Need for integrated and sustainable regulatory surveillance of veterinary biologicals Gábor Kulcsár VBRN Advisory Group Meeting of HMA, Visegrád, 28 April 2011.

Introduction of the VBRN Advisory Group Importance of interaction between different regulatory branches Maintaining testing competency Meeting of HMA, Visegrád, 28 April 2011.

Introduction of Veterinary Batch Release Network (VBRN) VBRN: a specific network within the General OMCL network EU/EAA countries, MRA partners (CH) Yearly plenary sessions (annual meetings) Confidential exchange of quality and technical information on IVMPs and related methods Supervised by an elected advisory group Meeting of HMA, Visegrád, 28 April 2011.

VBRN Advisory Group Members: – 4 elected members from VBRN network (4 years) – director of EDQM – EU Commission representative – an observer from EMA Follow issues and propose solutions to the network for adoption Liasing with partners (HMA, EMA, manufacturers) Meeting of HMA, Visegrád, 28 April 2011.

Authority control of immunological veterinary medicinal products (IVMP) IVMP Licensing authorities: Marketing authorisation, variation, renewal, pharmacovigilance OMCLs: OBPR, OCABR, CAP test, Market Surveillance Study Inspectorates: GMP inspections Meeting of HMA, Visegrád, 28 April 2011.

Regulatory structure in different Member States Meeting of HMA, Visegrád, 28 April Licensing authorityInspectorateOMCL Licensing authority + Inspectorate OMCL Licensing authority + OMCL Inspectorate Licensing authority + Inspectorate + OMCL

Weak points of the system I. variety of regulatory structures in different member states leading to: – lack of communication and interaction between participants – limited access to information (registration or variation dossiers, ongoing stability data, results of inspections, test results) Meeting of HMA, Visegrád, 28 April 2011.

Weak points of the system II. difficulty of availability of OMCLs competent for testing – loss of testing competency – assessors, inspectors: loss of experience with the products and methodologies Meeting of HMA, Visegrád, 28 April 2011.

Conclusions and suggestions I. More effective communication and interaction between the different authority branches would be beneficial. Results of GMP inspection should be available to the licensing authorities and OMCLs. Licensing authorities should inform inspectors on suspected weak points at the manufacturers. Assessors and OMCL members should join the inspection team. Meeting of HMA, Visegrád, 28 April 2011.

Conclusions and suggestions II. Pharmacovigilance data should be available for the assessors. Inspectors should communicate the inspection data to licensing authorities and OMCLs. It must be checked continously if all changes in production and control covered by accepted variations. OMCLs should inform assessors and inspectors on all quality anomalies, they detected Meeting of HMA, Visegrád, 28 April 2011.

Conclusions and suggestions III. Independent testing capacity should be maintained to ensure OCABR, OBPR activity, CAP testing program Funding and support are required at the EU and Member States level Meeting of HMA, Visegrád, 298April 2011.

Thanks for your attention! Meeting of HMA, Visegrád, 28 April 2011.