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European Communities – Measures Affecting the Approval and Marketing of Biotech Products (WT/DS291, WT/DS292, WT/DS293): Report of the Panel
from ANNEXES A TO F
Published online by Cambridge University Press: 13 December 2017
Summary
TABLES SUMMARIZING THE HISTORY OF THEINDIVIDUAL APPROVAL PROCEDURES AT ISSUE IN THIS DISPUTE
The Panel has prepared a series of tables summarizing relevant aspects of the history of the individual approval procedures at issue in this dispute The tables were prepared on the basis of information provided by the Parties, and in particular the detailed chronologies of individual approval procedures submitted by the European Communities
Since the Panel's findings tend to focus on specific stages of individual approval procedures, it seemed useful to provide some background information on developments and activities at other procedural stages Consistent with their limited purpose, the Panel's tables do not reflect any and all activities of member State authorities, EC authorities or applicants of which the Panel has been made aware. It should also be noted that the information provided in the tables is more detailed for those stages and activities which the Panel has focused on for the purposes of its analysis, and less detailed for other stages and activities.
In preparing the tables, the Panel has found it useful to distinguish the following procedural stages, which also reflect the main stages of the approval procedures set out in the relevant EC approval legislation for biotech products (Directives 90/220 and 2001/18 as well as Regulation 258/97):
(a) Consideration of application at member State level (“Member State Level”)
(i) Initial assessment of application by lead CA. (“Lead Member State Level”).
(b) Consideration of application at Community level (“Community Level”)
(i) Circulation of lead CA assessment to other member States (“Other Member States”).
(ii) Consultation of EC scientific committee (“Scientific Committee Process”).
(iii) Preparation of draft measure to be submitted to the Regulatory Committee (“Commission”).
(iv) Consideration by the Regulatory Committee of the draft measure submitted by the Commission (“Regulatory Committee Process”).
(v) Preparation of draft measure to be submitted to the Council (“Commission”).
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- Dispute Settlement Reports 2006 , pp. 2245 - 2766Publisher: Cambridge University PressPrint publication year: 2008
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