Workshop on the Veterinary Pharmacovigilance System in the EU Madrid, Spain, 2728 May 2002

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Workshop on the Veterinary Pharmacovigilance
System in the EUMadrid, Spain, 27-28 May 2002

• How does it operate EMEA perspective
• Kornelia GreinHead of Sector, Safety of
  Veterinary Medicines, EMEA

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Veterinary Pharmacovigilance Role of the EMEA

• There is legislation laying down the obligations
  of marketing authorisation holders, competent
  authorities in member states, EMEA and
  Commission
• EMEA has, together with CVMP and
  Pharmacovigilance Working Party, produced
  guidelines and Standard Operating Procedures
  which describe in detail actions to be taken (who
  has to do what, when and how)
• Interested parties (incl. industry, veterinarian,
  farmer and consumer associations) were consulted
  on European level
• Procedures do not address veterinarians or
  farmers and pet owners directly
• For details see Annex

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Veterinary Pharmacovigilance Role of the EMEA

• EMEA, CVMP and Pharmacovigilance Working Party
• Centralised Marketing Authorisations (PSURs and
  SADRs)
• Rapid alerts, NUIS for centralised and
  non-centralised MAs
• Actions for centralised and non-centralised MAs
• General pharmacovigilance issues
• Guidelines and SOPs for centralised and
  non-centralised MAs
• Input to VICH
• Preparation and training of candidate countries
  for EU accession under PERF initiative
• Development and maintenance of EudraVigilance

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Veterinary Pharmacovigilance - Situation

• Centralised Marketing Authorisations
• Reports on SADRs
• Reporting occurs not in all of the EU Member
  States
• Frequency of reporting varies between the
  countries
• Reports received are processed swiftly
  circulated to member states and CVMP immediately
  for consideration
• PSURs
• Submitted and processed diligently
• Time between submission to EMEA and assessment by
  CVMP normally 1-3 months
• PSURs fulfil in general requirements of
  guidelines
• Adverse effects reported not from all EU member
  states, and concern only some species more
  likely to contain reports on adverse effects in
  companion animals than in food producing animal
• Summary Procedure ?
• Reporting still to be improved

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Veterinary Pharmacovigilance - Situation

• Mutual recognition and national marketing
  authorisations
• PSURs EMEA not involved
• Reports on SADRs
• No obligation to inform EMEA this will change
  with establishment of EudraVigilance
• However a few EU member states submit reports
• Member States may bring up issues of concern at
  PhVWP
• Summary not possible

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Veterinary Pharmacovigilance - Situation

• Rapid Alerts
• EMEA, CVMP and PhVWP disseminate information,
  assess situation and prepare conclusions and
  recommendations according to legislation,
  guidelines
• Exchange of information with MAHs during
  procedure
• In case of restrictions / suspension widespread
  information including EMEA website
• Experience of the Rapid Alerts occurred so far
  for veterinary medicinal products Co-operation
  by the parties concerned mostly good, but there
  can be also delay and reluctance to act or
  provide information as requested
• Summary Procedure, Co-operation ?

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Veterinary Pharmacovigilance - Situation

• Recommendations for additional/changed warnings
• For centralised products
• Need evolves from SADRs /PSURs
• MAH informed early on CVMP/PhVWP considerations,
  and invited for hearing, where appropriate
• Experience so far acceptable timeframe,
  procedures in place provide for swift
  implementation of CVMP recommendations
• Conclusions made public
• Summary ?
• For mutual recognition or national products
• Concerns raised by Member States and brought to
  attention of PhVWP concerning a single product or
  group of similar products
• Experience considerations under such process
  slow
• Evolving recommendations do not have a binding
  effect and may or may not be implemented,
  therefore not leading to enhanced safety of
  product, as intended, or to harmonisation between
  products or countries
• Summary unsatisfactory procedure

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EMEA Future role

• Commission proposal for amending EU legislation
  for medicinal products foresees removal of
  renewals of marketing authorisations, compensated
  by increased frequency of PSURs
• Concerns regarding safety of products in future
• Issue of debate during consultation of proposal
  with Council and Parliament
• To ensure safety without review of marketing
  authorisations at renewal adequate
  pharmacovigilance reporting prerequisite

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EMEA Future role (cont)

• Operating procedures in place for centralised
  products efficient at present reporting requires
  improvement.
• With constantly increasing number of centrally
  authorised products and hoped increased reporting
  a technically advanced data processing system is
  required ? EudraVigilance
• Role to play for pharmacovigilance products
  authorised through mutual recognition procedure
  or nationally authorised products where
  considerations beyond one Member State are
  required
• Exchange of pharmacovigilance information between
  Member States, EMEA and Commission throughout the
  EU ? EudraVigilance
• Focal point for pharmacovigilance information
  exchange and discussion forum in EU also outside
  regulatory authorities
• Exchange of pharmacovigilance information with
  countries outside the EU, eg US FDA ?
• Continue to provide support to accession
  countries
• Role in promoting pharmacovigilance in EU?
  Certainly, but what is to be done exactly?

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EMEA Future role (cont)

• Role in promoting pharmacovigilance for
  veterinary medicinal products
• How to better involve veterinarians, pet owners
  and farmers? Role at EU level?
• Specific information material for them (papers?
  web? EudraVigilance?)
• Feedback mechanisms?
• Brief guideline or SOP for veterinarians, pet
  owners and farmers in all EU languages?
• Support to EU member states
• Training?
• What else?

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Annex

• SADRs (Suspected Adverse Drug Reactions)
• Serious reactions EU MAH to inform MS, where
  reaction occurred, within 15 days after receipt
  of report. For centrally authorised products all
  relevant information on SADRs to be sent to EMEA
  by this MS
• Serious reactions - 3rd countries Only serious
  unexpected SADRs are reported individually to
  EMEA and MS, where authorised
• Unexpected non-serious reactions - EU and 3rd
  countries are reported only in PSUR
• Other suspected adverse reactions MAH required
  to collect, evaluate collate information on all
  suspected adverse reactions and include in PSUR
• PSURs (Periodic Safety Update Reports)
• Intended to provide Competent authorities with
  update of worldwide safety experience of a
  veterinary medicinal product at defined times
  post-authorisation
• MAHs to provide summary information together with
  critical evaluation of risk/benefit of product in
  light of new or changing post-authorisation
  information
• Purpose to ascertain, whether further
  investigation necessary, and/or changes to SPC,
  labelling or product information

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Annex

• Rapid Alert System (RA System)
• System to be used when member state has concern
  about a change in the balance between risks and
  benefits of a veterinary medicinal product that
  could require major changes in the status of a
  marketing authorisation,
• such as urgent variation, suspension or
  withdrawal of the marketing authorisation,
• recall of product from market,
• changes in Summary of Product Characteristics
  (SPS),
• or need to inform veterinary health care
  professional about an identified risk without
  delay.
• NUIS (Non-Urgent Information System)
• System for the exchange of potential concerns
  that do not fulfil the Rapid Alert System
  criteria, such as pharmacovigilance data, which
  do not require immediate or urgent action and/or
  where additional information is required from
  other member state, or provision of
  pharmacovigilance data not requiring response
• VEDDRA (List of clinical terms/terminology for
  animal suspected adverse reactions to veterinary
  medicines)
• standardised terminology for the reporting of
  adverse reaction to facilitate comparison of
  reaction, signal generation and electronic
  reporting
• developed with view to MedDRA (Medical Dictionary
  for Drug Regulatory Authorities), a list of
  clinical terms for the reporting of human
  suspected adverse reactions