Pharmacovigilance policy

ROVI^® BIOTECH LIMITED UK PHARMACOVIGILANCE PRIVACY POLICY

This Privacy Policy applies to the processing of personal data obtained as a result of communications received about adverse reactions or any other relevant information for the purposes of pharmacovigilance in relation to different aspects of the medicines owned by ROVI^® Biotech Limited UK or marketed by this entity (lack of effectiveness, prescriptions not in accordance with the technical sheet, etc.).

Who is the Controller for the processing of your data?

• Identity: ROVI^® Biotech Limited UK.
• Postal address: David House, Robert Street, Croydon CR0 1QQ.
• Telephone: + 44 (0) 203 642 06 77.
• E-mail: protecciondedatos@rovi.es

Who is the entity’s Data Protection Officer (DPO) and how can they help you?

The DPO is a legally provided figure whose main functions are to inform and advise the entity on the obligations that affect it in terms of personal data protection and supervise compliance. Additionally, the DPO acts as a point of contact with the entity to. Any question regarding the processing of personal data, so, if you wish, you can contact him:

• DPO contact information: dporovi@rovi.es

What personal data is collected?

Data relating to the patient:

• Contact information.
• Country, date of birth, age, sex, weight, height.
• Medical history (e.g. other pathologies, surgeries, diagnoses, allergies, pregnancies, etc.) and pharmacological history (other medications used by the patient).
• Information related to the adverse reaction (e.g. severity, date of onset, clinical course of the reaction, etc.)

Data relating to the notifier:

• Name and surname.
• Contact information (telephone, fax and e-mail).
• City, province.
• Profession/specialty.

For what purpose do we process your personal data?

Personal data will be processed to carry out research, detection, evaluation, understanding and prevention of adverse events and any other problem related to medicines owned by ROVI^® Biotech Limited UK or marketed by this entity, with the purpose of carrying out an evaluation of the specific case. In order to comply with the pharmacovigilance obligations that fall on the entity, which allow identifying and evaluating the risks associated with the use of medications. To fulfil this purpose, ROVI^® Biotech Limited UK may contact people who have reported adverse reactions to obtain more information about them.

How long will we process your data?

Your data will be kept until the legal responsibilities that correspond to ROVI^® Biotech Limited UK in terms of pharmacovigilance expire. Specifically, ROVI^® Biotech Limited UK must retain all documentation related to pharmacovigilance for at least 10 years from the cessation of marketing of the product. Therefore, personal information related to medication safety is retained during that period.

What is the legitimacy for the processing of your data?

The processing is necessary for reasons of public interest in the field of public health to guarantee high levels of quality and safety of medicines (art.9.2.i of the UK GDPR), being necessary for compliance with the legal obligations applicable to ROVI^® Biotech Limited UK regarding pharmacovigilance. Taking into account the above, it is completely necessary for ROVI^® Biotech Limited UK to process your data for the indicated purposes, so the provision of data for this purpose is mandatory, otherwise preventing compliance with its legal obligations.

To which recipients will your data be communicated?

The data may be communicated to the following third parties:

• The rest of the ROVI^® Group companies, whose identity can be consulted at http://www.rovi.es/company/company.php, to analyse and process the notified information.
• National and international regulatory organisations and entities.
• Health professionals who develop pharmacovigilance actions.
• Companies with which ROVI^® Biotech Limited UK has licensing or marketing agreements for medical products.
• All these assignments are intended to comply with the legal obligations that correspond to ROVI^® Biotech Limited UK in matters of Pharmacovigilance.

Notwithstanding the above, no personal data that identifies the patient or the notifier is provided in these data transfers, except to the companies of the ROVI^® Group.

What are your rights when you provide us with your data?

Anyone has the right to obtain confirmation as to whether we are processing personal data that concerns them or not. Interested parties have the right to access their personal data, as well as to request the rectification of inaccurate data or, where appropriate, request its deletion when, among other reasons, the data is no longer necessary for the purposes for which it was collected.

Under the conditions provided for in the UK General Data Protection Regulation, interested parties may request the limitation of the processing of their data or its portability, in which case we will only keep it for the exercise or defense of claims.

All the mentioned rights can be exercised through the contact methods listed at the beginning of this clause.

In the event of any violation of your rights, especially when you have not obtained satisfaction in their exercise, you can file a claim with the Information Commissioner’s Office (contact details accessible at https://ico.org.uk/).

In the event of communicating data from third parties, you assume the responsibility of informing them in advance of everything provided for in this clause and in article 14 of the UK General Data Protection Regulation, under the conditions established in said provision.