Sitemap

About Us

Our Mission, Vision and Values

What We Regulate and How We Regulate

Heads of Medicines Agencies

Our Strategic Plan 2021 – 2025

Contact Us

Mailboxes / E-mail Contacts

Our Location

Useful Links

Contacting HPRA for Brexit Queries – Out of Hours

Our Structure

Authority

Advisory Committees

HPRA Leadership Team

Patient Forum

Terms of Reference

Rolling work plan

Meeting reports

Resources

Publications & Forms

Guidance Documents

Forms & Applications

Information Leaflets

Newsletters & Reports

Corporate & Policy Documents

Standards of Service

Privacy and Data Protection

Data protection

Website and cookies

Information and transparency

Freedom of Information

FOI Publication Scheme

Gender pay gap reporting

Prompt Payments by Public Sector Bodies

Access to Information on the Environment

Authority and Licensing Reports

HPRA social media policy

MoUs and Agreements

HPRA Accessibility Statement

Re-use of public sector information

Consultations

Previous Consultations

Quality Management

Benchmarking

Recruitment

Graduate Programme

HPRA achievements and recognition

HPRA People Strategy

Report an Issue

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

Irprezide (Irbesartan / Hydrochlorothiazide) Tablets Recall

Valsartan

Valproate (Epilim▼)

Biosimilar Medicines

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

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

Standalone software and applications

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