Arzneimittelverpackungen

Arzneimittelverordnung, abbreviated AMV, is a German regulation that governs the handling of medicines within Germany and complements the broader Arzneimittelgesetz (AMG). It applies to human medicines and, in parallel, there are separate rules for veterinary products. The AMV draws on European Union medicines law and is periodically updated to reflect changes in EU directives and national needs.

The scope of the AMV includes requirements for the manufacturing, quality control, and distribution of medicines. It covers packaging and labeling, information to patients in the form of package inserts or labeling, and the storage and transport conditions necessary to maintain product quality. The regulation also addresses advertising restrictions, the responsibility of manufacturers and wholesalers, and the procedures for recalls or withdrawals when safety concerns arise.

Pharmacovigilance and safety monitoring are integral parts of the AMV. Manufacturers and distributors must establish systems to detect, assess, and report adverse drug reactions and other safety signals. The regulation also outlines traceability obligations for active substances and finished products, ensuring that products can be traced through the supply chain.

Enforcement and supervision are carried out by federal authorities, most notably the Federal Institute for Drugs and Medical Devices (BfArM) in cooperation with the Federal Ministry of Health and state authorities. The AMV works in tandem with the AMG to regulate the authorization, monitoring, and post-market safety of medicines marketed in Germany, aiming to protect public health and ensure reliable information for patients and healthcare professionals.