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Legislation and Guidelines



Relevant legislation, guidelines and other useful links for clinical trials of medicinal products for humans

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    EudraLex Volume 10 of the publication "The rules governing medicinal products in the European Union" 

    Clinical trials of medicinal products for human use are primarily regulated by the common European legislation, Regulation (EU) No. 536/2014. This regulation replaces Directive 2001/20/EC. 

    EudraLex Volume 10 contains all guidance documents and links to legislation relevant to clinical studies in the EU/EEA. Several documents in this volume have undergone updates and revisions to align with the requirements of the Regulation. New documents have also been created to address the novel elements introduced by this Regulation. 

     To differentiate between documents that apply to clinical trials authorised under Directive 2001/20/EC and those authorised under Regulation (EU) No 536/2014, they have been organised into two distinct pages. 

    For the duration of the transition period (ends 30th of January 2025), both sets of legislations will be available. 


    National legislation 

    Scientific Guidelines 

    Relevant Guidelines 

    National links 

    Relevant Agencies and Working Groups 

    Relevant portals and databases for clinical trials 

    • Clinical Trials Information System (CTIS) – CTIS is the single-entry portal for submitting applications and interacting on clinical trials in the EU and EEA – see also our webpage on CTIS  
    • EU Clinical Trials Register is a database for clinical trials conducted in the EU/EEA under Directive (EU) No. 2001/20 
    • is a website and online database of clinical research studies and information about their results. The website contains both privately and publicly funded clinical studies conducted worldwide.