Pharmacovigilance Privacy Policy
1. framework
At Tecnifar – Indústria Técnica Farmacêutica, S.A. (hereinafter referred to as Tecnifar), we respect the relationships we maintain with Patients, Health Professionals, Health Services, Partners, Regulatory Entities and other stakeholders in the Pharmacovigilance System, and we consider it extremely important to protect the privacy of all individuals whose personal information is processed in the performance of our activity.
2. Purpose and lawfulness of processing
Therefore, as Data Controllers, we share information on how we process this data for Pharmacovigilance purposes, in compliance with our legal duties to monitor the safety, quality and efficacy of medicines that are still in clinical development, which we market, distribute, promote, or for which we hold authorization.
3. Data collected
In strict compliance with these obligations, the continuous evaluation of the benefits and risks of medicines, as well as the reporting of reactions or suspected adverse events to the competent authorities, we are required to process certain data.
Pharmacovigilance legislation requires the adoption of procedures aimed at obtaining accurate and verifiable data for the scientific evaluation of reports of suspected adverse reactions, as well as the monitoring of the respective reporting process. In compliance with the above, the personal data of clinical trial participants and people for whom there has been or is a suspicion of an adverse reaction to a particular drug or other special cases of Pharmacovigilance (also referred to as the subjects of the notification) are processed, as well as the data of health professionals and third parties (referred to as the notifier) who collect and transmit the information in compliance with obligations arising from the legal framework of the national Pharmacovigilance system.
1) The following categories of data can be recorded for clinical trial participants and people who have suffered or are suspected of suffering an adverse reaction and/or other special pharmacovigilance cases:
a) Initials of the name (preferred) and/or name (when it is transmitted by the subject of the reaction or the notifier);
b) Date of birth and/or age;
c) Sex;
d) Anthropometric (weight and height);
e) Data on the adverse reaction (description, onset, duration, severity, evolution, identification of the suspected drug, date of onset, date of discontinuation, route of administration, daily dose, therapeutic indication, first use, data on concomitant medication, existence of previous reactions to the same drug, reintroduction of the same drug and suspected interaction);
f) Clinical data, diagnostic tests, allergies and pregnancy;
g) Clinical opinion on the causal relationship.
2) As for the health professionals who transmit the information, the following data can be recorded:
a) Name;
b) Place of work;
c) Contact;
d) Medical specialty.
3) With regard to third parties (non-health professionals) who transmit the information, the following data may be recorded:
a) Name;
b) Contact.
When the notifier is also the subject of a suspected adverse reaction or other special pharmacovigilance cases, this information can be added to the data provided in relation to the suspected adverse reaction.
We would point out that, in the case of clinical trials, in addition to the information mentioned above, additional information may be collected in accordance with the applicable legislation.
In accordance with the applicable legislation, the information collected in point 1, points e), f) and g), described above, relate to health and are therefore classified as sensitive personal data.
4. How the data collected is used
In compliance with our Pharmacovigilance obligations, we will use the information for the following purposes:
- Investigation of an event or suspected adverse reaction, as well as other special pharmacovigilance cases;
- Contact the subject of the notification or the notifier to obtain additional information about the adverse event that has been reported;
- Follow-up on the notification of a suspected adverse reaction or other special pharmacovigilance cases;
- Collate the information received on suspected adverse reactions or other special pharmacovigilance cases with the information available on other suspected adverse reactions perceived by Tecnifar in order to analyze the safety of a given batch, product or active substance;
- Provide the mandatory reports to the competent national and/or international regulatory bodies (such as INFARMED and the Eudravigilance database) for the analysis of the safety of a given batch, product, generic or active substance, along with other notifications from other sources.
5. Data retention
The data collected as part of the notification of a suspected adverse reaction or other special cases of Pharmacovigilance are kept for the period necessary to pursue the purpose of processing, under the terms of the legislation in force, in order to guarantee the safe use of our products.
6. Transmission of personal data
The personal data collected may be passed on to third parties in the event that one of our medicines is sold, assigned or licensed, in which case the purchaser, assignee or licensee will be required to ensure that their data is processed in accordance with the applicable legislation. The same can happen in cases related to medicines that are licensed, distributed and promoted by Tecnifar.
Tecnifar, as the promoter of a clinical trial and/or authorization holder, is obliged to keep detailed records of all suspected and actual adverse reactions occurring in Portugal, in any other member state or in third states, as well as to inform the competent authorities and their partners.
As an actor in the Pharmacovigilance system, we share information with the competent regulatory authorities (such as INFARMED I.P. and the European Medicines Agency), under the terms of the legislation in force.
INFARMED is the entity responsible for monitoring, coordinating and implementing the National Pharmacovigilance System for Medicines for Human Use, and may collect and process personal data as long as it is indispensable for carrying out its duties. In this sense, INFARMED is responsible for the processing of personal data resulting from its intervention in the monitoring, coordination and implementation of the National Pharmacovigilance System and the inspection powers it holds under the terms of the aforementioned law and regulations.
If Tecnifar chooses to hire an external entity to carry out pharmacovigilance activities, it will act on Tecnifar’s instructions and will implement the appropriate technical and organizational measures to protect personal data against accidental or unlawful destruction, accidental loss, alteration, unauthorized disclosure or access, as well as guarantee a level of security appropriate to the risks inherent in the processing and the nature of the data to be protected.
7. International data transmissions
Whenever we have to transfer personal data for pharmacovigilance purposes to a third country outside the European Union or an international organization, we will first analyse the admissibility of the transfer, adopt technical and organizational security measures and apply the standard data protection clauses adopted by the European Commission.
8. Treatment safety measures
Tecnifar implements security measures of a technical and organizational nature necessary to guarantee the security of the personal data provided to us, in order to prevent its alteration, loss, unauthorized processing and/or access, taking into account the current state of technology, the nature of the data stored and the risks presented by the processing. We have implemented specific procedures for collecting, processing and circulating information.
We have a computerized system structured to allow access to information according to different user profiles, with different levels of access and different information handling privileges. Preventing unauthorized access to information. User profiles are kept up to date and deleted when the user no longer has access privileges and passwords are periodically changed.
We guarantee restricted physical and logical access to the system’s servers, which must keep a record of access to information in order to control operations and carry out internal and external audits. Likewise, backups of information are made and kept in a place accessible only to the system administrator or, under his supervision, to other technicians bound by professional secrecy.
9. Data subjects’ rights
In compliance with and to the extent of the provisions of the applicable legislation on the protection of personal data, the data subject may, at any time, exercise the rights of access, rectification, erasure, portability, limitation and opposition to the processing of their personal data, by means of a written request addressed to Tecnifar’s Data Protection Officer through the contacts described in the following point.
Under the terms of the law, the data subject has the right to lodge a complaint regarding the protection of personal data with the competent supervisory authority, in the case of Portugal, the National Data Protection Commission (CNPD).
10. DPO contacts
If you have any questions about this Privacy Policy or how we use your personal data, please contact Tecnifar’s Data Protection Officer by e-mail: DPO@tecnifar.pt and/or from the address: Rua José Da Costa Pedreira, N.º 11 – B – Torre Sul, 1750-130 Lisboa.
11. Changes to the Privacy Policy
Tecnifar reserves the right to amend, add to or revoke this Pharmacovigilance Privacy Policy, in whole or in part, at any time, in compliance with the General Data Protection Regulation (GDPR) and other applicable legislation. Without prejudice, Tecnifar undertakes to announce any changes by means of relevant notification.
12. Change control
13. Distribution List
This document follows what is defined in the Document Management procedure (PT-SQ-001) and is controlled in the Documents and Records Map (PT-SQ-001 MOD-002).
Rev.00; 2019/07/29