovigilance, i.e. the detection, assessment, understanding and prevention of adverse reactions or of any other drug-related issue.

The data will then be processed for scientific research purposes.

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, Holders of the marketing authorisation for medicinal products, any sales dealers and distributors, Italian Regions, Local Health Authorities, Pharmacovigilance Office of hospitals or of Scientific Research and Treatment Institutes). The data collected, in a personal form and associated with an individual, may be processed only for the purpose of verifying information and for recording reports by the internal staff of the controllers/joint controllers or by technical partners appointed as data processors.

Solely after being made anonymous, said data will subsequently be shared with the scientific world and with all the subjects interested in pharmacovigilance.

There is no automated processing but only traditional ones, based on technological means and tools.

LEGAL BASIS FOR PROCESSING

For Pharmacare, pharmacovigilance is an ethical and scientific duty as well as a precise legal obligation (L. Decree 30 April 2015 - EU directive 2010/84 - EU directive 2012/26 - Regulation (EC) n. 726 / 2004 - EU regulation 1235/2010 - Implementation Regulation (EU) 520/2012), therefore the processing of personal data provided spontaneously is based on the pursuit of public interest objectives in the public health sector.

The provision of personal data is voluntary, but failure to provide it could jeopardise the correct performance of pharmacovigilance activities.

GUARANTEES

The data subjects involved in the processing of their data have the right to access these, to obtain confirmation of their existence as well as a copy of the same, to request and obtain the correction of the content or the cancellation, to object to the processing or to request that it be limited. The exercise of any other statutory rights is guaranteed, such as the portability of the data itself.

RETENTION

The retention of personal data for the purposes of internal management of the pharmacovigilance obligations is ensured for the entire duration of the marketing authorisation of the medicinal product affected by the report and for the ten years subsequent to the moment when the MA lapses. This time limit is extended indefinitely for scientific and research purposes only.

CONSENT

The data provided may be processed without the data subject’s consent to the processing pursuant to art. 9, paragraph 2 letter i) of EU Regulation 679/2016.

COMPLAINT

If you wish, you can consult the Italian Data Protection Authority website (http://www.garanteprivacy.it/) to lodge a formal complaint.

MANDATORY PROVISION

The provision of personal data for pharmacovigilance purposes as regards medicinal products is not mandatory by law but is an act of civility and responsibility. Any information regarding pharmacovigilance can be useful to ensure greater safety for all. Failure to provide it has no consequences of any kind.