ESSETI FARMACEUTICI S.r.l., in its role of Marketing Authorization Holder of its own medicinal products – with registered oice located at Via R. De Cesare 7, 80132 Napoli (NA) – and manufacturing plant of medicial products for third customers - located at Via Campobello 15, 00071 Pomezia (RM) – and collectively, in its role of Data Controller (hereinafter Controller), informs you pursuant to art. 13 of New Regulation GDPR (General Data Protection Regulation ) 2016/679 of 27th April 2016 (hereinaer, “GDPR”) that your data will be processed in the following ways and for the following purposes:
1. Subject to processing
The Controller processes personal identification data (ex. name, surname, address, tax code, telephone number) and sensitive data (e.g. data on the health and effects of medicinal products) you have communicated.
2. Purpose of the processing
Your data are processed for the purposes of Pharmacovigilance established by applicable national and community legislation, for example: • identify promptly adverse events and unknown adverse reactions and to quantify frequency and impact; • monitor the safety of a drug in daily practice (Surveillance post-Marketing); • recognize new adverse drug reactions (ADR) as quickly as possible; • improve and broaden information about suspected ADRs or already known ADRs; • evaluate the benefits of a drug on other types of therapy; • evaluate the causality assessment between administration of drug and the observed adverse reaction discover possible pharmacological interactions; • evaluate the data relating to safety reports received and entry in the company’s electronic register relating to spontaneous ADR reports; • maintain registers and the files of pharmacovigilance documentation; • perform or receive Pharmacovigilance audit; • fulfil the regulatory obligation to transmit electronically (via E2B) ADR reports to the European Medicine Agency (EMA) through entry of data into the Eudravigilance system; • fulfil the regulatory obligation to report to the competent authorities, to parties responsible to carry out pharmacovigilance activities, information of ADRs to comply with legal requirements and ensure that the medicinal products used have a favorable benefit/risk ratio for the population.
3. Methods of processing
The processing of your data is realized by means of the operations indicated in art. 4 of GDPR (collection, recording, organization, storage, consultation, processing, selection, extraction, comparison, use, communication, deletion of data). Your data are subject to both paper and electronic processing. The Controller has adopted a wide variety of security measures to protect Personal Data against the risk of loss, abuse or alteration. In particular: has adopted the measures referred to in art. 32 of the GDPR; The Controller uses the technology to encrypt data established by Standard AES (BCrypt). Data is subject to a daily back up and disaster recovery system. The Controller will process the personal data for the time necessary to fulfil the above purposes and in any case for no more than 15 years.