All users who wish to use SNOMED CT concepts can use SNOMED CT on the territory of the Federal Republic of Germany. Before SNOMED CT can be used, an affiliate license agreement for the use of SNOMED CT must be concluded with the National Release Center in Germany at BfArM. This license has to be applied via the MLDS portal (Member Licensing and Distribution Service), which is accessible via the NRC website. SNOMED CT has to be used in compliance with the affiliate licensing conditions. After accepting the affiliate license conditions SNOMED CT can be used free of charge within Germany.

An affiliate license for the use of SNOMED CT on the territory of the Federal Republic of Germany can be applied for at the National Release Center in Germany at BfArM. The application is made via the MLDS portal (Member Licensing and Distribution Service). In order to use MLDS you have to register first. Please follow the instructions for applying for a SNOMED CT affiliate license. The MLDS is a service of SNOMED International which is made available to member countries. The terms of the affiliate licensing conditions are to be respected.

Germany is member country of SNOMED International since 1 January 2021 on. BfArM has the role as the National Release Center for Germany.

Since then the MLDS portal (Member Licensing and Distribution Service) is activated at BfArM and affiliate licenses can be applied.

The responsibilities of TMF (Technology, Methods and Infrastructure for Networked Medical Research) as National Release Center for the pilot license were transferred to BfArM as National Release Center. When handing over the MLDS portal (Member Licensing and Distribution Service) was also transferred from TMF to BfArM. Your data in MLDS was also relocated. Your license is still valid, there is no action required on your part. However, please check whether the data you entered are still valid under the new licensing conditions.

The contact e-mail address you provide during registration in the MLDS portal (Member Licensing and Distribution Service) serves in the MLDS as an identifier / key for the life-cycle management of your sublicense. Please select the e-mail address to be entered carefully.

Your e-mail address should be available over the entire life-cycle of your planned or released software application. When registering it is therefore advisable to enter a functional e-mail of the organisation maintaining the deployed software and NO personal and project-related e-mail address.

When using an affiliate license for SNOMED CT the licensing conditions of SNOMED International must be respected. These contain the rights and obligations of the affiliate licensee as well as general conditions for the use of SNOMED CT. The affiliate licensee must ensure that the affiliate license conditions are also observed by all end users using his software products under his affiliate license.

In order to use SNOMED CT, the affiliate licensee must provide contact data and details of his organisation in the MLDS portal (Member Licensing and Distribution Service), describe the type of use and license, the current and planned use as well as the purpose of use and the implementation status. Furthermore, the affiliate licensee must provide information on his sublicensees or end users (organisations or individual users), disclose the number of software applications and the number of application workstations as well as the type of use (data collection or data evaluation and data aggregation with SNOMED CT). Please note the instructions when applying for a SNOMED CT license.

With the use of a affiliate license annual reporting obligations are associated. The affiliate licensee is obliged to prepare or renew annually a declaration of use.

This is done via the MLDS portal (Member Licensing and Distribution Service). There, the affiliate licensee must describe the current and planned use, the purpose of use and the implementation status of his software.

Furthermore, the affiliate licensee must provide information on his sublicensees or end users (organisations or individual users), disclose the number of software applications and the number of application workstations as well as the type of use (data collection or data evaluation and data aggregation with SNOMED CT). This declaration of use must be updated annually in the MLDS, at latest by 15 January of the current year.

An affiliate license is valid indefinitely as long as the annual reporting requirements are met. A declaration of use must be updated annually the service portal MLDS (Member Licensing and Distribution Service) by 15 January of the current year at the latest.

There are no costs for affiliate licensees and end users for the use of SNOMED CT on the territory of the Federal Republic of Germany. The costs for the membership of Germany in SNOMED International are covered by the German Federal Government. With the affiliate license under the membership basic training courses are offered conducted by SNOMED International.

Each software developer or software vendor who wants to distribute a software product in Germany containing SNOMED CT concepts requires an affiliate license which covers also the sublicenses for his end users. An affiliate license for Germany is also necessary if you hold already an affiliate license in another member country of SNOMED International. For the use of SNOMED CT in Germany you apply for a affiliate license via the MLDS portal (Member Licensing and Distribution Service).

As an affiliate licensee you are responsible for managing the sublicenses of your end users (disclosing names of organisations and number of individual users) and for disclosing the type of use of SNOMED CT concepts to SNOMED International. For your organisational or individual end users it is therefore not necessary to register for an affiliate license.

If you want to distribute your software product in another member country of SNOMED International, the corresponding affiliate license must be obtained from the National Release Center in that member country. Here you can find a list of SNOMED International member countries.

If you want to distribute your software product in a country which is not a member country of SNOMED International, you can request this via the MLDS portal (Member Licensing and Distribution Service) by selecting this respective country in the portal. Through the MLDS, this information will be forwarded directly to SNOMED International. License requests for other countries are not approved by the National Release Center at BfArM. Alternatively, please contact info@snomed.org directly.

The number of individual users within an organisation that has applied for an affiliate license is not limited within the territory of the Federal Republic of Germany. The number of application workstations must be specified in the annual declaration of use.

If your organisation works internationally, the licensing conditions of the respective member country apply in each country to which the user is assigned.

Usually, the organisation operating a software applies for an affiliate license. End users who use SNOMED CT concepts in a software system therefore do not require a separate affiliate license. If you are not sure, ask the operator of your software to confirm that he holds an affiliate license for the use of SNOMED CT for the respective software product in Germany.

Usually, the organisation operating a software applies for an affiliate license. The head organisation operating the software should apply for an affiliate license and also assume the obligations regarding the annual declaration of use. End users who use SNOMED CT concepts in a software system therefore do not need a separate affiliate license. If you are not sure, ask your head organisation to confirm that the software product is registered.

The number of individual applicants within an organisation who can apply for an affiliate license is not limited. In principle, one affiliate license per institution is sufficient. Typically, it makes sense to assign affiliate licenses to software products in order to be able to adequately track the associated annual declaration of use for the respective application purpose, scope of use and application workstations. Please note with a separate or additional application of an affiliate license annual reporting obligations are associated with.

Usually, the organisation operating a software applies for an affiliate license, who has the knowledge about the scope of use and the number of application workstations and can also keep track of these in the longer term. In the case of independent consortium partners, it should therefore be checked who will be available as a long-term contact partner for SNOMED International.

If the software will be operated in several separate instances by the individual consortium partners, it may make sense for each partner to apply for a separate affiliate license for its instance in the long term. Please note that annual reporting obligations are associated with the application for an affiliate license, which must then be tracked separately by each partner.

SNOMED International provides a wide range of training and information.

You can get a first overview of SNOMED CT via the SNOMED CT-Starter-Guide in German. SNOMED International provides extensive training material in an eLearning Plattform. Further documents can be found in the SNOMED International Document Library.

On the SNOMED International web pages you will also find answers to frequently asked questions.

The National Release Center at BfArM will be happy to answer your questions about snomed@bfarm.de. We are looking forward to support you or refer you to experts in Germany, e.g. in the standardization organisations and the Medical Informatics Initiative. Reference should also be made to the joint Interoperability Forum of HL7 and IHE in Germany.

When using SNOMED CT concepts in applications, the conditions specified in the affiliate license (especially in paragraph 8) must be observed. In all media, the notice must state in English or alternatively in German:

"This material* includes SNOMED Clinical Terms® (SNOMED CT®) which is used by permission of the International Health Terminology Standards Development Organisation (IHTSDO). All rights reserved. SNOMED CT®, was originally created by The College of American Pathologists. "SNOMED" and "SNOMED CT" are registered trademarks of the IHTSDO."

*ev. to be specified as "This text" / "This document" / "This software" / "This application" etc.

SNOMED CT is an international health terminology in English. Germany has been a member of SNOMED International since 01.01.2021. The BfArM has the responsibility to coordinate a German-language translation. There is no quality-assured German complete translation of the concepts available yet. Translations will be provided use-case based, primarily focussed on relevance to the German healthcare system.

In 2020, a working group has been established in the D-A-CH-LUX area to provide a coordinated German-language reference translation of SNOMED CT. BfArM is participating in this working group.

If you see an urgent need for translation, please send your request to snomed@bfarm.de , providing information to the specific translation need and background information. We will provide regular updates on the status of the translation on our website.