Privacy

Privacy statement of the FAMHP in accordance with the GDPR

For the FAMHP your privacy is of the highest importance. 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 naturally 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 individuals with regard to the processing of personal data and the free movement of such data.

Based on this general data protection regulation (GDPR), you are entitled to clear information about the processing of your personal data.

  1. Which personal data do we use?
  • identification data (e.g name, national insurance number and IP address);
  • contact details (e.g. postal or email address and telephone number);
  • medical data;
  • findings made in the context of inspections and enforcement powers of the FAMHP.

On every website or application of the FAMHP where personal data is requested or used, a separate disclaimer explains in more detail which data is processed.

  1. 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), as well as that of 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.
  1. 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.

  1. With whom do we 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.

  1. 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 also a copy of it.
  • 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 dpo@fagg-afmps.be or at the following address:

Federal Agency for Medicines and Health Products - FAMHP
For the attention of the Data Protection Officer
Eurostation II
Victor Hortaplein 40/40
1060 BRUSSELS

You must send 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
Drukpersstraat 35
1000 BRUSSELS
commission@privacycommission.be

FAMHP -website

Below you will find additional information about the processing of personal data that occurs specifically via the FAMHP website.

Situations Processed data

You can consult one or more pages of the FAMHP website.

IP address

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:

  • language choice
  • search engine used
  • keywords used
  • website you consulted
  • consulted pages
  • consultation time per page
  • list of downloaded files
  • date and time of access
  • browser used
  • platform and/or operating system installed on your computer
  • etc.
You contact the FAMHP via an electronic form. Name, first name and e-mail address that you register.

Cookies
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.

If you do not wish to use cookies, you can adjust your browser settings accordingly. With this setting it is possible that some graphic elements will not be displayed correctly.

Storage duration
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.

 

Last updated on 30/05/2018