Medicines Act (Austria)
Basic data | |
---|---|
Title: | Medicines Act |
Long title: | Federal law of March 2, 1983 on the manufacture and the
|
Abbreviation: | AMG |
Scope: | Republic of Austria |
Legal matter: | Pharmaceutical law |
Reference: | Federal Law Gazette No. 185/1983 |
Date of law: | March 2, 1983 |
Effective date: | April 1, 1984 |
Last change: | Federal Law Gazette I No. 59/2018 |
Please note the note on the applicable legal version ! |
The Austrian Medicines Act regulates the manufacture and sale of medicinal products in the Republic of Austria .
history
The Medicines Act of 1983 is the first law on the marketing of medicinal products in Austria. Before this area was essentially regulated by the 1947 Specialties Ordinance; this provided for a registration procedure for medicinal specialties, which was limited to a quality check of the medicinal product. The specialty order was repealed by the Medicines Act of 1983. In addition to the specialty regulations, Articles 222 - 227 of the 1973 trade regulations for the wholesale of pharmaceuticals and the 1972 prescription law were also important for the pharmaceutical trade.
With the Medicines Act, the pharmaceutical law was aligned with the corresponding regulations in other countries. An approval procedure was introduced in which the applicant had to prove not only the pharmaceutical quality but also that the medicinal specialty was sufficiently effective .
After the entry into force in 1984, the Medicines Act was amended several times, first with the AMG amendment of 1988. The AMG amendments of 1993 and 1996 set a number of guidelines of the European Union into Austrian law, a need to align with the EU Pharmaceutical law, which resulted from Austria's accession to the European Union on January 1, 1995. In the meantime, further changes and amendments have been made, primarily due to the further development of EU law.
structure
The Austrian Medicines Act is divided into 14 sections:
- Section I. General provisions
- Section II: Medicinal products
- III. Section: Clinical Trial
- Section IV: Drugs Advisory Board and Delimitation Advisory Board
- Section V. Advertising restrictions
- VI. Section: Sales
- VII. Section: Operating regulations
- VIII. Section: Pharmaceutical representative
- IX. Section: Drug Monitoring ( Pharmacovigilance )
- Section X: Fees
- XI. Section: Automation-Supported Data Traffic
- XII. Section: Confidentiality and Transparency
- XIII. Section: Sanctions
- Section XIV: Transitional and Final Provisions