Privacyverklaring

 

Angelini Pharma France SAS (hereinafter "Angelini" or "Data Controller"), in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data (hereinafter "GDPR" or "General Data Protection Regulation"), provides you with the following information on the processing of your personal data, in your capacity as a user/visitor of the website www.angelinipharma.nl (hereinafter the "Website").

1. Data controller and data protection officer (DPO)

The data controller is Angelini Pharma France SAS, whose registered office is located at 55 Avenue de Colmar 92500 Rueil-Malmaison, France, e-mail: privacy.france@angelinipharma.com.

Angelini Pharma France SAS is responsible for processing the data of Dutch users of the website and processes personal data in accordance with the General Data Protection Regulation (GDPR) and applicable Dutch national laws.

The data controller has appointed a Data Protection Officer (DPO), who can be contacted directly at the following addresses:

 Bird & Bird Privacy Solutions

Bird & Bird DPO Services SRL

Avenue Louise 235 Box 1

1050 Brussels

Belgium

E-mail: dpo.france@angelinipharma.com.

2. Purposes of processing and legal basis for processing

Any personal data you provide will be processed in accordance with the law, in a fair, lawful and transparent manner, for the purposes indicated below and in accordance with the following conditions of lawfulness (Legal basis for processing).

Purposes of processing	Legal basis for processing
a) Correct and complete management of any communication or request you may send to Angelini using the contact addresses available on the website or the "Contact Form" (for example a request for information or assistance) [management of your requests].	The processing of your personal data for this purpose is necessary for the performance of a contract or pre-contractual measures (interpreted here as the "legal relationship" established between you and the data controller, following your potential request) (Article 6(1)(b) of the GDPR).
b) Correct and complete management of pharmacovigilance reports.   This includes (i) investigating the adverse event; (ii) contacting the reporter to obtain, if necessary, additional information to that already provided ("follow-up"); (iii) comparing the information on the adverse event with information on other adverse events received by the controller in order to analyse the safety of the product, a generic component or an active ingredient as a whole; (iv) provide the competent authorities with the information required by law, so that they can analyse the safety of the product as a whole, a generic component or an active ingredient [pharmacovigilance].	The processing of your personal data for pharmacovigilance purposes is a legal obligation under the GDPR and applicable local laws (Article 6(1)(c)). The processing of “special categories of personal data” for this purpose is required in the public interest of public health to ensure high standards of safety and quality of medicinal products and medical devices (Article 9(2)(i) GDPR). In accordance with pharmacovigilance requirements, Angelini Pharma France SAS undertakes to cooperate with the Dutch health authorities, in particular the Dutch Medicines Agency (CBG - College ter Beoordeling van Geneesmiddelen), where necessary to ensure product safety.
c) Compliance with legal obligations. In certain circumstances, we are required by law to use your personal data (for example, to inform you of a possible security breach involving your data and the steps we have taken to remedy the situation) [compliance with legal obligations].	The processing of your personal data for this purpose constitutes a legal obligation (Article 6(1)(c) of the ).

 

3. Categories of data processed

The data controller may process the following categories of personal data:

• if you send communications or requests to Angelini, your personal data necessary for the proper management of your communication or request (in particular, first and last name, postal address, e-mail address and telephone number) and any other personal data you may include in your message or in any material you send to us (for the purposes referred to in paragraph 2, letter a) ;
• if you make reports in the context of pharmacovigilance, the data necessary to comply with the legal obligations applicable to the data controller (for the purposes referred to in paragraph 2, point b)). More specifically, as a "reporter", in order to guarantee the accuracy and relevance of the data and its verifiability for the purposes of the scientific evaluation of the reports: the e-mail address or telephone number, in order to obtain, if necessary, additional information to that already communicated ("follow-up"); and, in order to manage the report correctly, any classification as a healthcare professional (e.g. doctor, dentist, nurse, etc.). doctor, dentist, nurse, pharmacist, forensic doctor) or a type of non-medical professional, such as a patient, lawyer or person in a relationship with the subject to whom the report refers (e.g. friend, relative, assistant). As the subject to whom the report refers (the "patient"): initials of the surname and first name, town and country of residence, age (or age range) and/or date of birth, sex, height and weight and data relating to sexual life or revealing racial or ethnic origin, health of the subject (medical history, any current or previous pathologies, pharmacological and non-pharmacological therapies, pregnancy, breastfeeding), "special categories of data" concerned by pharmacovigilance obligations, in particular with regard to "safety information" on the medicinal product, such as adverse effects, special situations (abuse, overdose, improper use (misuse), therapeutic error, "off-label" use, occupational exposure), exposure during pregnancy or breastfeeding, with or without associated adverse effects, lack of efficacy or suspected transmission of an infectious agent by the medicinal product ;
• all data necessary to comply with legal obligations (for the purposes referred to in paragraph 2, letter c) (such as, for example, your contact details for communications required by law or the authority).
• Please note that without your personal data, we may not be able to process your pharmacovigilance report, respond to your requests or communicate with you on any other applicable matter.

4. Data sources

The data controller obtains your personal data:

• directly from you and during your interaction with us;

in the context of pharmacovigilance, also by the "reporter", if different from the person to whom the report refers, as well as by other pharmaceutical companies, including companies in the Angelini Pharma group, linked to the data controller by pharmaceutical product licensing and distribution agreements.

5. Data must be provided

The provision of your personal data in order to manage your requests (purpose referred to in paragraph 2, letter a) is necessary to enable the data controller to process your request: failure to provide your personal data would make it impossible to respond to your request (in particular, to respond to a request for information or assistance that you have made).

The provision of your personal data for pharmacovigilance purposes (in accordance with paragraph 2, letter b) and to meet legal obligations (in accordance with paragraph 2, letter c) is compulsory insofar as it is required by law.

6. Methods of processing

The data is processed using automated and non-automated tools, with a logic strictly linked to the purposes of the processing and, in all cases, with methods and procedures capable of guaranteeing the security and confidentiality of the data.

7. Categories of recipients of personal data

For the purposes indicated above (paragraph 2), your personal data may be shared with:

• persons authorised by the data controller to process personal data (employees or collaborators of the controller);
• Processors designated by the data controller (IT, technology and telematics service providers, Internet operators; providers of pharmacovigilance report management services, consumer service providers);
• to independent subcontractors (for the management of your requests: telecommunications and communication service providers, courier and shipping companies; for pharmacovigilance: national and European medicines agencies, other pharmaceutical companies, including companies in the Angelini Pharma group, linked to the data controller by pharmaceutical product licensing and distribution agreements or, in the event of the transfer of marketing authorisations for pharmaceutical products; to comply with legal obligations: public authorities).
• Your data may also be transmitted, in accordance with the law, to tax, police, judicial and administrative authorities, for the detection and prosecution of offences, the prevention and safeguarding against threats to public security, to enable the data controller to establish, exercise or defend legal claims, and for other reasons connected with the protection of the rights and freedoms of others.

8. Data retention period

We retain your personal data for a limited period, depending on the purpose of the processing. At the end of this period, your data will be permanently deleted or, in any event, rendered irreversibly anonymous.

Your personal data will be stored in accordance with the conditions and criteria specified below:

• for the management of your requests (purpose referred to in paragraph 2, letter a) for a maximum period of 6 (six) months from the correct and complete management of your request;
• for pharmacovigilance purposes (objective referred to in paragraph 2, letter b) for as long as the medical product is authorised and for at least 10 (ten) years after expiry of the marketing authorisation;
• to comply with legal obligations (purpose referred to in paragraph 2, letter c) for a maximum period of 5 (five) years from the end of the calendar year in which the data controller complied with the legal obligation, in order to document and be able to demonstrate correct compliance with the law (for example, the fact that we have correctly informed you of any security breaches that may have affected your data and the measures we have taken to remedy such situations).
• For technical reasons, the termination of processing and subsequent deletion of your personal data, or their anonymisation, will take place within 30 (thirty) days of the terms indicated above.
• This is without prejudice to cases where retention for a longer period is required in the event of litigation, at the request of the competent authorities or by virtue of applicable law.

9. Transfer of personal data outside the EU/EEA

Your personal data may be transferred to countries outside the European Union (EU) or the European Economic Area (EEA) which nevertheless offer an adequate level of data protection, as established by specific resolutions issued by the European Commission (https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/adequacy-decisions_en).

The transfer of your personal data to non-EU/EEA countries that do not ensure an adequate level of protection will only be carried out after the data controller and the data recipients have concluded specific agreements, containing safeguards and appropriate guarantees for the protection of your personal data, known as "standard contractual clauses", also approved by the European Commission (https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/standard-contractual-clauses-scc/standard-contractual-clauses-international-transfers_en), or if the transfer is necessary for the management of your requests.

You can write to privacy.france@angelinipharma.com to request a copy of the guarantees that apply to the transfers of personal data concerned.

10. Rights of the person concerned

As a data subject, you have the following rights in relation to your personal data :

• obtain confirmation as to whether or not personal data relating to you are being processed and, where appropriate, obtain access to the data and related information (in particular, the purposes of the processing; the categories of personal data concerned; the recipients or categories of recipients to whom the data have been or will be disclosed; the data retention period or the criteria for determining it; the existence of a right to rectify or erase the data or a right to restrict or object to the processing; the right to lodge a complaint with a supervisory authority; the origin of the data; the possible existence of an automated decision-making process, including profiling and, in this case, significant information on the logic used and the importance and envisaged consequences of this processing for the data subject; appropriate safeguards in the event of transfer of personal data outside the EU/EEA), as well as a copy of such personal data, provided that this does not adversely affect the rights and freedoms of others (right of access);
• obtain rectification of your personal data, i.e. obtain the correction, amendment or updating of any data that is inaccurate or has become inaccurate, as well as the integration of incomplete personal data, including by providing additional information (right of rectification);
• request the erasure of your personal data when, in particular, (i) it is no longer necessary for the purposes for which it was collected or processed, or (ii) it has been processed unlawfully, or (iii) it must be erased in order to comply with a legal obligation (right to erasure). Erasure may not be carried out if, in particular, the processing is necessary for compliance with a legal obligation or for the establishment, exercise or defence of legal claims;
• obtain a restriction on the processing of your personal data, i.e. the controller retains the data without being able to use it. This right may only be exercised where, in particular, (i) the accuracy of the personal data is contested, for the period necessary for the controller to verify the accuracy of the data, or (ii) the processing of the data is unlawful and a restriction on the use of the data is requested, instead of its erasure, or (iii) although the controller no longer needs it for the purposes of processing, the personal data is necessary for you to establish, exercise or defend a legal claim (right to restriction of processing);
• receive from the controller your personal data, processed on the basis of a contract, in a structured, commonly used and machine-readable format, and that it be transferred, where technically possible, directly to a third party indicated by you (right to data portability).
• object, on grounds relating to his or her particular situation, at any time, to the processing of personal data concerning him or her, based on Article 6(e) or (f) of (1 ), including profiling based on those provisions, and to processing for the purposes of direct marketing (right to object).

To exercise these rights, you may contact the data controller at any time by writing to Angelini Pharma France SAS, 55 Avenue de Colmar 92500 Rueil-Malmaison, France or to the e-mail address privacy.france@angelinipharma.com or by writing to the Data Protection Officer (DPO), Bird & Bird Privacy Solutions, Bird & Bird DPO Services SRL, Avenue Louise 235 Box 1, 1050 Brussels, Belgium or to the e-mail address dpo.france@angelinipharma.com.

11. Claims

If you believe that your personal data has been processed in a way that does not comply with the GDPR, you have the right to lodge a complaint with the French data protection authority, the CNIL (Commission Nationale de l'Informatique et des Libertés), for more information: www.cnil.fr.
Dutch users can also lodge a complaint with the Dutch data protection authority, Autoriteit Persoonsgegevens (AP), for more information: www.autoriteitpersoonsgegevens.nl.

The complaint may also be lodged with a data protection authority other than the French  or Dutch authority, if the latter is that of the EU Member State in which you have your habitual residence or the place where the alleged breach took place.

12. Cookies and similar technologies

For more information on the use of cookies and similar technologies by the website, please refer to the specific cookie policy [insert link to cookie policy].

13. Links to other websites

The website may contain links to third-party websites.

Angelini cannot guarantee and accepts no responsibility for the content and information provided by such third parties, their completeness or accuracy, nor for the content of such third party websites and the products and services potentially provided through such third party websites, nor for the processing of users'/vistors’ personal data by such third parties.

This privacy notice applies solely to our website.

14. Amendments to this notice

The constant evolution of our activities may lead to changes in the characteristics of the processing of your personal data described above. Consequently, this privacy notice may be subject to changes and additions over time, which may also be necessary in the light of new legislation on the protection of personal data.

The updated version of this privacy notice will be published on this page, indicating the date of the last update. Please refer to this page when accessing the website.