What's New

February 2007

Question from industry - Repeated use MRP EMEA/CMDv/48749/2007
Question from industry - Data requirements on generic application EMEA/CMDv/48685/2007
Report of the January CMD(v) meeting - for release EMEA/CMDv/37854/2007

January 2007

Report of the December CMD(v) meeting - for release EMEA/CMD(v)/7364/2007
Question from Industry - Trade name EMEA/CMDv/482733/2006

December 2006

Report of the outcome of the 1st cycle BEMA/1st_cycle
Benchmarking of european medicines agencies BEMA/exec
Work Plan 2007 EMEA/CMDv/434974/2006
Question from Industry - National transfer of MAH EMEA/CMDv/482731/2006

November 2006

Permanent Secretariat Support to the HMA Management Group HMA-MG&-PS BPG
Standard Operating Procedure for Disagreement in Procedures Referral to CMD(v) CMD(v)/SOP/001
Best Practice Guide for Veterinary Mutual Recognition Procedure CMD(v)/BPG/001
Report of the Novembre CMD(v) meeting - for release EMEA/CMDv/457688/2006
Best Practice Guide for Contact with Representative Organisations CMD(v)/BPG/013
Best Practice Guide for Active Substance Master File (ASMF) in the Mutual Recognition and Decentralised Procedures CMD(v)/BPG/011

October 2006

Best Practice Guide for the Repeat Use Procedure CMDv/BPG/003
Report of the October CMD(v) meeting - for release EMEA/CMDv/416001/2006

September 2006

IFAH-Europe / CMD(v) 2005 Survey on the Mutual Recognition Procedure for Veterinary Medicinal Products 2005-IFAH/CMD(v) survey
Question from Industry - Target species extension EMEA/CMDv/365373/2006
Report of the September CMD(v) meeting - for release EMEA/CMDv/375184/2006
List of the CMD(v) members and their qualifications CMD(v)/GUI/007
EU Heads of Medicines Agencies meeting in Helsinki - September 2006 Press Relase HMA/PR/09-06

August 2006

IFAH-Europe / VMRFG 2004 Survey on the Mutual Recognition Procedure for Veterinary Medicinal Products 2004-IFAH / VMRFG Survey
IFAH-Europe / VMRFG 2003 Survey on the Mutual Recognition Procedure for Veterinary Medicinal Products - 2003 2003-IFAH / VMRFG Survey
IFAH-Europe / VMRFG 2002 Survey on the Mutual Recognition Procedure for Veterinary Medicinal Products - 2002 2002-IFAH / VMRFG Survey
VMRFG / FEDESA Survey Mutual Recogntion Procedure for Veterinary Medicinal Products - 2001 2001-VMRFG / FEDESA Survey
VMRFG / FEDESA Survey Mutual Recognition Procdure for Veterinary Medicinal Products - 2000 2000-VMRFG / FEDESA Survey
VMRFG / FEDESA Survey Mutual Recognition Procedure for Veterinary Medicinal Products - 1999 1999-VMRFG / FEDESA Survey

July 2006

Question from industry - answer to question on generics EMEA/CMDv/266052/2006
Report of the July CMDv meeting - for release EMEA/CMDv/289019/2006
Question from industry - Q&A on diagnostic kits EMEA/CMDv/225335/2006
Report of the June CMD(v) meeting - for release EMEA/CMDv/239786/2006

June 2006

IFAH-Europe-CMD(v) 2006 DCP survey questionnaire Questionnaire for VDCP
IFAH-Europe-CMD(v) 2006 MRP survey questionnaire questionnaire for VMRP
Best Practice Guide for Handling the renewals in the Mutual Recognition and Decentralised Procedure CMD(v)/BPG/007
Report of the May CMD(v) meeting - for release EMEA/CMDv/195249/2006

May 2006

Benchmarking of European Medicines Agencies - Steering Group May 2006 BEMA/05-06
EU Heads of Medicines Agencies - May 2006 Press Release HMA/PR/05-06
Position Paper on Requirements for starting Material of Biological Origin CMD(v)/POS/001
Best Practice Guide for Type IA Variations CMDV/BPG/004
Best Practice Guide for Automatic Validation of Applications of the Mutual Recognition Procedures CMDV/BPG/008
Best Practice Guide for Type II Variations CMDV/BPG/006
Best Practice Guide for Type IB Variations CMDV/BPG/005
Report of the April CMD(v) meeting - for release EMEA/CMDv/150453/2006

April 2006

Rules of Procedure CMD(v) ROP-001-00
Report of the March CMD(v) meeting - for release EMEA/CMDv/105619/2006

March 2006

Clock start dates 2006 / 2007 CMD(v) GUI-005-00
Guidance for documentation to be submitted by a member state when reference medicinal product is not authorised in the RMS CMD(v)/GUI/006
Report of the February CMDv meeting - for release EMEA/CMDv/67631/2006

February 2006

Best Practice Guide for processing of SPC labelling and packaging provided in support of Mutual Recognition and Decentralised Applications CMD(v)/BPG/009
CMD(v) annotated QRD template TEM-006
Downloadable QRD template - Summary of Product Characteristics TEM-006-version01/2006
Best Practice Guide for Veterinary Decentralised Procedure CMD(v)/BPG/002
Report of the January CMD(v) meeting - for release EMEA/CMDv/29366/2006

December 2005

Report of the CMD(v) meeting - For release CMDV/071/05-Final

November 2005

Report of the CMD(v) meeting - for release CMDV/005/05-Final

October 2005

Questions and answers relating to the implementation of Directive 2001/82/EC as amended by Directive 2004/28/EC VMRF/456/05
Report of the VMRFG meeting - for release VMRF/477/05-final

September 2005

Report of the VMRFG September Meeting - for release VMRFG/429/05-final
New composition and new chair of Heads of Medicines Agencies Management Group 09/05

July 2005

Report of the VMRFG Meeting – for release VMRFG/364/05-Final
EU Heads of Medicines Agencies - July 2005 press release HMA/PR/07_05
Question from industry : Abridged (generic) application for an antiobiotic injection EMEA-VMRF-213-05

June 2005

Report of the VMRFG meeting - for release VMRFG/304/05-FINAL

May 2005

Report of the VMRFG meeting for Release (May 2005) VMRF/254/05

April 2005

Question from industry : the same veterinary medicinal product registred by two companies with different trade name VMRF/166/05
Question from industry : fixed combination product submitted as bibliographical application VMRF/053/05
Report of the VMRFG meeting for Release (April 2005) VMRF/197/05

March 2005

Question from industry : submission of a single part III for all strengths VMRF/054/05
Report of the VMRFG for Release (March 2005) VMRF/139/05

February 2005

Report of the VMRFG for release (February 2005) VMRF/087/05

January 2005

Definition of the term "same medicinal product" VMRF/414/04
Authorisation of colorants in veterinary medicinal products in the EU VMRF/069/98
Question from industry: MRP when two national authorisations exist VMRF/284/04
Question from industry: Clinical Studies and GLP (Good Laboratory Practice) standards VMRF/540/04
Report of the VMRFG for Release (January 2005) VMRF/032/05

December 2004

Report of the VMRFG for Release (December 2004) VMRF/572/04

November 2004

Report of the VMRFG for Release (November 2004) VMRF/547/04

October 2004

Report of the VMRFG for Release (October 2004) VMRF/488/04

September 2004

Best Practice Guide for the Reference Member State VMRF/242/03
Report of the VRMFG of Release (September 2004) VMRF/424/04
Press release of the HEVRA meeting in The Hague (The Netherlands) - 8-9/09/2004 HEVRA/01/04

July 2004

Report of the VMRFG for Release (July 2004) VMRF/371/04

June 2004

The Mission Statement of the HEVRA group has been released

Survey Procedure for collection of data VMRF/032/02
Report of the VMRFG for Release (June 2004) VMRF/327/04

May 2004

The new HEVRA web site has been released !!
Experience it now !
and give your feedback

Parallel Applications VMRF/038/99
Report of the VRMFG for Release (May 2004) VMRF/259/04

April 2004

Question from industry : Change of address of MAH VMRF/219/04
Report of the VMRFG for Release (April 2004) VMRF/227/04
Report of the VMRFG for Release (March 2004) VMRF/180/04
Question from Industry : Change of the scoring tablet VMRF/229/04

February 2004

Give your feedback on the new HEVRA web site which include Accessing Countries and Mutual Recognition partners.
New HEVRA website The relooked web site will be officially launched on the 1st of May 2004

Report of the VMRFG for Release (February 2004) VMRF/117/04

January 2004

Happy New Year 2004 for all HEVRA web site users from the webmaster.

Report of the VMRFG for release (January 2004) VMRF/032/04
Question from Industry : Extension to a new species VMRF/244/03
Question from industry : Regulatory Affairs Consultant could apply for a Marketing Authorisations on behalf of a Company outside the EEA VMRF/182/03
Report of the VMRFG for Release (December 2003) VMRF/248/03

November 2003

Report of the VMRFG for release (November 2003) VMRF/229/03
Question from industry : Transfer of marketing authorization via MRP VMRF/190/03
Question from industry : Withdrawal an application during the validation VMRF/208/03
Report of the VMRFG for release (October 2003) VMRF/202/03

October 2003

Question from industry : Use of Feedgrade Antibiotics in Veterinary Premixes VMRF/163/03

September 2003

Report of the VMRFG for release (September 2003) VMRF/171/03

August 2003

Reasons for withdrawals in 2002 VMRF/142/03
Report of the VMRFG for release (July 2003) VMRF/151/03

July 2003

Report of the VMRFG for release (June 2003) VMRF/124/03

June 2003

Press release of the joint HoA/HEVRA meeting in Athens (Greece) - 27/05/2003 HEVRA/04/03
Press release of the HEVRA meeting in Athens (Greece) -27/05/2003 HEVRA/03/03
Report of the VMRFG for release (May 2003) VMRF/097/03

April 2003

Question from industry : Classification of products VMRF/064/03
Document management : Standardisation of e-mail headings during MRP VMRF/075/02
Document management : Guidance for e-mail use during Mutual Recognition Procedure VMRF/074/02
Classification of teat dips as medicines (replace VMRF/072/97) VMRF/060/03
Question from industry : Informed Consent Applications in a CMS VMRF/187/02
Report of the VMRFG for Release (March 2003) VMRF/052/03
Report of the VMRFG for Release (April 2003) VMRF/071/03

March 2003

The HEVRA web site will be redesigned this year in view of the Enlargement of the European Union and to incorporate Iceland, Norway and Lischtenstein as participant of the Mutual Recognition procedure.

Press release of the joint HoA/HEVRA meeting in Athens (Greece) - 25/02/2003 HEVRA/02/03
Press release of the HEVRA meeting in Athens (Greece) -25/02/2003 HEVRA/01/03

February 2003

Question from industry : Generic Applications-essential similarity VMRF/195/02
Question from Industry : Classification of Veterinary Tissue Adhesives VMRF/211/02
Report of the VMRFG for Release (February 2003) VMRF/030/03

January 2003

Information about "Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)" have been updated.

Report of the VMRFG for Release (January 2003) VMRF/015/03

December 2002

Press release of the joint HoA-HEVRA meeting in Hillerød (Denmark) - 27-28/11/2002 HEVRA/05/02
Report of the VRMFG for release (December 2002) VMRF/205/02

November 2002

Report of the VRMFG for release (November 2002) VMRF/196/02

October 2002

Report of the VMRFG for release (October 2002) VMRF/174/02

September 2002

Summary Reasons for Withdrawals in 2001 VMRF/149/02
Report of the VMRFG for release (September 2002) VMRF/138/02

August 2002

Press release of the joint HoA-HEVRA meeting in Segovia (Spain) - 28/05/2002 HEVRA/04/02
Press release of the HEVRA meeting in Segovia (Spain) - 29/05/2002 HEVRA/03/02
Press release of the joint HoA/HEVRA meeting in Hillerød (Denmark) - 03/07/2002 HEVRA/02/02
Press release of the HEVRA meeting in Hillerød (Denmark) - 03/07/2002 HEVRA/01/02

July 2002

Best Practice Guide VMRF/258/00
VMRFG Report for Release (July 2002) VMRF/134/02
Proposed Meeting Dates in 2003-2004 VMRF/126/02

June 2002

Report of the VMRFG for release (June 2002) VMRF/119/02

May 2002

The list of VMRFG Contact points has been updated.

Report of the VMRFG for release (May 2002) VMRF/099/02

April 2002

Report of VMRFG for Release (April 2002) VMRF/082/02
Revised VMRFG/FEDESA Questionnaire VMRF/030/02

March 2002

Report of the VMRFG for release (March 2002) VMRF/058/02

February 2002

Report of the VMRFG for release (February 2002) VMRF/040/02

January 2002

Report of the VMRFG for release (January 2002) VMRF/011/02
REVISED Report of the VMRFG for release (December 2001) VMRF/012/02

December 2001

Note : "Table of decisions" is replaced by "Report for Release" in the VMRFG section

HEVRA Press release (22 November 2001) HEVRA/07/01

November 2001

Report of the VMRFG for release (November 2001) VMRF/248/01

October 2001

Clock start dates for 2002-2003 VMRF/186/01
Report of the VMRFG for release (October 2001) VMRF/223/01
Joint meeting Heads of Agencies / HEVRA 27 September 2001 HEVRA/06/01
Meeting of the Heads of European Veterinary Regulatory Authorities, 27 september 2001 HEVRA/05/01

September 2001

USE OF ERYTHROSIN IN VMRP VMRF/187/01
Starting dates in 2001 and 2002 VMRF/262/00
Report of the VMRFG for release (September 2001) VMRF/193/01

August 2001

Question from industry : Change of the name of the Marketing Authorisation Holder VMRF/171/01

July 2001

Report of the VMRFG for Release (July 2001) VMRF/174/01

June 2001

Meeting of the Heads of European Veterinary Regulatory Authorities, 8 June 2001

Report of the VMRFG for Release (June 2001) VMRF/143/01
Meeting of the Heads of European Veterinary Regulatory Authorities, 8 June 2001 HEVRA/06/08
Reasons for withdrawal in 2000 VMRF/117/01
Report of the VMRFG for Release (May 2001) VMRF/120/01

May 2001

Minutes of the Workshop on "Future of Telematics in Pharmaceuticals" (zipped files) ITWorkShop/01
Report of the VMRFG for Release (April 2001) VMRF/105/01

April 2001

Press release of the last Meeting of the Heads of European Veterinary Regulatory Authorities, 20 March 2001 HEVRA/03/01
Report of the VRMFG for Release (March 2001) VMRF/071/01

March 2001

Report of the VMRFG for Release (February 2001) VMRF/054/01

February 2001

Meetings during the Swedish presidency HEVRA/01/01
Report of the VMRFG for Release (January 2001) VMRF/024/01

January 2001

Report of the VMRFG for Release (December 2000) VMRF/282/00
Report of the VMRFG for Release (November 2000) VMRF/257/00
Report of the VMRFG for Release (October 2000) VMRF/240/00

December 2000

Procedure for collection of data and handling replies to VMRFG/FEDESA MRP Questionnaire VMRF/273/00
Revised VMRFG/FEDESA Questionnaire VMRF/138/00

November 2000

Conclusions of the last FEDESA/HEVRA InfoDay (5 October 2000) HEVRA/07/00

October 2000

FEDESA-VMRFG Survey 1999 (HTML Format)

Press release of the last HEVRA's meeting HEVRA/06/00
Report of the VMRFG for Release (11 September 2000) VMRF/218/00

September 2000

Question from industry : National or Mutual Recognition Procedure VMRF/226/00
Report of the VMRFG for Release (17 July 2000) VMRF/198/00
Best Practice Guide VMRF/148/99

August 2000

Report of the VMRFG for Release (19 June 2000) VMRF/184/00

July 2000

OIE-World Wide Public Consultation on Antimicrobial Resistance (21 June-21 September 2000)

June 2000

Question from industry : Change of name during a procedure VMRF/191/00
Report of the VMRFG for Release (15 May 2000) VMRF/114/00

May 2000

CADREAC MEMBERS Participation as observers at VMRF meetings HEVRA/05/00
Report of the VMRFG for Release (17 April 2000) VMRF/094/00

April 2000

Veterinary Mutual Recognition Index

Press release of the last meeting of HEVRA (10 april 2000) HEVRA/02/00
Report of the VMRFG for Release (6 March 2000) VMRF/083/00
Start Dates for Mutual Recognition Procedures for 2000 VMRF/036/99

March 2000

Report of the VMRFG for Release (7 February 2000) VMRF/041/00
VMRFG Meeting dates for 2001 VMRF/228/99

February 2000

Report of the VMRFG for Release (10 January 2000) VMRF/021/00

January 2000

EU Import Structure for Switzerland to Import Veterinary Medicinal Products VMRF/110/99
Report of the VMRFG for Release (6 December 1999) VMRF/227/99
Report of the VMRFG for Release (8 November 1999) VMRF/210/99

December 1999

Line extensions : Requirements for the content of the dossier - Quality part VRMF/129/99

November 1999

Report of the VMRFG for Release (11 October 1999) VMRF/198/99

October 1999

Report of the VMRFG for Release (13 September 1999) VMRF/180/99

September 1999

Report of the VMRFG for Release (12 July 1999) VMRF/160/99

August 1999

Addition of the Answers page which contains the responses of the VMRFG to the question asked by the way of the Question page.

Report of the VMRFG for Release (14 June 1999) VMRF/137/99

June 1999

Addition of the Question page to ask questions to the VMRFG.
Addition of the Web links page which offers direct links to other web sites involving in the medicinal products fields.
Update of the directory page : links to the Fees page have been added.

Proposal for Improvement of Transparency in MRP VMRF/079/99
Report of the VMRFG for Release (10 May 1999) VMRF/113/99

May 1999

Report of the VMRFG for Release (12 April 1999) VMRF/092/99

April 1999

Publication of the HEVRA's web site with the following URL : http://www.hevra.org

Report of the VMRFG for Release (15 March 1999) VMRF/076/99

March 1999

Report of the VMRFG for Release (15 February 1999) VMRF/057/99

February 1999

Direct links to European Institution and Member State's web sites
VMRFG Works
Creation of the HEVRA's web site. Please send your comments to the webmaster

Ectoparasiticidal for Use in "Animals for Consumption" and "Pet Animals" respectively VMRF/107/98
Colostrum and colostrum substitutes VMRF/086/98
Authorisation of Ectoparasiticidal Collars for Companion Animals VMRF/068/98
Classification of teat dips as medicines VMRF/072/97
Report of the VMRFG for Release (11 January 1999) VMRF/014/99
Decisions Report for Release (7-8 December 1998) VMRF/168/98
Decisions Report for Release (9 November 1998) VMRF/149/98
Decisions Report for Release (12-13 October 1998) VMRF/136/98
Decisions Report for Release (7-8 September 1998) VMRF/119/98
Decisions Report for Release (6-7 July 1998) VMRF/114/98