| Legislation | Description of duty | §, para. | Form of fulfilment | Method of fulfilment | Frequency of performance (per year) | |
|---|---|---|---|---|---|---|
Application for authorisation or notification of a clinical trial of a medicinal product - Part I (Part I refers to the clinical trial dossier, which is common across the EU). | Articles 5 and 6 | form | electronically: > form on the website | 1 / year | ||
Application for authorisation or notification of a clinical trial of a medicinal product - Part II (Part II refers to the nationally specific part of the clinical trial dossier). | Articles 5 and 7 | form | electronically: > form on the website | 1 / year | ||
Authorisation of a substantial modification of a clinical trial of a medicinal product. | Article 16 | form | electronically: > form on the website | cannot be determined | ||
Submission of information on the start of a clinical trial of a medicinal product. | Article 36 | Other | electronically: > form on the website | cannot be determined | ||
Submission of information on the completion of the clinical trial. | Article 37 | Other | electronically: > form on the website | cannot be determined | ||
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