- Overview
- Research and development
- Adaptive pathways
- Advanced therapies
- Clinical trials
- Compassionate use
- Compliance
- Data on medicines (ISO IDMP standards)
- Geriatric medicine
- Innovation in medicines
- Non-pharmaceutical products
- Orphan designation
- Paediatric medicines
- Pharmacovigilance
- PRIME: priority medicines
- Quality by design
- Scientific advice and protocol assistance
- Scientific guidelines
- Search guidelines
- Biologicals
- 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
- ICH
- Multidisciplinary
- Non-clinical
- Q&A on quality
- Quality
- Marketing authorisation
- Advanced therapies
- Accelerated assessment
- Biosimilars
- Compliance
- Clinical data publication
- Conditional marketing authorisation
- Data on medicines (ISO IDMP standards)
- Generic medicines
- Guidance documents
- Orphan medicines
- Medicines for use outside EU (Article 58)
- Paediatric medicines
- Pharmacovigilance
- Pre-authorisation guidance
- Product information
- Submission dates
- Templates for assessors
- Post-authorisation
- Advanced therapies
- Compliance
- Data on medicines (ISO IDMP standards)
- Medicine shortages
- Orphan medicines
- Improving quality of submissions
- Paediatric medicines
- Parallel distribution
- Pharmacovigilance
- European Risk Management Strategy
- Good pharmacovigilance practices
- Incident management plan
- Medical literature monitoring
- Medication errors
- Medicines under additional monitoring
- Periodic safety update reports
- Pharmacovigilance system
- Post-authorisation safety studies
- Regulatory and procedural guidance
- Signal management
- 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
- Post-authorisation measures
- Renewals
- Annual renewal of conditional marketing authorisations
- PASS
- PAES
- Article 46 paediatric study submission
- Risk management plan (RMP)
- PSURs
- Transfer of marketing authorisations
- Transparency
- Article 61(3) Notifications
- Withdrawals and cessation
- Marketing and cessation notification
- Sunset clause monitoring
- Other
- Certificates for products
- 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
- Herbal products
There are currently no documents published in this section
Related links
- Guideline on the categorisation of Extension Applications (EA) versus Variations Applications (V)
- Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
- Notice to Applicants - Volume 2B - Presentation and content of the dossier - Application form (Word
- Notice to Applicants - Volume 2B - Electronic application form (zip file)
- Notice to Applicants - Volume 2B - Presentation and content of the dossier - User guide to the application form
- Q&A: Type II Variations vs Extension applications
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