Marketing authorisation holders must implement two safety features on the packaging of prescription-only medicinal products for humans. This is stated in the implementation measures derived from Directive 2011/62/EU for the prevention of the entry of falsified medicinal products for human use in the legal supply chain. As from 9 February 2019, these safety characteristics must be present on the packaging of medicinal products.
There are several exceptions:
- Safety characteristics do not have to be applied on the packaging of some prescription-only medicinal products in case they are included in the ‘white list’ in Appendix 1 to Regulation EU/2016/161 (page 24).
- Safety characteristics have to be applied on the packaging of some over-the-counter medicinal products in case they are put on the ‘black list’ in Appendix 2 to Regulation EU/2016/161 (page 25). An example of over-the-counter medicinal products that still require safety features are omeprazole 20 mg and 40 mg hard capsules.
The purpose of these safety characteristics is to protect consumers better against falsified medicines. It is then possible to use these features at the pharmacy to check that the medicinal products are genuine. The measures are intended to prevent falsified medicinal products from entering the legal supply chain and sales channels.
The two safety characteristics that have to be added are:
- a unique identifier, processed into a 2D barcode
- what is referred to as an anti-tampering device, for example a seal on the outer packaging. This lets the pharmacist see that the packaging has not previously been opened.
The marketing authorisation holder must apply these safety features on the outer packaging. For all prescription-only medicinal products that have no outer packaging, the safety characteristics must be applied on the direct packaging.
Marketing authorisation holder is responsible
The marketing authorisation holder is responsible for the safety characteristics being placed on the packaging in due time. The safety characteristics mentioned above must be present on the packaging of all products on the market from 9 February 2019 onwards.
Medicinal products that do not have a safety feature before 9 February 2019 and are in stock with the manufacturer, marketing authorisation holder, wholesaler or pharmacy are entitled to an exemption. If such products do not yet have the safety features, a recall or repackaging are not required. These medicinal products may be delivered or distributed until the end of the expiry date on the packaging, with a transitional period until 2024.
The texts about the packaging in sections 17 and 18 of the QRD template must therefore be changed accordingly.
Adding safety characteristics
There are separate implementation plans for introducing the safety characteristics for:
- in the ‘Questions and answers’ document on the European Commission website (under 'Safety features')
- Medicinal products covered by the central procedure (EMA website)
- Packaging of medicinal products in the MRP/DCP (HMA website under the section of CMDh)
For packaging of medicinal products covered by the national procedure the MEB is adopting the CMDh implementation plan.
Marketing authorisation holders can add the safety characteristics during a regulatory procedure for the product information, such as renewal, a type II variation, a type IB (category C) variation or a type IA variation.
If it is not possible to implement the safety characteristics using one of the above procedures, the marketing authorisation holder can submit the modification to the packaging text via an Article 61(3) notification. When submitting such an Article 61(3) notification, please take into account that the safety characteristics must be present from 9 February 2019 onwards on products that are on the market at that moment.
In Europe, the European database EMVO (European Medicines Verification Organisation) has been set up, to which all national verification systems are linked. The marketing authorisation holders provide data to the EMVO. Each Member State has also a national verification system.
In the Netherlands, the database is managed by the Stichting Nederlandse Medicijnen Verificatie Organisatie (NMVO) (Dutch Medicines Verification Organisation). They issue the unique identifiers and the associated matrix codes comprising the Nationaal Medicijnen Verificatie Systeem (NMVS) (Dutch National Medicines Verification System).
- More information about the NMVO (Dutch)
The marketing authorisation holder does not have to submit mock-ups in the Netherlands for the implementation of the unique characteristic if the mock-up complies with the requirements for legibility according to the Guideline on the readability of the labelling and package leaflet of medicinal products for human use.
If there are changes in the mock-up or if there is any doubt about the consequences for legibility, the marketing authorisation holder must submit a mock-up after all. The marketing authorisation holder must make its own assessment of whether this is necessary, based on the declaration of legibility.
Various agreements have been made in the CMDh about this European Commission Delegated Regulation, such as: