Recently Published (last 6 Months)
This is the 'Recently Published' page for the Human Medicines section
Added in July 2019
31 July 2019
- UPDATE - End of pilot for splitting of MRP/DCPs
- UPDATE - Template for Active Substance Master File (ASMF) Type IB Variation Assessment Report
- UPDATE - Template for Active Substance Master File (ASMF) Assessment Report (Applicant's Part)
- UPDATE - Template for Active Substance Master File (ASMF) Assessment Report (Resctricted Part)
- UPDATE - CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU)
- UPDATE - Lead Member State PSUR Follow-Up assessment report
- NEW - 2019 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
- NEW - Minutes from May 2019 CMDh meeting with Interested Parties
26 July 2019
25 July 2019
23 July 2019
22 July 2019
15 July 2019
- NEW - HaRP assessment reports for almotriptan; alprazolam; amlodipine; bemiparin sodium; bisoprorol; calcium carbonate; cetirizine dihydrochloride; colchicine; donepezil; etoposide (for infusion); fluorouracil (systemic use); haloperidol (oral solution); hyoscine butylbromide; macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride; melphalan; menotrophin; montelukast; pantoprazole; rupatadine fumarate; testosterone- transdermal/topical; vonorelbine (for infusion);
- UPDATE - List of safety concerns per approved Risk Management Plan (RMP) of active substances per product
8 July 2019
- NEW - PSUR assessment report for xenon
- UPDATE - CMDh Best Practice Guide (BPG) on Variation Worksharing (Chapter 7);
- UPDATE - Template of letter of intent for the submission of a worksharing procedure
- UPDATE - Cover Note to List of safety concerns per approved RMP of active substances per product
- UPDATE - Procedural advice on Validation of MR/Repeat-use/DC Procedures
- UPDATE - Article 30 Tracking table
5 July 2019
3 July 2019
Added in June 2019
26 June 2019
19 June 2019
13 June 2019
7 June 2019
- NEW - Art. 46 assessment report for Vigamox (moxifloxacin hydrochloride);
- NEW - Agenda and presentations from CMDh meeting with Interested parties in May 2019;
- UPDATE - List of safety concerns per approved Risk Management Plan (RMP) of active substances per product;
- UPDATE - Q&A on Usage Patents;
- UPDATE - Requirements on submissions (number and format) for New MA Applications within MRP, DCP or National procedures;
- UPDATE - Requirements on submissions (number and format) for Variations and Renewals within MRP and National procedures;
- UPDATE - Mandate for the Non-Prescription Medicinal Products Task Force;
4 June 2019
NEW - Report from the meeting held on 27-29 May 2019
3 June 2019
Added in May 2019
29 May 2019
28 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