Identity of data processing controller

Holder: Industrial Farmacéutica Cantabria, S.A. matriz del GRUPO CANTABRIA LABS (hereinafter “GRUPO CANTABRIA LABS”).
Address: Calle Arequipa, 1, 5a pl. – 28043 Madrid
Fiscal Identification Code: A39000914
Registre:</strong Inscribed in the Mercantile Register of Cantabria: Corporate Registry Book 22, Page 105, Sheet 1151, 1st inscription
Contact email: lopd@cantabrialabs.es

Other companies that form part of GRUPO CANTABRIA LABS

Baruma, S.L.
C/ Arequipa, 1, Madrid
CIF: B80592413

Dunar, Srl
C/Pirita, 9 torrejón de Ardoz, Madrid
CIF: B81045692

CELLHELIX, S.L.
Av/ Cardenal Herrera Oria, 95, Santander, Cantabria
CIF: B839772488

In accordance with the 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 and on the free movement of such data, and any other relevant and currently applicable legislation, the user is informed that the personal data provided, where applicable, are incorporated into an automatic file, which shall be used only for the purposes described in the pertinent form or contract.

1.- Data corresponding to persons of contact via the contact form

Responsible: GRUPO CANTABRIA LABS
Purpose: Resolve the query raised in the contact form.
We inform you that GRUPO CANTABRIA LABS will be able to send you information that could be of your interest. You can unsubscribe at any time at lopd@cantabrialabs.es
Legitimation: Express consent of the person concerned for the processing of their data to solve the query raised, by completing and sending the form you expressly state that you know and understand this Privacy Policy.
Term: The data provided will be treated for the time strictly necessary to deal with your request, as long as you do not indicate to GRUPO CANTABRIA LABS your wish not to receive commercial information, as long as you do not request its removal, and without prejudice to its conservation while the legal obligations applicable to GRUPO CANTABRIA LABS persist.
Recipients: GRUPO CANTABRIA LABS will not transfer the data to any third parties, unless the communication to other companies of GRUPO CANTABRIA LABS is necessary to resolve the query.
Rights: We inform you that you have the right to access, rectify, suppress, oppose, limit the processing and transfer of your personal data by writing to Att Departamento Legal, C/ Arequipa 1, 5º planta, 28043 Madrid, or by e-mail to lopd@cantabrialabs.es

2.- Data regarding clients, outsourcers or subscribers

Responsible: GRUPO CANTABRIA LABS
Purpose:</strong Manage the registration and participation in the corresponding training course.
We inform you that GRUPO CANTABRIA LABS will be able to send you information that could be of your interest. You can unsubscribe at any time at lopd@cantabrialabs.es
Legitimation: Express consent of the data subject to manage the registration and participation in the training course, by filling in and sending the form you expressly states that you know and understand this Privacy Policy.
Term: The data provided will be treated for the time strictly necessary to deal with your request, as long as you do not indicate to GRUPO CANTABRIA LABS your wish not to receive commercial information, as long as you do not request its removal, and without prejudice to its conservation while the legal obligations applicable to GRUPO CANTABRIA LABS persist.
Recipients: GRUPO CANTABRIA LABS will not transfer the data to third parties, unless communication to other companies is necessary for the correct development of the corresponding course.
Rights: We inform you that you have the right to access, rectify, suppress, oppose, limit the processing and transfer of your personal data by writing to Att Departamento Legal, C/ Arequipa 1, 5º planta, 28043 Madrid, or by e-mail to lopd@cantabrialabs.es

3.- Data relating to customers and/or service providers

Responsible: GRUPO CANTABRIA LABS
Purpose: Processing necessary for the execution of a contract in which the interested is a party.
We inform you that GRUPO CANTABRIA LABS will be able to send you information that could be of your interest. You can unsubscribe at any time at lopd@cantabrialabs.es
Legitimation: We inform you that the legal basis for the legal processing of data for this purpose is the legitimate interest of GRUPO CANTABRIA LABS.
Term: The data provided will be treated as long as you do not indicate to GRUPO CANTABRIA LABS your wish not to receive commercial information, as long as you do not request its removal, and without prejudice to its conservation while the legal obligations applicable to GRUPO CANTABRIA LABS persist.
Recipients: GRUPO CANTABRIA LABS will not transfer the data to third parties, unless communication to other companies is necessary for the correct provision of the services.
Rights: We inform you that you have the right to access, rectify, suppress, oppose, limit the processing and transfer of your personal data by writing to Att Departamento Legal, C/ Arequipa 1, 5º planta, 28043 Madrid, or by e-mail to lopd@cantabrialabs.es

4.- Data relating to candidates

Responsible: GRUPO CANTABRIA LABS
Purpose: In the event that you have provided your data to any of the companies that are part of GRUPO CANTABRIA LABS as a potential candidate for membership of any of the group’s companies, we inform you that GRUPO CANTABRIA LABS will use the details exclusively to manage your candidacy for any of the vacancies that may exist in any of the GRUPO CANTABRIA LABS companies.
Legitimation: Express consent of the interested party for the processing of their data to manage their candidacy for any of the vacancies that may exist in any of the companies of GRUPO CANTABRIA LABS, by filling in and sending the form you expressly states that you know and understand this Privacy Policy.
Term: The data provided will be kept for a period of twenty-four (24) months, unless you do not request its deletion beforehand and without prejudice to its conservation while the legal obligations applicable to GRUPO CANTABRIA LABS persist.
Recipients: GRUPO CANTABRIA LABS will not transfer the data to third parties, and only in the event that your profile fits one of the group companies and exclusively for this purpose.
Rights: We inform you that you have the right to access, rectify, suppress, oppose, limit the processing and transfer of your personal data by writing to Att Departamento Legal, C/ Arequipa 1, 5º planta, 28043 Madrid, or by e-mail to lopd@cantabrialabs.es

5.- Claims

Responsible: GRUPO CANTABRIA LABS
Purpose: In the event that you have submitted a claim for any reason to any of the companies that are part of GRUPO CANTABRIA LABS, we inform you that they will use the data exclusively to resolve your claim.
Legitimation: Express consent of the interested party for the processing of their data to resolve their claim, by filling out and sending the form you expressly states that you know and understand this Privacy Policy.
Term: The data provided will be treated for the time strictly necessary to deal with your request, as long as you do not indicate to GRUPO CANTABRIA LABS your wish not to receive commercial information, as long as you do not request its removal, and without prejudice to its conservation while the legal obligations applicable to GRUPO CANTABRIA LABS persist.
Recipients: GRUPO CANTABRIA LABS will not transfer the data to third parties, except for communication to other GRUPO CANTABRIA LABS companies, in the event that the claim requires such communication and exclusively for that purpose.
Rights: We inform you that you have the right to access, rectify, suppress, oppose, limit the processing and transfer of your personal data by writing to Att Departamento Legal, C/ Arequipa 1, 5º planta, 28043 Madrid, or by e-mail to lopd@cantabrialabs.es

6.- Newsletters

Responsible: GRUPO CANTABRIA LABS
Purpose: In the event that you have registered for any newsletter or commercial information service from any of the companies that are part of GRUPO CANTABRIA LABS, we inform you that they will use the data for the sole purpose of keeping you informed of their activity.
You can unsubscribe at any time at lopd@cantabrialabs.es.
Legitimation: We inform you that the legal basis for the legal processing of data for this purpose is is your consent, by completing and sending the form you expressly state that you know and understand this Privacy Policy.
Term: The data provided will be treated, as long as you do not indicate to GRUPO CANTABRIA LABS your wish not to receive commercial information, and without prejudice to its conservation while the legal obligations applicable to GRUPO CANTABRIA LABS persist.
Recipients: GRUPO CANTABRIA LABS will not transfer the data to third parties.
Rights: We inform you that you have the right to access, rectify, suppress, oppose, limit the processing and transfer of your personal data by writing to Att Departamento Legal, C/ Arequipa 1, 5º planta, 28043 Madrid, or by e-mail to lopd@cantabrialabs.es.

7.- Pharmacovigilance, cosmetovigilance and market surveillance (hereinafter “Surveillance”)

CANTABRIA LABS takes the safety of its products and data protection seriously.
Industrial Farmacéutica Cantabria, S.A. and its affiliated companies (hereinafter referred to as “CANTABRIA LABS”) develop and market prescription medicines, over-the-counter medicines, medical devices, cosmetics intended for use on humans, as well as food supplements (hereinafter referred to as “CANTABRIA LABS products”). We must monitor the safety of all CANTABRIA LABS products that we develop or market in any country.
Our Pharmacovigilance, cosmetovigilance and market surveillance obligations require us to process certain data that directly or indirectly identify the individual (hereinafter “personal data”) in relation to the patients affected by the adverse events we receive and the individuals who report them. This allows us to meet the stringent requirements that require us to continuously assess the benefits and risks of CANTABRIA LABS products and to report suspected adverse events or reactions to the relevant regulatory bodies.
This Statement on Data Protection in the field of Pharmacovigilance, Cosmetovigilance and Market Surveillance (hereinafter the “Statement”) contains important information for you on how we process personal data for Pharmacovigilance, Cosmetovigilance and Market Surveillance purposes within the framework of our obligations under the applicable data protection legislation.
All personal data are processed exclusively for the purposes of Surveillance and only where relevant and appropriate to properly document, assess and report the adverse event you have submitted in accordance with our Surveillance obligations.
If you have any questions about this Statement or how we use your personal data, please contact us using the contact details at the end of this Statement.

7.1 – Categories of data
We may need to process (including collecting, storing or otherwise using) the following personal data:

Relating to the Patient / User::

– first name and surname / initials
– date of birth / age group, gender, weight, height;
– health information, medical history and health status, which, for example, may include:

• details of the CANTABRIA LABS product that is suspected to have caused the adverse event, such as the dose administered or prescribed,
• the reason for the administration or prescription of the CANTABRIA LABS product and any changes to your usual dosing schedule;
• details of other medicines or products you are currently taking or were taking at the time of the adverse event, including the doses administered or prescribed, how long you have been taking the medicine, why you were taking it and any changes to your usual dosing schedule;
• details of the adverse event experienced, the treatment received in relation to the adverse event and any possible long-term effects on his/her health as a result of the adverse event;
• as well as other medical history considered relevant by the notifier, including documents such as test reports, medication history and the patient’s medical history.

Concerning the Notifier::

– name and surname;
– contact details (e.g. name, e-mail address, telephone number, fax number); profession (this may determine the questions to be asked in relation to an adverse event, depending on the degree of medical expertise assumed);
– relationship with the subject of the report.

7.2 – Purpose

Within the framework of the fulfilment of our obligations under the Oversight obligations, we may process personal data in order to:

– investigate the adverse event;
– contact you to obtain further information about the adverse event reported;
– cross-check the adverse event information with information on other adverse events received by CANTABRIA LABS to analyse the safety of a production batch, a CANTABRIA LABS product or an active substance as a whole; and
– to submit the mandatory reports to national or regional regulatory bodies to enable them to analyse the safety of a production batch, a CANTABRIA LABS health product, a generic product or an active substance as a whole;

7.3 – Transfer of personal data

In the context of fulfilling our Surveillance obligations, we may share or disclose personal data:

– within the CANTABRIA LABS group, in order to analyse and process a reported adverse event;
– with the competent regulatory bodies, in relation to suspected adverse events;
– with external service providers of the CANTABRIA LABS group, such as safety database providers, call centre operators and, in the event that you have communicated the details of your suspected adverse reaction to our sales representatives, the sales network service company concerned. We maintain appropriate data protection safeguards with those service providers with whom the CANTABRIA LABS group shares personal data and who perform services or tasks on our behalf;
– with other pharmaceutical companies that have marketing or distribution agreements or other licensing agreements with the CANTABRIA LABS group, in the event that FV obligations relating to a CANTABRIA LABS product require such exchange of security information. Please note that we maintain appropriate data protection safeguards with those business partners with whom the CANTABRIA LABS group shares personal data and who perform services or tasks on our behalf;
– with a third party in the event of the sale, assignment or transfer of a particular CANTABRIA LABS product or related project or therapeutic area, in which case we would require the purchaser, assignee or transferee to handle the personal data in question in accordance with applicable data protection legislation;
– where adverse event information (e.g. clinical case studies or abstracts) is published. In such cases we will remove any identifiers from the publication in order to keep your identity confidential.
– Third countries. CANTABRIA LABS hosts its Surveillance databases in Spain. However, we may need to transfer your personal data to other members of the CANTABRIA LABS group or to external business partners and regulatory bodies. These may be located in countries for which the European Commission has not decided to ensure an adequate level of data protection (hereinafter “third countries”). Whenever we need to transfer your personal data for monitoring purposes to an external business partner located in a third country we will apply standard data protection clauses adopted by the European Commission as adequate safeguards.

7.4 – Security of your personal data.

We have implemented appropriate advanced technical and organisational measures to protect the security of personal data processed for Oversight purposes.
These measures include safeguards and procedures designed to restrict access to personal data to those employees who need access to it in the performance of their responsibilities. We have physical, electronic and procedural measures in place to protect personal data against accidental loss, destruction or damage and against unauthorised access, use or disclosure. Where reasonably possible we will process personal data in encrypted or pseudonymised form.

7.5 – Retention periods

We will use and store your personal data in accordance with legally required requirements for the retention and reporting of Surveillance information. These requirements oblige us to store Surveillance information, which may include personal data, for at least the entire life cycle of the product and until 10 years after the relevant medicinal product or medical device has ceased to be marketed.

7.6 – Legal basis for processing your personal data

CANTABRIA LABS processes personal data relevant for the purposes of Surveillance, which includes special categories of personal data and for the purpose of:
– investigating the adverse event;
– comply with the legal obligations arising from the applicable laws and regulations on Surveillance and its legitimate interests for the purposes of Surveillance, considering that
– the legislation on vigilance has been enacted for reasons of substantial public interest in the field of public health and safety of medicinal products or medical devices.

7.7 – Information about your rights

You have the right to:

– request information about your personal data processed by CANTABRIA LABS;
– request correction of your personal data if it is incorrect or incomplete. During the evaluation of such a request, you have the right to restrict the processing of your personal data;
– request the transfer of your personal data to you or to another person in a commonly used format;
– lodge a complaint with a data protection authority;
– object to the processing of your personal data provided that such processing is based solely on the legitimate interest of CANTABRIA LABS;
– request the erasure of your personal data if it is no longer necessary for the purposes of processing or if there is no legal basis for further processing.

However, these rights may be limited in compliance with Surveillance obligations. Your rights are limited where there is a legal basis for processing your personal data; for example, we cannot delete information collected as part of an adverse event report unless that information is incorrect. We will ask you to identify yourself in a timely manner before granting any request for access to or correction of your personal data.

7.8 – Origin of the data

In the event that the personal data have not been obtained from the data subject, CANTABRIA LABS will inform about the source of information through which the data have been received at the time of contacting the data subject.

7.9 – Contacting us

If you have any questions regarding surveillance data protection or data protection in general, please use the contact form provided or contact our company’s data protection officer at the following address:

Industrial Farmacéutica Cantabria, S.A.
Calle Arequipa, nº1, 5th floor, 28043, Madrid
Spain

lopd@cantabrialabs.es
Tlf.: 913824022

8.- Raffles

Responsible: GRUPO CANTABRIA LABS
Purpose: To manage your participation in a promotion of GRUPO CANTABRIA LABS.
We inform you that GRUPO CANTABRIA LABS will be able to send you information that could be of your interest. You can unsubscribe at any time at lopd@cantabrialabs.es
Legitimation: Express consent of the interested party for the treatment of their data for the purpose, by filling in and sending the form you expressly states that you know and understand this Privacy Policy.
Term: The data provided will be treated, as long as you do not indicate to GRUPO CANTABRIA LABS your wish to remove it and without prejudice to its conservation while the legal obligations applicable to GRUPO CANTABRIA LABS persist.
Recipients: GRUPO CANTABRIA LABS will not transfer the data to third parties.
Rights: We inform you that you have the right to access, rectify, suppress, oppose, limit the processing and transfer of your personal data by writing to Att Departamento Legal, C/ Arequipa 1, 5º planta, 28043 Madrid, or by e-mail to lopd@cantabrialabs.es

9.- Visitors

Responsible: GRUPO CANTABRIA LABS
Purpose: Confirm the identity of the visitors, identify the reason for their access, channel them appropriately to the person whose name they have mentioned, as well as guarantee the security of all persons within the offices and/or facilities of GRUPO CANTABRIA LABS. We inform you that GRUPO CANTABRIA LABS will be able to send you information that could be of your interest. You can unsubscribe at any time at lopd@cantabrialabs.es
Legitimation: Express consent of the interested party for the treatment of their data for the purpose, by filling in and sending the form you expressly states that you know and understand this Privacy Policy.
Term: The data provided will be treated, as long as you do not indicate to GRUPO CANTABRIA LABS your wish to remove it and without prejudice to its conservation while the legal obligations applicable to GRUPO CANTABRIA LABS persist.
Recipients: GRUPO CANTABRIA LABS will not transfer the data to third parties.
Rights: We inform you that you have the right to access, rectify, suppress, oppose, limit the processing and transfer of your personal data by writing to Att Departamento Legal, C/ Arequipa 1, 5º planta, 28043 Madrid, or by e-mail to lopd@cantabrialabs.es

10.- Image captures

Responsible: GRUPO CANTABRIA LABS
Purpose: The images may be used for institutional, formative and professional purposes guaranteeing that in no case will be harmed the honour right in the terms foreseen in the Organic Law 1/1982, of 5 May, on Civil Protection to the Right to Honour, Personal and Family Intimacy and to One’s Own Image.
Legitimation: Express consent of the interested party for the treatment of their data for the purpose, by filling in and sending the form you expressly states that you know and understand this Privacy Policy.
Term: The data provided will be treated, as long as you do not indicate to GRUPO CANTABRIA LABS your wish to remove it and without prejudice to its conservation while the legal obligations applicable to GRUPO CANTABRIA LABS persist.
Recipients: GRUPO CANTABRIA LABS will not transfer the data to third parties.
Rights: We inform you that you have the right to access, rectify, suppress, oppose, limit the processing and transfer of your personal data by writing to Att Departamento Legal, C/ Arequipa 1, 5º planta, 28043 Madrid, or by e-mail to lopd@cantabrialabs.es

Exercise of rights common to all personal data

You have the right to obtain confirmation on whether any company of GRUPO CANTABRIA LABS is processing your personal data, therefore, you may at any time access your personal data, rectify inaccurate details, request their deletion, processing restriction, portability or opposition to data processing with the purposes outlined.

You can write to:
Att Departamento Legal, C/ Arequipa 1, 5º planta, 28043 Madrid

Or by email to:
lopd@cantabrialabs.es

Please note that you can withdraw your consent at any time

GRUPO CANTABRIA LABS undertakes to deal with any requests sent to it, either by e-mail or by letter. In this regard, GRUPO CANTABRIA LABS will respond within one month of receiving the request. However, the possibility of a two-month extension must be taken into account, depending on the complexity of the request, as well as the number of requests. Such an extension shall be informed within one month of receipt of the request.

Data veracity and update

GRUPO CANTABRIA LABS presumes that the personal data facilitated via the different channels and media are true, that they are supplied directly by the titleholder, that they claim to be who they are, that the data are updated, that the party affected /concerned shall report any modification to their data as soon as it occurs.

Use of Cookies

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Data of minors
The services provided by GRUPO CANTABRIA LABS are destined to individuals of full age in accordance with Spanish legislation. GRUPO CANTABRIA LABS assumes that the natural individuals who provide the data using different channels (electronic, web, social networks) meet this criterion.

Data security

GRUPO CANTABRIA LABS has implemented in its working centres, premises, systems, communication infrastructures, etc., the safety measures required by law. It has also adopted the logical, physical, organisational and contractual measures, which prevent the unauthorised access of third-parties to data, the destruction, modification, reproduction, dissemination, transmission or reuse thereof.

Validity and modification of the privacy policy

The privacy policy established by GRUPO CANTABRIA LABS takes effect from the date of its publication on the corresponding website; the user can file it and/or reproduce it. GRUPO CANTABRIA LABS is authorised to modify its privacy policy, informing the user.