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Annual Report 2020
For several years, we have emphasised the importance of collaboration in carrying out our role to ensure better outcomes for public and animal health protection., • Containment of the development of antimicrobial resistance (AMR) is essential for public and animal health., • We delivered a number of Laboratory Animal Science and Tr a i n i n g ( L A S T ) l e c t u res in relation to the legislative and regulatory aspects of scientific animal protection, SCIENTIFIC ANIMAL PROTECTION – HPRA Annual Report 2020 37 Authorisation and Registration • Import, export and holding of controlled drugs (for legitimate purposes) are subject to licensing., This reflects our role not just to protect but also to enhance public and animal health.
https://assets.hpra.ie/data/docs/default-source/corporate/annual-reports/annual-report-2020.pdf?sfvrsn=20117e18_6Guide to applications for a variation to a manufacturer's authorisation
There may be substances obtained from a biological source (e.g. extracted from a plant or animal source) which do not require a biological test to determine appropriate quality of the substance., ) - Isolation/purification - Modification (e.g. pegylation) - Other (e.g. manufacture of the low bioburden bulk intermediate) - Manufacture of the final dosage form 1.3.1.6 Human or animal extracted products Human or animal extracted products: Select this category where processing steps are carried out in relation to the manufacture of a biological product containing active substances derived from human or animal sources (cells, tissues, fluids), with the exception of blood., An example would be allergen products, which are derived from non-animal sources such as grass-pollen. 1.3.2 Batch certification (list of product types) Complete this section with regard to final QP certification of the finished dosage form of a biological product., See Appendix 4 regarding requirements for remote batch certification by the Qualified Person. 1.3.2.1 Blood products 1.3.2.2 Immunological products 1.3.2.3 Cell therapy products 1.3.2.4 Gene therapy products 1.3.2.5 Biotechnology products 1.3.2.6 Human or animal extracted products 1.3.2.7 Tissue engineered products 1.3.2.8 Other biological medicinal products 1.4 Other products or manufacturing activity Note: where a manufacturer carries out processing steps in relation to herbal or homoeopathic dosage forms (e.g. tablets) then there will be an entry for the relevant dosage form (sections 1.1 to 1.2) in addition to the entry in this section., o In circumstances where GMP documentation is stored remotely from the site for periods of time, it is considered that risks associated with this practice are assessed and documented, e.g. controls to ensure the integrity of the records, protection from loss, damage, etc.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0182-guide-to-applications-for-a-variation-to-a-manufacturer's-authorisation-v2.pdf?sfvrsn=93ab3999_16Annual Report 2021
They demonstrated an exceptional commitment to the protection of public and animal health throughout 2021 and I commend and thank them for their efforts., Beechinor Director of Veterinary Sciences Dr Caitríona Fisher Director of Quality, Scientific Affairs and Communications Retired 1 October 2021 Ms Grainne Power Director of Human Products Authorisation and Registration Ms Sinead Curran Director of Human Products Monitoring Mr John Lynch Director of Compliance Retired 8 August 2021 Ms Elizabeth Stuart Director of Human Resources and Change As I reflect on what has been another busy and productive year for the organisation, I am incredibly proud and inspired by the level of dedication shown by everyone in the HPRA to ensure the continued protection of human and animal health during unprecedented times., E x c i t i n g F u t u re of Work The pandemic demonstrated the importance of adopting an agile approach to how we work to achieve our goals of ensuring the protection of human and animal health., Moreover, i t i s c r i t i c a l w e c o n s o l i d a t e a n d s t rengthen both existing and newly established relationships to further enhance national systems to better regulate both human and animal health products., Finally, I w o u l d l i k e t o t h a n k a l l m y H P R A c o l l e a g u e s w h o , t h roughout 2021, maintained their absolute commitment to both public and animal health protection.
https://assets.hpra.ie/data/docs/default-source/corporate/annual-reports/annual-report-2021.pdf?sfvrsn=93747c18_8Annual Report 2023
Thank you for your outstanding commitment to the protection of public and animal health not just nationally but also through your significant contributions at European and international level., However, a d v e r s e e v e n t reports from veterinarians and animal owners continue to be received directly by the HPRA., • Containing the development of antimicrobial resistance (AMR) is essential for public and animal health., The HPRA is required to collect and make publicly available, on an annual basis, statistical information on the use of animals in procedures, including information on the actual severity of the procedures. 31 Scientific Animal Protection 32 Inspections and Compliance • During 2023, there were 32 inspections performed to monitor animal welfare standards and compliance with legislation., • We delivered a number of Laboratory Animal Science and Tr a i n i n g ( L A S T ) l e c t u res in relation to the legislative and regulatory aspects of scientific animal protection
https://assets.hpra.ie/data/docs/default-source/corporate/annual-reports/hpra-annual-report-2023.pdf?sfvrsn=1baa79f8_28Notification of a PS of a CE marked IVD under Article 70
FORMCHECKBOX Yes FORMCHECKBOX No b.Has the device been manufactured using non-viable tissue or cells of human or animal origin, or their derivatives?, FORMCHECKBOX Performance study plan (PSP) (which sets out the rationale, objectives, design, methodology, monitoring, conduct, record-keeping and the method of analysis for the performance study) Version number FORMTEXT Date FORMTEXT FORMCHECKBOX Investigator’s brochure (IB) OR Instructions for use FORMCHECKBOX A copy of the opinion of the relevant Ethics Committee concerned on the details of the aspects covered by its opinion (if available) FORMCHECKBOX Documents used to obtain informed consent FORMCHECKBOX Description of arrangements for data protection and confidentiality of personal information SECTION E: Declaration Signed on behalf of FORMTEXT .
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f1011-notification-of-a-ps-of-a-ce-marked-ivd-under-article-70-v1.docx?sfvrsn=3079d2d9_5Guide to applications for a variation to a manufacturer's authorisation changes tracked
There may be substances obtained from a biological source (e.g. extracted from a plant or animal source) which do not require a biological test to determine appropriate quality of the substance., ) - Isolation/purification - Modification (e.g. pegylation) - Other (e.g. manufacture of the low bioburden bulk intermediate) - Manufacture of the final dosage form 1.3.1.6 Human or animal extracted products Human or animal extracted products: Select this category where processing steps are carried out in relation to the manufacture of a biological product containing active substances derived from human or animal sources (cells, tissues, fluids), with the exception of blood., An example would be allergen products, which are derived from non-animal sources such as grass-pollen. 1.3.2 Batch certification (list of product types) Complete this section with regard to final QP certification of the finished dosage form of a biological product., See Appendix 4 regarding requirements for remote batch certification by the Qualified Person. 1.3.2.1 Blood products 1.3.2.2 Immunological products 1.3.2.3 Cell therapy products 1.3.2.4 Gene therapy products 1.3.2.5 Biotechnology products 1.3.2.6 Human or animal extracted products 1.3.2.7 Tissue engineered products 1.3.2.8 Other biological medicinal products 1.4 Other products or manufacturing activity Note: where a manufacturer carries out processing steps in relation to herbal or homoeopathic dosage forms (e.g. tablets) then there will be an entry for the relevant dosage form (sections 1.1 to 1.2) in addition to the entry in this section., o In circumstances where GMP documentation is stored remotely from the site for periods of time, it is considered that risks associated with this practice are assessed and documented, e.g. controls to ensure the integrity of the records, protection from loss, damage, etc.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0182-guide-to-applications-for-a-variation-to-a-manufacturer's-authorisation-v2-changes-tracked.pdf?sfvrsn=55c46b65_3Annual pharmacovigilance report 2021
Reports may also be received from veterinary health professionals and animal owners directly., Veterinary Surgeon/Veterinary Nurse, Pharmacist, animal owner) animal/human details: species, age, sex the name and veterinary product authorisation (VPA) number of the product in question details of the adverse event While the above outlines the minimum requirements for a valid SAE report, the reporter should endeavour to provide as comprehensive an account as possible in order to facilitate a full scientific evaluation., Figure 3: Number of SAE reports by category received from 2016 to 2021 Page 6 of 70 Page 7 of 70 2.1 Reports of adverse reactions Reports of SAEs are assessed by the relevant MAH and the HPRA for any association between the event and the product(s) administered to the animal(s), using an established causality assignment system as shown in Table 3 below., Veterinary professionals as well as persons licensed to sell or supply animal remedies are reminded of their obligation to notify the HPRA or the relevant MAH of all suspected adverse reactions., Eur.447* *≥80 % protection in hamsters Unknown 1 1 0 Pale mucous membranes, collapse NOS, ataxia, anaphylaxis ≤ 2 mins Page 41 of 70 bedinvetmab SC 1 1 1 Lethargy, crying, reluctant to move, monoparesis, localised pain, death by euthanasia ≤ 6 hr Attenuated canine distemper virus, strain BA5 10 4 CCID 50 * 10 6 CCID 50 Attenuated canine adenovirus type 2, strain DK13 10 2.5 CCID 50 - 10 6.3 CCID 50 Attenuated canine parvovirus type 2, strain CAG2 10 4.9 CCID 50 - 10 7.1 CCID 50 Attenuated canine parainfluenza virus type 2, strain CGF 2004/75 10 4.7 CCID 50 - 10 7.1 CCID 50 *CCID50: 50% cell culture infective dose) SC 1 1 1 Death by euthanasia, multiple organ haemorrhage, thrombocytopenia ≤ 30 days Bedinvetmab Live Bordetella bronchiseptica bacteria strain B-C2: ≥10 8.0 and ≤10 9.7 cfu 1 , Live canine parainfluenza virus strain Cornell ≥10 3.0 and ≤10 5.8 TCID 50 2 1 colony forming units 2 Tissue
https://assets.hpra.ie/data/docs/default-source/product-updates/annual-pharmacovigilance-report/veterinary-medicines/annual-pharmacovigilance-report-2021.pdf?sfvrsn=94619f74_1Code of Conduct
Staff who deal with personal data concerning members of the public will comply with applicable Irish and EU data protection legislation., When taking decisions, staff will: - ensure that the measures taken are proportional to the aim pursued - avoid restricting the rights of stakeholders or imposing charges on them when those restrictions or charges are not reasonable in relation to the purpose of the action pursued - strike a fair balance between the interests of individual stakeholders and the general interests of public and animal health - take into consideration the relevant factors and give each of them its proper weight in the decision, whilst excluding any irrelevant elements from consideration - respect the legitimate and reasonable expectation of stakeholders that decisions will be consistent both between different staff and at different times 4.5 Fairness Staff will act fairly and reasonably by: - complying with employment equality and equal status legislation - avoiding any unjustified discrimination between individuals based on nationality, sex, racial or ethnic origin, religion or belief, disability
https://assets.hpra.ie/data/docs/default-source/corporate/terms-of-reference/mgt-p0025-code-of-conduct-v6.pdf?sfvrsn=ba09971b_5Guide to parallel trade-veterinary medicines changes tracked
AuthorisationApproval to parallel trade a veterinary medicinal product is granted under the European Communities (Animal Remedies) (No. 2) Regulations 2007.in line with the Regulation., Under the mechanism, the holder, or beneficiary, of a patent or supplementary protection certificate for a pharmaceutical product filed in a Member State at a time when such protection could not be obtained in one of the above-mentioned new Member States for that product, may rely on the rights granted by that patent or supplementary protection certificate in order to prevent the importation and marketing of that product in the Member State or States where the product in question enjoys patent protection or supplementary protection, even if the product was put on the market in that new Member State for the first time by him or with his consent., Any person intending to import or market a pharmaceutical product covered by the above paragraph in a Member State where the product enjoys patent or supplementary protection, must give one month’s notice to the holder or beneficiary of such protection of their intention, prior to submitting the application, and confirm that they have done so in the application regarding that import., Manufacturers in Ireland are authorised under the European Communities (Animal Remedies) (No. 2) Regulations 2007., An application for an animal remedies wholesaler’s licence should be made to the HPRA Guide to Parallel ImportsTrade for Veterinary Medicines AUT-G0081-23 19/24 Department of Agriculture, Food and the Marine.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0081-guide-to-parallel-trade---veterinary-medicines-v3-changes-tracked.pdf?sfvrsn=7c04911e_3Guide for class I manufacturers on compliance with European Communities (medical devices) regulations1994 changes tracked
In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order: - eliminate or reduce risks as far as possible (inherently safe design and construction),-), - where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated, - inform users of the residual risks due to any shortcomings of the protection measures adopted., EN 11135 series EN 10993 series 8.2 Tissues of animal origin must originate from animals that have been subjected to veterinary controls and surveillance adapted to the intended use of the tissues., Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be carried out so as to provide optimal security., Where appropriate, certificates of origin from suppliers of materials of animal origin that could be associated with a substantial degree of risk of infection or adverse reaction should be requested., Protection against radiation 11.1 General 11.1.1.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/sur-g0006-guide-for-class-i-manufacturers-on-compliance-with-european-communities-(medical-devices)-regulations-1994-v3-changes-tracked.pdf?sfvrsn=4e4258f6_3