Safety features protect consumers against falsified medicines
The packaging of prescription-only medicinal products must have safety features from 9 February 2019 onwards. The pharmacy can use these features for checking that the medicines are genuine and thereby protect consumers better against possible falsification.
This is stated in the European directive that is intended to prevent falsified medicinal products for human use from getting into the legitimate medicines chain.
Companies, wholesalers and pharmacies now have 18 months in which to modify the packaging of medicinal products.
Two safety features are applied to the outer packaging:
- A unique identifier, processed into a 2D bar code (matrix of blocks).
- What is referred to as an anti-sabotage (anti-tampering) feature, for example a seal on the outer packaging. This shows the pharmacist that the packaging has not previously been opened.
Marketing authorisation holder responsible for placing the safety features
The marketing authorisation holder is responsible for safety characteristics being present from 9 February 2019 onwards on the packaging of all prescription-only medicinal products and in exceptional cases on the packaging of over-the-counter medicinal products.
In the Netherlands, the NMVO (the Netherlands Medicines Verification Organisation Foundation) is responsible for the introduction of the new European system. The NMVO builds, tests and populates the national database, that issues the unique identifier and the corresponding matrix code. The NMVO also informs all the parties involved about the process.
- Information about the NMVO (Dutch)
Information for companies
Information for companies about the safety characteristics on the packaging of medicinal products and how they are to be placed:
Pharmacy responsible for inspection
A number of aspects will change for pharmacies when the safety characteristics are introduced. They become responsible for checking the features, for instance, before dispensing the medicines to the patients.
The unique identifier (the 2D code) includes the product number, the serial number, the batch number and the expiry date. In addition, that same information must also be legible on the outer packaging to the naked eye. The 2D code is linked to a unique number in the European database in which all unique identifiers are assigned. The pharmacy has to scan the 2D code on the packaging and deactivate it. They must also check the seals.
The pharmacy thus checks both the identity and the authenticity of the medicinal product. If the check of the 2D code shows that this particular pack has already been disabled, the medicinal product cannot be given to the patient. In such cases, the pharmacy must alert the Dutch Health and Youth Care Inspectorate (IGJ).