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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 Art. 4 para 7 of the EU General Data Processing Regulation (GDPR) is DIMDI, Waisenhausgasse 36-38a, 50676 Cologne, represented by the director, Dr. Dietrich Kaiser. You can contact our data protection officer at Data Protection or via our postal address by addressing your communication to "The Data Protection Officer".
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.

If you contact us by email or via a contact form, we will store the information you provide (your email address, name and telephone number, if applicable) to process your request. We will delete the relevant data after a specific period if such storage is no longer required or will limit the processing of such in the event of legal storage obligations.

Your rights

You have the following rights with respect to your personal data:

  • Right to information
  • Right to rectification or deletion
  • Right to restrict processing
  • Right to object to processing
  • Right to data portability

You also have the right to appeal to a data protection supervisory authority regarding how we process your personal information.

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:

  • Browser type and version
  • Operating system used
  • 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)
  • Date and time of access
  • IP address, anonymised in truncated form

In addition to the above data, cookies are also stored on your computer when you use our website. Cookies are small text files that are stored on your computer when you access specific pages or functions. They cannot be assigned to individuals and do not contain personal information. Cookies 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 (for example in the download centre or when logging into restricted areas) 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.

You can configure your browser settings to prevent cookies from being stored on your computer. For details, please refer to the relevant instructions for your browser.

Objection or withdrawal of consent regarding the processing of your data

You can withdraw your consent to the processing of your data at any time. Such revocation will affect the legitimacy of the processing of your personal data after you have declared such revocation.

You can object to processing insofar as we base the processing of your personal data on a balance of interests. This applies in particular if processing is not required to fulfil a contract with you, as stipulated in the following description of the functions and offers on our website. In the event of an objection, please explain why we should not process your personal information as we have done. We will then review the situation and will either cease processing, modify the data processing or set out our compelling legitimate reasons for continuing to process your data.

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 do not transfer your personal data to third parties for commercial purposes.

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 at DIMDI.

The legal basis is Art. 6 para 1 page 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 Art. 6 para 1 page 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 wholesaler

As part of the "Permits for pharmaceutical wholesaler" procedure, your personal data (name, address) will be forwarded to us in the form of an Excel document by the responsible department at the BMG (Federal Ministry of Health). This document is prepared by us and published on the PharmNet.Bund website as a PDF file in a public register.
Legal basis:

  • § 52a AMG (German Medicines Act)
  • § 64 AMG (German Medicines Act) (see § 4)
  • Directive 2001/83/EG (see Art. 80)
  • Pharmaceutical Trade Regulation (Arzneimittel-HandelsV)

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 once it is no longer necessary for the purpose of the storage. Changes or additions may only be made by the BMG, and please contact the BMG for such corrections. You can appeal to the BMG (Federal Ministry of Health) and DIMDI to object to the processing of your data at any time by the BMG (Federal Ministry of Health) and DIMDI.

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 Art. 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 DIMDI to object to the processing of your data at any time.

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, no. 3 and § 2 subparagraph 1, no. 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, e-mail address, address) are stored in the DIMDI 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, e-mail address, address) are stored in the DIMDI 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, DIMDI 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.

Changes to this privacy statement

DIMDI 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.


Sources for the privacy statement template
Extracts from: Formularhandbuch Datenschutzrecht (Form Manual Data Protection Law) Koreng/Lachenmann/Editor, publisher C.H. Beck, 2nd edition 2018.

Last modified: 6/12/19

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