VMRFG FAQ

Here are the answers to the questions asked to the VMRFG by the way of the Question page.

Question Reference
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
Question from industry : Obligation to make SPC’s available for Veterinary Medicinal Products VRMF/471/04
Question from industry : Change of address of MAH VMRF/219/04
Question from Industry : Residue Data in the Udder VMRF/226/03
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
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
Question from industry : Dossier Requirements – Mutagenicity Data VMRF/128/03
Question from industry : Use of Feedgrade Antibiotics in Veterinary Premixes VMRF/163/03
Question from industry : Dossier requirements -Well-established use VMRF/050/03
Question from industry : Classification of products VMRF/064/03
Question from industry : Informed Consent Applications in a CMS VMRF/187/02
Question from industry : Generic Applications-essential similarity VMRF/195/02
Question from industry : Generic Applications-Expert reports VMRF/104/02
Question from Industry : Generic Applications-Abridged VMRF/179/02
Question from Industry : Harmonisation of SPC’s VMRF/201/02
Question from Industry : Menbutone VMRF/180/02
Question from Industry : Classification of Veterinary Tissue Adhesives VMRF/211/02
Question from Industry : Packaging-Blisters VMRF/151/02
Question from industry : DMF in CTD format VMRF/007/03
Question from industrie : Compliance with TSE guidelines VMRF/073/02
Question from industry : Repeat use of Mutual Recognition Procedure VMRF/257/01
Question from industry: SUBMISSION OF TRANSLATIONS VMRF/209/01
Question from industry : Question regarding tradename VMRF/176/01
Question from industry (FEDESA) – Compliance with TSE guidelines VMRF/112/01
Three questions relating to TSE VMRF/100/01
Question from industry : interpretation of note for guidance for TSE (EMEA/410/01) VMRF/111/01
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
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
Question from industry : Informed consent for the same company VMRF/123/00
Question from industry : National or Mutual Recognition Procedure VMRF/226/00
Question from industry : Registration of generic medicinal products for two target species VMRF/145/00
Question from industry : Change of name during a procedure VMRF/191/00
RECOMMENDATION TO PHARMACEUTICAL COMPANIES on the number of dossiers to be sent to the EMEA for the VMRP VMRF/037/00
Question from industry : Requirements for marketing authorisation of pure substances VMRF/121/99