In accordance with Art. 4 paragraph 7 of the GDPR,  the “DATA CONTROLLER” is the company PHARMA LINE S.r.l., with registered office in Milan – Via Agostino Bertani 2 – Tel 0376 329660 – Fax 02 700503129 – E-mail info@pharma-line.it, C.F. E P.IVA 01492260201, (hereinafter, ‘Data Controller’).

The ‘DATA PROTECTION OFFICER’ (DPO) is Matteo Majocchi of law firm “WE-BRIDGE Tax Legal Compliance”, who can be reached at the following e-mail address: dpo@pharma-line.it

DATA PROVIDED
Personal and contact data (such as name, surname, telephone number and e-mail address) of the Reporter. Health-related data of Patient, whose identity should, however, remain anonymous. Where the identity of the Reporter coincides with the identity of the Patient, this circumstance will not have to be disclosed within the report.

PROCESSING  METHODS
The data will be processed in accordance with the regulatory framework of reference, using both analogue and IT tools, in compliance with the security measures laid down in Regulation (EU) 679/2016. 

PURPOSES OF DATA PROCESSING
Our Pharmacovigilance obligations require us to collect and manage reports of adverse reactions and/or side effects related to products marketed by Pharma Line S.r.l. We will process the data contained in the report (including any special categories of data ex art. 9 GDPR) for the purpose of managing the reports and providing feedback to the Reporter.

LEGAL BASES FOR THE PROCESSING

Fulfilment of a legal obligation
(art. 6 (1)(c) – art. 9 (2)(b) of GDPR)
Reasons of public interest in the area of public health
(art. 9 (2)(i) of GDPR)

PROVISION OF DATA
Failure to provide the requested data will result in the inability to manage reports and provide feedback

STORAGE PERIOD OF YOUR DATA
Your data will be stored only for the period of time necessary to process the data for the purposes for which they are processed. PHARMA LINE S.r.l. will delete data provided upon expiry of a ten years period, as sets forth by the law.  

DATA SHARING
Data provided will be processed exclusively by persons authorised to process and appropriately instructed, as well as by processors linked to the Data Controller by a specific contract (Art. 28 of EU Regulation 679/16). The data will be processed only for the purposes pursued. Therefore, the authorized persons will process the data only where strictly necessary. Your data will be not disclosed to any countries outside the European Union.

RECIPIENTS OF DATA

Your data may be communicated to the Regulatory Authorities, in relation to a suspected adverse event, in accordance with pharmacovigilance regulations.

Personal data may be disclosed to the company Clinpharma S.r.l., with registered office in S. Sebastiano al Vesuvio (NA), Via Fellapane n. 17, for the provision of pharmacovigilance services.

Personal data may also be disclosed to other pharmaceutical companies that are our partners, where pharmacovigilance obligations for a product require the exchange information in the field of security. These entities will process the data as autonomous data controllers.

DATA SUBJECTS RIGHTS

In your quality of data subject, you shall exercise certain rights. In particular, you have the following rights toward Pharma Line S.r.l.: right of access; right of rectification; right to erasure or to be forgotten; right to restriction of processing; right to data portability; right to object; right to obtain a copy of the safeguards.

You always have the right to lodge a complaint with the Data Protection Authority.