Status: 2024
I. The controller within the meaning of the General Data Protection Regulation and other national data protection laws of the member states, as well as other data protection provisions
Bundesinstitut für Arzneimittel und Medizinprodukte
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Telephone: +49 (0)228 99 307-0
Fax: +49 (0)228 99 307-5207
E-mail:
poststelle@bfarm.de
Website: www.bfarm.de
As an independent higher federal authority in the portfolio of the Federal Ministry of Health (BMG), the Federal Institute for Drugs and Medical Devices (BfArM) is subject to the provisions of the General Data Protection Regulation (GDPR) and the Federal Data Protection Act (BDSG).
II. The Data Protection Officer of the controller
Arian Mehrpuyan
Contact options:
- E-mail: datenschutz@bfarm.de
- De-Mail: poststelle@bfarm.de-mail.de
- Telephone: +49 (0)228 99 307-0
- Special electronic authority mailbox (beBPo) - receiver: "Bundesinstitut für Arzneimittel und Medizinprodukte, Justitiariat"
- Federal Portal (Bundesportal) for online services and data subject rights under the General Data Protection Regulation
III. General information on the processing of data
1. Scope of the processing of personal data
As a matter of principle, we collect and use personal data of users only to the extent necessary for the provision of a functional website and of our content and services. As a rule, the personal data of the users are collected only with their prior consent. Exceptions apply in those cases where obtaining prior consent is not possible for factual reasons, the processing is technically necessary for providing the website or the processing of the data is permitted by legal regulations.
Insofar as further processing of personal data is required in order to provide our services, we will inform you of this fact at the appropriate point (such as through our online application portal) and refer you to the relevant section of this policy.
2. Legal basis for the processing of personal data
Insofar as the data subject has given their consent for operations involving the processing of personal data, the legal basis is article 6 para. 1 lit. a) of the General Data Protection Regulation (GDPR). Where the processing of personal data is necessary for the performance of a contract to which the data subject is a party, the legal basis is article 6 para. 1 lit. b of the GDPR. This also applies to processing operations that are necessary for the performance of pre-contractual measures. Insofar as the processing of personal data is necessary for the fulfilment of legal obligations to which the BfArM is subject, the legal basis is article 6 para. 1 lit. c) of the GDPR. In case processing is necessary in order to protect the vital interests of the Data Subject or of another natural person, the legal basis is article 6 para. 1 lit. d) of the GDPR.
If the processing of personal data takes place within the context of the performance of tasks which are in the public interest or are carried out in the exercise of official authority conferred on the BfArM as the controller, the legal basis is article 6 para. 1 lit. e) of the GDPR in conjunction with section 1 para. 1 and 3, section 4 para. 1 and 4 of the Act on Successor Institutions to the Federal Health Agency (BGA-NachfG) in conjunction with section 77 para. 1 of the German Medicinal Products Act (AMG). The statutory delegation of tasks, which is one of the legal bases for our processing of personal data in conjunction with Article 6 para. 1 lit. e) of the GDPR, has been transposed into a number of special laws at the national level. In addition to the aforementioned AMG, these include the Narcotics Act (BtMG), the Medical Devices Act (MPG), the Medical Devices Safety Plan Ordinance (MPSV) and the Basic Substances Monitoring Act (GÜG). These legal bases also apply, in particular, to the processing of personal data in connection with the forms provided on this website.
3. Deletion and storage period of data
The personal data of the data subject shall be deleted or blocked as soon as the purpose of the storage ceases to apply. In addition, storage may take place as provided for by the European or national legislator in Union regulations, laws or other provisions to which the controller is subject. The data will also be blocked or deleted if a storage period prescribed by the aforementioned standards expires, unless the continued storage of the data is necessary for the conclusion or fulfilment of a contract.
IV. Provision of the website and creation of log files
1. Description and scope of the data processing
Each time our website is accessed, our system automatically collects and processes data and information from the computer system of the accessing computer.
This involves collecting the following data:
- Information about the type and version of the browser used
- Operating system of the device accessing the page
- IP address
- Date and time of access
- Websites from which the user's system accesses our website
- Page accessed/Name of the file accessed
- Data volume transferred
- Message whether the access/retrieval was successful
- Website visited by you after the visit to our website
The aforementioned data is also stored in the log files of our system. For as long as you visit our website, your IP address is processed for the delivery of data to your computer. The IP address is then shortened by two bytes (e.g. 192.168.xxx.xxx) and saved in this form. Thus, it is no longer possible to associate the shortened IP address to the calling computer. Other data that enables the data to be associated with users is not stored. Neither is the aforementioned data stored together with the users’ other personal data.
2. Legal basis for the data processing
The legal basis for the temporary storage of the data is article 6 para. 1 lit. e) of the GDPR in conjunction with section 1 para. 1 and 3, section 4 para. 1 and 4 of the Act on Successor Institutions to the Federal Health Agency (BGA-NachfG) in conjunction with section 77 para. 1 of the German Medicinal Products Act (AMG).
3. Purpose of the data processing
The temporary storage of the IP address by the system is necessary so that the website can be delivered to the user's computer. This necessitates storing the IP address of the user for the duration of the session. The subsequent storage of the anonymised IP address serves to protect our information technology systems from hacker attacks and to optimise our Internet offering.
4. Storage period
The data is deleted as soon as it is no longer required to achieve the purpose for which it was collected. In case the provision of the website requires the collection of personal data or of data attributable to particular persons, this is the case as soon as the respective session has ended. The data stored in the log file are no longer attributable to particular users. They are stored for the period of one year. The data will not be passed on to third parties or used in any other way.
5. Possibility of objection and removal
The collection of data for the provision of the website and the storage of the data in log files is absolutely necessary for the operation of the website. This means that there is no possibility for users to object, as the data is stored in the log files without being associated with a particular person.
V. Cookies
1. Description and scope of the data processing
Our website uses cookies, which are text files stored in the Internet browser or by the Internet browser on the user's computer system. When a website is accessed, a cookie may be stored on the user's operating system. This cookie contains a particular string of characters which enables the browser to be uniquely identified when the website is called up again.
Cookies may also be used on linked pages without us being able to inform users of this. Most browsers are set to accept cookies automatically. However, the storage of cookies can be deactivated or the browser can be set to notify users as soon as cookies are sent.
2. Legal basis for the data processing
The legal basis for the processing of personal data using cookies is article 6 para. 1 lit. e) of the GDPR in conjunction with section 1 para. 1 and 3, section 4 para. 1 and 4 of the BGA-NachfG in conjunction with section 77 para. 1 of the German Medicinal Products Act (AMG).
3. Purpose of the data processing
We use cookies on our website to make our website more user-friendly. Some elements of our website require the calling browser to be identifiable even after the change to another page. This concerns the adoption of language settings and the memorisation of search terms. The cookies we use are also used for load balancing purposes and to ensure that user requests are always sent to the same server during a session. The user data collected by means of technically necessary cookies is not used for the creation of user profiles.
4. Matomo (Piwik)
Diese Website nutzt den Web-Analysedienst Matomo, 150 Willis St, 6011 Wellington, New Zealand (vormals Piwik), zu dem Zweck und in unserem Interesse, Ihre Nutzung unserer Website zu analysieren. Über die so gewonnenen Statistiken können wir unser Angebot verbessern und auch für Sie als Nutzer interessanter ausgestalten.
Für diese Auswertungen werden keine Cookies auf Ihrem Computer gespeichert, sondern sie erfolgen anhand der Browserdaten, wobei Ihre IP-Adresse um die letzten beiden Blöcke gekürzt und anschließend kodiert wird. Eine Identifizierbarkeit Ihrer Person kann damit ausgeschlossen werden. Die mittels Matomo von Ihrem Browser übermittelte IP-Adresse wird nicht mit anderen von uns erhobenen Daten zusammengeführt. Rechtsgrundlage für die Datenverarbeitung ist Art. 6 Abs. 1 lit. f DS-GVO.
Sie haben das Recht, der Datenverarbeitung zu widersprechen, indem Sie den folgenden Haken entfernen und so das Opt-out-Plugin aktivieren:
Sie können sich hier entscheiden, ob in Ihrem Browser ein eindeutiger Webanalyse-Cookie abgelegt werden darf, um dem Betreiber der Website die Erfassung und Analyse verschiedener statistischer Daten zu ermöglichen. Wenn Sie sich dagegen entscheiden möchten, wählen Sie bitte die entsprechende Option, um den Matomo-Deaktivierungs-Cookie in Ihrem Browser abzulegen.
In diesem Fall wird in Ihrem Browser ein sog. Opt-Out-Cookie abgelegt, was zur Folge hat, dass Matomo keinerlei Sitzungsdaten erhebt. Bitte beachten Sie, dass die vollständige Löschung Ihrer Cookies zur Folge hat, dass auch das Opt-Out-Cookie gelöscht wird und ggf. von Ihnen erneut aktiviert werden muss.
5. Storage period, possibility of objection and removal
Cookies are stored on the user's computer and transmitted from that computer to our site. This means that users also have full control over the use of cookies, with the transmission of cookies being deactivated or restricted by changing the settings of the Internet browser. Cookies that have already been saved can be deleted at any time, including automatically. If cookies are deactivated for our website, it may no longer be possible to use all the functions of the website to their full extent. The cookies we use are so-called session cookies whose validity is only maintained for the duration of the respective session.
VI. E-mail contact
1. Description and scope of the data processing
It is possible to contact us via the e-mail address provided in the Imprint. In this case, the personal data of the user transmitted with the e-mail will be stored. The intended purpose of the storage of this data is to enable us to contact users if necessary in the course of processing requests.
This does not involve the passing on of data to any third parties, with the data being used exclusively for processing the conversations.
2. Legal basis for the data processing
The legal basis for the processing of the data is article 6 para. 1 lit. a) GDPR if the users have given their consent.
The legal basis for the processing of data transmitted in the course of sending an e-mail is article 6 para. 1 lit. e) GDPR in conjunction with section 1 para. 1 and 3, section 4 para. 1 and 4 of the BGA-NachfG in conjunction with section 77 para. 1 of the AMG.
3. Purpose of the data processing
In the case of contact by e-mail, the purpose of storing the e-mail address is to enable us to reply to the sender.
The provision of the address only becomes mandatory if requests from users give rise to fees, as can be the case for requests under the German Freedom of Information Act (IFG). If a request gives rise to fees, users will be made aware of this before processing begins and will be asked for their consent. If the request is not confirmed within the deadline set in the letter, the personal data collected will be deleted together with the request. With your consent, you will also be asked to provide your postal address, if this has not already been provided. This will allow for the delivery of a written fee notice. Providing your telephone number only helps to process the request in a more timely fashion. Should there be any uncertainties on our part with regard to the questions provided to us, this would allows us to consult those persons wishing to make contact to us in a quicker and more uncomplicated manner.
4. Storage period
The data will be deleted as soon as they are no longer required to achieve the purpose for which they were collected and if this would be no longer in conflict with any applicable regulations on the storage of data, in particular with the “Registration Directive on the Processing and Management of Documents in Federal Ministries”, which is applied by way of analogy in Federal Authorities. According to this directive, the registered personal data and conversations will be stored for a period of 10 years for the purposes stated. They will not be passed on to third parties.
5. Possibility of objection and removal
Users have the possibility to revoke their consent to the processing of their personal data at any time. Users who have contacted us by e-mail can object to the storage of their personal data at any time. All personal data stored in the course of contacting us will be deleted in this case. In such a case, the conversation cannot be continued.
VII. Web analysis by means of Matomo
1. Scope of the processing of personal data
We use the open source software tool Matomo (formerly PIWIK) on our website to analyse the surfing behaviour of users. We operate Matomo without the use of cookies. Calling up individual pages of our website triggers the storage of the following data:
- Two bytes of the IP address of the calling system of the user.
- The web page called up
- The website from which the user was directed to the website called up (referrer)
- The sub-pages which are called up up from the website called up
- The time the user spent on the website
- The frequency of access to the website
In this context, the software runs exclusively on the servers of our website. The data of the users is stored exclusively on these servers and will not be passed on to any third parties.
2. Legal basis for the processing of personal data
The legal basis for the processing of the aforementioned data is article 6 para. 1 lit. e) of the GDPR in conjunction with section 1 para. 1 and 3, section 4 para. 1 and 4 of the BGA NachfG in conjunction with section 77 para. 1 of the AMG.
3. Purpose of the data processing
The processing of the aforementioned data enables us to analyse the surfing behaviour of the users. By evaluating the data obtained, we are able to compile information on the use of the individual components of our website, which allows us to constantly improve our website in terms of user friendliness. Anonymising the IP address sufficiently takes account of the users’ interest in the protection of their personal data.
4. Storage period
The anonymous log data is deleted as soon as it is no longer required for our recording purposes, which is the case after 30 days. Only the reports generated from this data are subject to subsequent processing.
VIII. Rights of the Data Subject
Processing the personal data of the users makes these users into data subjects within the meaning of the GDPR. Users of our website therefore have the following rights vis-à-vis the BfArM in the capacity as a controller.
These data subject rights can be asserted in several ways. You are welcome to contact us by letter, telephone, e-mail, De-Mail, beBPo or via the Federal Portal (Bundesportal), addresses above under I. and II.
1. Right of access to personal data
Users have the right to ask us, as the controller, for confirmation as to whether personal data relating to them are being processed by us.
If such processing is taking place, users have the right to request the following information from the controller:
- the purposes for which the personal data are processed;
- the categories of personal data which are processed;
- the recipients or categories of recipients to whom the personal data concerning them have been (or will be) disclosed;
- the planned storage period of the personal data relating to the users or, if specific information on this cannot be obtained, the criteria for determining the storage period;
- the existence of a right of rectification or erasure of personal data concerning the users, a right to restriction of processing by the controller or a right to object to such processing;
- the existence of a right to lodge a complaint with a supervisory authority;
- any available information on the origin of the data if the personal data are not directly collected from the data subject;
- whether any automated decision-making processes - including profiling - within the meaning of article 22 para. 1 and 4 of the GDPR are involved and, at least in those cases, any useful information on the logic involved as well as on the scope and intended effects of such processing for the data subject.
Users have the right to request information as to whether any personal data concerning them is transferred to any third countries or international organisations. In this context, they may request to be informed about the appropriate safeguards as per article 46 of the GDPR in relation to the transfer.
This right of access may be restricted to the extent that it is likely to render impossible or seriously interfere with the achievement of the research or statistical purposes and insofar as the restriction is necessary for the fulfilment of the research or statistical purposes.
2. Right of rectification
Users have a right of rectification and/or completion vis-à-vis the controller if the processed personal data concerning them are inaccurate or incomplete. The controller is under an obligation to rectify the data immediately.
The right of rectification may be restricted to the extent that it is likely to render impossible or seriously interfere with the achievement of the research or statistical purposes and insofar as the restriction is necessary for the fulfilment of the research or statistical purposes.
3. The right to restrict the processing
Users have a right to request the restriction of the processing of personal data concerning them under the following conditions:
- where users contest the accuracy of the personal data concerning them for a period enabling the controller to verify the accuracy of the personal data;
- where the processing is unlawful and you object to the erasure of the personal data and instead ask for a restriction of the use of the personal data;
- where the controller no longer needs the personal data for the purposes of processing, but the users need them for purposes such as the assertion, exercise or defence of legal claims, or
- where users have objected to the processing pursuant to article 21 para. 1 of the GDPR and it is not yet clear whether the legitimate grounds of the controller override the grounds that they have invoked.
Where the processing of personal data relating to users has been restricted, it shall be permitted to process these data (excepting their storage) only with the consent of the users or for the establishment, the exercise or the defence of legal claims or for the protection of the rights of another natural or legal person or for reasons of substantial public interest as far as the Union or a Member State is concerned.
If the right to have the processing of the data restricted is limited in accordance with the aforementioned conditions, users shall be informed by the controller prior to the restriction being lifted.
The right of users to restrict the processing of their data may, in turn, be restricted to the extent that it is likely to render impossible or seriously interfere with the achievement of the research or statistical purposes and insofar as the restriction is necessary for the fulfilment of the research or statistical purposes.
4. Right of erasure
Obligation of erasure
Users have the right to ask the controller for the immediate deletion of personal data concerning them and the controller is under an obligation to delete such data immediately if one of the following conditions is met:- The personal data concerning the user are no longer necessary for the purposes for which they were collected or otherwise processed.
- Users withdraw their consent on which the processing was based pursuant to article 6 para. 1 lit. a) or article 9 para. 2 lit. a) of the GDPR and no other legal basis for the processing exists.
- Users object to the processing pursuant to article 21 para. 1 of the GDPR and there are no overriding legitimate grounds for the processing or they object to the processing pursuant to article 21 para. 2 of the GDPR.
- The processing of the personal data of the user was unlawful.
- The deletion of the personal data concerning the user is necessary for compliance with a legal obligation under Union or Member State legislation to which the controller is subject.
- The personal data concerning the user have been collected in relation to information society services provided pursuant to article 8 para. 1 of the GDPR.
- Provision of information to third parties
If the controller has made the personal data concerning the data subject publicly available and is under an obligation to erase them pursuant to article 17 para. 1 of the GDPR, the controller shall take reasonable steps, including technical measures - having regard to the available technology and the cost of implementation - to inform controllers processing the personal data that data subjects have requested erasure of any links to, or any copies or replications of those personal data.
Exceptions
The right to erasure does not exist insofar as the processing is necessary- for the exercise of the right of free speech and information;
- for compliance with a legal obligation which requires processing under Union or Member State legislation to which the controller is subject or for the performance of a task carried out in the public interest or in the exercise of the official authority vested in the controller;
- for reasons of public interest in the field of public health pursuant to article 9 para. 2 lit. h) and i) and article 9 para. 3 of the GDPR;
- for archiving purposes in the public interest, for scientific or historical research purposes or for statistical purposes pursuant to article 89 para. 1 of the GDPR, where the right referred to under lit. a) is likely to render impossible or seriously interfere with the achievement of the purposes of such processing, or
- for the assertion, exercise or defence of legal claims.
5. Right to be informed
Where users have exercised the right to rectification, erasure or restriction of processing vis-à-vis the controller, the latter shall be obliged to inform all recipients to which the personal data concerning them have been disclosed of this rectification or erasure, unless this proves to be impossible or would involve undue hardship. Users have the right to be informed of the existence of these recipients by the controller.
6. Right to data portability
Users have the right to receive the personal data concerning them that they have provided to the controller in a structured, commonly used and machine-readable format. In addition, users have the right to transmit those data to another controller without hindrance from the controller to whom the personal data have been provided, insofar as
- the processing is based on consent pursuant to article 6 para. 1 lit. a) of the GDPR or article 9 para. 2 lit. a) of the GDPR or on a contract within the meaning of article 6 para. 1 lit. b) of the GDPR; and
- the processing is carried out with the aid of automated procedures.
In exercising this right, users also have the right to have personal data relating to them transferred directly from one controller to another controller to the extent this is technically feasible. This must not interfere with the freedoms and rights of other persons. The right to data portability shall not apply if the processing necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.
7. Right of objection
Users have the right to object, on grounds relating to their particular situation, at any time to the processing of the personal data relating to them, which is based on article 6 para. 1 lit. e) GDPR, including to profiling based on those provisions.
The controller shall no longer process the personal data of the user, unless they can prove the existence of compelling legitimate grounds for the processing which override their interests, rights and freedom, or for the establishment, exercise or defence of legal claims.
Users shall have the option of exercising their right to object in relation to the services provided by an information society by means of automated procedures using particular technical specifications, Directive 2002/58/EC notwithstanding.
Users also have the right to object, on grounds relating to their particular situation, to the processing of personal data concerning them which is carried out for scientific or historical research purposes or for statistical purposes pursuant to article 89 para. 1 of the GDPR.
The users’ right of objection may be restricted to the extent that it is likely to render impossible or seriously interfere with the realisation of the research or statistical purposes and insofar as the restriction is necessary for the fulfilment of the research or statistical purposes.
8. Right to revoke the declaration of consent under data protection law
Users shall have the right to revoke their declaration of consent under data protection law at any time. The revocation of consent shall not affect the lawfulness of the processing that has taken place on the basis of the consent until its revocation.
9. Automated individual decision-making, including profiling
Users shall have the right not to be subject to a decision based solely on automated processing, including profiling, which produces legal effects concerning them or similarly significantly affects them. This shall not apply if the decision:
- is necessary for entering into, or performance of, a contract between the user and the controller,
- is authorised by Union or Member State legislation to which the controller is subject and that legislation contains appropriate measures to safeguard the rights and freedoms of users and their legitimate interests or
- is based on the user’s explicit consent.
However, such decisions shall not be based on special categories of personal data within the meaning of article 9 para. 1 of the GDPR, unless article 9 para. 2 lit. a) or g) of the GDPR applies and appropriate measures have been taken to protect the rights and freedoms and legitimate interests of users.
With regard to the cases referred to in a) and c), the controller shall take reasonable steps to safeguard the rights and freedoms as well as the legitimate interests of the users, including at least the right to obtain the intervention of a person on the part of the controller, to express their point of view and to contest the decision.
10. Right to lodge a complaint with a supervisory authority
Without prejudice to any other administrative or judicial remedy, users shall have the right to lodge a complaint with a supervisory authority, in particular in the Member State of their residence, place of work or the place of the alleged infringement, if they consider that the processing of personal data relating to them infringes the GDPR.
The supervisory authority to which the complaint has been lodged shall inform the complainant of the status and outcome of the complaint, including the possibility of a judicial remedy under article 78 GDPR.