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.