Source: http://apvma.gov.au/node/151
Timestamp: 2017-02-20 18:20:57
Document Index: 23689749

Matched Legal Cases: ['art 1', 'art 2', 'art 2', 'art 3', 'art 1', 'art 2', 'art 2', 'art 3']

HomeRegistrations and permitsRegistrations and permitsChemical product registrationChemical product registrationApplying for approvals, registrations and variationsApplying for a label approvalWhich products/chemicals require registrationWhich products/chemicals require registrationDoes my veterinary product need to be registered?Does my veterinary product need to be registered?User guide: what is or isn't a veterinary product?User guide: what is or isn't a veterinary product?Animal cosmetic productsAnimal cosmetic productsExcluded animal cosmetic products—acceptable cosmetic messagesAnimal feed productsAnimal feed productsAcceptable nutritional messagesFeed supplements—acceptable nutritional messagesOther requirements for whole unprocessed animal tissueDevices, equipment and physical barrier productsOther products that don't require registrationRegistration self-assessment tool (veterinary)Does my agricultural product need to be registered?Changes to stockfeed and petfood regulationEND product FAQsNovel productsArrangements for products of low regulatory concernArrangements for products of low regulatory concernRegistration modelsRegistration modelsOral electrolyte products for the treatment of horses in exerciseReserved chemical productsListed chemical productExemptionsSubstances not permitted for use on food-producing animals in AustraliaBefore you applyBefore you applyAbout the approval and registration processWho can applyRestricted chemical productsConditions of approval or registration and label approvalPre-application assistanceMinor variationsTechnical assessmentThe risk analysis processTimeframe and feesInterchangeable Constituent Determination - Item 29What to include in your applicationWhat to include in your applicationData guidelinesEvidence of Good Manufacturing Practice (GMP) for veterinary chemical productsEvidence of Good Manufacturing Practice (GMP) for veterinary chemical productsProviding evidence of good manufacturing practice (GMP)Guidance for preparing information listsDossiersRequired informationStatutory criteriaStatutory criteriaActive constituentChemical productChemical productSafety criteriaEfficacy criteriaTrade criteriaLabelling criteriaSatisfying the statutory criteriaAg Labelling CodeVet Labelling CodeApply nowAfter you applyAfter you applyWhat happens nextPreliminary assessmentRequiring samples or further informationRequiring samples or further informationRequiring additional informationRequiring samples to be given for analysisExtended assessment period and maximum response periodRecategorising an application item or module levelRenew a registrationRenew a registrationAbout the application processTimeframe and feesApply nowTechnical policyTechnical policyNo-observed-effect level (NOEL) and no-observed-adverse effect level (NOAEL): use in animal health risk assessmentsAfter registrationAfter registrationChanges to products and activesChanges to products and activesReporting relevant informationAnnual return of activesAnnual return of activesAnnual reporting of actives–frequently asked questionsLevies charged on registered product salesLevies charged on registered product salesDeclaration of leviable valuesNotice of levy assessmentPrimary and secondary applicationsData guidelinesData guidelinesListing of data guidelinesLabelling codesLabelling codesGlobally harmonized system of classification and labellingListing of labelling codesPermitsPermitsBefore you applyBefore you applyAbout the application processTypes of permitsTypes of permitsAgricultural permitsExport, research and miscellaneous permitsMinor use and emergency permitsMinor use and emergency permitsGuide for determining emergency uses or research purposesGuide for determining minor usesPre-application assistanceWho can applyWho can applyFit and proper person testTechnical assessmentTimeframe and feesAbility to comply with conditionsWhat to include in your applicationWhat to include in your applicationData guidelinesDossiersRequired informationStatutory criteriaStatutory criteriaActive constituentChemical productChemical productSafety criteriaEfficacy criteriaTrade criteriaSatisfying the statutory criteriaLabelling requirementsAfter you applyAfter you applyWhat happens nextPreliminary assessmentRequiring samples or further informationRequiring samples or further informationExtended assessment period and maximum response periodRecategorising an application item or module levelApply nowExtend the duration of a permitSearch for a permitManufacturingManufacturingManufacturing licencesManufacturing licencesManufacturers’ Licensing SchemeApplying for a manufacturing licenceWho can applyManufacturing licence feesLicence conditionsAfter you applyVariation of a manufacturing licenceAudits to obtain and vary a licenceApply nowResponsibilities of manufacturersExporting veterinary chemical productsManufacturing overseasManufacturing overseasGMP in overseas premisesRecognition of overseas GMP authoritiesOverseas GMP documentationAcceptable evidence of GMP complianceAPVMA audits of overseas manufacturersContract manufactureContract manufactureRelease for supplyPerforming release for supplyResponsibilities in contract manufactureGood Manufacturing Practice (GMP)Good Manufacturing Practice (GMP)The legislative basis for the APVMA’s role in manufacturing quality and licensingManufacturing PrinciplesVeterinary manufacturing permitAuditsAuditsArranging and undergoing an auditAudit ratings and scoresAudits of Australian veterinary chemical product manufacturing sitesAudits of overseas manufacturing sites by APVMA-authorised auditorsAudit closureThe GMP audit cycleRisk-based scheduling of GMP auditsLicensed manufacturersImport and exportImport and exportImporting agricultural chemicals or veterinary medicinesImporting agricultural chemicals or veterinary medicinesResponsibilities of importersExport certificatesExport certificatesBefore you applyBefore you applyAbout the application processTimeframe and feesWho can applyCommon types of certificatesWhat to include in your applicationWhat to include in your applicationInformation to be provided with a request for a section 70 certificateInformation to be provided with applications for certificates of exportApply nowHolders and nominated agentsHolders and nominated agentsChange a holder or nominated agentChange a holder or nominated agentAbout the application processTimeframe and feesDefinition of roles and actions for holders, nominated and authorised agents and authorising partiesMaking changes to veterinary products and actives—clarification for industryGetting assistance from the APVMAGetting assistance from the APVMAGeneral assistancePre-application assistancePre-application assistanceApplying for pre-application assistanceGetting the most out of pre-application assistancePre-application assistance— timeframes and feesHow to withdraw a request for pre-application assistanceHow to apply for pre-application assistanceTechnical assessmentOther Australian Government requirementsOther Australian Government requirementsDrinking water guidelines—pesticidesLimits on use and disclosure of informationLimits on use and disclosure of informationInformation and the use of informationLimitation periodsApplication informationInformation listsAuthorising partyTrade-related aspects of intellectual property rightsExceptionsSeek review of a decisionSeek review of a decisionReviewing decisionsApproval or variation of an active constituent or registrationPermitsRenewal of registrationCertificates for exporting agricultural and veterinary chemical productChange the holder or nominated agentManufacturing licencesApplications and decisionsApplications and decisionsApplication summariesApplication summariesApplication summariesTransitional arrangementsTransitional arrangementsApplicationsChemical reviews commenced before 1 July 2014Chemicals and ProductsChemicals and ProductsSearch registered chemical products and permitsSearch registered chemical products and permitsSearch PubCRISUsing PubCRISReport a problem with a chemicalReport a problem with a chemicalAdverse Experience Reporting ProgramAdverse Experience Reporting ProgramThe importance of the programScope of the programWho can report an adverse experience?Adverse Experience Reporting Program for veterinary medicinesAdverse Experience Reporting Program for agricultural chemicalsWhat happens nextHow do I report an adverse experience?Using chemicalsUsing chemicalsInformation for farmersInformation for farmersChemicals and farmingUseful links for farmersInformation for veterinariansChoosing a chemicalUnderstanding pesticide chemical labelsConcerns about chemicalsUsing chemicals correctlyUsing chemicals correctlyWorkplace health and safetyProtective clothingSpraying chemicalsUsing veterinary medicinesUsing pool chemicalsChemicals in the newsChemicals in the newsInformation about glyphosate useCurrent review of 2,4-D and IARC’s assessmentHendra virus vaccineHendra virus vaccineProduct registrationSafety, health and side effectsAdverse reactions and how to report themSummary of adverse experience reports made to the APVMA about Hendra virus vaccineRelated linksParkinson's disease and agricultural chemical regulationPyrethrin and pyrethroid use on catsPyrethrin and pyrethroid use on catsAPVMA's roleToxicityGuidance for cat ownersSpray driftPesticides and veterinary residuesChemical reviewChemical reviewListing of chemical reviewsChemicals nominated and prioritised for reconsiderationChemicals nominated and prioritised for reconsiderationSystem to prioritise nominated chemicals for reviewChemical review processChemical review processLegislative basisRegulatory scienceHistory of the chemical review programThe reconsideration processTimeframes for chemical reviewsSupplying chemicals and chemical products in AustraliaSupplying chemicals and chemical products in AustraliaSupply and sale of hormonal growth promotantsHydroponic Product Sellers and agvet chemicalsActive constituentsActive constituentsAPVMA standards for Active ConstituentsActive constituents not requiring evaluationGeneral list of impurities and classes of impurities of toxicological concernProcess for developing a standard for active constituentsApproval of active constituentsTrade-related aspects of intellectual property rights protectionHormonal growth promotantsCompliance and EnforcementCompliance and EnforcementReport suspected non-complianceRecallsCompliance monitoringCompliance monitoringThe ongoing responsibilities of holdersThe ongoing responsibilities of holdersConditions set by the APVMAMaintaining particularsProduct stewardshipCertificates issued under section 70 of the Administration ActEvidential certificatesAdministering holder and nominated agent detailsMonitoring and audit activitiesMonitoring and audit activitiesApproved analystsApproved analystsCriteria for Appointment as Approved AnalystAudits and inspections frequently asked questionsCurrent compliance campaignsGood Manufacturing Practice (GMP)Good Manufacturing Practice (GMP)Arranging and undergoing an auditAuditing of Australian veterinary chemical product manufacturing sitesAudits of overseas manufacturing sites by APVMA-authorised auditorsSwimming Pool Sanitation and the Agricultural and Veterinary Chemicals Code 1994Advertising agricultural and veterinary chemical productsCompliance and Enforcement PolicyCompliance and Enforcement PolicyDisclosure of informationCompliance and Enforcement FrameworkCompliance and Enforcement FrameworkOur compliance and enforcement principlesOur compliance and enforcement authority and powersAPVMA Compliance—our risk-based approachResponsive compliance and enforcementOur powers to manage risk and enforce complianceNoncompliance and recallsPowers to manage risk or enforce complianceEnforcement actionsCivil and criminal actionsAPVMA administration and oversight of compliance and enforcementCompliance and Enforcement guidelinesCompliance and Enforcement guidelinesExemptions from certain offence provisions of the Agvet CodeCancellation or suspension of a permit for noncompliance or prior convictionsCancellation or suspension of a registration or permit to prevent imminent riskConsent to import chemical productsEnforceable directionsEnforceable undertakingsFormal warningsInfringement noticesNotices to attend, give information or produce documents or thingsStop supply or recall noticesSubstantiation noticesSection 99 noticesOur scienceOur scienceOffice of the Chief ScientistAPVMA standard on good regulatory scienceScience FellowsRegulatory Science NetworkThe application of science to regulatory risk assessmentThe application of science to regulatory risk assessmentNanotechnology regulationThe risk analysis frameworkAboutAboutAPVMA basicsAPVMA basicsWhat we regulateWhat we don't regulateWhat we don't regulateProducts we don’t regulateProduct advice and competitionUse of chemicalsWorkplace health and safetyLab testing and product trialsManagement of use of pesticides and veterinary medicinesHow we regulateOur structureOur structureChief Executive OfficerOur boards and committeesOur boards and committeesAdvisory BoardAudit CommitteeRegistration Liaison CommitteeAPVMA cost recovery arrangementsAPVMA cost recovery arrangementsCost recovery questions and answersAcronyms and glossaryAcronyms and glossaryDefinition of termsAbbreviations and acronymsOther informationOther informationCorporate governanceOur functions and powersThe role of the APVMAThe role of the APVMAThe APVMA's regulatory activitiesThe APVMA's regulatory activitiesAccess to safe and effective agricultural and veterinary chemicalsOngoing compliance to ensure safety and efficacyThe Record and RegisterA trusted regulatorA trusted regulatorOrganization of economic cooperation and developmentVICHJoint FAO/WHO Meeting on Pesticide ResiduesJoint FAO/WHO Expert Committee on Food AdditivesHarmonisationCollaborative and overseas assessmentsCollaborative and overseas assessmentsUse of international data, assessments, standards and decisions—guide for applicantsThe Rotterdam and Stockholm conventionsCommunication, decision making and informationCommunication, decision making and informationCommunication between applicants and the APVMACommunication between applicants and the APVMAWhen we will notify applicantsConsultation and collaborationConsultation and collaborationPublic consultationsTransparencyData handling by the APVMAData handling by the APVMAApproach to managing confidential commercial information (CCI)Applications without written consent for reference productsExternal adviceVision, mission and purposeChemical regulation basicsChemical regulation basicsOverview of agvet chemical regulationThe chemical and permit databasesProduct regulation according to riskLegislative frameworkRisk managementService charterHow we make decisionsHow we make decisionsBackground to the reforms and the section 6A guidelinesOverarching principles and processes for the effective and efficient regulation of agricultural and veterinary chemical productsApprovals and registrationsPreliminary assessmentPermitsLicencesRecategorising applicationsAltering applicationsSection 159 in the context of applications under the Agvet codeLimits on use of informationReconsidering approvals and registrationsVarying relevant particulars and conditionsModule DescriptorsFormulation typesAccess to information held by the APVMAAccess to information held by the APVMAAgricultural and Veterinary Chemicals Code requestsFreedom of InformationFreedom of InformationFreedom of information disclosure logAccess, accountability and reportingAccess, accountability and reportingQuarterly report: October–December 2016Quarterly report: October–December 2016Analysis by type of applicationMajor and non-technical product applicationsApplication by item numberAverage decision timeOther regulatory functions2016–17 year to date performance overviewGlossary of termsQuarterly report: July–September 2016Quarterly report: July–September 2016Part 1: Overview July–September 2016Part 2: Applications for products, actives and permitsPart 2: Applications for products, actives and permitsPerformance statistics July–September 2016: Applications commencedPerformance statistics July–September 2016: Applications finalisedPerformance statistics July–September 2016: Average decision timePerformance statistics July–September 2016: Performance by assessment typePerformance statistics July–September 2016: Preliminary assessment applicationsPerformance statistics July–September 2016: Staffing considerationsPerformance statistics July–September 2016: Timeframe performancePerformance statistics July–September 2016: Work-in-progressPerformance statistics July–September 2016: Pre-application assistancePart 3: Other timeframe performance results July–September 2016APVMA Regulator Performance FrameworkAPVMA legal expenditureAnalysis of time to complete a product applicationAnnual Procurement PlanAuditsInformation Publication SchemeInformation Publication SchemeInformation publication scheme agency planPesticides and Veterinary Medicines Product SalesPublic Interest Disclosure ProceduresPart 1: OverviewPart 2: Applications for products, actives and permitsPart 2: Applications for products, actives and permitsApplication typesApplications commencedApplications finalisedAverage decision timeAverage decision timeInterpreting average decision timeInterpreting timeframe performancePerformance by type of product assessmentPre-application assistancePreliminary assessmentStaffing considerationsTimeframe performanceWork-in-progressAgency contracts over $100,000Indexed list of filesPart 3: Other timeframe performance resultsStatutory appointmentsPortfolio Budget StatementsCareersCareersConditions of EmploymentEquity and DiversityProcedures for Determining Breaches of the APS Code of Conduct and for Determining SanctionSocial mediaSocial mediaAPVMA Twitter policyDisclaimerTerms of UseOnline servicesNews and publicationsNews and publicationsNewsAPVMA relocationAPVMA relocationAPVMA relocation advisory committee terms of referenceFrequently Asked Questions—RelocationRegulatory updateMedia ReleasesPublic consultationsPublic consultationsClosedPublic Release SummariesTrade Advice NoticesCrop groupsProjectsProjectsImproved access to chemicalsImproved access to chemicalsThe crop groupings projectThe crop groupings projectCrop groupings project—consolidated responses to phase I consultation—March 2016Lower regulatory approaches to registrationLower regulatory approaches to registrationApplication profiling and registration pathwaysApplication profilingOnline fast-track registration systemExpanded list of notifiable variationsStandards and monographs for low risk productsContestability of the efficacy assessmentContestability of the efficacy assessmentAgricultural scientific reviewersVeterinary scientific reviewersEventsEventsPrevious APVMA eventsPrevious APVMA eventsAPVMA Advisory Board Futures Forum 2014APVMA Advisory Board Futures Forum 2014APVMA Advisory Board Futures Forum 2014 - SummationAPVMA Nanotechnology Regulation Symposium 2014Industry Information and Education Session in Sydney on 1 June 2015Industry Information and Education Sessions in Melbourne on 17 August 2015Program and speaker information—Canberra Industry Information and Education Session 15 and 16 October 2015Industry Information and Education Session in Canberra 15 and 16 October 2015Industry Information and Education Session in Canberra 15 and 16 October 2015Transcript for Andrew Negri, Australian Institute of Marine ScienceTranscript for Chris Lee-SteereTranscript for Distinguished Professor Jim RiviereTranscript for Distinguished Professor Nancy Monteiro-RiviereTranscript for Dr Jason Lutze, APVMATranscript for Dr Phil ReevesTranscript for Dr Raj Bhula, APVMATranscript for Ms Janis Baines, FSANZTranscript for Professor Michael RobertsIndustry Information and Education Sessions in Canberra 8–9 November 2016Program and speaker information—Canberra Industry Information and Education Sessions 8–9 November 2016Industry Information and Education Sessions in Melbourne on 9 May 2016PublicationsPublicationsAPVMA GazetteAdverse Experience Reporting Program annual reportsPortfolio Multicultural Plan 2013–15Corporate documentsAnnual reportsManualsTrainingTrainingTraining workshops and eventsTraining workshops and eventsPermits eLearning module (text only)Registrations eLearning module (text only)eLearning modulesOnline services updateFormsContact us This content is current only at the time of printing. This document was printed on 21 February 2017. A current copy is located at http://apvma.gov.au/node/151 Print this page
You are hereHomeCompliance and EnforcementCompliance monitoringMonitoring and audit activitiesGood Manufacturing Practice (GMP)Arranging and undergoing an audit Arranging and undergoing an audit
This page contains information about arranging and participating in an audit for GMP compliance. General information about audits by APVMA-authorised auditors is in GMP audit procedure.
At the conclusion of the audit of an Australian manufacturing site, the auditor provides an audit report to the manufacturing facility. Audit reports for overseas sites are provided either to the manufacturing site or the registration holder, whoever commissioned the audit.
The manufacturer should review the audit report and develop a plan to address any non-conformances identified in the audit.
The original report should be signed by the manufacturer’s representative and sent to the APVMA along with a completed Response to GMP Audit Report form within 25 working days of the audit being completed. The form also seeks feedback from the manufacturer about the conduct of the audit.
Unofficial audits by GMP consultants
Manufacturers may engage APVMA-authorised GMP auditors, or any other suitably qualified consultants, to audit their plant at any time to:
advise on and assist in meeting requirements of the GMP Code (or equivalent).
However, you cannot use the report of a consulting audit as evidence of GMP compliance for licensing purposes. Audits for licensing purposes can only be carried out by APVMA-authorised GMP auditors, and an auditor cannot perform this task if they have been engaged by the manufacturer on GMP-related consulting matters (other than for licensing or auditing purposes) in the previous two years.
If non-conformances are identified during the audit, the manufacturer should submit evidence of the corrective actions taken to address them to the auditor within the agreed timeframe. If the auditor considers it appropriate, they may also conduct a verification audit of the site. Once the auditor has assessed the corrective actions as satisfactorily addressing the nonconformances, they will advise us. We will assess this information and provide advice to the appropriate party.
Selecting and contracting an auditor
If the APVMA require you to have an audit by an APVMA-authorised auditor, select an auditor from the APVMA-authorised GMP auditors list and contact them. Obtain a quote and arrange for the audit to be conducted at a time suitable to both parties. After booking the audit:
for an Australian audit, submit a Pre-Audit Notification and Information form to the APVMA
for an overseas audit, submit a Pre-Audit Notification Form—Overseas Audits.
Audit charges vary depending on the duration of the audit, the complexity of the manufacturing premises and category of manufacture, and the travel required. The auditor, not the APVMA, determines the audit charges.URL: http://apvma.gov.au/node/151Content last updated: 4 November 2015Content last reviewed: 4 November 2015