Better protection against falsified medicinal products

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.

Coding and serialisation of medicinal products

This is the procedure used to guarantee that you medicines are safe!

Pharmaceutical manufacturers

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).

Pharmacists

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.

Patients

If patients obtain medicines following this procedure, they can be sure not to receive a falsified product.

Investment in increased safety

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.

Implementation of the EU Directive 2011/62
  • EU Directive published (2011)
  • Del. Regulation published (2016)
  • Foundation of AMVO (2016)
  • EU Directive implemented (09.02.2019)

From February 9th 2019 until including February 8th 2020 a stabilisation period of 12 months takes place to guarantee a smooth start and the security of supply with medicinal products. During this time period all people and organisations involved have the opportunity to obtain and to correct possible process or application errors as well as to stabilise the newly implemented processes. Details regarding the stabilisation period can be found in the information document on the stabilisation period.

Stabilization period
114 days left