emea注冊要求

1、European Medicines Agency Inspections7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 95 E-mail: mail@emea.eu.int http://www.emea.eu.int EMEA 2006 Reproduction an

2、d/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London, 27 April 2005 EMEA/CVMP/134/02 Rev 2 Consultation CPMP/QWP/227/02 Rev 2 ConsultationCOMMITTEE F

3、OR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)GUIDELINE ON ACTIVE SUBSTANCE MASTER FILE PROCEDURE DISCUSSION AT THE HMPC November 2005 – January 2006 ADOPTION B

4、Y THE HMPC 22 January 2006 DRAFT AGREED BY QUALITY WORKING PARTY February 2006 ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION 23 March 2006 ADOPTION BY CVMP FOR RELEASE FOR CONSULTATION 20 April 2006 END OF CONSULTA

5、TION (DEADLINE FOR COMMENTS) 30 August 2006 Note: From 1st November 2005, Directive 2004/24/EC 1 relating to traditional herbal medicinal products came into force in all Member States in the European Union allowing the e

6、stablishment of a simplified procedure for the registration of traditional herbal medicinal products for human use. In order to facilitate the use of the ASMF procedure in the area of herbal medicinal products, the Com

7、mittee for Herbal Medicinal Products proposes an Annex on herbal substances/preparations (see Annex 1, table 3) to the Guideline on the Active Substance Master File procedure. It should be noted that the principles which

8、 are outlined in this guideline in relation to traditional herbal medicinal products are equally applicable to other herbal medicinal products, both for Human and Veterinary use, which do not follow the simplified regi

9、stration procedure. The new table (Annex 1, table 3) takes into account the particularities of herbal substances/preparations whilst also highlighting that this procedure is/can be applied to active substances/preparatio

10、ns of herbal origin, whether they be for human or veterinary use. 1 Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004, amending, as regards traditional herbal medicinal products, Direct

11、ive 2001/83/EC on the Community code relating to medicinal products for human use. GUIDELINE ON ACTIVE SUBSTANCE MASTER FILE PROCEDURE TABLE OF CONTENTS EXECUTIVE SUMMARY.................................................

12、....................................................... 4 1 INTRODUCTION............................................................................................................. 4 2 SCOPE.............................

13、................................................................................................. 4 3 LEGAL BASIS..........................................................................................................

14、....... 4 4 MAIN GUIDELINE TEXT.............................................................................................. 4 4.1 Content of the Active Substance Master File...........................................

15、..................... 4 4.2 Use of the Active Substance Master File Procedure..................................................... 5 4.3 Content of the Ma Dossier when the Active Substance Master File Procedure is used

16、6 4.4 Changes and updates to the Active Substance Master File........................................... 6 ANNEX 1.........................................................................................................

17、.......................... 8 ANNEX 2................................................................................................................................. 13 ANNEX 3............................................

18、..................................................................................... 14 ANNEX 4............................................................................................................................

19、..... 15 ANNEX 5................................................................................................................................. 16 EMEA/CVMP/134/02 Rev 2 Consultation EMEA 2006 3/17 CPMP/QWP/227/02 Re