Product information – QRD ( Quality Review of Documents)

1.      

Guidelines of the EU Commission 

- Safety Features for Medicinal Products for Human use – questions and answers - HERE

- Implementation plan for the introduction of the safety features on the packaging of nationally authorised medicinal products for human use - HERE

- Guideline on the packaging information of medicinal products for human use authorised - HERE

2.

Documents of EMA

2.1 QRD

- QRD Templates - HERE

- QRD convention for the EMA QRD templates - HERE

-  Working group on Quality Review of Documents - HERE

- Compilation of QRD decisions on stylistic matters in product information - HERE

2.2 Terms

- Terms for “batch number” and “expiry date” to be used on the labelling - HERE

- How to prepare and review a summary of product characteristics - HERE

- Policy on combined Summaries of Product Characteristics (SmPCs) - HERE

- Tables of non-standard abbreviations - HERE

- Expression of strength in the name of centrally authorised human medicinal products - HERE

- Compilation of QRD decisions on use of terms - HERE

- Excipients in the label and package leaflet of medicinal products for human use - HERE

- Guideline on declaration of storage conditions - HERE

- Member states contact points for translations review - HERE

3.

CMDh - HERE 

- CMDh Recommendations - HERE

-  PhVWP Recommendations - HERE

- Harmonisation of SmPCs - Article 30 Referrals - HERE

- Core SmPC/PL - HERE

4.

EDQM  

- Standard Terms Database - HERE

5. MedDRA  - HERE