State Medicines Control Agency of Lithuania

Company code 191351864
Žirmūnų str. 139A, Vilnius, Lithuania
E-mail: vvkt@vvkt.lt,
Phone: +370 5 263 92 64
Fax: +370 5 263 92 65

INFORMATION

+370 (5) 2124059

Choose category and type

Documents list
Name	Numeris


Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial

List of Documents Required by the State Medicine Control Agency of Lithuania (SMCA) for Approval of Clinical Trial

Application form for the clinical trial in Lithuania

4.5 Requirements for reporting Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (ADRs) from Clinical Trials (CTs) conducted in the Republic of Lithuania to the State

Law on ethics of biomedical research

Guideline for Good clinical practice

Decree of the Ministry of Health On the import and export of investigational products and trial related materials

World assotiation declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects

Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice

Principles of good labaratory practice for non-clinical (experimental) labaratory studies


© 2003-2010 State Medicines Control Agency of Lithuania Sprendimas: Idamas. Naudojama Smart Web sistema.