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Pharmacovigilance

Pharmacovigilance is the set of activities aimed at identifying, assessing, understanding and preventing adverse reactions, that is, any adverse and unintended effects that occur as a result of taking a medication.

Reporting adverse drug reactions is critical because it allows prescribers to properly inform physicians who prescribe them, protect patients who take them, and ensure a favorable benefit-risk ratio for the population.

How to report an adverse reaction

  • For the patients

Any adverse reaction or side effect occurring in the course of or following drug therapy should be reported promptly to the health care provider, attending physician, or pharmacist. A suspected adverse reaction can be reported by:

  • Qualsiasi reazione avversa o effetto indesiderato che si verifichi nel corso o in seguito alla terapia farmacologica deve essere segnalato tempestivamente all’operatore sanitario, al medico curante o al farmacista. Una sospetta reazione avversa può essere segnalata da:
  • AIFA’s website for online reporting.
  • For health professionals

Healthcare workers are required to report to the Italian Medicines Agency (AIFA) any adverse event associated with the use of medicines. Practitioners can report a suspected adverse reaction by:

  • the appropriate form available on the website of the Italian Medicines Agency (AIFA) at the link Adverse Reaction Reporting Forms, under “Health Care Practitioner Form.”
  • AIFA’s website for online reporting.

The AIFA portal provides constant updates on pharmacovigilance.

If a patient or physician would like to report any adverse reaction directly to OFFHEALTH or otherwise ask for other drug information, please send an email to the address given in Section 10) of the Pharmacovigilance Information Notice.

Before providing any data and sending the email, please read the information below.

Policy on the processing of pharmacovigilance data in accordance with Article 13 of the European Regulation 2016/679 on the protection of individuals with regard to the processing of personal data (GDPR)

1. Data Controller & Data Protection Officer:

The Data Controller is OFFHEALTH S.p.A. with registered and administrative office in Via Giovanni Paisiello, 10 – 50144 – Firenze (FI)and can be contacted through the email address privacy@OFFHEALTH.it. The Company has identified the Data Protection Officer (DPO) in accordance with Article 37 of the Regulation, who can be contacted for matters concerning the processing of your data, at the following email address: dpo@OFFHEALTH.it

2. Purpose of processing.

The personal data you voluntarily provide will be collected and processed exclusively in connection with pharmacovigilance activities, which the Company is required to perform by law. The data will be collected and processed exclusively for the proper performance of activities related and instrumental to the purposes proper to pharmacovigilance such as, for example: (i) identification of unknown adverse reactions; (ii) improvement and enhancement of information on suspected adverse reactions already known; (iii) assessment of the causal link between. drug administration and the observed adverse reaction; (iv) notification to the competent authority of such information to ensure that the drugs used have a favorable benefit/risk ratio for the population.

3. Legal Basis of Treatment

The legal basis for the processing is identified in the fulfillment of legal obligations under applicable laws and regulations in the field of pharmacovigilance (including DL April 30, 2015 – EU Directive 2010/84 – EU Directive 2012/26 – Regulation (EC) No.726/2004 – EU Regulation 1235/2010 – EU Implementing Regulation 520/2012), to which OFFHEALTH is subject and for reasons of public interest in the field of public health. For this reason, your consent is not required for the processing of your personal data.

4. Nature of processing

The provision of personal data for drug pharmacovigilance purposes is not compulsory, but represents an act of civility and responsibility, necessary for the Company to fulfill the obligations imposed by current regulations. Any refusal could jeopardize the proper handling of the report.

5. Method of Processing and Period of Retention of Data

The processing of the personal data provided may be carried out using manual, computerized and telematic tools, with logic strictly related to the purposes for which the data were collected and in any case suitable to guarantee the security and confidentiality of the data processed. The retention of personal data for purposes of internal management of pharmacovigilance obligations is guaranteed for the entire duration of the marketing authorization of the medicinal product concerned by the report and for ten years after the authorization lapses. This time limit is extended, according to applicable legislation, indefinitely for scientific and research purposes only and/or for anonymized data.

6. Scope of Knowability & Disclosure of Data

The data will be processed by personnel authorized to process them in accordance with Article 29 of the Regulations, as well as communicated to and processed in anonymous form by third parties, for the purposes indicated above, such as subjects accessing the National Pharmacovigilance Network as well as to subjects obliged to carry out pharmacovigilance activities (AIFA, marketing authorization holders of medicines, Italian Regions, Local Health Units, Pharmacovigilance Office of hospitals or Scientifically Characterized Research and Treatment Institutes). The personal data provided may also be communicated, for the above-mentioned purposes, to the following categories of subjects: (i) persons, companies, associations that provide services or activities of assistance and consulting in legal, information technology and control matters with respect to OFFHEALTH Companies; (ii) subjects whose right to access personal data is recognized by provisions of law and/or secondary regulations or orders of public authorities. The subjects belonging to the categories listed above will use the data as autonomous data controllers and in relation to the specific activity carried out, or, in relation to the activity carried out, as data processors in accordance with Article 28 of the Regulations duly appointed by means of a dedicated deed of appointment, indicating the processing methods and the security measures that they will have to adopt for the management and storage of the personal data of which the Company is the Data Controller. The complete list of subjects to whom your personal data have been or may be communicated is available to you upon request to be made by e-mail to the address privacy@OFFHEALTH.it. Please note that the communication of personal data to public or private entities will be made only if required by law or regulation or if it is necessary for the performance of institutional functions.

7. Transfer of Data Abroad

The management and storage of personal data will take place on servers located within the European Union of the Data Controller and/or third party companies appointed and duly appointed as Data Processors. Therefore, the data are not currently being transferred outside the European Union; only anonymized data may be sent outside the European Union. It is in any case understood that the Data Controller, should it become necessary, will have the right to move the location of the servers within the European Union and/or to countries outside the European Economic Area (EEA). In this case, the Data Controller assures as of now that any transfer of data outside the EEA will take place in accordance with Articles 44 ff. of the Regulations and the applicable legal provisions by entering into, if necessary, agreements that guarantee an adequate level of protection, including standard contractual clauses and any additional guarantees provided by the European Commission.

8. Rights of the Interested Parties

We inform you, with reference to the data processed by the Company, you may exercise at any time, by written request to be sent to the e-mail address: privacy@OFFHEALTH.it , the rights set forth in Articles 15 to 22 of the GDPR:

  • Right of access;
  • Right to rectification, updating and deletion
  • Right to object to processing for legitimate and specific reasons;
  • Right to obtain rectification of inaccurate personal data without undue delay.
  • Right to obtain restriction of processing under Article 18(1) of EU Regulation 679/2016;
  • Right to data portability to the extent and in the manner provided by Article 20 of EU Regulation 679/2016 and the guidelines on data portability;
  • Right to bring complaints to the competent authority. The data controller shall provide you with information regarding the action taken regarding the request under Articles 15 to 22 without undue delay and, in any case, no later than one month after receipt of the request. This period may be extended by two months if necessary, taking into account the complexity and number of requests. The data controller shall inform the data subject of such extension, and of the reasons for the delay, within one month of receipt of the request.

9. Complaints

If you wish, you may consult the Privacy Guarantor (http://www.garanteprivacy.it/) to propose a formal complaint.

10. Provider contacts for Pharmacovigilance:

E-mail: pharmacovigilance@direnzo.biz Dr. Milad Espahbodinia(m.espahbodinia@direnzo.biz) Dr. Chiara Empiri (c.empiri@direnzo.biz) Tel. 06 77209020 Fax. 06 70474067

OFFHEALTH Spa

Date last updated 03/05/2024