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For all queries relating to the applications on the FAMHP portal, please contact our services via the following email address: support.portal@fagg-afmps.be.
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The Federal Agency for Medicines and Health Products takes your privacy very seriously. This privacy declaration informs you regarding the protection of your personal data by the FAMHP, your rights and how to exercise them.
All personal data (i.e. data relating to an identified or identifiable natural person) that you entrust to the FAMHP is processed with the requisite due care and attention. This naturally means that all processing of this personal data complies :
| DATA COLLECTED | REASONS FOR THIS COLLECTION |
| Legal forms document | The actors are identified by the CBE number (Crossroads Bank for Enterprises). In the case of foreign undertakings that do not have a CBE number, the FAMHP will take care of registering the actor with the CBE. To do this, the actor registers a copy of the legal form of the undertaking (actor) and then, based on this document and other information, the FAMHP registers the actor with the CBE. Depending on the origin (country), the legal forms may contain private information. |
| Telephone/mobile/fax/e-mail | In the context of medical devices, the FAMHP may have to contact the contact person identified by the actor on the portal. |
| The INSS number of the responsible persons and/or users of the application | The INSS (Social Security Identification Number), is used to authenticate and identify persons logging in to the portal. In the absence of this information, the FAMHP takes care of registering users with the CBSS/NR and obtaining the INSS number. |
| Surname, first name, sex, date of birth and place and country of birth of the manager of the undertaking or the users of the portal | The INSS (Social Security Identification Number), is used to authenticate and identify persons logging in to the portal. In the absence of this information, the FAMHP takes care of registering users with the CBSS/RN and obtaining the INSS number. In order to do so, this information is collected for the purposes of obtaining the INSS number. |
| Electronic identification data via the website and online applications: IP address, cookies, connection times | See point 6 of this document |
Your personal data is processed in the context of the FAMHP mission as defined by the Act of 20 July 2006 on the establishment and operation of the Federal Agency for Medicines and Health Products, namely: 'To ensure, from their design to their use, the quality, safety and effectiveness of medicinal products for human use and medicinal products for veterinary use (including homeopathic medicinal products, plant based medicinal products and magistral and officinal preparations), as well as medical devices and accessories and raw materials for the preparation and production of medicinal products. To ensure the quality, safety and effectiveness of all operations performed with human blood and body tissue, from harvesting to use.'
In this context, the personal data that you have communicated is processed by the FAMHP for the purposes of market oversight for medical devices, through :
The FAMHP will keep your personal data for as long as the actor is active on the medical devices market. The information is then archived in accordance with the law on archives. You will find the retention times applied by the FAMHP in the archive selection list available from the State Archives.
The FAMHP does not share your personal data with other parties except in accordance with legal requirements. The FAMHP may communicate your personal data to the following recipients :
Throughout the whole duration of the processing, you will have the following access rights, in accordance with the legislation in force :
Should you wish to exercise one of the above-mentioned rights, or if you have any questions concerning the processing of your personal data by the FAMHP, you may contact the FAMHP data protection officer. You may do this by sending an e-mail to dpo@afmps.be, or by writing to :
Please attach a scan or 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 may be extended to 60 days.
Should you feel that the FAMHP has not processed your personal data in accordance with the legislation in force, you may submit a complaint to the Data Protection Authority :
The FAMHP uses small files called cookies, which are installed on the hard disk of your computer and used to remember your preferred language and for statistical purposes.
If you do not want these cookies, you just need to adjust your browser settings accordingly. Depending on your settings, it is possible that certain graphical elements may not be displayed correctly.
Cookies are stored for 13 months. In exceptional cases such as legal proceedings, your personal data may be stored for longer than this.
The documents presented on this website are for information purposes only and cannot therefore be considered legally binding documents.
However, in connection with the applications hosted on this website, the documents can be used within the strict and confidential framework of the inspections carried out by FAMHP officials. These documents can be considered legally binding.
Without prejudice to powers of the officers of the criminal investigation department, the statutory officials of the Federal Agency for Medicines and Health Products (FAMHP) and staff connected with the FAMHP on the basis of a permanent employment contract, and who have been appointed by the King, perform an inspection of the contents of the information that is submitted by economic operators registered with the FAMHP and that has been included on this website.
The law and regulations texts that are represented in their consolidated form, are only mentioned for information purposes. Consequently, they do not create any rights or obligations other than those arising from the legally approved and published legal texts; only the latter are legally binding. The FAMHP cannot be held liable for the information provided on this website. Although we aim to publish updated and correct information, we cannot guarantee the result, and we will attempt to correct any errors reported to us. Nor can the FAMHP be held liable for errors or any direct or indirect damage that could arise from your access to or the use of this website, or for damage or any virus affecting your computer or your ICT equipment.
Some of the documents published on this website may contain references or links to information originating from other organisations. The FAMHP cannot however provide any guarantee whatsoever on the relevance, updating or the correctness of such external information material and rejects out of hand any liability in this respect. The associations, organisations and Internet sites presented on this website have been objectively selected with the sole intention of providing the most relevant information to visitors of our website. We cannot guarantee the completeness, correctness or updating of this information. The mention of certain companies or products does not at all imply that they are preferably recommended in comparison with other similar companies or products that are not mentioned.
This website, and the information and applications it contains, are the property of the FAMHP. Unless stated to the contrary, the entitlements are not subject to any time limit whatsoever and apply to all countries. Consequently, any partial or full reproduction of this website, in whatever form, is subject to the prior permission of the FAMHP. An exception is made for use by schools and for educational non-commercial purposes. The creation of hyperlinks to this website is free and no prior permission is required for this purpose. It is however forbidden to integrate this website's pages into the pages of another website. Any reproduction of this website must state the source. Translations made of one's own accord must be accompanied by the statement ‘translation not done by the author of the text’ and stating the source.
Legal action will be taken in the event of failure to observe these stipulations and any improper use of the website, or a part thereof.