Overview EU legislation in the Field of Veterinary Medicinal Products TAIEX April 2011 Istanbul Jan Vaarten DVM FVE Executive Director Text

- Background and short introduction FVE - EU Legislative procedures - Legislation on veterinary medicines

FVE is a Federation of 44 veterinary organisations in 38 European countries Through its members, FVE represents over veterinarians

Members Austria Belgium Bosnia & Herzegovina Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France FYR of Macedonia Germany Greece Hungary Iceland Ireland Italy Latvia Lithuania Luxembourg Malta Montenegro Netherlands Norway Poland Portugal Romania Serbia Slovak Republic Slovenia Spain Sweden Switzerland Turkey United Kingdom Observers Albania Ukraine

FVE also includes four international groups: 1.Veterinary Practitioners (UEVP) 2.Hygienists and Public Health Veterinarians (UEVH) 3.Veterinary State Officers (EASVO) 4.Veterinarians in Education, Research and Industry (EVERI)

EU Veterinary Week / Students Rainer Schneichel Ljiljana Markus Walter Winding Stephen Ware Christophe Buhot (Germany) (Croatia) (Austria) (UK) (France)

FVE’s Mission The European veterinary profession, embodied by FVE, strives to promote animal health, animal welfare and public health across Europe Together with its members, FVE aims to support veterinarians to deliver their professional responsibilities at the best possible level, recognized and valued by the society.

FVE Activities & Priorities FVE Secretariats Network Group meeting Brussels, 17 Feb Federation of Veterinarians of Europe One Profession, One Vision, One Voice

1951: Treaty of Paris European Community for Coal and Steel France, Germany, Italy, Belgium, The Netherlands and Luxembourg

18 April the Treaty of Paris, establishing the ECSC

1951 Treaty of Paris (ECSC) 1957 Treaty of Rome (TEC, EEC & Euratom) 1986 Single European Act 1992 Treaty of Maastricht (TEU) 1997 Treaty of Amsterdam 2002 Treaty of Nice 2008 Treaty of Lisbon Legal base: Treaties

Treaty of Amsterdam signed in Amsterdam on 2 October 1997, and entering into force on 1rst May 1999

TREATY Lays down the mandate Member States have given to EU It describes: EU goals, its competences and the areas wherein it can be active, role of the institutions, procedures, etc. Everything EU does, is based on a provision in the Treaty

EU Institutions that play a role in legislation European Commission (The European Union): Inititiates Council of the European Union (Member States): Decides European Parliament (Citizens): Co-decides

Institutional triangle Commission (Union) Parliament (citizens) Council (member states)

European Parliament

Different categories of legislation - Regulation - Directive - Decision

Regulation (“EU Law”) –Uniform in all MS –General application –Binding in its entirety –Directly applicable in all MS (in gen. 20 days after publ.)

Directive (“framework law”) –binding the MSs to the results to be achieved –leaves national authorities the choice of forms and methods –certain period for transposition and implementation

Areas for Veterinary Legislation Trade Health protection and disease control Animal welfare Zootechnical Aspects Feeding stuffs Foodstuffs Veterinary Medical and Biotechnical Products Veterinary Qualifications

- Directive 2004/28/EC amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products - Directive 90/176/EC laying down the conditions governing the preparation, placing on the market and use of medicated feeding stuffs

- Regulation EC 470/2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin - Regulation EC 854/2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption

Directive 2004/28/EC: veterinary medicinal products The European Parliament and the Council of the European Union, Having regard to the Treaty.... Having regard to the proposal from the European Commission.... Acting in accordance with the procedure....

11 Titles 1.Definitions 2.Scope 3.Marketing 4.Manufacture and Imports 5.Labeling and Package insert 6.Possession, distribution and dispensing 7.Pharmacovigilance 8.Supervision and sanctions 9.Standing Committee 10.General Provisions 11.Final provisions

Marketing Art 5.: No vmp may be placed on the market of a MS unless a MA has been granted... Art 6.: A vmp for food producing animals can only have a MA when the active substances are classified by the Regulation on residue limits Art 8.: In the event of a serious epizootic event MSs may provisionally allow the use of a immunological vmp... Art 10 and 11.: MSs shall take measures to ensure that if there is no authorised vmp, the veterinarian is allowed to use other products --> Cascade

Cascade 1 ) a vmp authorised in the MS for another species or indication 2) a product authorised in the MS for human use or a vmp authorised in another MS for the same or another species or indication 3) an extemporaneously prepared vmp

Horse intended for slaughter Cascade for food prod. animals ** (only MRL category I,II,III vmps !) Vmp for other species / indication Human product Vmp from other MS Extemp product (WP: 28 days) Products on the list of products essential for the treatment of equidae (To be recorded in passport and WP: 6 months ) Horse not intended for slaughter (Must be declared in passport) Products authorised for horses not intended for slaughter (autorisation only alllowed if no other product is available) Cascade for companion animals ** Vmp for other species / indication Human product Vmp from other MS Extemp product **: by way of exception to avoid unacceptable suffering For all horses products with full authorisation for horses Treatment of horses

Distribution Art 66. MSs shall take all appropriate measures to ensure that the retail supply of vmps is conducted only by persons who are permitted to carry out such operations by the legislation of the MS concerned Exemptions possible (however not for antimicrobials) Required to keep detailed records for POM vmps Date Identity of vmp Batch number Quantity Name and address of supplier or recipient Name and address of prescribing vet

Distribution Article 67 A veterinary prescription shall be required for dispensing to the public for certain categories of vmps including vmps for food producing animals

Pharmacovigilance Art 72 MSs shall take all appropriate measures to encourage the reporting to the competent authorities of suspected adverse reactions to vmps MSs may impose specific measures on practitioners in respect of the reporting of suspected serious or unexpected adverse reactions and human adverse reactions

Regulation (EC) 470/2009 laying down community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin ( = MRL Regulation)

- Having regard to the Treaty establishing the European Community, and in particular article 37 and article 152 (4)(b) - having regard the proposal from the Commission - acting in accordance with the procedure of article 251

Article 1: subject matter and scope MRL: maximum concentration of a residue of a pharmacologically active substance which may be permitted in food of animal origin (allowed up to certain maximum) Reference point for action: residue level for control reason of a pharmacologically active substance for which no MRL is laid down (not allowed substances)

Art 2. Definitions Residues of pharmacologically active substances means all pharmacologically active substances, expressed in mg/kg or ug/kg on fresh weight basis, whether active substances, excipients or degradation products and their metabolites which remain in food obtained from animals Food producing animals means animals bred raised, kept or harvested for the purpose of producing food

Art. 8 Procedures For MRL, applicant for marketing authorization submits application to European Medicines Agency For reference point for action the European Commission or a Member State submits application to European Medicines Agency - substances authorized in third countries - substances that can be used through the cascade for food producing animals

4 Categories 1. maximum residue limit 2. provisional MRL - data not complete - no grounds for supposing that residues constitute a hazard to human health - maximum for 5 years 3. no need to establish MRL 4. no MRL any presence of a pharmacologically active substance may constitute a hazard to human healt

Amendment to Directive 2001/82 scope of list of products for the treatment of food producing horses is extended

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