European Medicines Agency - Marketing authorisation - Paediatric medicines: Marketing authorisation

Overview
Advanced therapies
Legal framework
Meetings and workshops
Biosimilars
Compliance
Data on medicines (ISO IDMP standards)
Fees
How to pay
Pharmacovigilance fees
Questions and answers
Orphan designation
Legal framework
Paediatric medicines
Paediatric Regulation
Workshops
Pharmacovigilance
Legal framework
Implementation
Meetings
Public health threats
Antimicrobial resistance
Antimicrobial resistance in human medicine
Biological and chemical threats
Ebola
Falsified medicines
Buying medicines online
Pandemic influenza
Vaccines
Antivirals
2009 (H1N1) influenza pandemic
Medicines
Safety updates
News archive
Guidance
Zika
Support for early access
Supporting SMEs
Applying for SME status
Engaging with SMEs
Research and development
Adaptive pathways
Advanced therapies
Advanced therapy development
Certification procedures for SMEs
Scientific guidelines
Clinical trials
Clinical trial regulation
Compassionate use
Compliance
Good clinical practice
Working group
Q&A
Inspections procedure
Coordination
Good laboratory practice
Good manufacturing practice
Coordination
EudraGMDP
Q&A
Working group
Joint audit programme
Mutual recognition agreements
Data on medicines (ISO IDMP standards)
SPOR master data
Referentials and organisations
Substances and products
Stakeholder engagement
Geriatric medicine
Innovation in medicines
Medicines and emerging science
Nanotechnology
Biomarkers
Methodologies and statistics
Non-pharmaceutical products
Plasma Master File
Certifications
Submission dates
Procedure
Dossier
Application form
General information
Background documents
Coordinators list
Vaccine antigens
Dossier
Ancillary medicinal substances
Assessment templates and guidance
CHMP opinions on consultation procedures
Orphan designation
Annual report
How to apply
Submission deadlines
Questions and answers
Guidance and forms
Incentives
Transfers
Paediatric medicines
Funding for paediatric medicines
Needs for paediatric medicines
Rewards and incentives for paediatric medicines
Paediatric clinical trials
Paediatric investigation plans
PIPs: Questions and answers
Standard PIPs
Paediatric formulations
Class waivers
Templates, forms and submission dates
Mailing list
Scientific guidelines: Paediatrics
Pharmacovigilance
EudraVigilance
System overview
Registration
Electronic reporting
Access to data
Security
Change management
EudraVigilance training
PRIME: priority medicines
Quality by design
Q&A: quality by design
Scientific advice and protocol assistance
How to submit a request
Novel methodologies / biomarkers
Parallel consultation with HTA bodies
Guidance
Scientific guidelines
Search guidelines
Biologicals
Active substance
Finished product
Clinical efficacy and safety
Alimentary tract and metabolism
Blood and blood-forming organs
Blood products
Cardiovascular system
Dermatologicals
Genitourinary system and sex hormones
Anti-infectives for systemic use
Antineoplastic and immunomodulating agents
Rheumatology / musculoskeletal system
Nervous system
Respiratory system
Radiopharmaceuticals and diagnostic agents
Allergy/immunology
Biostatistics
General
Clinical pharmacology and pharmacokinetics
Product-specific bioequivalence guidance
Q&As: clinical pharmacology and pharmacokinetics
ICH
Quality
Safety
Efficacy
Multidisciplinary
Considerations
Multidisciplinary
Biosimilar
Cell therapy and tissue engineering
Gene therapy
Herbal medicinal products
Nanomedicines
Paediatrics
Pharmacogenomics
Vaccines
Non-clinical
Environmental risk assessment
Non-clinical development
Pharmacokinetics and toxicokinetics
Pharmacology and safety pharmacology
Toxicology
Q&A on quality
Part 1
Part 2
Quality
Active Substance
Manufacturing
Impurities
Specifications, analytical procedures and analytical validation
Excipients
Packaging
Stability
Pharmaceutical development
Quality by Design
Specific types of products
Post approval change management protocols
Marketing authorisation
Advanced therapies
Advanced therapy classification
Summaries of advanced therapy classification
Marketing authorisation
Accelerated assessment
Biosimilars
Compliance
Pharmacovigilance inspections
Pharmacovigilance Inspectors Working Group
Inspections procedure
Sampling and testing
Q&A
Programmes
Programme partners
Clinical data publication
Support for industry
Industry guidance
Background to clinical data publication policy
Documents from advisory groups on clinical-trial data
Conditional marketing authorisation
Data on medicines (ISO IDMP standards)
Generic medicines
Generic and hybrid applications
Guidance documents
Data exclusivity / Generics / Biosimilars
Post-opinion
Templates
Orphan medicines
Activities after designation
Market exclusivity
Medicines for use outside EU (Article 58)
Q&A
Questions 1-15
Questions 16-30
Questions 31-38
Paediatric medicines
Paediatric requirements for marketing-authorisation applications
Paediatric-use marketing authorisations
Pharmacovigilance
Patient registries
Risk management
Risk management plans
Pre-authorisation guidance
Product information
Templates
How to prepare an SmPC
Exemptions
Linguistic review
Mock-ups and specimens
Reference and guidelines
Excipients labelling
Submission dates
Timetables
Templates for assessors
Post-authorisation
Advanced therapies
Pharmacovigilance
Compliance
Good distribution practice
Product defects and recalls
Notifying
Alert procedure
Data on medicines (ISO IDMP standards)
Data submission on authorised medicines
Reporting requirements for authorised medicines
How to submit
Guidance documents
Registration
Training
Medicine shortages
Shortages catalogue
Orphan medicines
Change of sponsor details
Removal
Improving quality of submissions
Paediatric medicines
Annual reports on deferrals
Deadlines for placing paediatric medicines on the market
Paediatric requirements for variations and extensions
Submitting results of paediatric studies
Parallel distribution
FAQ
Guidance
Pharmacovigilance
European Risk Management Strategy
Good pharmacovigilance practices
GVP development
Superseded guidance
Incident management plan
Medical literature monitoring
Medication errors
Recommendations on medication errors
Medicines under additional monitoring
Information materials
List of medicines under additional monitoring
Periodic safety update reports
Pharmacovigilance system
Post-authorisation safety studies
Regulatory and procedural guidance
Signal management
PRAC recommendations
Post-authorisation procedural Q&A
Regulatory and procedural guidance
Templates for assessors
Templates for industry
Dossier submission requirements
Classification of changes
Pre-submission queries service
Changing the name of a medicinal product
Annual re-assessment
Guidance
Post-authorisation measures
Renewals
Guidance
Annual renewal of conditional marketing authorisations
PASS
PAES
Article 46 paediatric study submission
Risk management plan (RMP)
PSURs
Guidance
Transfer of marketing authorisations
Guidance
Transparency
Guidance
Article 61(3) Notifications
Guidance
Withdrawals and cessation
Marketing and cessation notification
Guidance
Sunset clause monitoring
Guidance
Other
Certificates for products
Requesting certificates
Referral procedures
Q&A: Urgent Union Procedures (Article 107i)
Q&A: Article 13 referral procedures
Q&A: Article 20 pharmacovigilance procedures
Q&A: Article 20 non-pharmacovigilance procedures
Q&A: Article 29(4) referral procedures
Q&A: Article 30 referral procedures
Q&A: Article 31 pharmacovigilance referrals
Q&A: Article 31 non-pharmacovigilance referrals
Guidance
Variations
Article 5 procedure
Grouping of variations
Variations regulation
Type-IA variations
Type-IB variations
Type-II variations
Guidance
Type-II variations: extension applications
Guidance
Worksharing
Herbal products
EU monographs and list entries
Regulatory and scientific support
Scientific guidelines
Q&A: Herbal medicines
Procedures

Main navigation

Paediatric medicines: Marketing authorisation

Related documents

Related EU legislation

Related content

Contact point: