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Posts Tagged ‘the netherlands’

New report form for falsified medicines

March 15, 2019

The Netherlands

Since February, all prescription medicines have a unique code and sealed packaging. The purpose of these safety features is to detect counterfeit medicines in the regular distribution channel. Any problem with the code or the seal can be reported within 24 hours via the report form for falsified medicines.

More information can be found here.

The Dutch authorities will compensate companies for additional costs due to the Falsified Medicines Directive

December 5, 2018

The Netherlands

As a result of the Falsified Medicines Directive, companies are obliged to adapt the packaging of their medicines which leads to additional costs. These additional costs cannot always be compensated by a price increase, due to the Drug Price Act (Wet geneesmiddelenprijzen). As a pharmaceutical company, it might be challenging to maintain a reasonable profit margin in case of a low sales number and a low pharmacy price.

The Ministry of Health, Welfare and Sport in the Netherlands has therefore decided to compensate these additional costs when the following conditions are met:

  • The medicine concerned has an estimated sales volume of less than 250,000 packages in 2018, and
  • The difference between the maximum price per package and the pharmacy purchase price:
    • at an estimated volume of less than 100,000 packages in 2018: is smaller than €0.34 and €0.34 is 3% or more of the pharmacy purchase price;
    • at an estimated volume of 100,000 to 250,000 packages: is smaller than €0.12 and €0.12 is 3% or more of the pharmacy purchase price; and
  • the pharmacy purchase price is not higher than the maximum price per package.

In summary, this applies to products that are cheaper than €11.33/package (in case of a sales volume of <100,000) or cheaper than €4 (in case of a sales volume of 100,000-250,000).

Applications for compensation of these additional costs need to be submitted before 15 December 2018, 12h:

More information can be found here and in Staatscourant Nr. 60878.