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Guide to applications for a new 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., 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-g0140-guide-to-applications-for-a-new-manufacturer's-authorisation-v11.pdf?sfvrsn=6dca09cc_12Guide to applications for a new 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., 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-g0140-guide-to-applications-for-a-new-manufacturer's-authorisation-v11-changes-tracked.pdf?sfvrsn=ad5e3a0d_3Guide to Parallel Imports - Veterinary Medicines changes tracked
Authorisation is granted under the European Communities (Animal Remedies) (No. 2) Regulations 2007., 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 Department of Agriculture, Food and the Marine.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0081-guide-to-parallel-imports---veterinary-medicines-v2_changes-tracked.pdf?sfvrsn=24846d18_2Guide to biosimilars for healthcare professionals
Examples of biological medicines include: - recombinant proteins such as insulin, epoetin (erythropoeitin) and follicle stimulating hormone (FSH); - enzymes, such as imiglucerase and agalsidase, which are used in enzyme replacement therapy; - monoclonal antibodies, which are highly targeted engineered antibodies used to treat a wide variety of conditions such as cancer and arthritis; - blood-derived products such as clotting factors; - vaccines; - animal-derived products such as heparin., Pre-clinical testing can include both cell-based and in limited cases in vivo animal testing and provides assurance that any minor difference seen in physiochemical comparability will not have any impact on the desired functionality of the molecule., For biosimilars, pre-clinical in vivo animal testing is generally not necessary and the amount and type of any in vivo testing required is evaluated on a case-by-case basis., For example, in the case of pharmacokinetic and pharmacodynamic studies, animal data would be superseded by human data., If the reference medicine is benefiting from patent protection for some indications, these cannot appear in the medicine information of the biosimilar.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut_g0141-guide-to-biosimilars-for-healthcare-professionals-v4.pdf?sfvrsn=688c384d_10Annual Report 2022
I would like to take this opportunity to commend HPRA colleagues for the apparent seamless nature in which they have worked to address the challenges presented by the pandemic, while also ensuring that the vital work undertaken by the organisation in the protection of public and animal health continued., Dr Nolan’s a p p o i n t m e n t i s a reflection not only of her exemplary contribution to the protection of human and animal health and safety in Ireland but also of the emphasis the organisation places on co-operation and collaboration across the wider regulatory network., Finally, a s I e n d m y reflections on 2022 and attention turns to the upcoming year, I w o u l d l i k e t o t h a n k t h e C h i e f E x e c u t i v e , m a n a g e m e n t a n d a l l t h e s t a ff of the HPRA for their continued and steadfast commitment to the protection of public and animal health in Ireland., Scientific Animal Protection 33 350 300 250 200 150 100 50 0 Authorisations 2 7 6 1 1 9 2019 1 9 0 1 1 0 2020 2 2 0 9 5 2021 2 2 1 9 1 2022 3 0 8 1 4 3 2018 Individuals – New Projects – New 34 Inspections and Compliance • During 2022 there were 23 inspections completed to monitor animal welfare standards and compliance with legislation. 48% of these were performed as unannounced inspections, with 52% performed on an announced basis, • 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/annual-report-2022.pdf?sfvrsn=a7a07b18_14Guide to ethics committees assessment of project applications under scientific animal protection legislation changes tracked
Guide to ethics committees assessment of project applications under scientific animal protection legislation changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/guide-to-ethics-committees-assessment-of-project-applications-under-scientific-animal-protection-legislation-v3_ct.doc?sfvrsn=c74f6c18_2Guide to biosimilars for healthcare professionals changes tracked
Examples of biological medicines include: - recombinant proteins such as insulin, epoetin (erythropoeitin) and follicle stimulating hormone (FSH); - enzymes, such as imiglucerase and agalsidase, which are used in enzyme replacement therapy; - monoclonal antibodies, which are highly targeted engineered antibodies used to treat a wide variety of conditions such as cancer and arthritis; - blood-derived products such as clotting factors; - vaccines; - animal-derived products such as heparin., Pre-clinical testing can include both cell-based and in limited cases in vivo animal testing and provides assurance that any minor difference seen in physiochemical comparability will not have any impact on the desired functionality of the molecule., For biosimilars, pre-clinical in vivo animal testing is generally not necessary and the amount and type of any in vivo testing required is evaluated on a case-by-case basis., For example, in the case of pharmacokinetic and pharmacodynamic studies, animal data would be superseded by human data., If the reference medicine is benefiting from patent protection for some indications, these cannot appear in the medicine information of the biosimilar.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut_g0141-guide-to-biosimilars-for-healthcare-professionals-v4-changes-tracked.pdf?sfvrsn=b57499f3_6Guide to Parallel Trade - Veterinary Medicines
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 Department of Agriculture, Food and the Marine.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0081-guide-to-parallel-trade---veterinary-medicines-v3.pdf?sfvrsn=bfb6d7b7_5Notification of a clinical investigation under Article 82 MDR
FORMCHECKBOX Yes FORMCHECKBOX No Has the device been manufactured using non-viable tissue or cells of human or animal origin, or their derivatives?, The content and structure of documents submitted should be in line with relevant regulatory requirements and associated standards. 1 For Article 82 clinical investigations of a CE marked device, please submit: FORMCHECKBOX Clinical investigation plan (CIP) which sets out the rationale, objectives, design, methodology, monitoring, conduct, record-keeping and the method of analysis for the clinical investigation Version number: FORMTEXT Date: FORMTEXT FORMCHECKBOX Investigator’s brochure (IB) OR Instructions for use FORMCHECKBOX Investigator’s brochure (IB) OR Instructions for use FORMCHECKBOX A copy of the opinion of the relevant Ethics Committee 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 FORMCHECKBOX Proof of insurance cover or indemnification of subject, device, please submit: FORMCHECKBOX Clinical investigation plan (CIP) which sets out the rationale, objectives, design, methodology, monitoring, conduct, record-keeping and the method of analysis for the clinical investigation Version number: FORMTEXT Date: FORMTEXT FORMCHECKBOX Investigator’s brochure (IB) FORMCHECKBOX Instructions for use for the device FORMCHECKBOX Details of clinical and preclinical data for the device FORMCHECKBOX Details of novel features of the device FORMCHECKBOX Summary of benefit/risk analysis and risk management including information regarding known or foreseeable risks, undesirable side-effects, contraindications and warnings FORMCHECKBOX Monitoring plan FORMCHECKBOX A copy of the opinion of the relevant Ethics Committee 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, (Experts used will be subject to the HPRA’s procedures for protection of confidentiality and impartiality.)
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0923-notification-of-a-clinical-investigation-under-article-82-mdr-v2.docx?sfvrsn=8e6dfba0_5Application form to be submitted when applying for designation as a Notified Body
FORMTEXT FORMTEXT Confidentiality 16 Documentation on professional secrecy procedure including protection of proprietary data FORMTEXT FORMTEXT Liability 17 Documentation of the liability insurance, proof that the liability insurance covers cases where the notified body may be obliged to withdraw or suspend certificates FORMTEXT FORMTEXT Financial Resources 18 Documentation of the financial resources required to conduct the conformity assessment activities, related operations, including the ongoing commitments for certificates issued to demonstrate the continuing viability of the notified body and consistency with the range of products certified FORMTEXT FORMTEXT Quality System 19 Quality Manual and a list of related documentation on the implementation, maintenance and operation of a quality management system, including policies for assignment of personnel to activities and their responsibilities FORMTEXT FORMTEXT , procedures relating to conformity assessment activities and other related documents reflecting the scope of conformity assessment activities including, in particular procedures relating to: FORMTEXT FORMTEXT -Qualification and classification FORMTEXT FORMTEXT -Quality system assessments FORMTEXT FORMTEXT -Risk management FORMTEXT FORMTEXT -Pre-clinical data evaluation FORMTEXT FORMTEXT -Clinical evaluation FORMTEXT FORMTEXT -Representative sampling of technical documentation FORMTEXT FORMTEXT -Post-market clinical follow up FORMTEXT FORMTEXT -Communications from regulatory authorities including competent authorities and designating authorities FORMTEXT FORMTEXT -Communication and analysis of the impact of vigilance reports on device certification FORMTEXT FORMTEXT -Consultation procedures for drug-device combination products, devices utilising animal
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0128-application-form-to-be-submitted-when-applying-for-designation-as-a-notified-body-v7.docx?sfvrsn=36faa57d_5