PharmNet.Bund - Privacy

Data Privacy Declaration

The protection of your personal data is very important to us. Below you will find our data privacy declaration for collecting and processing your data when you visit the PharmNet.Bund website.

Information on the collection of personal data when you use our website

Personal data is any information, that can be specifically attributed to you, e.g. name, address, email addresses, user behaviour.

The responsible person in accordance with Article 4 para 7 of the EU General Data Protection Regulation (GDPR) is BfArM Office Cologne, Waisenhausgasse 36-38a, 50676 Cologne, represented by the president, Prof. Dr. Karl Broich. You can contact the data protection officer Mr. Arian Mehrpuyan at the following e-mail: datenschutz@bfarm.de.

The cooperation with the Federal authorities and the states is regulated in § 67a of the Arzneimittelgesetz (German Medicines Act) and is a shared responsibility in accordance with Article 26 GDPR.

The data privacy declaration including the contact details of the responsible person and the data protection officer of the Federal Ministry of Health is available via the following link: English Version - Bundesgesundheitsministerium.
The data privacy declaration including the contact details of the responsible person and the data protection officers of the individual states is available on the website: Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten.

We offer you various possibilities to communicate with us electronically. In the following we describe the processing of personal data that takes place.

Contact by email

Contact by email is possible via various functional email boxes.

If you send us an email, the data transmitted by you (e.g. surname, first name, address), but at least the email address, as well as the information contained in the email including any personal data transmitted by you are processed for the purpose of contact and dealing with your request.

The legal basis for the processing of data transmitted in the course of sending an email is Article 6 para 1 letter e GDPR in conjunction with Article 1 para 1 and 3, Article 4 para 1 and 4 BGA-NachfG in conjunction with Article 77 para 1 AMG. Insofar as consent is requested and granted by you for the processing of data, the legal basis for this processing is Article 6 para 1 letter a GDPR.

A processing of the personal data transmitted by you is necessary for the purpose of processing your request as well as in the case of anonymous requests for individualization of the respective inquiry.

The data are erased as soon as they are no longer necessary for achievement of the purpose and regulations on storage, in particular the " Registraturrichtlinie für das Bearbeiten und Verwalten von Schriftgut in Bundesministerien", which is applied analogously in federal authorities, no longer stand in the way.

The personal data and conversations entered will be stored for a period of 10 years for the above-mentioned purposes. They will not be passed on to third parties.

Contact by contact form

If you use a contact form for communication, the statement of your name and of your email address is necessary. Without these data, your request transmitted by contact form cannot be processed.

The legal basis for the processing of the data transmitted with the contact form, including that of the transmitted message itself, is Article 6 para 1 letter a GDPR, based on the consent given. The data will be processed for the purpose of processing your request.

The data are erased as soon as they are no longer necessary for achievement of the purpose and regulations on storage, in particular the " Registraturrichtlinie für das Bearbeiten und Verwalten von Schriftgut in Bundesministerien", which is applied analogously in federal authorities, no longer stand in the way.

The personal data and conversations entered will be stored for a period of 10 years for the above-mentioned purposes. They will not be passed on to third parties.

Visiting our website

In the case of purely informative use of our website, i.e. if you do not register or otherwise provide us with information, we will only collect the data transmitted by your browser to our server. If you wish to view our website, we collect the following data that is technically necessary for us to display our website and to ensure stability and security:

• Information about the browser type and version used
• Operating system used by the accessing device
• Website from which you arrived on our site (Referrer URL)
• Pages and files accessed on our site
• Where appropriate, the website you visited after our site (by clicking an external link on our website)
• Message whether the access/retrieval was successful and the amount of data transferred
• Date and time of your access
• IP address

Temporary storage of the IP address by the system during the current session is technically necessary to enable delivery of the website to the user's computer.

The listed data is also stored in the log files of our system. However, before the IP address is saved, it is shortened by two bytes (e.g.: 192.168.xxx.xxx). In this way, it is no longer possible to assign the shortened IP address to the calling computer. Other data which allow the data to be assigned to users are not stored.

The aforementioned data is also not stored together with other personal data of the user.

The legal basis for the temporary storage of data is Article 6 para 1 letter e GDPR in conjunction with Section 3 BDSG in conjunction with Article 1 para 1 and 3, Article 4 para 1 and 4 BGA-NachfG in conjunction with Article 77 para 1 AMG.

The data will be deleted as soon as they are no longer necessary for the purpose for which they were collected. In the case of the collection of personal or personally identifiable data for the provision of the website, this is the case as soon as the respective session is ended. The data stored in the log file can no longer be assigned to the users. They are stored for 4 months for the purpose of optimising the website and ensuring the security of our information technology systems. The data will not be passed on to third parties or used in any other way.

The complete IP address will only be saved in case of suspicion of misuse and error analysis. It is used exclusively for the purpose of averting danger in the event of attacks on the information technology systems or for error analyses in order to be able to analyse and correct any errors that may occur.

The legal basis for this is Article 6 para 1 sentence 1 letter e GDPR in conjunction with § 3 BDSG. All IP addresses stored in this context are deleted after 7 days.

Use of cookies

In addition to the aforementioned data, cookies are stored on your computer when you use our website. This is done on the basis of Article 6 para 1 sentence 1 letter e GDPR in conjunction with § 3 BDSG. The precondition for storage of the cookies is that acceptance of cookies has been activated in your browser settings (e.g. Microsoft Edge, Internet Explorer, Mozilla Firefox, Opera, Apple Safari).

Cookies are small text files that are stored on your computer when you access specific pages or functions. The cookies contain a characteristic string of characters that enables the browser to be uniquely identified when the website is called up again. Our cookies cannot be assigned to individuals and do not contain personal information. They do not harm your computer and do not contain viruses.

You can generally use the PharmNet.Bund website without accepting cookies. However, we use session cookies for our search applications and special pages to facilitate your use of the site. These temporary cookies are automatically removed from your computer after the browser session has finished. You can continue to use our search applications even if you disable the storage of cookies.

In addition, a session cookie is set after the click on the "Close" button in the banner reference displayed at the end of the browser window when you first visit our website. In this way, the banner reference is hidden for the time of the browser session. After the end of the browser session, this cookie is automatically removed from your computer again.

You can prevent storage of cookies on your computer via the settings in your browser. You can also delete cookies manually or set your browser such that it automatically deletes all the cookies after the end of the session. Please remember that the Matomo deactivation cookie (see "Objection against use of the Matomo analysis tool") is also erased and you must again object to recording of statistical data when you use our website next.

Use of the Matomo analysis tool

We use the Matomo analysis service in order to analyse the use of our website and to improve it regularly. With the statistics which we obtain, we can improve our offer and make it more interesting for you as a user.

This website uses Matomo with an extension for anonymisation of the IP addresses. In this way, IP addresses are processed curtailed, a direct reference to a person can be ruled out in this way. The IP address transmitted by your browser via Matomo is neither merged with other data collected by us nor passed on to third parties.

If individual pages of our website are accessed, the following data are stored:

• two bytes of the IP address of your accessing system (anonymous)
• browser type and version
• operating system used
• the accessed website
• the website, from which you access us (referrer URL) - to the extent that your browser does not suppress this
• the pages and files which you access on our website
• if applicable, the website which you visit after ours (by clicking of an external link on our website)
• date and time of your access
• the duration of your stay on the website
• the frequency of your access to the website
• your location (country)

Within the framework of our web analysis, no tracking cookies are set on your computer. The Matomo software and the data collected by means of Matomo are exclusively operated, stored and processed on our own servers.

Objection against use of the Matomo analysis tool

If you do not agree to the completely anonymous storage and evaluation of the data from your visit, you can object to the storage and use below by a mouse click at any time.

In this case, a so-called opt-out cookie (deactivation cookie) will be placed on your browser, with the result that Matomo does not collect any more session data.

Preventing the use of Matomo is possible by removing the following tick and thus activating the opt-out plug-in:

In addition, the "Do not track" function has been activated in the Matomo installation for the PharmNet.Bund website. If your browser does support this function and you have activated the function in the browser settings, no data are recorded by Matomo, even if you do not use the aforementioned deactivation cookie.

Functions and offers on our website

We offer further services in addition to the purely informational use of our website. To do this, we typically require additional personal information that is subject to the aforementioned principles of data processing.

We use external service providers to process your data. These third parties are bound by our instructions and are subject to our control.

We do not transfer your personal data to third parties for commercial purposes, and only in a few cases do we forward your personal data to such third parties. You will receive more information when entering your personal data, and below in the description of the offer.

Clinical Trials

Your personal data stated within the framework of the "Clinical Trials" procedure (name, email) are transmitted by the competent higher federal authorities for storage and publication in the PharmNet.Bund Clinical Trials application. Further, the higher federal authorities and state authorities transmit personal registration data (name, address, telephone/fax number, email) of employees of the authorities for production of access authorisations for the database.

Legal bases:

• § 67 a German Drugs Act (AMG)
• § 1 subsection 1 number 1 e und § 3 DIMDI-AMV
• §§ 40 – 42 b German Drugs Act (AMG)
• Article 57 Regulation (EC) no. 726/2004
• Article 41 Regulation (EC) no. 1901/2006

Storage and publication of your personal data in PharmNet.Bund are for an unlimited time. The personal data stated are deleted as soon as they are no longer necessary for fulfilment of the purpose pursued with the storage. Amendments or addenda can only be made by the higher federal authorities in cooperation with the submitting pharmaceutical entrepreneurs or sponsors. For corrections, please therefore contact the higher federal authorities.

Special application "Product Information Text" (PIT)

After completion of the procedure, the marketing authorisation holders or their authorised representatives submit the final text versions of the Summary of Product Characteristics (SmPC) and Package Leaflet (PIL) via the special application and forward them to the competent federal higher authorities (Sections 11 (1a), 11a (3) of the AMG).

With the exception of the ID from the Registration and user administration (RuBen), no personal data is recorded or stored in the application. No personal data is transmitted to the Medicinal Product and Application Database of the federal higher authorities. The special application "PIT" is not accessible to the public.

Special application "Sunset Clause" (SSC)

Notifications regarding marketing and discontinuation of marketing of medicinal products are recorded by the marketing authorisation holders or their authorised representatives and are transmitted to the competent federal higher authorities (Section 29 (1b), (1c) and (1d) German Medicinal Products Act (AMG)).

With the exception of the ID from the Registration and user administration (RuBen), no personal data is recorded or stored in the application. No personal data are transmitted to the Medicinal Product and Application Database of the federal higher authorities. The special application "Sunset Clause" is not accessible to the public.

GMP register

In the GMP register, information on the manufacture and importation of drugs is stored and provided within the framework of the central drugs information system according to § 67a of the AMG on the basis of the DIMDI-AMV (DIMDI Drugs Ordinance) and §§ 13, 64 and 72 AMG (German Drug Law).

Your personal data are forwarded by us to the European Medicines Agency (EMA) for providing this information in the pertinent database of the European Union, EudraGMDP. A part of the EudraGMDP database is publicly accessible, however all the personal data, just like the entire PharmNet.Bund GMP register, are only accessible to entitled authorities.

Within the framework of data collection by the competent authorities (GMP inspectorates), personal data (surnames and first names, e-mail addresses, tel. no.) of employees of the pharmaceutical enterprises, e.g. Qualified Persons, Quality Control Manager, Production Manager, are sometimes also recorded in the PharmNet.Bund GMP register.

The legal basis is Article 6 para 1 sentence 1 letter c GDPR.

After collection, your data are stored for no more than ten years after the cessation of the reason for their collection, i.e. they are erased no earlier than ten years after the time at which a document (Manufacturing and Importation Authorisation or certificate of Good Manufacturing Practice) is no longer approved or is irrevocably no longer valid.

Newsletter

When you sign up for our newsletter, we implement the double-opt-in procedure: After your registration, we will send you an email to the email address you specified, in which we ask you to confirm your registration. Only after this confirmation will we store your email address to send the newsletter to you. The legal basis is Article 6 para 1 sentence 1 letter a GDPR.

You can revoke your consent to the receipt of our newsletter at any time and unsubscribe. You can use the link provided in each newsletter email or use the form to sign up.

Pharmaceutical Brokers

In accordance with § 52c para 2 Arzneimittelgesetz (AMG), the German Medicines Act, a pharmaceutical brokers may only commence its commercial activity following notification to the competent authority in accordance with § 67 para 1 sentence 1 AMG and registered by the authority in a public register pursuant to § 67a AMG.

Information that identifies you personally (name, address) will be forwarded to us by the relevant state authorities by post, fax or email. We will publish this data on the PharmNet.Bund website in a public register.

The legal bases for the register is § 52c in conjunction with § 67 para 1 sentence 1 and § 67a Arzneimittelgesetz (AMG) and Article 85b of Directive 2001/83/EC.

The publication of your personal data on the PharmNet.Bund website is for an indefinite period. The personal data on the PharmNet.Bund website will be deleted if it is no longer required for the purpose of such storage. You can contact us to object to the processing of your data at any time.

Result reports of clinical trials

Your personal data stated within the framework of the "Result reports of clinical trials" procedure (name, email, telephone/fax number) are transmitted by the competent higher federal authorities in the form of two PDF documents (confirmation letter and result report) and an XML file. The result report document is published by us in the PharmNet.Bund applications "Clinical Trials" and "Klinische Prüfungen" and in the drug information system of the National Government and the States (AMIce). The XML file serves allocation of the result report document to the correct data record in the database and is stored. The confirmation letter is also stored but not published.

Legal bases:

• § 42 b German Drugs Act (AMG)
• § 1 subsection 1 number 1 e and § 3 DIMDI-AMV
• Notice of the Federal Ministry of Health concerning the publication of results of clinical trials according to § 42 b of the German Drugs Act
• Joint information of the Federal Institute for Drugs and Medical Devices (BfArM), the German Institute of Medical Documentation and Information (DIMDI) and the Paul Ehrlich Institute (PEI) about the publication of trial sites in results reports according to § 42 b of the German Drugs Act

Storage and publication of your personal data in PharmNet.Bund are for an unlimited time. The personal data stated are deleted as soon as they are no longer necessary for fulfilment of the purpose pursued with the storage. Amendments or addenda can only be made by the higher federal authorities in cooperation with the submitting pharmaceutical entrepreneur or sponsor. For corrections, please therefore contact the higher federal authorities.

Sales quantities for veterinary drugs (TAMR)

Pharmaceutical companies and wholesalers

Since 1 January 2011, pharmaceutical companies and wholesalers have been obliged to notify the nature and quantity of the drugs sold by them to veterinary surgeons. The report is done annually by electronic means by no later than 31 March of the calendar year following the period of the report.

Legal bases:

• § 47 subparagraph 1c of the German Medicinal Products Act in conjunction with
• DIMDI Medicinal Product Ordinance § 1 subparagraph 1, number 3 and § 2 subparagraph 1, number 3

So that you as a pharmaceutical company or wholesaler can report the sales quantities of veterinary medicinal products, you must register for the upload application on the PharmNet.Bund website. Your personal data stated within the framework of the "Veterinary Drugs Sales Quantities" procedure (name, email address, address) are stored in the customer database. Your personal data are forwarded to the Federal Office of Consumer Protection and Food Safety (BVL), if necessary, where they are exclusively used for the dispatch of mails to remind you of your report duty or for inquiries on reported quantities of drugs.

The aforementioned personal data are erased as soon as they are no longer necessary for fulfilment of the purpose pursued with the storage.

Authority employees

Via a download portal on the PharmNet.Bund website, the evaluated report data of the medicinal products sold to veterinary surgeons are provided to the Federal Office of Consumer Protection and Food Safety (BVL) and the state authorities. To be able to use this download portal, you must register for the application as an authority employee. The information on personal data necessary for this (name, email address, address) are stored in the customer database. These personal data are deleted as soon as they are no longer necessary for fulfilment of the purpose pursued with the storage.

In addition, BfArM must ensure that information on drugs which have exclusively been registered for poultry are only used by the authority employees for the purpose of veterinary drug monitoring and not for supervisory purposes.

Legal basis is DIMDI Drugs Ordinance § 3 subparagraph 1, sentence 2.

This is confirmed by you as an authority employee by means of a form. We exclusively store this form with the personal data stated by you (surname, first name) for proof of your confirmation. The personal data on the form are not processed in any other way.

The aforementioned forms (in hard copy or digital) are destroyed or deleted as soon as they are no longer necessary for fulfilment of the purpose pursued with the archiving.

Your rights

You have the following rights towards us with a view to the personal data concerned with you:

Right to information according to Article 15 GDPR

With the right to information, the data subject is given extensive insight into the data concerned with him and other important criteria, such as the purposes of processing of the duration of the storage.

Right to rectification according to Article 16 GDPR

The right to rectification contains the possibility for the data subject to have incorrect personal data concerned with him corrected.

Right to erasure ("right to be forgotten") according to Article 17 GDPR

The right to erasure contains the possibility for the data subject to have data erased with the controller. However, this is only possible if the personal data concerned with him are no longer necessary, are processed unlawfully or a consent in this regard has been withdrawn.

Right to restriction of the processing according to Article 18 GDPR

The right to restriction of the processing contains the possibility for the data subject to prevent a further processing of the personal data concerned with him for the time being. A restriction comes about above all in the examination phase of other attendance to rights by the data subject.

Right to objection to the processing according to Article 21 GDPR

The right to objection contains the possibility for the data subject to object to the further processing of his personal data in certain specific situations, to the extent that this is justified by attending to public tasks or public and private interests.

Right to withdrawal of the data protection law declaration of consent

You have the right to withdraw you data protection law declaration of consent at any time. The withdrawal of the consent does not affect the lawfulness of the processing done on the basis of your consent up to the time of withdrawal.

Right to data portability according to Article 20 GDPR

The right to data portability contains the possibility for the data subject to receive the personal data concerned with him in a commonly used, machine-readable format from the controller in order to have them forwarded to another controller if need be.

You also have the right to complain to a data protection supervisory authority about the processing of your personal data by us.

Changes to this privacy statement

We reserves the right to occasionally amend this data privacy declaration to adapt it to the current situation. We therefore recommend that you perform a regular review of this data privacy declaration to keep it up to ensure it is always the most recent version.