Notice under Article 13 of EU Regulation 2016/679 for Pharmacovigilance Reports Submitted via the Website

Pursuant to Article 13 of EU Regulation 2016/679 on personal data protection, we inform you that the processing of your personal data, including those belonging to special categories under Article 9 of EU Regulation 2016/679, will be carried out in accordance with the principles of fairness, lawfulness, and transparency, respecting your right to privacy.

The processing of your personal data (name, surname, address, telephone number, email) and health-related data (Article 9 EU Regulation 2016/679), provided by telephone, email, or fax, has the following purposes:

- Spontaneous reports of suspected adverse drug reactions and related inquiries from the Medical/Pharmacovigilance Department staff, in compliance with Italian pharmacovigilance regulations, submitted to L. MOLTENI & C. dei F.lli Alitti Società di Esercizio S.p.A..
- Requests for information or clarifications regarding MOLTENI drugs sent to L. MOLTENI & C. dei F.lli Alitti Società di Esercizio S.p.A..

For the purposes mentioned above, data processing may occur through paper-based, electronic, and telematic tools, always ensuring the utmost confidentiality, relevance, and proportionality in terms of data registration and retention periods.

The processing will comply with the security measures provided under Article 32 of EU Regulation 2016/679 to safeguard the confidentiality, integrity, and completeness of the processed data.

For the same purposes, data may be processed by the following categories of personnel and/or managers: PHARMACOVIGILANCE DEPARTMENT and MEDICAL DEPARTMENT of L. MOLTENI & C. dei F.lli Alitti Società di Esercizio S.p.A.

Your personal data will not be disclosed but may be communicated to authorized parties. Such communications are limited to data strictly necessary for the recipient to perform their tasks and/or fulfill the purposes connected to the communication.

Pursuant to Articles 15 et seq. of EU Regulation 2016/679, you may request access to your data at any time, as well as updates, rectifications, additions, and deletions of data or restrictions on processing. Additionally, you have the right to object, in whole or in part, for legitimate reasons, to the processing of your personal data, even if relevant to the purpose of collection. Under Article 77 of EU Regulation 2016/679, you also have the right to file a complaint with the Data Protection Authority if you believe the processing violates the Regulation. All requests can be addressed to Molteni's Data Protection Officer via email at dpo@moltenifarma.it or by regular mail to: L. MOLTENI & C. dei F.lli Alitti Società di Esercizio S.p.a., S.S. 67 (Tosco Romagnola) – Loc. Granatieri – 50018 Scandicci (Fi).

The Data Controller is L. MOLTENI & C. dei F.lli Alitti Società di Esercizio S.p.A.

The Controller has appointed authorized personnel within the relevant Departments involved in the processing of personal data.