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1. In order to receive a permit for the commencement of a clinical trial, the sponsor or a person authorised by the sponsor must submit an application signed with the State Agency of Medicines (ZVA).
The form of the application for a clinical trial is available on the website of the European Commission.
Applications for clinical trials of Zva shall also be accepted by electronic means (e-application), i.e. by submitting a CD (CD ROM) together with a signed cover letter or by using an e-mail firstname.lastname@example.org.
in an e-application, the information must be considered and sequentially arranged in the following folders:
• general information related to the application;
• patient-related information;
• a study protocol;
• information on the investigational medicinal product;
• study centres and researchers;
• study insurance.
It should be noted that electronic submission of documents covers first-time applications for clinical trials.
The Register regarding clinical trials of medicinal products in the countries of the European Economic Area, including Latvia, is publicly available.
The Register shall enable citizens to find information on studies based on the following search parameters: country, age, gender, study phase, study status, diagnosis, etc., as well as, where necessary, the possibility of contacting the sponsor of the study in question.
2. In the case of observations of the use of medicinal products, an application shall be submitted in a free form and documents shall be attached in accordance with Paragraph 129 of Cabinet Regulation No. 289.
Documents to be submitted