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My HPRA:
Login
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About Us
Medicines
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
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About Us
Our Mission, Vision and Values
What We Regulate and How We Regulate
Heads of Medicines Agencies
Our Strategic Plan 2021 – 2025
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Mailboxes / E-mail Contacts
Our Location
Useful Links
Contacting HPRA for Brexit Queries – Out of Hours
Our Structure
Authority
Advisory Committees
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Patient Forum
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Rolling work plan
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Corporate & Policy Documents
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Prompt Payments by Public Sector Bodies
Access to Information on the Environment
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Re-use of public sector information
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COVID-19 Vaccine Adverse Reaction
Human Medicines Adverse Reaction
Veterinary Medicines Adverse Reaction
Serious Adverse Event (Clinical Trials)
Medicine Quality Issue / Defect
Medical Device Adverse Incident
Tissues and Cells Adverse Reaction
Cosmetics - Undesirable Effect
Protected disclosures
Legislation
Extranets
Decommissioning the Extranet online registration system
News and Events
Medicines
COVID-19 vaccines and treatments
Suspected side effects reported in Ireland and the EU/EEA
Reporting side effects of COVID-19 vaccines
COVID-19 vaccines
COVID-19 treatments
Updates and information for healthcare professionals
Beware of misleading vaccine information
Our Role
Medicines Information
Find a medicine
Generic / Interchangeable List
Traditional Herbal Medicines
Homeopathic Medicines
Human Vaccines
ATC codes
Medicines Shortages
Electronically communicated caution in use letters for batch-specific requests
Safety Information
Reporting Suspected Side Effects
Medicines Safety: Benefits and Risks
Identifying and Understanding Risks
Managing and Communicating Risks
Enforcement
Educational Materials
Consumer advice
Safety Notices
Quality Information
Quality Defects
Recalls
Sartan Recalls
Sampling and Analysis
Regulatory Information
Classification of Medicines
Medicines Authorisation
Pharmacovigilance and Post Authorisation Safety
Clinical Trials
Generic and Interchangeable Medicines
Manufacturers
Wholesale Distribution
Retailers
Market Compliance and Surveillance
Medicine Fees
Export Certification
Consultations
Product Information Update (PIU)
National Scientific and Regulatory advice
Information for Brokers
Active Substance Registrations
News & Events
Special Topics
Valproate (Epilim▼)
Topiramate (Topamax ▼) pregnancy prevention programme and restrictions on use
Biosimilar Medicines
Valsartan
Irprezide (Irbesartan / Hydrochlorothiazide) Tablets Recall
Falsified Medicines Legislation
HPV School Immunisation
Emergency Medicines
About this Legislation
Emergency Medicines Portal
How to use the Emergency Medicines Portal
Check the Register
Privacy notice - Emergency Medicines register
Emergency Contact Details
Reporting Side Effects
Veterinary
Our Role
Veterinary Medicines Information
Find a Medicine
Veterinary shortages
Safety Information
How We Monitor Safety
Adverse Reaction/Event Reporting
Information on pharmacovigilance for marketing authorisation holders and applicants
Annual Pharmacovigilance Reports
Pharmacovigilance inspections
Safety Notices
Regulatory Information
Medicines Authorisation
New veterinary regulation (Regulation 2019/6)
Veterinary Clinical Field Trials
Packaging changes to authorised veterinary medicines
Additional Activities
Market Compliance and Surveillance
Manufacturers
Veterinary Medicines Fees
Export Certificates
Consultations
Accessing unauthorised Veterinary Medicines
Availability of veterinary medicines in Ireland
Special Topics
Use of veterinary medicines in food-producing animals
Antibiotic Resistance
Care in Use and disposal of sheep dips
Exceptional authorisation of veterinary medicines
Use of antibiotics in dairy cows
Supply of veterinary medicines that are heat sensitive
Worm resistance in sheep
The role of the HPRA in VMP authorisations - a presentation
Antiparasitic Veterinary Medicinal Products
Classification of veterinary medicines in Ireland
Contact details
Veterinary News & Events
Scientific Animal Protection
3Rs
Authorisations
Monitoring
Statistical Reporting
Alternative Approaches
Animal Welfare Body
National Committee
SAP Guides and Forms
Training Requirements and Courses
SAP within the HPRA
Contact Details
Useful Links
Medical Devices
COVID-19 Updates
Regulation of Face Masks and Gloves
In-Vitro Diagnostic (IVD) Tests for COVID-19
Notice to manufacturers on the marketing of nasal sprays claiming virucidal and antimicrobial actions
Our role
Safety Information
Reporting safety issues
Monitoring device safety
Safety communications
User Engagement
Consumer advice
Regulatory Information
Common aspects of the regulations
Medical Devices Regulation
In Vitro Diagnostic Medical Devices Regulation
Registration
Medical Devices News & Events
Special Topics
Philips Sleep and Respiratory Care Devices
Breast Implants
Vaginal Mesh Implants
Automated External Defibrillators – Safety updates
Heater-Cooler Devices and Mycobacterium Chimaera
Near-patient testing
Contact Medical Devices
Cosmetics
Our Role
Safety Information
Reporting Undesirable Effects
Why report a serious undesirable effect?
Safety Notices
Tips on how to spot counterfeit cosmetics
Regulatory Information
Making, Importing or Selling Cosmetic Products in Ireland
Placing Cosmetic Products on the Irish market
Updates to restricted/prohibited ingredients
Distribution or retail of Cosmetic Products in Ireland
Certificate of Free Sale for Cosmetics
Reading List
News & Events
Special Topics
Sunscreen
Labelling
Tooth Whitening
Aerosols
Hair Straightening Products
Controlled Substances
Our Role
Controlled Drugs
Legislation
Licences
Application forms, Report forms and Guides
Medical Cannabis Access Programme
Precursor Chemicals
Legislation
Categories of Precursor Chemicals
Requirements for Operators and End Users
Inspections
Application and report forms
Blood, Tissues, Organs
Our Role
Blood
Safety Information
Regulatory Information
Tissues and Cells
Safety Information
Regulatory Information
Organs
Safety Information
Regulatory Information
Organ Establishment List
Blood and Tissues Establishments List
Inspection Process
Special Topics
News and Events
Reporting Adverse Reactions / Events
Safety Topics
Safety Notices
Date Printed: 13/09/2024