1 1 Topics “out of the scope of VICH” Brigitte Boenisch IFAH-Europe 2 nd VICH Outreach Forum Meeting Washington, 19 th /20 th February 2012 – how and by which organisation should they be addressed?

2 2 VICH Needs assessment survey Thank you very much for your reply  excellent overview of your needs for translation, discussion and training At same time demonstrated necessity to better explain :  What type of subjects can you expect to be treated by VICH?  Which topics need to be looked after by other organisations/bodies?

3 3 What VICH can do VICH develops harmonised technical data requirements to support the marketing authorisations for veterinary medicinal products  VICH Guidelines Guidelines relating to studies (study design and testing strategy) to support product registration Quality, safety, efficacy and bioequivalence Pharmacovigilance (post-marketing safety monitoring)

4 4 What VICH cannot do VICH does not normally develop guidance on how to carry out the regulatory assessment of the data or on the regulatory assessment approach Regulatory assessments are done by the regulatory authorities of the VICH countries and regions VICH does not prescribe a regulatory system/legal basis, nor the dossier contents It is the responsibility of the governments in the different countries/regions to establish a system for the authorisation and control of veterinary medicinal products

5 5 Products within the scope of VICH Veterinary medicinal products, including  pharmaceuticals,  biologicals and  medicated premixes

6 6 Products outside the scope of VICH Certain product categories submitted with the needs assessment fall outside the scope of VICH  New diagnostic techniques for the identification of parasites  Use of homeopathic products  Regulated via legal systems of countries/regions concerned

7 7 “Out of scope” topics submitted via VICH Needs assessment survey Topics can be further grouped into Legal Regulatory Enforcement (monitoring & control) Political (eventually becoming legal)

8 8 “Out of scope”: Legal topics Definitions (e.g. categorization of new active ingredients, generic products vs. new products) Use of specific substances/products i. Standardize the use of ractopamine in the different regions (restrictions for its commercialization according to WTO) ii. Discuss the use of testosterone on aquaculture because of its residues iii. Discuss the indiscriminate use of hormones for reproduction of feeding purposes in countries which allow these products iv. Discuss the situation of homeopathic products originating from countries which have had, or have in the future, radiation or radiation- like problems v. Beta agonists and their derivatives

9 9 “Out of scope”: Regulatory topics Evaluation of safety of live micro-organism used as animal feed additives Efficacy of poultry vaccine (live /killed virus or bacteria) Calculation of withdrawal period on edible tissues

10 “Out of scope”: Enforcement (monitoring & control) topics State control and monitoring of quality of VMPs How to control maximum residue levels in veterinary medicinal products Control methods of MRL (maximum residue levels) Reference material for the analysis of biological and immunological products

11 “Out of scope”: Political topics Antimicrobial resistance in food-producing animals, foods and animal feeds and correlation between AMR in animals, foods and animal feeds and AMR in human health Responsible and prudent use of veterinary antiparasitics

12 Summary “Out of scope” topics submitted via VICH Needs assessment survey: Legal Regulatory Enforcement (monitoring & control) Political (eventually becoming legal)  To be addressed via legal and regulatory systems of countries/regions concerned

13 Summary Legal systems/regulatory framework: Responsibility of local/regional governments and competent authorities Support from OIE in establishing/developing further the appropriate systems Much experience available from countries/ regions actively involved with VICH: ― legal terminology/definitions, ― regulatory processes, ― monitoring & control in the field  Contacts established during Outreach Forum useful starting point for exchange

14 THANK YOU FOR YOUR ATTENTION !