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
Redress options
Applicant State Agency of Medicines has the right to contest the decision in accordance with procedures prescribed by the Law on Administrative Procedure
Reminder
Applications for clinical trials and observations for the use of medicinal products and documentation attached thereto shall comply with the requirements and recommendations of Cabinet Regulation No. 289, which are available
https://www.zva.gov.lv/lv/industrijai/klinisko-petitiones-sponsorships/cricketing-aid-discount.

If the letter of authorisation of the submitter is in a foreign language, it shall be submitted to the State Agency of Medicines by adding a translation in Latvian. In attesting the accuracy of the translation of the document, the translator shall, on the final page of the translation, draw up a statement in the official language after the text. The statement shall contain: in capital letters the words “TRANSLATION CORRECT”; the translator's given name, surname and personal code; the translator's signature; the name of the place of proof; the date of the statement.
Laws and regulations
Farmācijas likums
(Saeima; likumi; 5/8/1997)
Noteikumi par zāļu klīniskās izpētes un lietošanas novērojumu veikšanas kārtību, pētāmo zāļu marķēšanu un kārtību, kādā tiek vērtēta zāļu klīniskās izpētes atbilstība labas klīniskās prakses prasībām
(Ministru kabinets; noteikumi; 289; 4/1/2010)
Zāļu valsts aģentūras maksas pakalpojumu cenrādis
(Ministru kabinets; noteikumi; 641; 1/1/2020)
Service references
Zāļu valsts aģentūra
Contact details: Adrese:  Jersikas iela 15, Rīga, LV-1003
Tālrunis: 67078424, 29447659
E-pasts:  info@zva.gov.lv
https://www.zva.gov.lv/
Information about service restored: 17.02.2021
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