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

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

Apr 10, 2023 139 likes •367 views

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.

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Veterinary and Phytosanitary Regulation Department

Prepared by Mr. Stephen Spiteri and Dr. Andrew Agius

Revision of the EU legislation on Veterinary Medicinal Products (VMPs)

Veterinary Medicines and Nutrition Section

Veterinary Regulation Directorate (VRD)

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Introduction

2 Veterinary Medicines and Animal Nutrition Section

  • 1. From a Directive to a Regulation  What changes?!
  • Regulation will be implemented as published, without the

need for transposition

  • An all-encompassing Regulation
  • 2. Who represents you?!
  • VMANS – Maltese Presidency Team
  • Our partners and colleagues
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Veterinary Medicines and Animal Nutrition Section

Stakeholders:

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

Problem drivers

  • Multi-species market
  • Pluri-national markets
  • Language problems (on packs)
  • Complex authorisation requirements
  • Complex post-authorisation requirements
  • Lack of clarity of the legislation
  • Legislation not suited to innovation
  • One size fits all

Limited revenue to industry Against single market principle High administrative burden No innovation, no incentive for research

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Veterinary Medicines and Animal Nutrition Section

Scope of the New Regulation Proposal

  • Availability
  • Innovation
  • Improving the single market economy
  • Reducing administrative burden
  • Reducing risks of AMR
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What does it cover?!

Veterinary Medicines and Animal Nutrition Section

 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

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Veterinary Medicines and Animal Nutrition Section

What does all this mean.... for YOU?!

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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

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Veterinary Medicines and Animal Nutrition Section

The industrial process of pharmaceutical products

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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
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Veterinary Medicines and Animal Nutrition Section

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Veterinary Medicines and Animal Nutrition Section

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

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Veterinary Medicines and Animal Nutrition Section

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Veterinary Medicines and Animal Nutrition Section

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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
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Veterinary Medicines and Animal Nutrition Section

Food producing animals:

  • Metaphylaxis
  • Withdrawal periods
  • Records

Pets:

  • Prophylaxis
  • Retail

PIL:

  • Language requirements for medicines
  • Maltese PIL
  • Other Language
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Record Keeping and Retail

  • 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
  • Date of Transaction
  • Name of

VMP

  • Batch number
  • Expiry date of

VMP

  • Quantity received or supplied
  • Details of the supplier or recipient
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T

  • o much paper!?

Let’s try to streamline...any ideas?!

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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
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Veterinary Medicines and Animal Nutrition Section

Mutually beneficial to work together System based on trust and ethic Working hand in hand with all stakeholders

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Veterinary Medicines and Animal Nutrition Section