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Classification of methods of supply for veterinary vaccines_2007
Veterinary vaccines are but one of the available measures for animal owners for disease prevention; on farms other tools include the farmer’s animal purchase policy, husbandry methods and other factors., The WG recommended that for all vaccines designated LM and permitted for sale without prescription, the following advice be added to the product labelling or package leaflet: (i) the disease condition for which the vaccine induces protection; (ii) the requirement that consideration be given to herd history and (iii) the desirability of seeking veterinary advice before use., Vaccines falling into this category should have a package leaflet specifying (a) what the vaccine induces protection against, (b) the necessity for consideration of herd history and (c) the desirability of seeking advice from a veterinary practitioner when first purchased by the end-user., ‘Companion Animal Medicine (CAM)’ – refers to a companion animal medicine which may be sold or supplied only – (i) from a pharmacy, (ii) byaregistered veterinary practitioner (iii) fromapremisestowhichananimalremediesmerchant’slicence relates, or (iv) fromapremises to which a companion animal medicine seller's registration relates., In deciding the route of sale or supply for an animal remedy, the Board has due regard to the need to protect public health, animal health, animal welfare and the environment and accordingly has due regard to – (a) theneedfor prior professional diagnosis, (b) theneed for particular skill or training in the administration of the animal remedy in order to avoid unnecessary risk to the target animal or the person administering the product to the animal, and (c) theneed for professional or specialist training in relation to the storage, handling or disposal of the animal remedy. 2.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/methods-of-supply/classification-of-methods-of-supply-for-veterinary-vaccines_2007.pdf?sfvrsn=c0df9df7_2Guide to applications for renewals and amendments to breeder, supplier, user authorisations under sap legislation
Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-5 2/7 CONTENTS 1 SCOPE 3 2 INTRODUCTION 3 3 APPLICATIONS FOR AN AMENDMENT OR RENEWAL OF A BREEDER/SUPPLIER/ USER AUTHORISATION 3 3.1 Amendment 3 3.2 Renewal 4 3.3 Site master file (SMF) 4 3.4 Declaration and undertaking 4 4 MAKING AN APPLICATION 4 4.1 Timeline 4 4.2 Naming convention 5 4.3 Administrative details 5 4.2 Fees 6 APPENDIX 1 DEFINITIONS 7 Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-5 3/7 1 SCOPE This guidance is intended to assist applicants in completing a HPRA ‘Application for amendment/renewal to a breeder/supplier/user authorisation under scientific animal protection, However, only renewal applications which are due to the expiry of an existing authorisation will result in the extension of the duration of the authorisation. 3 APPLICATIONS FOR AN AMENDMENT OR RENEWAL OF A BREEDER/SUPPLIER/ USER AUTHORISATION Provide the breeder/supplier/user authorisation holder details and complete the relevant section(s) of the form. 3.1 Amendment Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-5 4/7 A change to any of the designated persons (see Appendix 1 for definitions) will require an amendment., Applications are not validated as eligible Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-5 5/7 for HPRA scientific animal protection (SAP) assessment until all necessary documentation has been provided., Appendix (where applicable) Cover letter (where applicable) The following table shows an example of how the files should be named for a hypothetical amendment/renewal application from a hypothetical establishment with the establishment authorisation number AE12345: DOCUMENT FILE NAME Breeder/supplier/user application form AE12345_Application form The SMF AE12345_SMF The compliance officer’s CV AE12345_CVCO The DV’s CV AE12345_CVDV The animal care and welfare officer’s CV AE12345_CVACWO The information officer’s CV AE12345_CVIO The training officer’s CV AE12345_TO Cover letter AE12345_Cover letter 4.3 Administrative details Due to the possible sensitive nature of information contained in breeder/supplier/user establishment applications, the HPRA provides a secure online system to enable submission of Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-5 6/7 applications and, Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-5 7/7 APPENDIX 1 DEFINITIONS Animal care and welfare officer – the person(s) indicated in Regulation 45 of the Regulations who is responsible for overseeing the welfare and care of the animals in the establishment.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0112-guide-to-applications-for-renewals-and-amendments-to-breeder-supplier-user-authorisations-pdf-v4.pdf?sfvrsn=2c2f911_13Manage my alerts
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https://www.hpra.ie/my-alerts/manage-my-alertsGuide to new, amendment and renewal applications for individuals under SAP legislation changes tracked
No. 543 of 2012 (hereafter referred to as the Regulations). 2 INTRODUCTION All individuals performing the following rolesactivities involving animals used for scientific purposes: - project management, - carrying out procedures on animals, and - performing euthanasia on animals; must submit the following forms to the HPRA, where applicable: - ‘Application for an Individual Authorisation under Scientific Animal Protection Legislation’, - ‘Application for an Amendment to an Individual Authorisation under Scientific Animal Protection Legislation’, - ‘Application for a Renewal of an Individual Authorisation under Scientific Animal Protection Legislation’, - ‘Application for Reactivation of an Individual Authorisation under Scientific Animal Protection Legislation’., CV and training record templates can be found on the HPRA website., under Guidance documents for Scientific Animal Protection., However, individual authorisations can be reactivated HPRA Guide to New, Amendment, Renewal and Reactivation Applications for Individuals under Scientific Animal Protection Legislation AUT-G0097-1011 10/14/15 upon payment of the appropriate fee., under Scientific Animal Protection LegislationLegislation’ form, duly completed and signed by the applicant and the compliance officer HPRA Guide to New, Amendment, Renewal and Reactivation Applications for Individuals under Scientific Animal Protection Legislation AUT-G0097-1011 12/14/15 - Training records and a training plan should be submitted, if the purpose of the amendment is to add neuromuscular blocking agents., Tel: +353 1 676 4971 Email: sap@hpra.ie Fees: Fees are detailed in the ‘Guide to Fees for Scientific Animal Protection’, which can be found at www.hpra.ie.on the HPRA website.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0097-guide-to-new-amendment-and-renewal-applications-for-individuals-under-sap-legislation-v11-changes-tracked.pdf?sfvrsn=353d6518_8Annual statistical report_SAP_2016
The Directive is among the world’s most advanced pieces of legislation concerning animal welfare., After generating as much information as possible using non-animal alternatives, animal studies can be necessary to fill knowledge gaps in order to safeguard human, animal and environmental health., This is the fourth report to be prepared by the HPRA since it became the competent authority for the protection of animals used for scientific purposes., Mice were the most commonly used species at 85% of the total animal use., A single use of an animal extends from the time when the first technique is applied to the animal until the completion of data collection, or when the animal is removed from the project.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/veterinary-medicines/sap-statistical-reports/annual-statistical-report_sap_2016.pdf?sfvrsn=3f2ed12c_1Guide to new, amendment, renewal and reactivation applications for individuals under SAP legislation
No. 543 of 2012 (hereafter referred to as the Regulations). 2 INTRODUCTION All individuals performing the following activities involving animals used for scientific purposes: - project management, - carrying out procedures on animals, and - performing euthanasia on animals; must submit the following forms to the HPRA, where applicable: - ‘Application for an Individual Authorisation under Scientific Animal Protection Legislation’, - ‘Application for an Amendment to an Individual Authorisation under Scientific Animal Protection Legislation’, - ‘Application for a Renewal of an Individual Authorisation under Scientific Animal Protection Legislation’, - ‘Application for Reactivation of an Individual Authorisation under Scientific Animal Protection Legislation’., CV and training record templates can be found on the HPRA website, under Guidance documents for Scientific Animal Protection., completion of a relevant approved animal training course., The appropriate form for completion is determined based on the following criteria: - If an existing individual authorisation is due to expire in less than six months, but more than 28 days, the ‘Application for a Renewal of an Individual Authorisation under Scientific HPRA Guide to New, Amendment, Renewal and Reactivation Applications for Individuals under Scientific Animal Protection Legislation AUT-G0097-11 8/13 Animal Protection Legislation’ form must be completed and submitted to the HPRA ( see section 6.1 of this guide ), Fees: Fees are detailed in the ‘Guide to Fees for Scientific Animal Protection’, which can be found on the HPRA website.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0097-guide-to-new-amendment-renewal-and-reactivation-applications-for-individuals-under-sap-legislation-v10.pdf?sfvrsn=d169db6_9Annual statistical report_SAP_2017
The Directive is among the world’s most advanced pieces of legislation concerning animal welfare., Although complete replacement of animal studies is the ultimate goal of the Directive, this is not currently possible., Where biological processes are not sufficiently understood or are very complex, non-animal research or test methods are often not available., After generating as much information as possible using non-animal alternatives, animal studies can be necessary to fill knowledge gaps in order to safeguard human, animal and environmental health., This is the fifth report to be prepared by the HPRA since it became the competent authority for the protection of animals used for scientific purposes.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/veterinary-medicines/sap-statistical-reports/annual-statistical-report_sap_2017.pdf?sfvrsn=eb0c728c_1NCPA Introduction to AWB - Leaflet
• Animal husbandry, c a re and health, and welfare assessment, • Ensuring best practices to protect and enhance animal welfare, Contacting your AW B Yo u c a n c o n t a c t t h e A n i m a l Welfare Body for this establishment at Introduction to Animal We l f a re Bodies By the National Committee for the Protection of Animals Used for Scientific Purposes D3-2 An Coiste Náisiúnta um Chaomhnú Ainmhithe a Úsáidtear ar Mhaithe le hEolaíocht National Committee for the Protection of Animals Used for Scientifc Purposes • Communication: Encourage open communication and provide opportunities for all stakeholders to contribute to AWB meetings, Recommended reading and further guidance Here are some resources for AWB members: • ‘Caring for Animals aiming for better science - Animal Welfare Bodies and National Committees’ issued by European Commission • Guiding principles on good practice for Animal Welfare and Ethical Review Bodies • EFPIA/RSPCA webinar on Animal Welfare Body – A catalyst for progress • EFPIA Framework document – Assessing and benchmarking ‘Culture of Care’ • NC3Rs Culture of Care resource library • NC3Rs webinar and video – Culture of Care: Creating the right environment for animal care National Committee for the Protection of Animals Used for Scientific Purposes This Committee, appointed by the Minister for Health, serves as a statutory body., • Establishment support: Ensure facilities and systems are in place for optimal animal welfare, and AWB members should be familiar with animal units’ functioning
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/1-ncpa-cnca---online-leaflet-2024.pdf?sfvrsn=edc475a9_3Application for an amendment or renewal to a project authorisation under SAP legislation
Application for an Amendment and/or Renewal to a Project Authorisation under Scientific Animal Protection Legislation For details on completing this application form, please see the ‘Guide to Amendment and Renewal Applications for Projects under Scientific Animal Protection Legislation’., Please see the ‘Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation’ for details., SECTION H: Increase in TOTAL ANIMAL NUMBERS (if applicable) If the amendment involves an increase in animal numbers, please complete the fields below., I1: REplacement If new procedures or animal models have been added, justify why live animals are required instead of using alternative (non-animal) methods., Further information in relation to fees can be found on the HPRA website under ‘Regulation’ and ‘Scientific animal protection’.
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0377-application-for-an-amendment-or-renewal-to-a-project-authorisation-under-sap-legislation-v11.docx?sfvrsn=54c66c75_10Annual statistical report_SAP_2022
15 DECEMBER 2023 Annual statistical report for animals used in Ireland under scientific animal protection legislation - 2022 Annual Statistical Report 2022 2/20 CONTENTS 1 INTRODUCTION 3 2SUMMARY 5 3 DATA ON THE USES OF ANIMALS FOR RESEARCH AND TESTING PURPOSES 5 3.1Speciesand numbers of uses of animals for research and testing purposes 5 3.2Reuse of animals 6 3.3Origin of animals at the first use 7 3.4Projectpurposes 8 3.5Useof animals to meet legislative requirements 11 3.6 Use by genetic status for research and testing purposes 12 3.7Actualseverityof uses of animals for research and testing purposes 12 4DATAONTHE USES OF ANIMALS FOR THE CREATION AND MAINTENANCE OF GENETICALLY ALTERED ANIMAL LINES 13 5TRENDS 16 6 CONCLUSION 19 7 APPENDIX: DEFINITIONS 19 3/20 1 INTRODUCTION The Health Products Regulatory Authority (HPRA) is the State agency with responsibility for the protection of animals used for scientific purposes, the regulation of human and veterinary, The Directive is among the world’s most advanced pieces of animal welfare legislation., Although complete replacement of animal studies is the ultimate goal of the Directive, for the moment the use of live animals continues to be necessary to protect human and animal health and the environment., After generating as much information as possible using non-animal alternatives, animal studies can sometimes be necessary to fill knowledge gaps., This is the tenth report to be prepared by the HPRA since it became the competent authority for the protection of animals used for scientific purposes.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/veterinary-medicines/sap-statistical-reports/annual-statistical-report_sap_2022.pdf?sfvrsn=13179b12_1