INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I. P., abbreviated as INFARMED, I. P., is a public institute under a special regime, in accordance with the portuguese law, part of the State's indirect administration, with administrative and financial autonomy and its own assets.
INFARMED, I. P. pursues the attributions of the Portuguese Ministry of Health, under the supervision and tutelage of the respective minister.
INFARMED, I. P. is a central agency with jurisdiction over the whole national territory and has its headquarters in Lisbon - Parque da Saúde de Lisboa, Av. do Brasil, No. 53, Lisbon.
In accordance with INFARMED’s organic statute, its mission is to regulate and supervise human medicines and health products in accordance with the highest standards of public health protection and to guarantee the access of health professionals and citizens to quality, effective and safe medicines and health products.
Additionally, under the terms of the respective organic statute, INFARMED, I. P. is responsible for:
Contributing to the formulation of national health policies, namely in the definition and execution of policies for medicines for human use and health products, which includes medical devices and cosmetic products;
Regulate, evaluate, authorise, discipline, supervise, cross-check, as a reference for laboratories, and ensure the surveillance and control of research, production, distribution, marketing and use of medicines for human use and health products, which includes medical devices and cosmetic products;
Regulate and supervise the research, production, distribution, marketing and use of medicines for human use and health products, which includes medical devices and cosmetic products;
Ensure compliance with the rules applicable to the authorisation of clinical trials of medicines, as well as the control of compliance with good clinical practice in their conduct;
Ensure the quality, safety, efficacy and cost-effectiveness of medicines for human use and health products, which includes medical devices and cosmetic products;
Monitor the consumption and use of medicines for human use and health products;
Promote the access of health professionals and consumers the information needed for the rational use of medicines for human use and health products, which includes medical devices, cosmetic products;
Promote and support, in liaison with domestic and foreign universities and other research and development institutions, the study and research in the fields of pharmaceutical science and technology, biotechnology, pharmacology, pharmacoeconomics, and pharmacoepidemiology;
Ensure the appropriate integration and participation within the European Union system for the evaluation and supervision of medicinal products for human use, including liaison with the European Medicines Agency and the European Commission and other European institutions;
Ensure adequate integration and participation within the network of authorities for medicines for human use and health products, which includes medical devices, cosmetic products, of the European Union and the network of official quality testing laboratories for medicines in Europe;
Ensure the State's other international obligations within the scope of its attributions, namely within the scope of the European Union, as well as within the scope of the Council of Europe and especially of the European Pharmacopoeia Commission and of the United Nations Organisation, in the area of the control of narcotics and psychotropic substances;
Develop national and international cooperation activities, of a bilateral or multilateral nature, within the scope of its attributions;
INFARMED, I. P., provides and receives collaboration from the services and organisms of the direct and indirect or autonomous administration of the State, within the scope of its attributions;
Within the scope of its attributions, INFARMED, I. P. may, under the terms foreseen by law, establish partnerships or enter into associations with other public or private sector entities, profit or non-profit, namely business associations, universities or institutions and services integrated in the National Health Service.
Within the scope of its competences and attributions, INFARMED, I.P. acts as the controller of personal data.
Collection and processing of personal data
INFARMED, I.P. Privacy Policy is established according to the data protection rules resulting from the General Data Protection Regulation (GDPR) and transposed to national legal order through Law no. 58/2019, of 8 August and concerns privacy practices in the course of INFARMED, I.P. activity, including online sites and other services managed by this body within the scope of its attributions and competences.
Personal data made available during interaction with the various services are treated with the security and confidentiality required by the legal framework applicable to personal data protection.
INFARMED's General Policy on Security and Privacy applies exclusively to INFARMED's websites and services under its responsibility.
Whenever accessing the websites of other entities or organisations, even if this access is a result of the use of links made available in INFARMED's website, INFARMED, I.P. should be aware of the respective privacy policies.
The access and use of the services and website under the responsibility of INFARMED, I.P., are of free access to the user, who is assumed to have read, understood and accepted the respective conditions.
Responsible for treatment
The collection and processing of personal data carried out in the course of INFARMED's activity shall respect the principles listed below:
- Lawful, fair and transparent use of the data collected;
- Exclusive destination of the personal data collected for the purpose(s) of processing explicitly defined;
- Collection exclusively of personal data considered indispensable for the purpose(s) agreed upon;
- Permanent updating and elimination of personal data, after the legal deadlines that oblige their maintenance have passed;
- Adoption of adequate technical and organisational measures to guarantee the integrity and confidentiality of personal data;
- Obtaining, whenever justified, the express consent of the data subject, as well as the subsequent updates;
- Obtaining, whenever there is a sharing of personal data, a declaration of compliance with the GDPR, regarding subcontracting entities;
- Processing sensitive data in accordance with the GDPR and national legislation;
- Adequate and up-to-date training of its employees in the processing of personal data;
- Timely response and communication to requests and complaints regarding the exercise of the rights of data subjects or personal data breaches.
Subcontractor
INFARMED, I.P. as a subcontractor is committed to comply with the privacy agreements and personal data processing contracted with the entities responsible for data processing.
Exercise of rights
Data subjects are guaranteed the right to access, update, rectify or delete their personal data.
You may exercise these rights by written request addressed to INFARMED, Autoridade Nacional do Medicamento e Produtos de Saúde I.P., to the address Parque da Saúde de Lisboa, Av. do Brasil, 53, 1749-004, Lisbon, or via e-mail dpo@infarmed.pt .
You have the right to file a complaint with the Comissão Nacional de Proteção de Dados (CNPD), the competent national supervisory authority, if you consider that the processing carried out violates your rights and/or the applicable personal data protection laws.
This Privacy Policy, which you should read carefully, may be changed.
The alterations shall enter into force as from the date of its publication on this site, with express reference to the date of update.
The terms and conditions of the Privacy Policy are governed and interpreted in accordance with Portuguese law.
To settle any conflicts arising from the interpretation and application of this General Security and Privacy Policy, the court of the Lisbon area has jurisdiction, to the exclusion of any other.
Last reviewed 20th August 2020.