Information about the Falsified Medicines Directive (FMD)
Update for marketing authorisation holders
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. The Delegated Regulation 2016/161 gives effect to parts of the FMD and contains legal measures for the implementation of the Directive.
An important element in the delegated regulation is 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.
Supply and management of unique codes
The Medicines Evaluation Board (MEB) cooperates with the Dutch Medicines Verification Organisation (NMVO) to coordinate the implementation of the safety features and to answer questions about the packaging. The NMVO owns the NMVS, the system in which the product number, batch number, expiry date and the unique serial number (‘unique identifier’) is stored. These elements also appear in the 2D data matrix on the packaging. In addition, the product number, batch number and expiry date of the medicinal product must be clearly legible on the packaging.
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. 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.
- For more information, registration and financial contribution, please visit the NMVO website (in Dutch).
- For more information about registering products on the European Hub, please visit the EMVO website.
The safety features must be applied to packaging of prescription-only medicinal products. There are a few exceptions:
- No safety features need to be placed on the packaging of certain prescription-only medicinal products. These are listed on the 'white list', under Annex 1 of Regulation EU/2016/161 (page 24).
- However, safety features must be placed on the packaging of certain over-the-counter medicinal products. These are listed on the 'black list', under Annex 2 of Regulation EU/2016/161 (page 25).
An example of over-the-counter medicinal products that still require safety features are omeprazole 20 mg capsules.
Furthermore, a separate rule applies to medicinal products that are not provided with safety features before 9 February 2019 and are in stock at the manufacturer, marketing authorisation holder, wholesale supplier or pharmacy. If such products do not yet have the safety features, recalling or repackaging them is not required. These medicinal products may be supplied or made available until the end of the expiry date of the packaging, with a transitional period until 2024.
In addition, 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 Q&A on the implementation of delegated regulation 2016/161 is published on the website of the European Commission. Q&A version 10 has recently been published on the EU website about falsified medicines (under ‘Safety features’).