tailieunhanh - INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES COMMISSION

Many have gone above and beyond the call of duty to make this special issue possible. The editorial team at Forced Migration Review has been the anchor on which we have all relied. The authors of the articles and those who submitted pieces we could not include deserve special recognition. Their work was done after-hours, often in the field during time they did not have. Ricardo Ernst, my fellow guest editor, has been an able partner responding with feed- back from all corners of the globe. The Fritz Institute team, and especially Ivy Cohen, has provided ideas and input crucial to pulling the images and words together. A special thanks is also due to Lynn Fritz whose. | EN EN EN INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES COMMISSION Communication from the Commission - Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products 1. INTRODUCTION Commission Regulation EC No 1234 2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products1 hereinafter the variations regulation was published in the Official Journal on 12 December 2008. The variations regulation aims to establish a simple clearer and more flexible legal framework for the handling of variations to marketing authorisation of medicinal products while ensuring a high level of protection of public and animal health. The variations regulation lays down general rules on the types and classification of variations in Articles 2 and 3 and in Annex II. In addition Article 4 1 a charges the Commission with the task of drawing up guidelines on the details of the various categories of variations. Consequently this guideline provides details of the classification of variations into the following categories as defined in Article 2 of the variations regulation minor variations of Type IA minor variations of Type IB and major variations of Type II and provides further details where appropriate on the scientific data to be submitted for specific variations and how this data should be documented. It should be noted that the general documentation accompanying every application for variations to the term of a marketing authorisation is laid down on Annex IV of the variations regulation and in 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 of variations to the terms of marketing authorisations for medicinal .