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16 September 2016 EMA/76622/2016 Press Office
Guidelines and concept papers
Adopted during the CHMP meeting 12-15 September 2016 The guidelines and concept papers which have been adopted during this meeting of the Committee for Medicinal Products for Human Use (CHMP) will be published shortly Documents for public consultation will also be available under Document search/Public consultations.
Committee/Working Party
Reference number
Document
Status
ICH
EMA/CPMP/ICH/2711/1999
Adopted
Joint CHMP/CVMP/CMDh/CMDv Working Group on Active Substance Master File Procedures (ASMF WG) Blood Products Working Party
EMA/422206/2016
Addendum (R1) to International Council for Harmonisation (ICH E11) Guideline 'Clinical Investigation of Medicinal Products in Paediatric Population' The worksharing procedure for the assessment of active substance master file (ASMF): Competent Authority version Guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use Guideline on the core SmPC for human Anti-D immunoglobulin for intramuscular use Guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency BWP report: Viral safety of plasma-derived and urine-derived medicinal products with respect to Zika virus Q/A on deletion of a non-significant specification parameter
Apr 29, 2016 - Press Office. Guidelines and concept papers ... Concept paper on the revision on the 'Guideline on the ... provided in the regulatory submission.
Sep 12, 2016 - updated and the Package Leaflet is proposed to be updated accordingly. ..... of a detailed analysis on a safety meta-analysis reporting a higher.
Sep 16, 2016 - Send a question via our website www.ema.europa.eu/contact ... Name of medicine. INN ... in patients with HCV/HBV co-infection are available.
Sep 16, 2016 - PSUR assessment resulting in an update of section 2 of the Package Leaflet to include references to methadone and buprenorphine (already mentioned in the SmPC) as examples of opioid substances that are contraindicated. This update was
Jun 12, 2017 - Send a question via our website www.ema.europa.eu/contact ... and emergency information and procedures prior to the start of the meeting.
Dec 16, 2016 - Initial applications; List of outstanding issues (Day 180; Day 120 for ...... Post-meeting note: The company withdrew the application on 16 ...
Jan 21, 2018 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the ... and emergency information and procedures prior to the start of the meeting. Disclaimers. Some of the information contained in this agenda i
May 4, 2017 - Re-examination of initial application procedures under Article 9(2) of ...... scientific advice given to companies during the development of ...
Oct 28, 2016 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the .... 4. Any Other Business. 11 ... position) in support of their candidature as per the SAWP Mandate requirements [see. Article 2(10)].
Mar 31, 2017 - Minutes of BMWP meeting held by Adobe connect on 16 November 2016 ..... sessions were considered as beneficial tool for learning and ...
Feb 13, 2017 - Minutes of BMWP meeting held by Adobe connect on 10 January 2017. Action: For information. Review of the composition of drafting groups ...
Jan 21, 2018 - Minutes of the ExcpDG face-to-face meeting held on 9-10 October 2017. (EMA/695162/2017). Action: For information. The CHMP noted the minutes. Work plan for the CHMP Excipients Drafting Group (ExcpDG) for the revision of the EC guidelin
Sep 15, 2016 - Send a question via our website www.ema.europa.eu/contact ... information adopted by PRAC are also available to MAHs on the ... As liver function may change during treatment with {product name}, a close monitoring of.
Mar 31, 2017 - Nominations, along with a short statement in support of candidature, should be sent by 31 .... Action: For discussion and agreement. The CHMP ...
Dec 5, 2016 - ORGAM topics can be discussed at the CHMP Plenary. Please .... Report from the PCWP/HCPWP workshop on social media held on 19 ... that should be provided in marketing authorisation applications and/or Master Files.
