Estonia – Regulation 23 - Conducting Clinical Trials

(4) In order to conduct a clinical trial of a veterinary medicinal product, an application and the information and documents specified in subsection (1) shall be submitted to the Agency of Medicines, taking into account the provisions of subsections (2) and (3).

(07.10.2005 entered into force 21.10.2005 - RTL 2005, 105, 1604)

(5) The approval of the ethics committee of clinical trials (hereinafter ethics committee) may be submitted to the Agency of Medicines also after the submission of the application, indicating the date of obtaining the approval.

(6) Confirmation of the payment of the state fee which shall set out the date of making the payment, the amount paid and the bank account number from which the payment was made, or a document certifying payment of the state fee shall be appended to the application for conducting a trial.

§3. Submission of application for conducting trial

(1) An application for trial shall be submitted in the format set out in Annex 1 and Annex 2 to the Regulation on paper in A4 format and the information set out in Annex 1 shall be submitted additionally electronically on CD-ROM in XML format. The documentation of a trial of veterinary medicinal products shall be submitted on paper in A4 format in the format set out in Annex 3 to the Regulation.

(2) An application for trial and the appended documents shall be submitted in a single copy in Estonian or in English.

§4. Tasks of the Agency of Medicines upon submission of application for conduct of trial

(1) On the receipt of an application for a trial, except for a clinical trial of a veterinary medicinal product, the Agency of Medicines shall enter the following information in the EudraCT database which is available only to the competent authorities of the member states of the European Economic Area (hereinafter Member States), the European Medicines Agency and the European Commission.

1) application for trial;

2) all amendments made to the application;

3) all amendments made to the trial protocol;

4) positive opinion of the ethics committee;

5) notification of termination of the clinical trial;

6) reference indicating how compliance with good clinical practice has been verified.

(2) At the reasoned request of a Member State, the European Medicines Agency or the European Commission, the Agency of Medicines shall give information concerning the clinical trial in question in addition to the information contained in the EudraCT database.