Medicinal Products Import Act 2010 (AWEG)
On 18.08.2010, the Medicinal Products Import Act 2010 was published in the Federal Law Gazette, Federal Law Gazette I No. 79/2010 and comes into force on 19.08.2010.
The primary objective of the Medicinal Products Import Act is to protect the health of patients and consumers by ensuring safe, high-quality and effective medicinal products.
This goal is achieved through the controlled import of medicinal products for use on humans or animals for medical, dental, veterinary or scientific purposes, under the condition that the treatment success cannot be achieved with a medicinal product approved and available in Austria.
The following can be regarded as significant innovations:
- Restructuring and differentiation between medicinal products, blood products and products of natural healing resources
- BASG / AGES PharmMed becomes the central authority due to the abolition of the authorization powers of the federal states
- Competence of BASG / AGES PharmMed for the import of natural medicinal products from third countries
- The import permit issued by decision will be replaced by a certificate.
- Immunological medicinal products for human use (vaccines) are covered by the scope of the AWEG for the first time.
- Shortening of the notification period to two instead of six months after transfer from the EEA after entry into force of the electronic submission regulation of the BASG
- Distinction between a pure notification procedure and the certificate of marketability for blood products
- Special provisions regarding the import of larger quantities of immunological human medicine specialties in emergency situations
- Extensive control and monitoring powers, also through increased cooperation with customs authorities
- Possibility of taking samples of imported medicinal products
- Regulations concerning the purchase of medicinal products and blood products at a distance
Consultations:
MMMag. Bernd Unterkofler, MBA
Divisional Counsel
E-mail: pr_pharmmed@ages.at
Further information:
Medicines Import Act
