Recently Published (last 6 Months)

This is the 'Recently Published' page for the Human Medicines section

Added in September 2020

29 September 2020

24 September 2020

23 September 2020

22 September 2020

15 September 2020

Added in July 2020

31 July 2020

NEW - Template for RMS Assessment Report on Similarity
UPDATE - RMS Day 70 Overview template
UPDATE - RMS Day 120 Overview template
UPDATE - PSUR summary assessment report for doxylamine hydrogen succinate, pyridoxine hydrochloride

29 July 2002

NEW - Report from the meeting held on 21-22 July 2020
NEW - Art.45 Assessment report on valproic acid
NEW - Art.46 Assessment report on fosrenol
NEW - Recommendations on common regulatory approaches for allergen products
 

27 July 2020

NEW - June 2020 CMDh Minutes

24 July 2020

NEW - Minutes from the CMDh meeting with IPs in May 2020

23 July 2020

UPDATE - Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines / Recommendation papers;

UPDATE - Article 30 Tracking table ;

21 July 2020

20 July 2020

17 July 2020

10 July 2020

08 July 2020

 

Added in May 2020

29 May 2020

28 May 2020

26 May 2020

11 May 2020

8 May 2020

6 May 2020

4 May 2020