What’s new

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
IFAH-VMRFG Questionnaire 2003 IFAH_VMRFG_Questionnaire_2003
IFAH-VRMFG Questionnaire 2004 IFAH_VMRFG_Questionnaire_2004
Question from industry : Obligation to make SPC’s available for Veterinary Medicinal Products VRMF/471/04
October 2004
VMRFG Meeting dates for 2006 VMRF/457/04
Starting dates for 2006 VMRF/458/04
Report of the VMRFG for Release (October 2004) VMRF/488/04
September 2004
Best Practice Guide for the Reference Member State VMRF/242/03
Best Practice Guide for Mutual Recognition Procedure VMRF/033/03
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

Starting Date for 2005 VMRF/188/04
VMRFG Meeting dates for 2005 VMRF/187/04
Contact points (rev. 18) VMRF/032/01
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
Repeat Use of the Mutual Recognition Procedure (Rev. 9) VMRF/053/98
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
Question from Industry : Residue Data in the Udder VMRF/226/03
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
Question from Industry : Variation Procedure for Deletion of a Route of Administration VMRF/214/03
Report of the VMRFG for Release (December 2003) VMRF/248/03

November 2003
Report of the VMRFG for release (November 2003) VMRF/229/03
Procedure for automatic validation of mutual recognition procedures (Rev. 2) VMRF/171/98
Question from industry : Dossier requirements –Mutagenicity Data (Well-Established Use) VMRF/196/03
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 : Dossier Requirements – Mutagenicity Data VMRF/128/03
Question from industry : Use of Feedgrade Antibiotics in Veterinary Premixes VMRF/163/03
September 2003
Best Practice Guide for the processing of Type Ia variations – Adopted VMRF/116/03
Best Practice Guide for the processing of Type II variations – Adopted VMRF/118/03
Best Practice Guide for the processing of Type Ib variations – Adopted VMRF/117/03
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
IFAH-Europe / VRMFG MRP Survey 2002 VMRF_IFAH_Survey_2002
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 : Dossier requirements -Well-established use VMRF/050/03
Question from industry : Classification of products VMRF/064/03
Starting Dates for 2004 VMRF/034/03
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 : Packaging-Blisters VMRF/151/02
Question from Industry : Menbutone VMRF/180/02
Question from Industry : Harmonisation of SPC’s VMRF/201/02
Question from industry : Generic Applications-essential similarity VMRF/195/02
Question from Industry : Generic Applications-Abridged VMRF/179/02
Question from Industry : Classification of Veterinary Tissue Adhesives VMRF/211/02
Question from industry : Generic Applications-Expert reports VMRF/104/02
Report of the VMRFG for Release (February 2003) VMRF/030/03
January 2003
Information about “Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)” have been updated.

Revised Starting dates for 2003 VMRF/129/02
Question from industry : DMF in CTD format VMRF/007/03
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
VMRFG/FEDESA MRP Survey 2001 VMRF_FEDESA_Survey_2001
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.

Question from industrie : Compliance with TSE guidelines VMRF/073/02
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
Question from industry : Repeat use of Mutual Recognition Procedure VMRF/257/01
Report of the VMRFG for release (January 2002) VMRF/011/02
REVISED Report of the VMRFG for release (December 2001) VMRF/012/02
FEDESA/VMRFG MRP Survey 2000 FEDESA/VMRFG/Survey/2000

December 2001
Note : “Table of decisions” is replaced by “Report for Release” in the VMRFG section

Role of vice-chairman VMRF/042/01
HEVRA Press release (22 November 2001) HEVRA/07/01
November 2001
Report of the VMRFG for release (November 2001) VMRF/248/01
October 2001
Question from industry: SUBMISSION OF TRANSLATIONS VMRF/209/01
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 : Question regarding tradename VMRF/176/01
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
Best Practice Guide for handling Renewals in the Mutual Recognition Procedure VMRF/055/01
Reasons for withdrawal in 2000 VMRF/117/01
Question from industry (FEDESA) – Compliance with TSE guidelines VMRF/112/01
Question from industry : interpretation of note for guidance for TSE (EMEA/410/01) VMRF/111/01
Three questions relating to TSE VMRF/100/01
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
Question from industry : in vitro screening assay for the detection of allergen-specific lgE antibodies in serum or plasma of pruritic canine patients VMRF/099/01
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
Question from industry : National transfer of a marketing authorisation VMRF/022/01
Question from industry : Application for an extension to an existing MAH and its informed consent authorisation VMRF/013/01
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
Question from industry : Informed consent for the same company VMRF/123/00
October 2000
FEDESA-VMRFG Survey 1999 (HTML Format)

Press release of the last HEVRA’s meeting HEVRA/06/00
FEDESA-VMRFG Survey 1999 (PDF Format) FEDESA-VMRFG_Survey_1999
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
Question from industry : Registration of generic medicinal products for two target species VMRF/145/00
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
RECOMMENDATION TO PHARMACEUTICAL COMPANIES on the number of dossiers to be sent to the EMEA for the VMRP VMRF/037/00
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
Question from industry : Requirements for marketing authorisation of pure substances VMRF/121/99
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
First FEDESA-VMRFG Questionnaire VMRF/135/99
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