​This means that it will be possible to apply for a study approved under the old directive during this time. If the study is not completed within 3 years after the regulation has come into force, the sponsor must ensure that the study in its entirety is transferred over to the new regulation. For further information regarding the transition period, please see Chapter 11 of CLINICAL TRIALS REGULATION (EU) NO 536/2014 QUESTIONS & ANSWERS.

Volume 10 of the publication "The rules governing medicinal products in the European Union" contains guidance documents applying to clinical trials. At present, both documents applicable to clinical trials authorised under Directive 2001/20/EC (i.e. the current applicable documents) and documents relevant to clinical trials authorised under Regulation (EU) No 536/2014 can be found listed in two separate pages on the Eudralex Volume 10 website.

During the transitional period, both sets of documents will apply accordingly and should be referred to respectively according to the legislation under which the Clinical trial is conducted.

At the end of the transitional period, all clinical trials shall be conducted under the Regulation and follow the set of documents applicable to the Regulation.

For further information, please see the EudraLex Volume 10 webpage.

Publisert: 30.03.2021

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