Translated using Hugo.lv
Authorisation of clinical trials of medicinal products and authorisation of observations on the use of medicinal products
Selected Organization: Zāļu valsts aģentūra
Brief description:
In order to receive a permit for the commencement of clinical trials of medicinal products and observations of the use of medicinal products, the sponsor or a person authorised by the sponsor shall submit an application and the documentation to be appended thereto to the State Agency of Medicines. The State Agency of Medicines shall review and evaluate the application for clinical trial of medicinal products and the documentation attached thereto.
Beneficiaries:
Legal persons governed by public law, Private law legal persons
Clinical trial sponsors or authorised by the sponsor
Period:
For clinical trials - 60 days; for observation of medicinal products - 30 days
Process description
Documents and forms
Other information
1. solis / Service requests
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 ct@zva.gov.lv.
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.
E-mail ct@zva.gov.lv
Mail State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Tālrunis: 67078424
Fakss: 67078428
Other contact details:
Working hours
2. solis / Receipt of services
Zva shall inform the applicant in writing within 5 (five) working days after the taking of the decision, indicating the reasons for the decision.
The authorisation shall not be issued until payment for the service has been made according to the ZVA Price List.
On the spot State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Tālrunis: 67078424
Fakss: 67078428
Other contact details: Klientu apkalpošana 11. kabinets.
Working hours
Mail State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Tālrunis: 67078424
Fakss: 67078428
Other contact details:
Working hours
3. solis / A service charge
Procedures for Settlement:

The payment for the service has been determined in accordance with the price schedule for the ZVA charge services (hereinafter - Price List):
• review of the application for clinical trials of medicinal products and the documentation attached thereto (Rule 43 of the Schedule);
• Conformity assessment of good clinical practice in the clinical trial centre in relation to the application for registration of medicinal products for registration of medicinal products (Section 44 of the Schedule):
• Essential amendments to the clinical trial documentation of medicinal products (Schedule, p. 45):

After providing the service, we will send an invoice to the specified email address. When you pay an invoice, you must specify the invoice number and date in the payment target.