The product information of medicinal products follows a specific template, the Quality Review of Documents (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, including an annotated template in English.
The CMDh 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)
- QRD Appendix I (Pregnancy)
- QRD Appendix II (Adverse reactions-MedDRA)
- QRD Appendix III (Storage conditions)
- QRD Appendix IV (EXP en Batch)
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. European legislation has come into effect in this matter. For example, the packaging of prescription-only medicinal products must contain a so-called “unique identifier” in the form of a 2D barcode. This is included in the QRD templates,
Questions and comments about the product information in general and the QRD template can be submitted to: dienstpostbusproductinformatie@cbg-meb.nl.