The main legal act which regulates the handling of medicinal products, granting of marketing authorisation of medicinal products, clinical trials and advertising of medicinal products and stipulates the liability in the area of medicinal products is the Medicinal Products Act. The main rights and obligations of the applicants, marketing authorizations holders, persons handling medicinal products and others vis-à-vis the Ravimiamet are enacted by this law.
The conditions and procedures for certain applications and proceedings are stipulated in several regulations of Minister of Social Affairs and English versions are available under the subject visible on left.
All laws and regulations which are regulating the field have not been translated into English and the translations of the regulations and laws published on our website may not be properly updated and may include provisions which have been amended or declared invalid.
Please address any questions related to the legislation to firstname.lastname@example.org