The product information of medicinal products follows a specific template, the QRD template. A distinction is made between templates for the Centralised procedure and templates for the Mutual recognition Procedure (MRP), Decentralised procedure (DCP) and referrals.
The product information templates are available on the European Medicines Agency (EMA) website in all languages.
An annotated version of the MRP/DCP QRD-template can be found on the HMA website.
For National procedures, the QRD template used for MRP, DCP and referrals applies.
Dutch versions of the QRD template
- Centralised procedure
- MRP/DCP/referral and National procedure
- Previous versions of the Dutch QRD template (Centralised procedure, MRP, DCP, referral and National procedure)
- Appendices (Additional information about specific sections of the product information)
Implementation plans QRD template
Separate implementation plans have been drafted for the centralised procedures and for the MRP/DCP plus referral procedures. For products that are authorised via a national procedure, the implementation plan for the MRP/DCP plus referrals is followed. The new QRD template must be implemented during an ongoing variation or in the case of a separate variation (no Type IA, unless it only concerns the addition of safety characteristics).
Addition of characteristics to prevent falsification
Specific rules have been set for medicinal product packaging, in order to prevent the entry of falsified medicinal products in the legal medicinal products distribution chain. For example, the packaging of prescription-only medicinal products must contain a so-called “unique identifier” in the form of a 2D barcode. European legislation has come into effect in this matter. The QRD template (version February 2016) was amended accordingly.
Separate implementation plans have been drafted to add these safety characteristics for packages of medicinal products in the MRP/DCP plus referral procedure and for medicinal products in the centralised procedure.
Implementation of this European legislation can take place during a regulatory procedure relating to the product information (such as renewal, Type II variation, Type IB variation, Type IA (C category) variation). If a regulatory procedure does not take place within 3 years of the implementation of the Delegated Act (February 2016), the amendment of the packaging texts can be submitted via an article 61(3) notification. This article 61(3) notification must also be submitted within 3 years of the implementation of the Delegated Act (February 2016).
This implementation does not require the submission of mock-ups, unless more changes are included in the mock-up, such as - for example - creating space on the packaging for the unique identifier.
Questions and comments about the product information in general and the QRD template can be submitted to: firstname.lastname@example.org.