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
Documents to be submitted
Application for authorisation of a clinical trial (available on the EC home page)
It is necessary to service step:
1
Hyperlink
Information regarding the service on the website of the State Agency of Medicines
It is necessary to service step:
1
Observations of use: List of observations on the use of medicinal products authorised by the State A
It is necessary to service step:
2
Register of clinical trials for medicinal products: Register of clinical trials of medicinal product
It is necessary to service step:
2
State Agency of Medicines Charge Services Price List
It is necessary to service step:
3
Vairāk informācijas pamatvalodā

SOCIAL SERVICES

FAMILY

ENTREPRENEURSHIP

FINANCES AND TAXES

HOUSING AND ENVIRONMENT

CULTURE, SPORTS, TOURISM

RIGHTS

EDUCATION

CONSULAR SERVICES

TRANSPORT

HEALTH