Revision of the EU legislation on Veterinary Medicinal Products - PowerPoint PPT Presentation

Veterinary and Phytosanitary Regulation Department Veterinary Regulation Directorate (VRD) Veterinary Medicines and Nutrition Section Revision of the EU legislation on Veterinary Medicinal Products (VMPs) Prepared by Mr. Stephen Spiteri and Dr. Andrew Agius

Veterinary Medicines and Animal Nutrition Section Introduction 1. From a Directive to a Regulation  What changes?! o Regulation will be implemented as published, without the need for transposition o An all-encompassing Regulation 2. Who represents you?! VMANS – Maltese Presidency Team o o Our partners and colleagues 2

Veterinary Medicines and Animal Nutrition Section Stakeholders: o Veterinary pharmaceutical industry o Veterinary surgeons o National competent authorities o Wholesale dealers o Retailers of veterinary medicines o Farmers, pet owners o SMEs

Veterinary Medicines and Animal Nutrition Section Problem drivers o Multi-species market Limited revenue to industry o Pluri-national markets Against single market principle o Language problems (on packs) o Complex authorisation requirements High administrative burden o Complex post-authorisation requirements o Lack of clarity of the legislation No innovation, no o Legislation not suited to innovation incentive for research o One size fits all 4

Veterinary Medicines and Animal Nutrition Section Scope of the New Regulation Proposal o Availability o Innovation o Improving the single market economy o Reducing administrative burden o Reducing risks of AMR

Veterinary Medicines and Animal Nutrition Section What does it cover?!  Marketing Authorisations  Lifetime of the medicinals (post-marketing authorisation)  Homeopathic medicine  Manufacturing Authorisations  Wholesale dealing  Supply and use  Advertising  Inspections and Controls  Penalties and restrictions

Veterinary Medicines and Animal Nutrition Section What does all this mean.... for YOU ?!

The main points for vets... Availability of drugs on the market for veterinary use Use of antimicrobials and measures to combat AMR Prescribing protocols Record keeping information by the veterinarians Retail of VMPs

Veterinary Medicines and Animal Nutrition Section The industrial process of pharmaceutical products

Veterinary Medicines and Animal Nutrition Section 3 fields of interest for you: 1. VMP availability 2. Prescription 3. Use 3 fields of interest for us: 1. Cooperation 2. Reduced administrative burden 3. Fighting AMR and counterfeit drugs

Veterinary Medicines and Animal Nutrition Section

Veterinary Medicines and Animal Nutrition Section Use outside the terms of the MA Prolongation of Period of Protection of Technical data Market harmonisation (SPCs, Central Procedure for authorisation ect...) Derogations for Limited Markets and Exceptional Circumstances

Veterinary Medicines and Animal Nutrition Section

Veterinary Medicines and Animal Nutrition Section

Veterinary Medicines and Animal Nutrition Section Standard requirements EU wide • Antimicrobials • Drugs requiring diagnosis • Psychotropic and Narcotic drugs EU wide validity • Prescription for all POM • Very useful for travelling pets with chronic diseases Stricter regulation of drug retail • Prescription by Suitably Qualified Persons • Off label use

Veterinary Medicines and Animal Nutrition Section Food producing animals: o Metaphylaxis o Withdrawal periods o Records Pets: o Prophylaxis o Retail PIL: o Language requirements for medicines o Maltese PIL o Other Language

Record Keeping and Retail • Date of Transaction Name of VMP • • Batch number Expiry date of VMP • • Quantity received or supplied • Details of the supplier or recipient • Date of Transaction Name of VMP • • Batch number Quantity received and supplied • • Name and address of supplier • Details of prescribing veterinarian and a copy of prescription

T oo much paper!? Let’s try to streamline ...any ideas?!

Veterinary Medicines and Animal Nutrition Section VMANs: • Implementing the regulation • Informing the stakeholders • Facilitating the transition to the new rules • We are available to answer your queries You: • Inform yourself on the new regulations • Attend the information sessions • Ask when in doubt • Follow the protocol

Veterinary Medicines and Animal Nutrition Section Mutually beneficial to work together System based on trust and ethic Working hand in hand with all stakeholders

Veterinary Medicines and Animal Nutrition Section