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 by the union - 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-system organ database - HERE




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AFETY
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EATURES FO
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MEDICINAL PRODUCTS F
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HUMAN USE