BADI members only
Product information – QRD ( Quality Review of Documents) 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 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 CMDh - HERE - CMDh Recommendations - HERE - Harmonisation of SmPCs - Article 30 Referrals - HERE - Core
SmPC/PL - HERE
EDQM - Standard Terms Database - HERE 5. MedDRA - HERE S AFETY F EATURES FO R MEDICINAL PRODUCTS F OR HUMAN USE |