EN PL

News

GMP laying down the guidelines for Quality Management System

26.02.2010
The DG Enterprise and Industry has launched a public consultation on part I chapter 1 of the good manufacturing practices laying down the guidelines on Quality Management System ...

MHRA: FAQs for variations submitted after 1 January 2010

26.02.2010
This document gives answers to frequently asked questions on variations submitted after 1 January 2010. ...

Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008

01.02.2010
The Commission “Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination ...

GMP laying down the guidelines for Quality Management System

01.02.2010
The DG Enterprise and Industry has launched a public consultation on part I chapter 1 of the good manufacturing practices laying down the guidelines on Quality Management System. ...

EDQM: Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopeia Monographers

01.02.2010
To be in line with the revision of the EU Regulation on Variations to marketing applications, the system for revision/renewal of CEPs will change for all requests for revision received from 1st ...

Compassionate use of medicines in the European Union

01.02.2010
This document describes how “compassionate use” programs may up in the European Union, and the role of the European Medicines Agency in these activities, in accordance with Article 83 of ...

EMEA: Procedure for orphan medicinal product designation – general principles

01.02.2010
Regulation (EC) No 141/2000 of 16 December 1999 lays down a community procedure for the designation of medicinal products as an orphan medicinal products and the criteria for designation orphan ...