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To report an adverse drug reaction

Complying with Article 13 of the Italian Code of Protection of Personal Data (Decree of Law no. 196/2003), Italfarmaco S.p.A. wishes to informs you about the processing of personal data provided by you on an optional basis via spontaneous reporting within the pharmacovigilance system.

1. Data processing purpose.

The personal data will be collected and processed exclusively for the purpose of pharmacovigilance, i.e. to fulfill the obligations imposed to Italfarmaco S.p.A. from Italian and European legislation on the safety of drugs. The legislation imposes to Italfarmaco S.p.A. to report to the Health Authorities any possible adverse reactions arising from use or exposure to a drug of Italfarmaco S.p.A. and to answer any requests by the Competent Authorities; The reactions are reported - usually - only indicating the initials and year of birth of the subject, and, with your specific consent, to contact you if necessary, and to reply to any further requests.

2. Consent to processing your data

The communication of your data to Italfarmaco S.p.A. is optional. For the purposes of paragraph 1, the processing of your personal data is subject to your written consent.
By giving your consent, Italfarmaco S.p.A is entitled to transmit to the Health Authority your data with respect to the purposes referred to in paragraph 1. In case of no consent, Italfarmaco S.p.A. will not be able to process your personal data for the above purposes.

3. Personal Data Processing

Your data will be processed by means of computer and telematic tools, or by manual elaboration, strictly related to the purposes for which the data was collected suitable for ensuring the security and confidentiality of the data processed.
In particular, personal data processed for the purposes referred to in paragraph 1 will be stored in Italy in the pharmacovigilance safety database of Italfarmaco S.p.A..

4. Communication scope, dissemination of data

The processing of your personal data is carried out by internal staff of Italfarmaco S.p.A. to this end appointed as "responsible" for the treatment.
Collected data may also be made available and processed by third parties, external treatment managers or self-owners, namely:

  • the Health Authorities responsible for pharmacovigilance;
  • companies carrying out maintenance services for IT systems of Italfarmaco S.p.A.;
  • the licensees or licensors of the medicinal product being reported in Italy and abroad, including outside the EU.

Personal information will not be disclosed in any way.

Personal data collected will be stored for the period of time required, in accordance with current regulations.

5. To exercise access rights under Article 7

It is possible to exercise the rights under Article 7 of Legislative Decree 196/2003, which follows, requesting at any time information on the processing of personal data made by Italfarmaco S.p.A., and to oppose the treatment in the cases prescribed by law, addressing the request to:
Italfarmaco S.p.A.
Via dei Lavoratori, 54
20092, Cinisello Balsamo (MI)

6. Personal Data Collection Handler

Italfarmaco S.p.A.
Via dei Lavoratori, 54
20092, Cinisello Balsamo (MI)

7. Responsible for data processing

Dr. Margherita D’Antuono
Responsabile del Servizio di Farmacovigilanza
Italfarmaco S.p.A.
Via dei Lavoratori, 54
20092, Cinisello Balsamo (MI)

For information purposes and as required by applicable law, here blow is reported the full text of Article 7 of Legislative Decree 196/2003.

ARTICLE 7 DECREE OF LAW No. 196 OF JUNE 30, 2003
(Right of access to personal data and to other rights)

  1. The concerned person has the right of obtaining the confirmation of the existence or less of personal data concerning him/herself, even though not yet recorded, and their communication in an intelligible form.
  2. The concerned person has the right of obtaining the indication:
    1. of the origin of personal data;
    2. of the purposes and modes of the handling;
    3. of the logics applied in case of handling performed with the aid of electronic instruments;
    4. of the identification particulars of the holder, person in charge and representative appointed in compliance with Article 5, Subsection 2;
    5. of the subjects or categories of subjects to whom the personal data may be communicated or who can be informed in quality of designated representative in the territory of the State, of responsible persons or persons in charge.
  3. The concerned person has the right of obtaining:
    1. the updating, rectification or, when he/she is concerned, the integration of data;
    2. the cancellation, conversion into an anonymous form or the blockade of data handled in infringement of the law, including those data whose storage is necessary in relationship to the purposes for which these data have been collected or later handled;
    3. the statement that the operations mentioned under letters a) and b) have been brought to the knowledge, also concerning their content, of those to whom data have been communicated or widespread, save the case that this fulfillment is found to be impossible or involves an employ of means overtly disproportionate versus the protected right.
  4. The concerned person has the right of opposing, fully or partly:
    1. due to legitimate reasons, to the handling of personal data concerning his/her person, though pertinent to the purpose of the collection;
    2. to the handling of personal data concerning him/herself to send advertising material or direct sale or to perform market surveys or commercial communication.
Having reviewed the information notice on data handling in compliance with Article 23 of the Decree of Law 196/2003, the undersigned, as the concerned parent or legal guardian of the concerned person, in references to the subjects listed in the above mentioned information notice and with reference to the stated purpose at paragraph 1 disclosure, and in particular for pharmacovigilance.

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