- Home
- Find medicine
- Human regulatory
- Pre-authorisation
- Post-opinion
- Post-authorisation
- Templates for assessors
- Templates for industry
- Dossier submission requirements
- Improving quality of submissions
- Post-authorisation procedural Q&A
- Article 5 procedure
- Variations regulation
- Type-IA variations
- Type-IB variations
- Type-II variations
- Type-II-variation / extension applications
- Grouping of variations
- Worksharing
- Changing the name of a medicinal product
- Annual re-assessment
- Post-authorisation measures
- Renewals
- Annual renewal of conditional marketing authorisations
- PASS
- Article 46 paediatric study submission
- PSURs
- Transfer of marketing authorisations
- Transparency
- Pharmacovigilance system
- Article 61(3) Notifications
- Withdrawals and cessation
- Marketing and cessation notification
- Sunset clause monitoring
- Urgent safety restrictions
- Other
- Certificates for products
- Product information
- Scientific advice and protocol assistance
- Scientific guidelines
- Search guidelines
- Quality
- Q&A on quality
- Biologicals
- Non-clinical
- Clinical efficacy and safety
- Clinical pharmacology and pharmacokinetics
- Alimentary tract and metabolism
- Blood and blood-forming organs
- Blood products
- Cardiovascular system
- Dermatologicals
- Genito-urinary system and sex hormones
- Anti-infectives for systemic use
- Antineoplastic and immunomodulating agents
- Rheumatology/Musculo-skeletal system
- Nervous system
- Respiratory system
- Herbal medicinal products
- Information on medicinal products
- Radiopharmaceuticals and diagnostic agents
- Allergy/Immunology
- Biostatistics
- General
- Multidisciplinary
- ICH
- Innovation Task Force
- SME office
- Paediatric medicine
- Geriatric medicine
- Orphan designation
- Herbal products
- Referral procedures
- Article 58 applications
- Compassionate use
- Pharmacovigilance
- Background
- Pharmacovigilance legislation
- Good pharmacovigilance practices
- Risk-management plans
- Medication errors
- Signal management
- Post-authorisation safety studies
- Medicines under additional monitoring
- Periodic safety update reports
- European Risk Management Strategy
- EudraVigilance
- Incident management plan
- Guidance
- Data submission on authorised medicines
- Advanced therapies
- Clinical trials
- Inspections
- Falsified medicines
- Quality by design
- Product defects and recalls
- Parallel distribution
- Medicine shortages
- Antimicrobial resistance
- Pandemic influenza
- New countries/EFTA
- Non-pharmaceutical products
- Fees
- Medicines and emerging science
- Adaptive pathways
- Biological and chemical agents
- Ebola
- Veterinary regulatory
- Pre-authorisation
- Post-authorisation
- Certificates for products
- Post-authorisation procedural Q&A
- Article 5 procedure
- Type IA variations
- Type IB variations
- Type II variations
- Type II variations vs Extension applications
- Extension applications
- Grouping of variations
- Worksharing of variations
- Changing the (Invented) Name of a Centrally Authorised Medicinal Product
- Renewals
- Follow-up Measures/Specific Obligations
- Transfer
- PSURs
- Mock-ups
- Must a product be marketed after the Authorisation has been granted (“Sunset Clause”)?
- Transparency
- Other
- General guidance
- Product information
- Scientific advice
- Scientific guidelines
- SME office
- Innovation Task Force
- Referral procedures
- Maximum residue limits
- Pharmacovigilance
- Inspections
- Quality by design
- Minor uses / minor species and limited markets
- Antimicrobial resistance
- Product defects and recalls
- Parallel distribution
- Legislative issues
- Fees
- Committees
- CHMP
- PRAC
- CVMP
- COMP
- HMPC
- CAT
- PDCO
- Working parties and other groups
- CHMP
- Biologics Working Party
- Patients' and Consumers' Working Party
- Healthcare Professionals' Working Party
- Quality Working Party
- Safety Working Party
- Scientific Advice Working Party
- Biosimilar Medicinal Products Working Party
- Biostatistics Working Party
- Blood Products Working Party
- Cardiovascular Working Party
- Central Nervous System Working Party
- Infectious Diseases Working Party
- Oncology Working Party
- Pharmacogenomics Working Party
- Pharmacokinetics Working Party
- Rheumatology / Immunology Working Party
- Vaccines Working Party
- Gastroenterology Drafting Group
- Radio-pharmaceuticals Drafting Group
- Scientific Advisory Group on Cardiovascular Issues
- Scientific Advisory Group on Anti-infectives
- Scientific Advisory Group on Diabetes / Endocrinology
- Scientific Advisory Group on HIV/Viral Diseases
- Scientific Advisory Group on Neurology
- Inter-Committee Scientific Advisory Group on Oncology
- Scientific Advisory Group on Psychiatry
- Scientific Advisory Group on Vaccines
- (Invented) Name Review Group
- Working Group on Quality Review of Documents
- Expert Group on 3Rs
- Active Substance Master File Working Group
- Geriatric Expert Group
- SmPC Advisory Group
- Modelling and Simulation Working Group
- Coordination Group
- CVMP
- Antimicrobials Working Party
- Efficacy Working Party
- Environmental Risk Assessment Working Party
- Immunologicals Working Party
- Quality Working Party
- Pharmacovigilance Working Party
- Safety Working Party
- Scientific Advice Working Party
- Inter-Committee Scientific Advisory Group on Oncology
- Ad Hoc Group on Veterinary Novel Therapies
- Working Group on Quality Review of Documents
- Expert Group on 3Rs
- Active Substance Master File Working Group
- COMP
- HMPC
- CAT
- PDCO
- CMDh
- CMDv
- CHMP
- News and Events
- Partners & Networks
- About Us
- What we do
- Who we are
- Agency structure
- Executive Director
- Deputy Executive Director
- Advisory functions
- Human Medicines Research and Development
- Human Medicines Evaluation
- Procedure Management and Business Support
- Inspections and Human Medicines Pharmacovigilance
- Veterinary Medicines
- Stakeholders and Communication
- Information Technology
- Administration
- Management Board
- European experts
- Logo and visual identity
- Agency structure
- How we work
- Legal foundation
- Transparency
- Integrated management system
- Funding
- Financial management and budgetary reporting
- Conflicts of interests
- Annual reports and work programmes
- Procedures
- Policies
- Road map to 2015
- Business hours and holidays
- 20th anniversary
- Careers
- Procurement
- Access to documents
- Contacts
- How to find us
- FAQs
- Privacy statement
- Legal notice
- Complaints
- Glossary
- Help