Notification of changes of clinical trials on medicinal products
In the case of relevant changes or additions to a clinical trial for a medicinal product, the proposer of a clinical trial must submit an application for the notification of changes.
Relevant changes under the previous paragraph are provided, when they impact the:
- safety and integrity of tested persons,
- scientific value of the clinical trial,
- the implementation of management of the clinical trial,
- the quality and safety of medicinal products in the clinical trial.
The application should be drafted based on the European Commission recommendations; EudraLex - Volume 10 Clinical trials guidelines.
The application must contain:
- an application letter with reasoning behind the change of the clinical trial;
- filled out and signed uniform European form for the notification of the change of clinical trial;
- explanations signed by the main researcher or researcher - coordinator, which must entail: the assessment of the:
- impact of the changes on tested persons who are included in the clinical trial;
- impact of changes on the assessment of results of the clinical trial;
- the benefits and risks, when necessary;
- the opinion of the National Medical Ethics Committee when the change impacts the ethical aspect of the clinical trial; if the procedure for the notification of the relevant change of the clinical trial is implemented simultaneously, the applicant must submit the opinion of the National Medical Ethics Committee immediately when it is available;
- evidence on the payment of procedure costs;
- the prescribed administrative fee.
Fees in connection with the notification and clinical trial approval procedures for children and orphan designation amount to half of the value of an individual fee.
There are no fees in connection to the notification or clinical trial of a medicinal product approval within the compassionate use programme.
- Judicial remedy: Appeal
- Competent authority: Ministry of Health