NLGeneralInformation object
Applied regulatory conventions
Declaration of Helsinki
ICH-GCP Guidelines
Other guidelines for good clinical practice (other than ICH-GCP)
International regulatory requirements
National regulatory requirements
Applicable national laws
Hospital Act
Data protection Act
Medical device act
Drug act
National regulations for volunteers exist for
Nutrition intervention in healthy people
Pharmaceuticals/drug trials
Network providing information on regulations and ethical requirements in studies
National Drug Investigation Centre
Official website providing relevant national legislation available
Yes
Official website providing relevant national legislation
www.reglek.com.mk
