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Laboratoires Juvisé Pharmaceuticals (hereinafter “Juvisé Pharmaceuticals”, “we”, “our”), acting as data controller, may collect and process your personal data in order to respond to your pharmacovigilance-related requests and reports.

Purposes

In this context, Juvisé Pharmaceuticals uses your personal data to ensure the prevention, monitoring, assessment, and management of adverse health events, including:

• collecting, recording, analysing, tracking, documenting, transmitting, and retaining data relating to all adverse health events;
• managing communications with the individual who reported the adverse health event (whether a member of an authorised association, a healthcare professional, a representative of a health authority, a patient, etc.), or with any consulted healthcare professional, in compliance with medical confidentiality, to obtain additional information on the reported event (for example, the treating healthcare professional).

Legal bases

These personal data processing activities are based on legal obligations imposed on Juvisé Pharmaceuticals by the health vigilance systems provided notably under the French Public Health Code.
Indeed, any company manufacturing, operating, or marketing a medicinal product is required to implement a pharmacovigilance system enabling the prevention, reporting, monitoring, and management of adverse health events (Article L.5121-24 of the French Public Health Code).
The collection of health data within this activity is necessary for reasons of public interest; its objective is in particular to ensure high standards of quality and safety of healthcare and medicinal products, devices or products, in accordance with Article 9 of the GDPR and Article 66 of the French Data Protection Act of 6 January 1978 as amended.

Data and data subjects concerned

The personal data we collect in the context of health vigilance activities is limited to the following categories:

• Data relating to the exposed person, necessary for assessing the adverse health event:
  • information allowing indirect identification of the data subject (demographic data such as age, year or date of birth, sex, weight, height), or an alphanumeric or alphabetic identifier compliant with existing forms, ensuring privacy protection. Data such as the national identification number or national health identifier are excluded;
  • data identifying the medicinal product involved in the adverse health event (type of medicine, device or product, batch or serial number, etc.);
  • health data, including treatments received, examination results, nature of adverse events, personal or family medical history, associated conditions, risk factors, and information on prescribing modalities and therapeutic management by the prescriber or healthcare professionals involved in care.
• Other data relevant for evaluating the adverse health event, such as socio-professional data, use of tobacco, alcohol or drugs, lifestyle habits, and behaviours.
• Data relating to ethnic origin, only where official documents concerning the characteristics of the medicine, device or product validated by a competent authority specify, based on scientific evidence, that ethnic origin may influence the product's efficacy or safety.
• Contact details of the person who reported the adverse health event or of a healthcare professional who can provide further information.

As part of pharmacovigilance declarations, if you are the individual affected by the reported adverse event, we may need to lift your anonymity.
Fields marked with an asterisk on the form are mandatory. Without this information, we will be unable to process your request.

Retention periods

We retain your data for a limited period, proportionate to the purpose of processing.
Your data is maintained in our operational databases for the duration of the report processing.
It is then archived in intermediate storage for the legally or regulatorily required retention period applicable to each health vigilance activity.
In the context of pharmacovigilance, your data is retained for ten (10) years from the expiry date of the relevant marketing authorisation (MA).
In the absence of a specific legal or regulatory retention period, your data will not be kept for more than seventy (70) years from the date the medicinal product, device or product is withdrawn from the market.
After report processing, indirectly identifying data relating to the exposed person is recorded in the international pharmacovigilance database, where it is retained for seventy (70) years from the date of withdrawal of the relevant medicinal product.

Recipients

Your personal data is collected directly from you. Only duly authorised Juvisé Pharmaceuticals employees, within the scope of their respective duties, have access to the processed personal data.
The following may also receive the data necessary to perform their duties, exclusively within the framework of their vigilance activities:

• processors acting on behalf of and under the responsibility of Juvisé Pharmaceuticals, within the limits of their functions and in accordance with their data processing agreements;
• other companies within the group to which Juvisé Pharmaceuticals belongs, involved in the operation or marketing of the relevant medicine, device or product;
• healthcare professionals involved in patient follow-up, as well as any other healthcare professional or stakeholder who can provide additional information;
• notified bodies responsible for assessing the medicine, device or product, excluding directly identifying data of the person exposed to the adverse health event who made the report;
• national public authorities (such as regional health agencies, health safety agencies, etc.) or foreign authorities responsible for health vigilance, within the framework of their statutory missions, as well as international authorities or health agencies (e.g. the European Medicines Agency), excluding directly identifying data of the person exposed to the adverse event who submitted the report.

Transfers outside the European Union

Any transfer of data to third parties located outside the European Economic Area is carried out in compliance with appropriate security measures, provided that one of the following conditions is met, along with other conditions set out in this privacy notice:

• the transfer is made to a country or international organisation recognised by the European Commission as ensuring an adequate level of protection in accordance with Article 45 of the GDPR (adequacy decision);
• the transfer relies on appropriate safeguards as defined in Article 46(2) of the GDPR, including standard contractual clauses approved by the European Commission, binding corporate rules, a code of conduct, or a certification mechanism.

Your rights over your data

You have the right to access, rectify, and restrict the processing of your personal data. Under the right to restriction of processing, you may, for example, request a temporary freeze of the processing while Juvisé Pharmaceuticals verifies the accuracy of your data.
These rights can be exercised at any time by email at: gdpr@juvise.com.
As the processing is based on compliance with a legal obligation, data subjects do not have the right to object to processing, the right to erasure, or the right to data portability.

You may also lodge a complaint with the CNIL or another data protection authority of an EU Member State.

If you are a healthcare professional reporting a pharmacovigilance case concerning a patient, please ensure that the patient is informed of the above and that he or she may exercise their rights with Juvisé Pharmaceuticals through you.