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Posts Tagged ‘FMD’

New Royal Decree with regards to the implementation of the Falsified Medicines Directive

May 9, 2019


On February 8, 2019, the Belgian Official Gazette published a Royal Decree amending both the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use and the Royal Decree of 21 January 2009 concerning instructions for pharmacists.

The modifications that have been made with regards to the implementation of the Falsified Medicines Directive, include: “Without prejudice to Article 6septies, § 2 of the Act, the unique identification mark is included on the packaging of all reimbursable, non-prescription medicines whose reimbursement is not limited to delivery at the hospital.”

More information can be found here.

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.

Practical recommendations for the new verification system against Falsified Medicines

February 12, 2019


In light of the Falsified Medicines Directive, that came into effect on 9th February 2019, FAMHP has issued practical guidelines for the handling of complications during the initial phase of the new verification system.

FAMHP and BeMVO have worked out an “alert”-procedure for when an issue arises during the scanning of a product. These guidelines describe the actions that need to be taken when an alert occurs. It is to be expected that numerous alerts and errors will pop up during the first weeks of operation of  this new verification system without evidence of a falsified product. Therefore, FAMHP has decided to introduce a transition period until 30th April 2019, during which the guidelines of circular letter 644 should be followed.

During this transition period, even though alerts occur during scanning, the pharmacist will still be allowed to deliver the product, provided that several requirements are met. These requirements are described in circular letter 644.

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.

Information about the Falsified Medicines Directive

October 26, 2018

The Netherlands

The Falsified Medicines Directive (FMD) (Directive 2011/62/EU) are measures to prevent falsified medicinal products for human use from entering the legal distribution chain.

This includes that all outer packaging of prescription-only medicinal products must bear safety features no later than 9 February 2019. These safety features are: a 2D matrix code and an anti-tampering device (e.g. a seal on the outer packaging) that can verify whether the packaging has already been opened.

Marketing authorisation holders including parallel importers who market prescription-only medicinal products in the Netherlands should contribute to the development and maintenance of the NMVS, a system where the unique identifier information is stored, owned by the Dutch Medicines Verification Organisation (NMVO). After 9 February 2019, no products may be released for the market without the features on the packaging. It is also mandatory to upload product information on the European Hub when the products are released.

The safety features must be applied to packaging of prescription-only medicinal products. However, there are a few exceptions:

  • Certain prescription-only medicinal products (white list): annex 1 of Regulation EU/2016/161.
  • Certain over-the-counter medicinal products (black list): annex 2 of Regulation EU/2016/161.
  • All forms and strengths of radiopharmaceutical products fall beyond the scope of this regulation. Therefore, these products do not have to be provided with safety features.

The European Commission has also published a Q&A on the implementation of delegated regulation 2016/161.

Falsified Medicines Directive in Luxembourg

December 6, 2017


As from 9 February 2019, the Falsified Medicines Directive (FMD) will apply. Based on this, the Luxembourg National Medicines Verification Organisation (LMVO) will implement a Luxembourg verification system in cooperation with the Belgian National Medicines Verification Organisation (BeMVO).

As stipulated in the FMD and the related Delegated Regulation, the system and its operations must be financed by the MAHs acting within the Luxembourg scope of the FMD.

Therefore, The LMVO requests:

  • A one-off registration fee
  • A yearly flat fee, in line with the recommendations of European National Medicines Verification (EMVO), will be invoiced as from February 2019.

The Luxembourg scope of the FMD is defined as follows:
– All products under prescription according to the Luxembourg legislation
– Plus the ‘black list products’ as identified in annex 2 of the Delegated Regulation
– Minus the ‘white list products’ as identified in annex 1 of the Delegated Regulation
– Plus all products defined by the Luxembourg Competent Authorities.

More details can be found here.

Falsified Medicines Directive: joint declaration

September 27, 2017


Riziv/Inami, FAMHP and BeMVO published together a joint declaration concerning the implementation of the Falsified Medicines Directive (FMD) in Belgium. In this joint declaration, several arrangements have been laid down to optimize the cooperation between the above-mentioned health authorities in accordance with the FMD. Among others, the starting date, the FMD score for Belgium, the alignment with Grand Duchy Luxembourg, instructions for package design and submission of variations, and major milestones of the implementation have been included.

Registration for Marketing Authorization Holders

June 21, 2017


Every Marketing Authorization Holder (MAH) that distributes medicinal products that fall within the Belgian scope of the Falsified Medicines Directive (FMD) by February 9th 2019 must register to and contract with the Belgian Medicines Verification Organisation (BeMVO). In addition, they must contribute in the overall costs of the system via the one-off registration fee and the yearly flat fee.

The scope of the FMD legislation is defined by the Belgian authorities as follows:
– All products that are subject to a prescription according to the Belgian legislation
– Plus the black list products as identified in annex 2 of the FMD
– Minus the white list products as identified in annex 1 of the FMD
– Plus all reimbursed products bearing a RIZIV/INAMI reimbursement serial barcode today; except if listed on the white list.

More details can be found in the scope decision table.

The different steps to be compliant and more information on how to use the Belgian Medicines Verification System can be found here.