Report an adverse effect

PRIVACY POLICY

In accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016, on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation; hereinafter: GDPR), we inform you that:

1.INTRODUCTION

1. The Controller, taking into account the state of the art, implementation costs, the nature, scope, context, and purposes of processing, as well as the risk of violating the rights or freedoms of natural persons of varying likelihood and severity of the threat, applies appropriate technical and organizational measures to ensure the protection of processed personal data, appropriate to the risks and data categories covered by the protection. This includes, in particular, securing data against unauthorized access, unauthorized collection, unlawful processing, and alteration, loss, damage, or destruction.

2. The Controller takes particular care to protect the interests of individuals to whom the data pertains, ensuring that the data collected is processed in accordance with the principles of lawfulness, fairness, transparency, purpose limitation, data minimization, accuracy, storage limitation, integrity, confidentiality, and accountability.

3. Providing personal data is voluntary but may be a condition for using certain services (or their specific parts), such as, for example, the adverse event reporting form.

4. Molteni Farmaceutici Polska sp. z o.o. is legally obliged to collect information on adverse side effects, interactions, lack of drug efficacy, quality complaints, and/or other aspects related to product safety or quality. If you provide us with information about Molteni Farmaceutici Polska sp. z o.o. products, for example via the form on our website, we will evaluate and review this information (which may include sensitive data, including your health status, side effects, and, where applicable, your name).

5. Molteni Farmaceutici Polska sp. z o.o. is also legally obliged to report significant adverse effects to relevant health authorities. As part of this procedure, we only share your data after pseudonymization, ensuring that no information directly identifying you is disclosed. We may also share such information with L. Molteni & C. dei F.lli Alitti S.p.A., based in Florence (Italy), provided they are required to report to the relevant health authorities.

6.The legal basis for processing your personal data is fulfilling our legal obligations or protecting our legitimate interests, particularly ensuring the highest standards of product safety and quality, or your consent.

7. If you provide any personal data regarding another person or enable us to collect such data, you declare that you have the authority to disclose this data and allow us to use it in accordance with this Privacy Policy.

8. We collect and process, among others, the following personal data: • Basic data – name, surname, gender, age, or date of birth, as well as the preferred language. • Contact details – information that enables contact, e.g., personal or business email address, mailing address, phone numbers, and social media profile. • Health information – your health status, existing medical conditions, and health information inferred from the information provided to us (particularly through the adverse event reporting form).

9. We may also collect information regarding your visits to our website. We may use such information to improve website content and for the purpose of compiling aggregate statistics on people using our site for internal and market research purposes. We may use cookies or similar technologies for these purposes. Details are governed by the Cookie Policy.

2.DATA CONTROLLER, CONTACT INFORMATION

The data controller is Molteni Farmaceutici Polska sp. z o.o., ul. Korzeniowskiego 39, 30-214 Kraków, registered in the Register of Entrepreneurs of the National Court Register maintained by the District Court for Kraków-Śródmieście, XI Commercial Division of the National Court Register under number KRS 0000183641, NIP 5210421696, REGON 010650109, with a share capital of PLN 1,364,000.00. For matters related to data protection, you can contact us at rodo@molteni.com.pl or Molteni Farmaceutici Polska sp. z o.o., ul. Korzeniowskiego 39, 30-214 Kraków.

3.PERSONAL DATA

Personal data is information that identifies you as an individual or relates to an individual who can be identified based on it. On the website www.molteni.com.pl, personal data is collected, particularly in relation to the reporting of adverse events and automatically while browsing our Website. While using the website, we may require the provision of basic personal data; in the case of healthcare professionals, we may request additional personal data. We may also collect personal data from other sources, including data brokerage companies, publicly available databases, social media platforms, and other third-party entities.

4.PURPOSE OF DATA PROCESSING

The Controller processes personal data for the purpose of pursuing legitimate and lawful interests, including but not limited to:

  1. Organizing your participation in events organized by Molteni Farmaceutici Polska sp. z o.o.;
  2. Personalizing and tailoring our website and communications to your interests and needs;
  3. Responding to inquiries about Molteni Farmaceutici Polska sp. z o.o. products and activities, as well as other types of correspondence (e.g., concerning adverse event reports);
  4. Receiving and handling reports submitted via the adverse event report form, email, or traditional mail;
  5. Handling requests related to data subject rights, where the scope of processed data includes the data provided as part of the request and data obtained during its processing;
  6. Fulfilling legal and regulatory obligations and ensuring compliance of Molteni Farmaceutici Polska sp. z o.o.’s activities with administrative laws, particularly providing information upon the request of competent authorities;
  7. Conducting analyses and statistics;
  8. Identifying the sender and handling their inquiry submitted via the adverse event report form, email, or traditional mail, within the scope of data that is not essential for contact or inquiry processing.

5.DURATION OF PERSONAL DATA STORAGE

We will store your personal data for as long as necessary or permitted due to the purposes for which it was obtained and as described in this Data Protection Information. When determining the storage period, we take the following criteria into account:

  1. The duration of the relationship with you and providing you access to the Website;
  2. Legal requirements applicable to us;
  3. Our legitimate interest (e.g., in connection with enforcing the Website’s Terms of Use, applicable limitation periods, litigation, or regulatory inquiries).

6.CATEGORIES OF RELEVANT DATA AND DATA SOURCE

1.Categories of relevant data (in the case of collecting data not directly from the data subject): First name(s), last name, business email address, and phone number, position held (specialization), REGON, NIP, PESEL, residential address/ business address.

2.Data source (in the case of collecting data not directly from the data subject) Information about the source of personal data is available after contacting rodo@molteni.com.pl.

7.RECIPIENTS OF DATA

Recipients of personal data may include members of the staff of Molteni Farmaceutici Polska sp. z o.o. and L. Molteni & C. dei F.lli Alitti S.p.A., based in Florence (Italy) (employees, external advisors, etc.), IT solution providers, entities providing HR and payroll process support, legal support services, and other entities if their involvement is necessary for processing purposes, and who are contractually obligated to maintain confidentiality and effectively protect your data. The Controller may also transfer personal data to public administration authorities, regulatory bodies, and law enforcement agencies, but only when necessary in connection with the above purposes, required by law, or necessary for the legitimate legal protection of Molteni Farmaceutici Polska sp. z o.o., in accordance with applicable legal provisions.

8.DATA SUBJECT RIGHTS

1.You have the right to access personal data, rectify it, delete it, or limit processing, as well as the right to object to processing, and the right to data portability. Additionally, you have the right to withdraw consent at any time without affecting the lawfulness of processing based on consent before its withdrawal (if data processing is based on consent), as well as the right to lodge a complaint with a supervisory authority.

2.To exercise the above rights, contact the Controller at: rodo@molteni.com.pl or at ul. Korzeniowskiego 39, 30-214 Kraków.

3. Providing data is voluntary, but necessary for entering into contracts, settling business activities, responding to inquiries, addressing complaints, reporting adverse events, and processing requests to exercise rights.

4. Your personal data will not be subject to automated decision-making or automated profiling.

9.PRIVACY POLICY UPDATE

We regularly review our Privacy Policy and update it as needed. This Privacy Policy may change. Any changes to this Privacy Policy become effective upon the publication of the updated version on this website. Using the website after the Privacy Policy changes means accepting them. The last update of the policy was made on 06.11.2024.

10.TRANSFER OF DATA ABROAD

Data collected through our Website may be stored and processed also in Italy, where L. Molteni & C. dei F.lli Alitti S.p.A., based in Florence, operates, as well as in any country where we engage service providers. Your personal data may also be processed, shared, or stored in countries outside the European Economic Area (EEA). Such countries may offer a different level of personal data protection. If we transfer your personal data to third-party companies in other jurisdictions, we ensure the protection of your personal data by applying the required level of protection according to applicable privacy data protection regulations through the implementation of appropriate technical and organizational measures. If your personal data is transferred to a service provider located in a third country (countries outside the European Union that do not provide a level of data protection comparable to EU law, as indicated by the relevant data protection authority) and processed in that country, Molteni Farmaceutici Polska sp. z o.o. ensures the protection of your personal data in compliance with applicable law. Should existing legal instruments concerning personal data protection be declared invalid and/or changed by the European Commission, we will adopt other appropriate and/or approved instruments to provide the necessary safeguards for the transfer of personal data to third countries.

11.USE BY MINORS

This website is not intended for individuals under 18 years of age. We do not knowingly collect personal data from such individuals. If you are under the indicated age, parental or legal guardian consent is required to use the Website. Please consult with a parent or legal guardian before using the Website. If you provide us with personal data of individuals under 18 years of age, you declare that you have the right to do so and that, upon request from Molteni Farmaceutici Polska sp. z o.o., you can prove that you have such a right.