Legislation requirements for control over veterinary products in - - PowerPoint PPT Presentation

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Legislation requirements for control over veterinary products in - - PowerPoint PPT Presentation

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Legislation requirements for control over veterinary products in South America Dr. Martn Santiago Minassian Americas Commitee of Veterinary Medicines (CAMEVET) OIE Regional Representation for the Americas Avenida Paseo Coln 315, 5to. piso

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Legislation requirements for control over veterinary products in South America

  • Dr. Martín Santiago Minassian

Americas Commitee of Veterinary Medicines (CAMEVET) OIE Regional Representation for the Americas

Avenida Paseo Colón 315, 5to. piso “D” (C1063ACD)- Buenos Aires, Argentina Tel/Fax: (54-11) 4331-3919 / (54-11) 4331-4939 Email: secretaria@camevet.org rr.americas@oie.int / Web: http://www.rr-americas.oie.int

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Registration and control

Objectives

  • Quality
  • Ensure the composition, purity and identity in

the products

  • Efficacy
  • Guarantee that a product will have the desired

effect

  • Safety
  • Assure that the product is not harmful for the

animals, the users or the consumers

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South American production and market

  • Animal population*
  • Bovine

317 million

  • Avian

5842 million

  • Swine

42 million

  • Animal health products market**
  • 2260 million US dollars

(8.7 percent growth related to 2005)

Sources: *OIE World Animal Health Information Database. Data for 2008 **International Federation for Animal Health 2008 annual report

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The past situation: 25 years ago

  • Official sector
  • Insufficient regulatory frameworks and resources
  • No communication between regulatory agencies
  • Veterinary products industry
  • Different product qualities
  • Industry itself did not guarantee the quality
  • Fraudulent market procedures
  • Farmers
  • Economical losses
  • Lack of demand on quality
  • Human health
  • Lack of control and avoidance residue systems
  • International commerce
  • Loss of markets
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The challenge

External

  • International exigencies
  • Veterinary Services as part of networks
  • Food quality
  • Regional Trade Agreements
  • Common regulations and sanitary measures

Internal

  • Health
  • Animals - Humans - Environment
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Harmonisation initiatives in South and Central America

Argentina Venezuela Uruguay Brasil Paraguay Southern Common Market (MERCOSUR) Central American Customs Union Andean Community El Salvador Costa Rica Guatemala Honduras Nicaragua Bolivia Chile Colombia Ecuador Perú

(Associated Member)

OIE Member Countries

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Harmonisation initiatives… MERCOSUR (South Common Market)

  • Creation of Veterinary Products Commission in 1992
  • Production of regulations for registration and control of

Veterinary Products from 1992 to 1997 Steps for harmonisation:

  • 1. Legal equivalence – National registration !
  • 2. Mutual recognisement of registration for products

complying on harmonised technical outlines, identified under a common classification system

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29/92 Creation of the Veterinary Products Commission 3/93 Proposal for the harmonised registration and control system for veterinary products 11/93 Regulatory Framework for veterinary products 44/93 Registration formularies 40/96 Veterinary products harmonisation system 76/96 Requisites for registration of antiparasitary products 2/97 Contents of product technical outlines and classification table 3/97 Requisites for registration of antimicrobial products 4/97 Requisites for production and control of vaccines, antigens and diluents for aviculture List of Mercosur regulations

Harmonisation initiatives…

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Andean Community

  • Approval of Decision 483 in year 2000
  • Covering the aspects related to the registration,

manufacture, control, marketing and use of veterinary products Steps for harmonisation:

  • 1. Legal equivalence !
  • 2. National registration !
  • 3. Submission and evaluation by Member countries

Harmonisation initiatives…

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Central American Customs Union

  • Approval of Central American Technical Regulation on

veterinary products in 2008

  • Covering the aspects related to the registration, manufacture,

control, marketing and use of veterinary products

  • Based on CAMEVET harmonised guidelines

Steps for harmonisation:

  • 1. Legal equivalence !
  • 2. Registration on each country under two systems
  • Common Sanitary Registration
  • Simplified Sanitary Registration

Applied for products included in the Harmonised List of Products (harmonised technical outlines)

Harmonisation initiatives…

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CAMEVET

Americas Commitee of Veterinary Medicines Technical Working Group based on the OIE Regional Representation for the Americas

Composition

Official Members

Veterinary Medicines Focal Points Representatives of Registration and Control agencies

Associated Members

Representatives of Veterinary Industrial Associations

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CAMEVET - Objectives

  • Harmonize

Guidelines and procedures for the registration and control of veterinary products

  • Support

Official veterinary medicines registration and control agencies

  • Communicate - Share

Information for official and industrial sectors

  • Train

Members of the official agencies

  • Organize - Participate - Link

Meeting and Conferences - International institutions

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(1992 – 2003) 124 Technical Outlines for pharmacological and biological products (supporting Mercosur) VIII Seminar (2002) Rules for Good Manufacturing Practices Audit Guides for Good Manufacturing Practices in pharmacological and biological products IX Seminar (2003) CAMEVET template for Free Sale Certificates CAMEVET template for Exportation Certificates X Seminar (2004) Registration forms for pharmacological and biological products XII Seminar (2005) Labelling for veterinary products XIV Seminar (2008) Good Practices for the use of veterinary products XIV Seminar (2008) Efficacy testing in antiparasitary products

Harmonised Guidelines

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Common requirements for registration and control of veterinary products in South America

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Common requirements

  • Manufacture of veterinary products
  • Good Manufacture Practices

Different requisites

  • No GMP exigencies
  • CAMEVET Rules
  • WHO Guidelines
  • Local regulations
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Common requirements

  • Product registration
  • Similar registration forms
  • Different requisites on stability and efficay

testing

  • Differencies in labelling requirements
  • Control activities
  • Lack of controls
  • Official control on every batch released
  • Reliance on the controls made by the

producers and periodic quality audits

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Unfinished tasks

Consolidation of Veterinary Medicines Registration and Control areas Active participation by OIE member countries Implementation of harmonized guidelines

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XVI Seminar on Harmonization of Registration and Control of Veterinary Medicines Cartagena, Republic of Colombia September 20 - 25, 2010

Associated events:

  • Veterinary Medicines Focal Points Training
  • Plenary Meeting of the Veterinary Industry
  • Commercial Exhibition
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¡Gracias por su atención!

  • Dr. Martín Santiago Minassian

Americas Commitee of Veterinary Medicines (CAMEVET) OIE Regional Representation for the Americas

Avenida Paseo Colón 315, 5to. piso “D” (C1063ACD)- Buenos Aires, Argentina Tel/Fax: (54-11) 4331-3919 / (54-11) 4331-4939 Email: secretaria@camevet.org rr.americas@oie.int Web: http://www.rr-americas.oie.int