Recently Published (last 6 Months)

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

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

Added in March 2020

31 March 2020

27 March 2020

25 March 2020

16 March 2020

10 March 2020

9 March 2020

6 March 2020

5 March 2020

4 March 2020