Medicinal Products Act (EEA-AMG).
Country
Type of law
Legislation
Date of original text
Date of latest amendment
Abstract
The law governs the circulation (marketing, distribution, and sale) of medicinal products and the handling of human tissues and cells within the European Economic Area (EEA), implementing EEA agreement provisions related to medicines. Medicinal products include both human and veterinary medicines, as defined by EU directives 2001/83/EC (human) and 2001/82/EC (veterinary). Medicinal products can only be marketed if authorized by the competent health authority. The law mandates a pharmacovigilance system for both human and veterinary medicines to monitor safety and side effects, ensuring ongoing assessment of benefit-risk balance. The law applies to animal medicines authorization, marketing, and monitoring. The text consists of 49 Articles. Titles and references of EEA legislation are included in the attachment.
Attached files
Web site
Long title of text
Act of December 18, 1997 on the marketing of medicinal products and the handling of human tissues and cells in the European Economic Area (EEA Medicinal Products Medicinal Products Act; EEA-AMG).
Notes
Consolidated version of the law as of 2016.
Repealed
No
Publication reference
Liechtensteinisches Landesgesetzblatt 812.103.
Source language
English
Legislation Amendment
No
Original title
Gesetz vom 18. Dezember 1997 über den Verkehr mit Arzneimitteln sowie den Umgang mit menschlichen Geweben und Zellen im Europäischen Wirtschaftsraum (EWR-Arznei- mittelgesetz; EWR-AMG).
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