EFPIA - What Medicinal Product Manufacturers need to know about the European Verification System EMVS
In a publication from March 2013, the EFPIA shows in a "Guidance for Manufacturers" what requirements a pharmaceutical company has to fulfil that it can be connected with the "European Medicines Verification System" (EMVS) - and thus also can comply with the requirements of the EU directive against counterfeit medicines.
From the EFPIA perspective enough details are known to be familiar with what is expected from pharmaceutical manufacturers to meet the requirements of the European directive. And the organisation also wants to avoid delaying the project. And although it is very important to concentrate on the technical points, other, superior aspects must be considered even more. It is emphasised that all pharmaceutical product manufacturers have to build the organisational capacities to be prepared for the future European system for the security of the distribution of medicines. Concrete examples are provided for activities pharmaceutical manufacturers have to pay attention to now.
The "European Stakeholder Model" (ESM) proposed by the EFPIA is based on the concept that any medicinal product must be checked with its delivery (point of dispensing verification). The technical implementation is accomplished via the EMVS. National systems can also be connected to this model.
Even though it is not sure whether the ESM and the EMVS will prevail, it is nevertheless clear that the system that will eventually be implemented will be very similar to the EFPIA model.
See the Details from EFPIA to the European verification system - and what provisions pharmaceutical companies have to make today.