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

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

- Declaration of storage conditions for medicinal products particulars and active substances (Annex) - Scientific guideline - HERE

- Declaration of storage conditions: 1. in the product information of pharmaceutical veterinary medicinal products, 2. for active substances ( Annex) - Scientific guideline - 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




S
AFETY
F
EATURES FO
R
MEDICINAL PRODUCTS F
OR
HUMAN USE