NLGeneralInformation object

Applied regulatory conventions

Declaration of Helsinki
Other ethical principles for medical research (other than Declaration of Helsinki)
ICH-GCP Guidelines
Other guidelines for good clinical practice (other than ICH-GCP)
International regulatory requirements
European regulatory requirements - European Directive 2001/20/EC, 2005/28/EC
National regulatory requirements
Regional regulatory requirements
Institutional regulatory requirements

Applicable national laws

Data protection Act
Drug act

National regulations for volunteers exist for

Not specified

Network providing information on regulations and ethical requirements in studies

Medicines Control Agency of Lithuania

Network Email
Official website providing relevant national legislation available

Yes

Official website providing relevant national legislation
Additional Information
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