The Irish Medicines Board: Sitemap

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- Our Structure
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- Standards of Service
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- Contact Us

Safety & Quality
- Advisory, Warning & Recall Notices
  - Human Medicines
    - Important Safety Warning: Relenza inhalation powder must not be nebulised or administered by mechanical ventilation.
    - Use of the IMB online ADR report forms and Drug Safety Newsletter (DSN) for CPD purposes
  - Medical Devices
  - Blood, Tissues & Cells
  - Veterinary Medicines
- How the IMB monitors product safety
  - Human Medicines
    - Drug Safety
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    - Defects in Medicines
    - Resources for Healthcare Professionals
  - Medical Devices
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- Reporting Suspected Product Problems
  - Safety Related Problems
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- Online Forms
  - Human Medicine -Adverse Reaction
  - Clinical Trial-Serious Adverse Event
  - Tissues&Cells-Adverse Reaction/Event
  - Quality Defect
  - Medical Device Incident User Report Form
  - Veterinary Medicine - Adverse Reaction
  - Gardasil Adverse Reaction

Human Medicines
- Generic and Interchangeable Medicines
- New Legislation Concerning Falsified Medicines
- New EU Pharmacovigilance Legislation
  - About the Legislation
    - Good Pharmacovigilance Practices
    - Related Publications
  - Latest News
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  - Guidance for Marketing Authorisation Holders
  - Search for Medicines Information
    - Summaries of Product Characteristics
    - Package Leaflets
    - Public Assessment Reports
    - Risk Management Plans
  - Reporting Suspected Adverse Reactions
    - www.adrreports.eu
  - Medicines under Additional Monitoring
  - EMA and HMA Committee Information
- HPV School Immunisation
  - Product Information
  - Possible Side Effects of Vaccination
  - Reporting Suspected Side Effects
  - National Monitoring Overview
  - Further Information
- Pandemic (H1N1) 2009
  - Anti-viral Medication
  - ADR Reporting
  - Counterfeit Medication
- Human Medicines
  - Licensing
    - New Product
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    - Homeopathics
    - Periodic Safety Updates
    - Fees
    - On-Line Applications
    - test
    - Legal Supply Status and Reclassification
  - Herbal Medicines
  - Traditional Herbal Medicines Registration
  - Homeopathic Medicines
  - Vaccines
  - Human Medicines Listing
  - Drug-Device Combination Products
  - Advertising of human medicinal products
  - Notification System for Exempt (unauthorised) Products
- Clinical Trials
  - Good Clinical Practice (GCP)
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- Manufacturing
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  - Authorised Manufacturers List
- Laboratory
- Wholesale Distribution
  - Licensing
    - New Applications
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  - Authorised Wholesalers List
- Export Certification
- Controlled Drugs and Precursor Chemicals
- Classification of Medicines

Veterinary
- Veterinary Medicines
  - IMB Veterinary Sciences
    - Functions of the IMB
    - Advisory Committee for Veterinary Medicines
    - Organogram
    - Contact Details
  - Availability of Veterinary Medicines
    - International Initiatives
    - National Initiatives
    - Exceptional Authorisations
    - Use Outside the Approved Authorisation
    - Supply and Importation
  - Licensing Activities
    - New Product Application
    - IMB as RMS
    - Joint Labelling Procedure
    - Partnership Initiative
    - Variation Application
    - Renewal Application
    - Transfer Application
    - Withdrawal
    - Marketing Status Notification
    - Batch Specific Request
    - Parallel Importation
    - Homeopathic Medicines
    - Herbal Medicines
    - Premixes
    - On-Line Applications
  - Additional Activities
    - Borderline Products
    - Clinical Trials
    - Use Outside the Approved Label
  - Safety
  - Drug Safety
    - Monitoring of Veterinary Medicines
    - PSUR Reporting Requirements
    - Adverse Reaction Reporting
    - Adverse Reaction Annual Reports
    - European Pharmacovigilance Guidelines
    - Antimicrobial Resistance
  - News and Publications
    - Overview of the Regulatory Process
    - Latest Safety News
    - Events
    - Recently Authorised Veterinary Medicines
    - Frequently Asked Questions
    - Guidelines and Forms
    - Newsletter
    - Fees
  - Useful Links
  - Veterinary Medicines Listing
  - Manufacturers Listing
- Scientific Animal Protection
  - About the Legislation
    - Functions of the IMB
    - National Committee
  - Authorisations
    - Fee Information
  - Monitoring
  - Statistical Reporting
  - Alternative Approaches
  - Animal Welfare Body
  - News & Publications
    - Application Forms
    - Frequently Asked Questions
    - Guidance Documents
    - Online Application Forms regulated by Directive 2010-63-EU and Submission System Demonstration
  - Useful Links
  - Scientific Animal Protection in the IMB
    - Contact Details

Medical Devices
- Pre-Market Activities
  - Clinical Investigations
  - Registration
  - Classification
  - Notified Body Management
  - Drug-Device Combination Products
- Post-Market Activities
  - Vigilance
  - Certificates of Free Sale
  - Compliance
- Auditing & Surveillance
- On-Line Services
- Information Leaflets
- Safety Notices
- SCHENIR Report: The safety of dental amalgam and alternative dental restoration materials for patien

Blood, Tissues, Organs
- Blood
  - Hospital Blood Bank Annual Report (HBBAR)
- Tissues & Cells
  - Tissues and Cells Updates
- Blood & Tissue Establishments
- Organs

Cosmetics
- What is a cosmetic product?
- Cosmetovigilance
- Cosmetic Legislation

Publications

Patients & Public
- About the IMB
- Consumer Information & Advice
- Consumer Research
- Reporting Safety and Quality Concerns
  - Reporting a Human Medicine Side Effect
  - Reporting a Veterinary Medicine Side Effect
  - Reporting a Medicine Quality Issue
  - Reporting a Medical Device Adverse Incident
  - Reporting a Cosmetic Product Undesirable Effect
- Search for Authorised Medicines
  - Product List - Human Medicines
  - Product List - Veterinary Medicines
- Subscribe to our Updates
- Corporate Publications
- Useful Links
- Healthcomplaints.ie
- patientsafetyfirst.ie

Please ignore the message titled ‘New page on homeopathy’ as this was sent in error

Glossary

Date Printed: 24 May 2013

Address: Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland.
Tel: 353-1-676 4971

The Irish Medicines Board - www.imb.ie