Integritetspolicy

Privacy Policy

Arvelle Therapeutics Sweden (516412-2714), a branch of Arvelle Therapeutics Netherlands B.V., a company of the Angelini Pharma Group (hereinafter “Arvelle” or “Controller“), pursuant to Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, on the protection of natural persons with regard to the processing of personal data (General Data Protection Regulation, hereinafter referred to as the “GDPR”), provides you with the following information on the processing of your personal data, in your capacity as users/browser of the website www.arvelletx.se (hereinafter the “Website”)

1. Data Controller and Data Protection Officer (DPO)

The Data Controller is Arvelle, with registered office in Östermalmstorg 1, 114 42 Stockholm, Sweden, email: nordics@angelinipharma.com.

The Data Controller has appointed a Data Protection Officer (DPO), who can be contacted directly at dataprivacy@arvelletx.com.

2. Purposes of processing and legal basis for the processing

All personal data provided by you is processed in compliance with the provisions of the law in a correct, lawful and transparent manner for the purposes set out below and according to the following conditions of lawfulness (Legal basis for processing).

Purposes of the processingLegal basis of the processing
a) Proper and comprehensive management of any communication or request you may send to Arvelle (for example a request for information or assistance) [management of your requests].Processing of your personal data for this purpose is necessary to the execution of a contract or to the execution of precontractual measures here construed as the “legal relationship” established between yourself and the Data Controller, following your potential request) (Art. 6.1.b of the GDPR).
b) Proper and comprehensive management of reports relating to pharmacovigilance [pharmacovigilance].The processing of your personal data for this purpose is a legal obligation (Art 6.1.d of the GDPR). The processing of “special categories of personal data” is necessary for reasons of public interest in the public health care sector, by way of guarantee of high quality and safety parameters in medicinal products and medical devices (Art. 9.2.i of the GDPR).
c) Compliance with legal obligations. In certain circumstances, legislation obliges us to use your personal data (for example to inform you of a potential security breach involving your data and the measures we have taken to address the situation) [compliance with legal obligations].The processing of your personal data for this purpose is a legal obligation (Art 6.1.c of the GDPR).

3. Categories of data processed

The Data Controller will process the following categories of your personal data:

in the event that you should submit communications or requests to Arvelle your personal data necessary to the correct management of your communication or request (in particular, name and surname, postal address, e-mail address and telephone number) and any other personal data you may include in your message;

if you should make any reports in relation to pharmacovigilance, the data necessary to comply with the related legal obligations assigned to the Data Controller. More specifically, as “reporting party”, as a guarantee of the exactness and pertinence of data and its verifiability for the purpose of the scientific assessment of the reports: e-mail address or telephone number, to obtain, if necessary, additional information with respect to that already communicated (“follow-up”); and, in order to manage the report correctly, any classification as medical-health care professional (for example doctor, dentist, nurse, pharmacist, medical examiner) or type of non health care professional, such as patient, attorney or person in relation to the subject to whom the report refers (for example friend, relative, assistant). As the subject to whom the report refers (the “patient”): initials of name and surname, city and country of residence, age (or age range) and/or date of birth, gender, height and weight and data relating to sex life or which reveals racial or ethnic origin, health of the subject (medical history, any current or previous pathologies, pharmacological and non-pharmacological therapies, pregnancy, breast-feeding) “special categories of data”) concerned by pharmacovigilance obligations, in particular in respect of “Safety information” on the medicinal product, such as adverse reactions, special situations (abuse, overdose, improper use (misuse), therapeutic error, “off-label” use, occupational exposure), exposure during pregnancy or breast-feeding, with or without associated adverse reactions, lack of efficacy or suspected transmission of infectious agent through the medicinal product;

all data necessary to comply with legal obligations (such as, for example, your contact data for communications required by the law or the authority).

4. Data source

Your personal data will be obtained by the Data Controller:

directly from you and your interaction with us;

in relation to the purpose 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 of the Angelini Pharma Group, linked to the Owner by licensing and distribution contracts for pharmaceutical products.

5. Nature of data conferral

The conferral of your personal data in order to manage your requests (purpose pursuant to paragraph 2, letter a) is mandatory to allow the Data Controller to process your communication: failure to provide such would make it impossible for you to receive a reply to your communication (in particular, to receive a response to a request you make for information or assistance). Conferral of your personal data for pharmacovigilance (purpose pursuant to paragraph 2, letter b) and to comply with legal obligations (purpose pursuant to paragraph 2, letter c) is mandatory insofar as it derives from provisions of the law.

6. Processing methods

Data processing is carried out using both automated and non-automated tools, with logic strictly related to the purposes of the processing and, in any case, with methods and procedures able to ensure the security and confidentiality of the data.

7. Categories of personal data recipients

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

to persons authorized by the Data Controller to carry out personal data processing operations (employees or collaborators of the Data Controller);

to the data processors appointed by the Data Controller (suppliers of computer, technological and telematic services, Internet operators; providers of pharmacovigilance report management services);

to autonomous data controllers (to handle your requests: couriers and dispatch companies; for pharmacovigilance: national and European medicine and drug agencies, other pharmaceutical companies, including companies of the Angelini Pharma Group, bound to the Data Controller by license contracts and distribution agreements for pharmaceutical products or, in the case of transfer of marketing authorizations for the pharmaceutical product; to comply with legal obligations: public authorities).

Your data may also be transmitted in accordance with the law to tax authorities, police and judicial and administrative authorities, for the assessment and prosecution of crimes, prevention and protection from threats to public security, to allow the Data Controller to ascertain, exercise or defend a right in court, as well as for other reasons related to the protection of the rights and freedoms of others.

8. Data retention period

We store your personal data for a limited period of time depending on the purpose of processing. After the expiry of this period, your data will be permanently deleted or in any case rendered irreversibly anonymous. Your personal data will be stored in accordance with the terms and criteria specified below:

for the management of your requests (purpose pursuant to paragraph 2, letter a) for a maximum period of 6 (six) months from the proper and comprehensive management of your request;

to comply with legal obligations (purpose pursuant to paragraph 2, letter c) for a maximum period of 10 (ten) years from when the calendar year ends during which the Data Controller has complied with the legal obligation, in order to document and be able to show correct compliance with the law (for example having correctly informed you of any security breaches that may have involved your data and the measures we took to address such situations).

For technical reasons, the termination of the processing and the consequent deletion of your personal data, or its anonymization, will take place within 30 (thirty) days from the terms indicated above.

This is without prejudice to cases where retention for a longer period is required for any litigation, requests by the competent authorities or under 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, however, 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 countries that do not belong to the EU/EEA and that do not ensure adequate levels of protection will be carried out only after the Data Controller and the recipients of the data have concluded specific agreements, containing safeguard clauses and appropriate guarantees for the protection of your personal data, so-called “standard contractual clauses”, also approved by the European Commission, or if the transfer is necessary for the management of your requests.

10. Rights of the data subject

As data subject, you have the right to:

have confirmation as to whether or not personal data concerning you are being processed and, if so, to obtain access to the data and related information (in particular, the purposes of the processing; categories of personal data processed; recipients or categories of recipients to whom the data have been or will be communicated; the period of retention of the data or the criterion for determining it; the existence of the right to rectify or erase the data or to limit or oppose 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 such cases, significant information on the logic used and the importance and expected consequences of such processing for the data subject; the appropriate safeguards in case of transfer of personal data outside the EU/EEA), as well as a copy of such personal data, provided that this does not harm the rights and freedoms of others (right of access);

obtain the rectification of your personal data, i.e. to obtain the correction, modification or updating of any inaccurate or no longer correct data, as well as to obtain the supplement of incomplete personal data, including by providing an additional statement (right of rectification);

request the deletion of your personal data when these, in particular, (i) are no longer necessary with respect to the purposes for which they were collected or processed, or (ii) they have been processed unlawfully, or (iii) they must be deleted in order to comply with a legal obligation, or, finally, (iv) you have opposed their processing (see below "right to object") and there is no prevailing legitimate reason allowing the Data Controller to proceed with the processing in any case (right to be forgotten). Deletion may not be carried out if, in particular, the processing is necessary for the fulfillment of a legal obligation or for the establishment, exercise or defense of a right in court;

obtain a restriction on the processing of your personal data, i.e. that the Data Controller retains such data without being able to use them. This right can be exercised only when, in particular, (i) the accuracy of the personal data is contested, for the period necessary for the Data Controller to verify the accuracy of such data, or (ii) the processing of the data is unlawful and a restriction on the use of the data is requested, instead of their deletion, or (iii) although the Data Controller no longer needs them for the purposes of processing, the personal data are necessary for you to ascertain, exercise or defend a right in court or (iv) you have objected to their processing (see below "right to object"), pending verification that the legitimate reasons of the Data Controller take precedence over those of the data subject (right to restriction);

obtain from the Data Controller your personal data, processed on the basis of a contract, in a standard format, and that they are transferred, where technically possible, directly to a third party indicated by you (right to portability).

In addition, as data subject, you also have the right to object, this means to:

object at any time, for reasons related to your particular situation, the processing of your personal data for opinion surveys. In this case, the Data Controller will refrain from any further processing of your personal data.

To exercise these rights, you may contact the Controller at any time, by writing to Arvelle Therapeutics, physical address Östermalmstorg 1, 114 42 Stockholm, Sweden or by approaching the DPO at dataprivacy@arvelletx.com.

11. Complaint

If you believe that your personal data has been processed unlawfully, you have the right to lodge a complaint with the data protection authority (in Sweden, the Swedish Authority for Privacy Protection (IMY), for more information www.imy.se). The complaint may also be made to a data protection authority other than the Swedish, if said data protection authority is that of the EU Member State in which You have your habitual place of residence or of the place where the alleged breach took place.

12. Cookie Policy

Last updated May, 2021

The following disclosure on the use of cookies on the website www.arvelletx.se  (hereinafter also referred to as the “Website”) is made to the user/visitor (“you”) in compliance with European and Swedish legislation governing personal data processing and electronic communication.

The Website is managed by Arvelle Therapeutics Sweden (516412-2714), a branch of Arvelle Therapeutics Netherlands B.V., a company of the Angelini Pharma Group (hereinafter “Arvelle” or “Controller“), which you can contact for any information or with any request in regard to the use of cookies on this Website by writing to nordics@angelinipharma.com.  Arvelle has appointed a Data Protection Officer (DPO), who can be contacted directly at dataprivacy@arvelletx.com.

For more information on personal data processing, see the specific Website Privacy notice.

What are cookies?

Cookies are small text files that the websites visited by the user send to and store on your computer or mobile device, before being sent back to the same websites at the next visit. Precisely thanks to the cookies, the website remembers the actions and preferences of the user (such as, for example, login data, the chosen language, font size, other display settings, etc.) so that they do not need to be entered again when the user visits the website again or browses from one page to another on it. The cookies are therefore used for IT authentications, session monitoring and the saving of information regarding the activities of users accessing a website. They may also contain a unique identifier code that can keep track of the user’s browsing within the website for statistical or advertising purposes. When browsing a website, the user can also receive cookies from different web servers or websites to that being visited (“third party cookies”) on their computer or mobile device. Some operations could not be carried out without using cookies, which in some cases are therefore technically necessary for the website’s actual function.

There are various types of cookies, depending on their characteristics and functions, and they can stay on the user’s computer or mobile device for different lengths of time: session cookies, which are automatically deleted when the browser is closed; and persistent cookies, which remain on the user’s device until a pre-established deadline.

In accordance with current legislation, use of cookies does not always require express user consent. More specifically, “technical cookies” do not require consent, i.e. those used only in order to transmit a communication on an electronic communication network, or to the extent strictly necessary to provide a service specifically requested by the user. In other words, these are cookies that are essential to website function or necessary to provide the activities requested by the user. For “profiling cookies”, on the other hand, i.e. those aimed at creating user profiles and used to send advertising messages in line with the preferences expressed when browsing the Internet, prior user consent is required. You can read more about cookies and how to recognize them at www.aboutcookies.org

Cookies used on the Website

The Website uses cookies for the correct function of the Website and for the provision of the services it contains, to understand and improve the user’s browsing experience, as well as to send you advertising in line with your preferences expressed in the context of browsing. Your use of the Website and your acknowledgement of our cookie policy indicates your consent to the cookies described in this policy. Please see “How you can control cookies” below for more information on how to withdraw your consent at any time.

In detail, the following cookies are on the Website.

Type of CookieWhat does it do?
Strictly necessary
cookies
These cookies are essential in order to enable you to move around the website and use its features, such as accessing secure areas of the website.
Performance
cookies
These cookies collect information about how you use our website, for instance which pages you go to most often, and if you receive error messages from certain web pages. These cookies do not collect information that identifies you. All information these cookies collect is aggregated and therefore anonymous. It is only used to improve how the website works. By using our website, you agree that we can place these types of cookies on your device.
Functionality
cookies
These cookies allow the website to remember choices you make (such as your language of choice or the region you are in) and provide enhanced, more personal features. These cookies can also be used to remember changes you have made to text size, fonts and other parts of the web pages that you can customise. The information these cookies collect will be anonymised and they cannot track your browsing activity on websites operated by third parties. By using our website, you agree that we can place these types of cookies on your device.
Targeting or
advertising
cookies
These cookies allow the website to remember choices you make (such as your language of choice or the region you are in) and provide enhanced, more personal features. These cookies can also be used to remember changes you have made to text size, fonts and other parts of the web pages that you can customise. The information these cookies collect will be anonymised and they cannot track your browsing activity on websites operated by third parties. By using our website, you agree that we can place these types of cookies on your device.

Please note that third parties (including, for example, advertising networks and providers of external services like web traffic analysis services) may also use cookies, over which we have no control. These cookies are likely to be analytical/performance cookies or targeting cookies.

How you can control cookies

Your web browser includes an option that allows you to refuse the setting of all or some cookies. However, if you do so, you may not be able to access parts of our website and it may make your browsing experience less enjoyable. Unless you have adjusted your browser setting so that it will
refuse cookies, our system will issue cookies as described above when you access our website. If you would like to delete any cookies on your computer, please refer to your browser manufacturer’s instructions by clicking ‘help’ in your browser menu.

Contact

info@arvelletx.se

Östermalmstorg 1 ,
114 42 Stockholm,
Sweden

At Arvelle we work with the highest degree of integrity. If you have come across something that is not right please use the link below to report it.

P-SE-CE-2100014 Maj 2021

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