In the EU, no medicine may be placed on the market without one (Article 6 of Directive 2001/83/EC). It is granted through the centralized procedure, where EMA assesses the application and the European Commission decides, or through national, mutual recognition or decentralized procedures. In the US, the closest equivalents are approvals under NDAs, ANDAs and BLAs. The authorization fixes the approved product information, which is the source for the SmPC, the label and the leaflet.
Why it matters for labeling
The marketing authorization number and the holder's name and address appear on the packaging, and everything printed has to stay consistent with the authorized product information. Changes to that information go through a variation, and labeling changes follow. It also governs promotion: advertising a medicine without a marketing authorization is prohibited (Article 87(1) of the Directive).
Common mistakes
- An authorization number or holder address that is out of date after a transfer
- One market's number on another market's pack
- Label changes made without the corresponding variation
- Promotional material prepared or used before authorization