Reporting form for adverse reactions – Information and consent

Disclosure pursuant to art. 13 of Legislative decree 196/2003

Dear Sir/Madam,
in accordance with article 13 of Legislative Decree no. 196 of 30 June 2003 (hereinafter the “Decree”), we hereby inform you about the processing of your personal data by PHARMANUTRA S.p.A. (hereinafter referred to as ‘PHARMANUTRA’).

1 Purpose of processing
Your personal and possibly sensitive data (such as name, surname, address, telephone numbers, e-mail, event description …), directly provided by you and collected through the registration form on this website, will be collected and processed exclusively for the proper implementation of activities related to and instrumental to the purposes of pharmacovigilance such as, for example: identification of any unknown adverse reactions; improvement and enhancement of the information on suspected adverse reactions already known; assessment of the causal link between the administration of the medicinal product and the observed adverse reaction; notification to the competent authority of such information to ensure that the medicinal products used have a favourable risk/benefit ratio for the population.

2 Methods of processing
The personal data you provide will be processed both through the use of paper tools and computer and telematic tools.

3 Provision of data
The provision of data is optional, although any refusal involves the impossibility for the owner to follow up on its reports or requests.

4 Communication and dissemination
The data will be processed by employees and collaborators of Pharmanutra spa and its associated companies as persons in charge and / or responsible for processing. In order to achieve the purposes indicated above, your personal data will be organized in special databases at PHARMANUTRA and will be made available, again for the purposes indicated above, to subjects who access the National Pharmacovigilance Network as well as to subjects obliged to perform pharmacovigilance activities (AIFA, marketing authorization holders of medicines, Italian Regions, Local Health Authorities, Pharmacovigilance offices of hospitals or Clinical Research Hospitals). The personal data provided may also be communicated, for the purposes indicated above, to the following categories of persons: persons, companies, associations that provide services or activities relating to assistance and advice on legal matters and pharmacovigilance towards the company Junia Pharma with which the same has entered into special confidentiality agreements under the law 196/2003. The data may also be communicated to the competent authorities, according to the terms of the law. Personal data will not be disclosed.

5 Rights of the interested party
In relation to the processing of their personal data you have the right to exercise the rights referred to in Article 7 of Legislative Decree 196/2003, reproduced in full here, by sending a communication to the following e-mail address: info@pharmanutra.it

6 Duration of storage 
The data will be kept for the time strictly necessary for the above purposes and in accordance with the terms of the law and in any case for a period not exceeding one year if in the meantime the right of opposition is not exercised by the person concerned.

7 Data controller The data controller is PHARMANUTRA S.p.A, via Campodavela n°1 56122 PISA – P.IVA 01679440501.
Latest update: 30/07/2024

I give my consent for the processing of any sensitive data necessary to carry out the purposes indicated in the information.