To better protect prescription-only medicinal products from being falsified is the objective of EU Directive 2011/62. To achieve this objective, packaging for medicinal products will bear new safety features and a data repository system is scheduled to be set up throughout all EU member states.
The deadline is February 2019. From this date, it should no longer be possible for falsifiers to introduce sometimes life-threatening falsified products into the legal supply chain.
Medicinal product packs are labelled with an unique serial number by the pharmaceutical manufacturers, who then enter that serial number into the European verification system (EU hub) and store it in a database.
Medicinal product wholesalers
The medicinal product wholesalers, who provide the link between the manufacturers and the pharmacies, will check the serial numbers in defined cases (e.g. for returned products).
Medicinal products are supplied to patients via public pharmacies, hospital pharmacies and self-dispensing doctors. Before being handed out, the serial number of each individual product pack has to be verified and decommissioned from the system.
If patients obtain medicines following this procedure, they can be sure not to receive a falsified product.
The pharmaceutical industry invests millions in protection against falsification of medicinal products. Among other things, this involves modification of entire packing lines and installing new IT systems at all the parties involved - from manufacturers to pharmacies.
All stakeholders in the healthcare sector, manufacturers, wholesalers and pharmacies together ensure, with great dedication and based on close cooperation, that the already high level of safety in the distribution of medicinal products is further improved, for the benefit of the patients.
Under the Directive, it is incumbent upon the pharmaceutical industry to ensure both the implementation and the funding of the system at the national level. This is why AMVO was founded.
On February 9, 2020 the stabilisation period ends and the start phase operations starts.
As of February 9, 2020 all verifying and dispensing locations in Austria must perform verifications, decommissionings and recommissionings according to the legal and contractual provisions.
The start phase operations shall provide all involved organisations with the opportunity to correct process and operator errors as well as implementation errors that occurred during the stabilisation period.
Information on the Start Phase Operations can be found here.
serialised packs in the Austrian system