Meeting of the Standing Committee on Medicinal Products for human use, Brussels - Main contents

© Kevin Bergenhenegouwen

CMTD(2017)1323 (Committee meeting)

DG Health and Food Safety

Title:

Meeting of the Standing Committee on Medicinal Products for human use - 14 November 2017

Date:

14 Nov 2017

Committee:

Standing Committee on medicinal products for human use

Associated Documents:

V054422/01 (Voting sheet)

Title:

Formal results of voting on Optimartk Art.31

V054419/01 (Voting sheet)

Title:

Formal results of voting on "Gadolinium containing medicinal products - Art 31"

D054418/01 (Draft implementing measure/act)

Title:

COMMISSION IMPLEMENTING DECISION of XXX concerning, in the framework of Article 31 of Directive 2001/83/EC i of the European Parliament and of the Council, the marketing authorisations for gadolinium-containing contrast agents for human use which contain one or more of the active substances “gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide and gadoxetic acid”

S054272/01 (Summary record)

Title:

MEETING OF THE STANDING COMMITTEE ON MEDICINAL PRODUCTS FOR HUMAN USE HELD IN BRUSSELS ON 14 NOVEMBER 2017 SUMMARY RECORD

A053716/01 (Agenda)

Title:

Agenda

D052873/02 (Draft implementing measure/act)

Title:

Draft COMMISSION IMPLEMENTING DECISION concerning, in the framework of Article 31 of Directive 2001/83/EC i of the European Parliament and of the Council, the marketing authorisation of “Optimark", medicinal product for human use

D052790/02 (Draft implementing measure/act)

Title:

Draft Commission Implementing Decision concerning, in the framework of Article 31 of Directive 2001/83/EC i of the European Parliament and of the Council, the marketing authorisations for gadolinium-containing contrast agents for human use which contain one or more of the active substances “gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide and gadoxetic acid”

Basic legal act(s):

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC   Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)   Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)   Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products   Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)   Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use   Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products   Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use