- General privacy statement of the FAMHP in accordance with the GDPR
- Additional information for specific processes
General privacy statement of the FAMHP in accordance with the GDPR
Your privacy is highly important to the FAMHP. This privacy statement gives you information about the protection of your personal data by the FAMHP, what your rights are and how you can exercise these rights.
All personal data (i.e. all data relating to an identified or identifiable natural person) that you entrust to the FAMHP will be handled with the necessary care. This implies that all processing of this personal data is carried out in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data.
Based on this General Data Protection Regulation (GDPR), you are entitled to receive clear information about the processing of your personal data. Below you will find a general statement for all processes by the FAMHP, but for certain specific processing some additional explanation will be given, or reference is made to an additional privacy declaration.
- Which personal data does the FAMHP use?
- Identification data, e.g name, national register number and IP address.
- Contact details, e.g. postal or email address and telephone number.
- Medical data.
- Findings made within the framework of FAMHP inspections and enforcement powers.
- Why and on what basis does the FAMHP use your personal data?
Your personal data is processed in the context of the FAMHP mission, as stipulated in the Law of 20 July 2006 on the establishment and operation of the FAMHP, namely:
“Ensuring, from development to use, the quality, safety, and efficacy of
- medicinal products for human use, and of veterinary medicinal products (including homoeopathic remedies and herbal medicinal products, pharmacy-made preparations, and officinal preparations),
- medical devices and accessories, and raw materials for the preparation and production of medicines.
Ensuring, from removal to use, the quality, safety, and efficacy of
- all operations involving blood and human tissue.”
Within this framework, personal data can be processed for the following activities:
- handling and evaluating applications for permits, certificates, approvals or other authorisations;
- registering notifications of manufacture, distribution or export of medical devices;
- recording, evaluating and investigating reports of side effects of medicines and adverse events and incidents with medical devices or blood, tissues and cells;
- performing checks and inspections;
- investigating potential violations and punishment or prosecution of offences detected;
- providing (scientific) advice and information within the competence area of the FAMHP;
- monitoring the use of antibiotics in animals intended for human consumption;
- ensuring traceability of medical devices in Belgium;
- determination and collection of taxes and fees due to the agency.
In addition to the information processed in the context of the FAMHP mission, personal data is also processed during the following activities that are necessary for the general functioning of the FAMHP:
- selection procedures for recruiting new staff;
- management of information about external experts on whom the FAMHP can call;
- management of information about suppliers who provide services to the FAMHP.
- How long will your personal data be stored?
The FAMHP stores your personal data for as long as necessary for the fulfilment of statutory tasks such as the follow-up of the safety of products or the monitoring of market participants in the sectors over which the agency has supervisory control.
The information is then archived in accordance with the provisions of the Public Record Act. The retention periods used by the FAMHP can be found in the Archive selection list at the State Archives.
- With whom does the FAHMP share your personal data
Depending on the specific context, the FAMHP may share data with other Belgian or international (government) authorities, provided that this is regulated within a legal framework. Your personal data will not be shared with other parties.
- What are your rights and how can you exercise them?
You have the following rights.
- Inspection: you can receive information about the processing of your personal data and a copy of it on demand.
- Rectification: if you believe that your personal data is incorrect or incomplete, you can ask for the personal data to be modified.
- Removal: you can request removal of your personal data.
- Restriction: you can request restriction of the processing of your personal data.
- Objection: you can object to the processing of your personal data..
- Withdrawal of consent: if you have given permission for the processing of your personal data, you always have the right to withdraw this consent.
- Data portability: you have the right to obtain the personal data you have provided to the FAMHP in a format that facilitates the smooth transfer of your data to another party.
Restrictions may apply to these rights for some processing activities. These restrictions are legally defined.
If you wish to exercise one of these rights, or if you have questions about the processing of your personal data by the FAMHP, you can contact the FAMHP data protection officer.
This can be done via email@example.com or at the following address:
Federal Agency for Medicines and Health Products - FAMHP
For the attention of the Data Protection Officer
Avenue Galilée 5/03
Please add a scan/copy of your identity card so that the FAMHP can identify you.
Your request will be processed within 30 calendar days. In exceptional cases, this period can be extended by 60 days.
If you believe that the FAMHP has not processed your personal data in accordance with the applicable legislation, then you have the right to file a complaint with the Data Protection Authority:
Data protection authority
Additional information for specific processes
Below you will find additional information about the processing of personal data that occurs specifically via the FAMHP website.
You consult one or more pages of the FAMHP website.
The following data can generally be used for statistical purposes and to improve the content of the website without establishing a link with your IP address:
|You contact the FAMHP via an electronic form.||Name, first name and email address that you register.|
The FAMHP uses small files (cookies) that are placed on the hard drive of your computer to remember your language choice and to compile statistics.
The storage period of the cookies is thirteen months.
In exceptional cases, such as legal proceedings, your personal data may be stored for a longer period.
The FAMHP regularly carries out surveys amongst patients and healthcare professionals, either through online questionnaire or through paper questionnaires. The purpose of these surveys is to assess certain risks or to assess the effectiveness of risk reduction procedures related to the use of medicinal or healthcare products. The results of these surveys help the FAMHP take decisions to improve the consumer safety of these products.
These surveys do not collect personal data, in other words they do not collect data relating to an identifiable physical person. To ensure your anonymity, you should not provide any information that may be used to identify you, such as your name, age or place of residence.
As personal data is not collected, the rights usually granted to individuals with regards to the protection of their personal data do not apply to this survey. This includes, amongst other things, the right to access, correct or delete personal data.
In order to enable the processing of orders, the following data are processed and stored: surname and first name, e-mail address and postal address. These data will not be used for other purposes or shared with third parties.
The processing is based on Article 6 §1 (b) of the GDPR (performance of a contract). There is a retention period of one year. All rights for data subjects mentioned under paragraph five of the general privacy statement are hereby applicable.
Reporting adverse reactions via the application eenbijwerkingmelden.be or notifieruneffetindesirable.be
More information on the processing of data through eenbijwerkingmelden.be or notifieruneffetindesirable.be can be found in the privacy statement of the application.