The following Acts and Regulations apply to Pharmacovigilance

Act

• The Medicinal Product Act No 93/1994

Regulations

• Regluation No. 46272000 concerning marketing authorisation for proprietary medicinal products, their labelling and package leaflets
• Regulation No. 582/1995 concerning registration and markething authorisation for parallel import (not available in english)
• Regulation No. 684/1997 conserning markething authorisation for herbal medicinal products (not available in english)

• Directive 2001/83/EC
• Regulation 726/2004