Recently Published (last 6 Months)
This is the 'Recently Published' page for the Human Medicines section
Added in May 2019
15 May 2019
- NEW - PSUFU assessment report for abciximab;
- NEW - PSUR assessment report for Sterillium (2-Propanol, 1-Propanol, mecetronium ethylsulfate);
- NEW - Art. 45 public assessment report for flucytosine;
- UPDATE - Template for cover letter for renewal;
- UPDATE - Template for cover letter for marketing authorisation applications;
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
3 May 2019
Added in April 2019
30 April 2019
29 April 2019
26 April 2019
23 April 2019
15 April 2019
- UPDATE - Information to be submitted by the Member State of the European Reference Medicinal Product;
- UPDATE - Standard form to be sent by the RMS to the MS of the ERP;
12 April 2019
11 April 2019
- NEW - PSUFU summary assessment reports for levonorgestrel (Part I and Part II);
- NEW - 2018 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures;
- NEW - Summary of CMDh activities in 2018;
- NEW - Art. 45 Assessment reports for quinine & quinidine, cinchonine and cinchonidine;Tetravac/Tetraxim (diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis vaccine (inactivated) adsorbed);Pentavac/Pentaxim (diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugated vaccine (adsorbed));Imovax Polio (inactivated poliovirus vaccine); disopyramide;
- NEW - Art. 46 Assessment reports for OctaplasLG (ABO-blood group specific human plasma proteins); Tetravac/Tetraxim (diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis vaccine (inactivated) adsorbed); Pentavac/Pentaxim (diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugated vaccine (adsorbed));
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation;
- UPDATE - Mandate for the Working Party on Variation Regulation;
10 April 2019
- NEW - PSUFU summary assessment reports for carbetocin and tramadol;
- UPDATE - Template for the End of Procedure;
- UPDATE - Procedural advice on Validation of MR/Repeat-use/DC Procedures;
3 April 2019
2 April 2019
Added in March 2019
29 March 2019
- NEW - Questions & answers: EU actions to prevent medicine shortages due to Brexit (link to EMA website)
27 March 2019
26 March 2019
25 March 2019
12 March 2019
11 March 2019
- NEW - Article 45 and 46 – Paediatric Regulation - EU Worksharing Procedure
- NEW - Summary assessment reports for ambrosia artemisiifolia, sublingual use and fluorocholine (18F);
- UPDATE - CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU);
- UPDATE - Recommendation for implementation of Commission Decisions or CMDh agreements following Union referral procedures where the marketing authorisation is maintained or varied
6 March 2019
5 March 2019
- UPDATE - Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP;
- NEW - Template for Notification of request for a time-limited exemption to continue batch control testing in the United Kingdom (UK) after UK’s withdrawal from the Union for a nationally authorised medicinal product;
- NEW - Contact points for requests for exemption to continue batch control testing in the United Kingdom (UK) after UK’s withdrawal from the Union for a nationally authorised medicinal product
4 March 2019
1 March 2019
Added in February 2019
26 February 2019
25 February 2019
22 February 2019
19 February 2019
18 February 2019
13 February 2019
12 February 2019
- NEW - PSUFU assessment reports for rosuvastatin and phenylephrine hydrochloride/tropicamide;
- NEW - Art. 45 assessment report for tropicamide;
- NEW - Art. 46 assessment report for Priorix (Live attenuated Measles virus (Schwarz strain), Live attenuated, Mumps virus (RIT4385 strain, derived from Jeryl Lynn strain), Live attenuated Rubella virus (Wistar RA 27/3 strain));
- UPDATE - Best Practice Guide for authorisation of non-prescription medicines in the Decentralised and Mutual Recognition procedures;
- UPDATE - Q&A on generic applications;
- UPDATE - Procedural advice: Validation of MR/Repeat-use/DC Procedures;
- UPDATE - Template for Cover letter for Variation Applications in the Mutual Recognition Procedure;
- UPDATE - 'Blue-box' requirements;
11 February 2019
7 February 2019
- NEW - Report from the meeting held on 28-30 January 2019
- UPDATE - Extension of pilot for splitting of MRP/DCPs
6 February 2019
5 February 2019
1 February 2019
Added in December 2018
18 December 2018
- NEW - Report from the December 2018 CMDh meeting;
- NEW - PSUFU summary assessment reports for atorvastatin and paroxetine;
- NEW - CMS validation checklist in MRP;
- NEW - Art. 46 assessment report for Berinert (C1-eserase inhibitor, human);
- UPDATE - Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP;
- UPDATE - CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008;
- UPDATE - Q&A on Variations;
- UPDATE - Q&A on QP declaration;
- UPDATE - Template of letter of intent for the submission of a worksharing procedure;
- UPDATE - Templates for Day 120/Day 180 Quality AR, Day 145 and Day 2015 CMS comments;
- UPDATE - CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product;
14 December 2018
11 December 2018
10 December 2018
6 December
Added in November 2018
30 November
- UPDATE - Requirements on submissions (number and format) for New MA Applications within MRP, DCP or National procedures AND for Variations and Renewals within MRP and National procedures
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
28 November
- NEW - November 2018 CMDh meeting with Interested Parties Agenda and presentations
- NEW - Art. 45 public assessment report for tinidazole
- NEW - Art. 46 public assessment report for trileptal (Oxcarbazepine)
- UPDATE - RMS Validation Checklist for human medicinal products in DCP
- UPDATE - Template - D100 CMS Comments
- UPDATE - Template - Cover letter Renewal
21 November
15 November
14 November