Regulatory and Pharmacovigilance Services

Privacy Pharmacovigilance EU / extra EU

Object of the Data processing

PROGE MEDICA S.r.l. with registered office in Novara, Largo Donegani 4/A 28100 and VAT 01728220037 (hereinafter, “Owner”), as Data Controller and Processor, informs you that it will process your personal data – both identifying (e.g. name, surname, address, telephone, e-mail, etc.) and both related to the state of health – (hereinafter, “Data”) communicated by you.

Processing purposes

The Owner informs you that your Data will be processed for the following purposes:

  • fulfill the pharmacovigilance obligations established by the Italian and European legislation regarding the safety and efficacy of medicines. This legislation requires our Company to provide the Health Authorities with information on possible adverse reactions resulting from use or exposure to one of our medicines;
  • fulfill to requests made by the Health Authorities;
  • with reference to contact Data only, to contact you if we need additional information regarding your health status after the use or exposure to one of our medicines or to answer your further requests;
  • if necessary, to establish, exercise or defend a legal or administrative right.

The processing of Data for the above-mentioned purposes will occur without your express consent as it is necessary to fulfill legal obligations under Articles. 6, c. 1, lett. c) and 9, c. 2, lett. b) of the GDPR or to rely on legitimate interests of the Owner, pursuant to art. 6, c. 1, lett. f) and 9, c. 2, lett. f) of the GDPR.

Processing methods.

  • The processing of your Data will be carried out by means of the operations indicated in art. 4 n. 2) of the GDPR and more precisely: collection, registration, organization, structuring, storage, consultation, processing, modification, selection, extraction, comparison, use, interconnection, communication, cancellation and destruction of data.
  • Your personal Data may undergo a pseudonymisation (separate storage of identified personal data from the personal data relating to health status).
  • Data may be processed using both hardcopy and electronic tools.
  • Your Data will be stored in a protected manner and accessible only to authorized personnel with logic strictly related to the purposes for which the Data are collected and, in any case, in order to guarantee the confidentiality and security by meeting the requirements art. 32 of the GDPR.

Recipients or categories of recipients

  • Your Data will be processed by subjects (employees or third parties) who carry out pharmacovigilance outsourced activities on behalf of the Owner, who have been specifically appointed, authorized and instructed to process your Data for the purposes and in the manner provided by this Privacy Policy.
  • Your data will also be communicated to consultants, physician, experts, insurers and to those who need to know them during a legal or administrative proceeding, when used to establish, exercise or defend a right.

Data transfer

  • Your Data may be transferred to third Countries, even in non-UE Countries, for the pharmacovigilance purposes above described.
  • Your data will be processed on servers, located in Italy, of the Owner and /or third-party companies appointed as Data Processors. In any case, it is understood that the Owner, if necessary, will have the right to move the server location in Italy, within the UE or in a non-UE country as well.
  • The Owner hereby ensures that the transfer of extra UE Data will take place in accordance with articles 44 ss. of the GDPR and with the applicable legal provisions, stipulating, if necessary, agreements guaranteeing an adequate level of protection.

Retention period

  • Your Data will be stored, implementing the security measures imposed by law, in our archives or in those of our IT providers, whose archives could also be located abroad.
  • The retention period will be established from time to time, based on the circumstances and kind of Data, but shall not in any case exceed 30 years.

Opposition right

In your capacity as an interested party, you have the right to object at any time to the processing of your Data made for the pursuit of a legitimate interest of the Owner.
In the event of opposition, your Data will no longer be processed, unless there are no legitimate reasons to proceed with the processing that prevail over the interests, rights and freedoms of the interested party or for the assessment, exercise or defence of a right in a court.

Right to propose a claim to the Guarantor.

In your capacity as an interested party, you may lodge a complaint with the Guarantor for the Protection of Personal Data if you consider that your rights have been violated, in accordance with the GDPR, according to the modalities indicated on the Guarantor website accessible on www.garanteprivacy.it.

Contacts.

You can exercise your rights and request an updated list of data processors at any time by contacting: privacy@progemedica.it