STRUCTURE AND CONTENTS
    • A 1 Procedures for Marketing Authorisation in Europe
      • A 1.1 Principle of the Common Market
        • A 1.1.1 Common Market as Objective of the Harmonisation of the Provisions for Marketing Authorisation
        • A 1.1.2 Conflict between Interests of Integration and Safety when Creating the Internal Market for Medicinal Products
        • A 1.1.3 Commission Communication on a Renewed Vision for the Pharmaceutical Sector
          • A 1.1.3.1 Commission's Objectives
          • A 1.1.3.2 Measures Proposed by the Commission
      • A 1.2 Kinds of European Legislation
      • A 1.3 Kinds of Guidelines and Implementation Procedure
        • A 1.3.1 Types of Guidelines in the Legal Sense
        • A 1.3.2 Procedure
        • A 1.3.3 Further Kinds of Documents
      • A 1.4 Legislative Process
      • A 1.5 The Fundamental Harmonisation Activities Relating to Marketing Authorisation of Medicinal Products in the European Community since 1965
        • A 1.5.1 The Fundamental Directive – Directive (EEC) No. 65/65
        • A 1.5.2 Directive (EEC) No. 75/318 - The „Testing“-Directive
        • A 1.5.3 Directive (EEC) No. 75/319 – Establishment of a Committee for Proprietary Medicinal Products and Introduction of the Multi-State Procedure
        • A 1.5.4 Directive (EEC) No. 83/570
        • A 1.5.5 Directive (EEC) No. 87/22 – The Concertation Procedure for High-Technology Medicinal Products, particularly deriving from Biotechnology
        • A 1.5.6 Regulation (EEC) No. 2309/93 and Directive (EEC) No. 93/39
        • A 1.5.7 Community Code relating to Medicinal Products for Human Use, Directive (EC) No. 2001/83
        • A 1.5.8 Directive (EC) No. 2004/27 and Regulation (EC) No. 726/2004
        • A 1.5.9 Directive (EC) No. 2004/24 - Traditional-Use Registration
        • A 1.5.10 Regulation (EC) No. 1901/2006 - Medicines for Children - The Paediatric Regulation
        • A 1.5.11 Regulation (EC) No. 1394/2007 on Advanced Therapy Medicinal Products
      • A 1.6 European Marketing Authorisation System (EMAS)
        • A 1.6.1 Procedures
        • A 1.6.2 Centralised Procedure
        • A 1.6.3 Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP)
        • A 1.6.4 National MA Procedure
        • A 1.6.5 Registration Procedure
    • A 2 Essential Terms and Provisions of European Pharmaceutical Law
      • A 2.1 Substance
      • A 2.2 Human Medicinal Product
        • A 2.2.1 The Term of "Medicinal Product" for Human Use
          • A 2.2.1.1 Definition of Art. 1 No. 2 of Dir. 2001/83
          • A 2.2.1.2 ECJ Jurisdiction regarding the Term Medicinal Product by Virtue of its Presentation
          • A 2.2.1.3 The Term Medicinal Product and the Applicability of EU Pharmaceutical Law
        • A 2.2.2 The Scope of Pharmaceutical Legislation - the Community Code
      • A 2.3 Manufacture and Importation
        • A 2.3.1 Manufacturing Authorisation
        • A 2.3.2 Authorisation for Importation
        • A 2.3.3 Legal Requirements for obtaining a Manufacturing Authorisation or an Authorisation for Importation
        • A 2.3.4 Qualified Person
        • A 2.3.5 Obligations of a Holder of a Manufacturing Authorisation or an Authorisation for Importation
      • A 2.4 Inspections and Supervision
        • A 2.4.1 Authorities Competent for Supervision and Inspections
        • A 2.4.2 Competences of Supervisory Authorities
        • A 2.4.3 Inspections Unit of the EMA
          • A 2.4.3.1 Responsibilities of the Inspection Unit
          • A 2.4.3.2 Inspectors Working Groups
        • A 2.4.4 EMA Certificates of Medicinal Products
        • A 2.4.5 Mutual Recognition Agreements (MRA)
    • A 3 European Medicines Agency (EMA) - Structure and Tasks
      • A 3.1 Legal Basis for Establishing the EMA
      • A 3.2 Agency´s Mission and Tasks
      • A 3.3 Organisation of the EMA
        • A 3.3.1 Structure - Overview
        • A 3.3.2 The Scientific Committees
          • A 3.3.2.1 CHMP, CVMP and HMPC
          • A 3.3.2.2 COMP
          • A 3.3.2.3 PDCO
          • A 3.3.2.4 CAT
        • A 3.3.3 The Executive Director
        • A 3.3.4 The Management Board
        • A 3.3.5 The Secretariat
      • A 3.4 Agency´s Independence / Code of Conduct / Corruption
        • A 3.4.1 Code of Conduct
          • A 3.4.1.1 Code of Good Administrative Behaviour
          • A 3.4.1.2 Conflict of Interest
      • A 3.5 Possibilities of Control and Influence for Community Institutions
        • A 3.5.1 Appointment of Management Board and Executive Director
        • A 3.5.2 Financial Provisions
        • A 3.5.3 General Provisions regarding Agency´s Competences
      • A 3.6 Scientific Advice
      • A 3.7 Incentives for Small and Medium-sized Enterprises
        • A 3.7.1 Definition of Micro, Small and Medium-Sized Enterprise
        • A 3.7.2 Essential Provisions of the SME Regulation
        • A 3.7.3 Scope of Application and Entry into Force of the Commission Regulation
    • A 4 Essentials to Marketing Authorisations (MAs) and Marketing Authorisation Applications (MAAs)
      • A 4.1 Location of the Applicant´s Registered Office
      • A 4.2 Different Types of Applications for Marketing Authorisation
        • A 4.2.1 Full and Mixed Data Application, Art. 8 (3) of the Community Code
        • A 4.2.2 Bibliographical Application, Art. 10a of the Community Code
          • A 4.2.2.1 ECJ Case C-440/83, "Scotia"
          • A 4.2.2.2 Well-Established Medicinal Use
        • A 4.2.3 Informed Consent Applications, Art. 10c of the Community Code
        • A 4.2.4 Generic Application
          • A 4.2.4.1 Definitions
            • A 4.2.4.1.1 Reference Medicinal Product (RMP)
            • A 4.2.4.1.2 Generic Medicinal Product - Essential Similarity
            • A 4.2.4.1.3 Same Active Substance
            • A 4.2.4.1.4 Same Pharmaceutical Form
          • A 4.2.4.2 Existence of a MA for the RMP - European Reference Product (ERP)
          • A 4.2.4.3 Exclusivity Period
            • A 4.2.4.3.1 Exclusivity Periods before Implementation of the Review
            • A 4.2.4.3.2 General Exclusivity Periods after Review, Art. 10 (1) subpar. 1 and 2 of the Community Code – ‘Global Marketing Authorisation’ –Application of New Protection Provisions
            • A 4.2.4.3.3 Extended Marketing Protection Period of 11 Years in Case of New Indications authorised within the First Eight Years of Data Exclusivity, Art. 10 (1) subpar. 4 of the Community Code/ Art. 14 (11) of Reg. 726/2004
            • A 4.2.4.3.4 Non-Cumulative Exclusivity Period of 1 Year in Case of a New Indication for a Well-Established Substance, Art. 10 (5) of the Community Code
            • A 4.2.4.3.5 Data Protection in Case of Switch of Classification, Art. 74a of the Community Code
            • A 4.2.4.3.6 Patent Protection and Conduct of Studies and Trials, Art. 10 (6) of the Community Code
          • A 4.2.4.4 Legal Requirements for an Application for MA for a Generic Medicinal Product
          • A 4.2.4.5 Special Requirements for Biosimilar Medicinal Products, Art. 10 (4) of the Community Code
        • A 4.2.5 Hybrid Applications - Line Extensions
        • A 4.2.6 Applications for “Fixed Combinations”, Art. 10b of the Community Code
      • A 4.3 Summary of Product Characteristics (SPC), Art. 11 of the Community Code - Nature and Content
        • A 4.3.1 Content of the SPC
      • A 4.4 Labelling and Package Leaflet
        • A 4.4.1 General Requirements introduced by Dir. 2004/27
          • A 4.4.1.1 Correct Labelling and Package Leaflet as Mandatory Requirement for the MA
          • A 4.4.1.2 Languages of Labelling and Package Leaflet
          • A 4.4.1.3 Requirement of Readability and Clear Comprehensibility - Necessity for Consultation with Target Patient Groups
            • A 4.4.1.3.1 Guidance concerning Patient Consultation
            • A 4.4.1.3.2 Forms of Patient Consultation
            • A 4.4.1.3.3 Requirements of Patient Consultation
            • A 4.4.1.3.4 Languages of Patient Consultation and Presentation of Results
          • A 4.4.1.4 Braille Format
        • A 4.4.2 Labelling
          • A 4.4.2.1 Outer Packaging
            • A 4.4.2.1.1 General Requirements
            • A 4.4.2.1.2 Blue Box
          • A 4.4.2.2 Immediate Packaging
            • A 4.4.2.2.1 Blister Packs
            • A 4.4.2.2.2 Small Immediate Packaging
        • A 4.4.3 Package Leaflet
          • A 4.4.3.1 Content of the Package Leaflet
          • A 4.4.3.2 Changes to the Package Leaflet not Connected with the SPC, Art. 61 (3) of the Community Code
      • A 4.5 Validity Period of a Marketing Authorisation
        • A 4.5.1 Renewal and Unlimited Validity
        • A 4.5.2 Special Case: MA granted under Conditions in Accordance with Art. 14 (7) of Reg. 726/2004
        • A 4.5.3 Requirement of Actual Marketing of the Authorised Product for Maintenance of the Validity of the MA
          • A 4.5.3.1 Start of the 3-Year Period from the Granting of the MA
          • A 4.5.3.2 Determination of the Notion “Marketing Authorisation”
          • A 4.5.3.3 Definition of "Placed on the Market"
          • A 4.5.3.4 Information to be provided from the MAH to the Competent Authority
          • A 4.5.3.5 Transitional Agreements
          • A 4.5.3.6 Granting of Exemptions from Application of the Reasons for Cessation
      • A 4.6 Compassionate Use
        • A 4.6.1 Compassionate Use according to Art. 83 of Reg. 726/2004 – Definition, Requirements and Procedure
          • A 4.6.1.1 Principles of Application of the Compassionate Use Provision
          • A 4.6.1.2 Compassionate Use Procedure
        • A 4.6.2 Authorisation according to Art. 126a of the Community Code
    • A 5 The Mutual Recognition and Decentralised Procedure
      • A 5.1 Key Terms of the Mutual Recognition Procedure
      • A 5.2 Overview of the Development of the Mutual Recognition Procedure as Means to Achieve Access to the Markets in more than one Member State since 1995
        • A 5.2.1 Situation from January 1, 1995 until December 31, 1997 – Transitional Period
        • A 5.2.2 Legal Situation from January 1, 1998 until entering into Force of Dir. 2004/27/EC
        • A 5.2.3 Legal Situation as of entering into Force of Dir. 2004/27/EC
        • A 5.2.4 Interpretation of "the Same Medicinal Product" in Art. 17 of the Community Code
      • A 5.3 Principle of Mutual Recognition as Basis for the Mutual Recognition Procedure and the Decentralised Procedure - Basic Elements
      • A 5.4 The Mutual Recognition Facilitation Group (MRFG) and Coordination Group (CMDh)
        • A 5.4.1 Development of the MRFG
        • A 5.4.2 Establishment of the Coordination Group (CMDh) in EU Pharmaceutical Legislation
      • A 5.5 Different Kinds of Applications for which the Mutual Recognition Procedure may be Used
        • A 5.5.1 Stand-Alone application
        • A 5.5.2 Bibliographical Applications
        • A 5.5.3 Informed Consent Applications
        • A 5.5.4 Generic Applications
        • A 5.5.5 Line Extensions
      • A 5.6 Principle of Mutual Recognition
        • A 5.6.1 Special Situations
          • A 5.6.1.1 Repeat Use of the MRP
          • A 5.6.1.2 Multiple Applications
          • A 5.6.1.3 Agreement on Timetable for the Procedure
        • A 5.6.2 Mutual Recognition Procedure (MRP)
          • A 5.6.2.1 Choice of RMS - Preparation of Submission
            • A 5.6.2.1.1 Initial Choice of RMS
            • A 5.6.2.1.2 Change of RMS
            • A 5.6.2.1.3 Dossier Update
            • A 5.6.2.1.4 SPC Update
            • A 5.6.2.1.5 Agreement on Timetable for the Procedure
          • A 5.6.2.2 Request for Preparation of an Assessment Report (AR)
          • A 5.6.2.3 Submission of an application for mutual recognition
          • A 5.6.2.4 Validation procedure
          • A 5.6.2.5 Recognition of the existing MA by CMS
            • A 5.6.2.5.1 Period of 90 Days for Recognition, Art. 28 (4) of the Community Code
            • A 5.6.2.5.2 Course of the 90-Day Period
            • A 5.6.2.5.3 Break-Out Session
          • A 5.6.2.6 Agreement is reached
          • A 5.6.2.7 Refusal of a CMS to recognise the MA due to “Potential Serious Risks to Public Health” – Referral to Coordination Group for Mutual Recognition and Decentralised Procedure (Human) (CMDh)
          • A 5.6.2.8 Potential Serious Risk to Public Health
        • A 5.6.3 Decentralised Procedure
          • A 5.6.3.1 Pre-Submission Discussions with the RMS
          • A 5.6.3.2 Application
          • A 5.6.3.3 Validation Procedure
          • A 5.6.3.4 Preparation of Draft AR, SPC, Labelling and Package Leaflet by RMS – Assessment Step I – Art. 28 (3)
          • A 5.6.3.5 90-Day Period for Approval – Assessment Step II – Art. 28 (4)
          • A 5.6.3.6 Agreement or Referral to CMDh
        • A 5.6.4 Procedure in the CMDh
          • A 5.6.4.1 CMDh Standard Operating Procedure: Disagreement in Procedures-Referral to CMDh
          • A 5.6.4.2 Oral Explanation in the CMDh
          • A 5.6.4.3 End of Day 60 of the Procedure in the CMDh
        • A 5.6.5 30-day Period for Granting of National MAs
        • A 5.6.6 MA from CMS which approved AR, SPC, Labelling and Package Leaflet
      • A 5.7 Arbitration Procedure – Community Referral
        • A 5.7.1 Situations in which Arbitration Procedure Applies
          • A 5.7.1.1 Disagreement between Member States in MRP or DCP, Art. 29 of the Community Code
          • A 5.7.1.2 Divergent Decisions between Member States, Art. 30 of the Community Code
            • A 5.7.1.2.1 Harmonisation of Particular Medicinal Products, Art. 30 (1) of the Community Code
            • A 5.7.1.2.2 List of Products to be harmonised, Art. 30 (2) of the Community Code
          • A 5.7.1.3 Community Interest Referral, Art. 31 of the Community Code
          • A 5.7.1.4 Follow-Up Referrals, Art. 35, 36 and 37 of the Community Code
        • A 5.7.2 CHMP Procedure
          • A 5.7.2.1 Hearing of the Applicant / MAH
          • A 5.7.2.2 Procedure to establish the Final Opinion – Negative Opinion
      • A 5.8 Withdrawal of Application
      • A 5.9 Binding Character of the Commission Decision
        • A 5.9.1 Wording of Art. 34 (3) of the Community Code – Difference to Former Versions
        • A 5.9.2 Decision as a Result of an Article 29 Referral
        • A 5.9.3 Decision as a Result of an Article 30 Referral
        • A 5.9.4 Decision as a Result of an Article 31 Referral
      • A 5.10 Maintenance of Harmonisation
      • A 5.11 Validity of the Marketing Authorisation
      • A 5.12 Marketing Authorisation Granted under Conditions
        • A 5.12.1 Definition of “Exceptional Circumstances“ in the Sense of Art. 22 of the Community Code
        • A 5.12.2 Obligations which may be imposed on the MAH
        • A 5.12.3 Validity of the MA
      • A 5.13 Refusal to Grant the Marketing Authorisation
      • A 5.14 Suspension, Withdrawal or Revocation of a Marketing Authorisation Granted via Mutual Recognition Procedure/Decentralised Procedure
        • A 5.14.1 Conditions for Suspension, Revocation, Withdrawal or Variation of a MA
        • A 5.14.2 Burden of Proof for the Grounds of Suspension, Withdrawal, Revocation or Variation of the MA
        • A 5.14.3 Procedure
      • A 5.15 Mutual Recognition Procedure / Decentralised Procedure Public Assessment Report (PAR)
        • A 5.15.1 Preparation of the PAR
        • A 5.15.2 Information Classified as Confidential
        • A 5.15.3 Time-Table for the Preparation of the PAR
      • A 5.16 Publication of Marketing Authorisations
      • A 5.17 Transfer of Mutual Recognition Procedure/Decentralised Procedure Marketing Authorisations
      • A 5.18 Renewal
        • A 5.18.1 Principles
        • A 5.18.2 Date for Renewal – Common Renewal Date and Optional Procedure for Earlier Renewal
        • A 5.18.3 Documentation to be submitted
        • A 5.18.4 Assessment Procedure and Renewal Decision
          • A 5.18.4.1 Deadline for Submission of the Renewal Application
          • A 5.18.4.2 Timetable for the Renewal Assessment
          • A 5.18.4.3 Scope of Assessment
    • A 6 The Centralised Procedure – Process and Details
      • A 6.1 Scope of the Centralised Procedure
        • A 6.1.1 Definition of the Term “New Active Substance”
        • A 6.1.2 Determination of the “Date of Entry into Force of Reg. 726/2004”
        • A 6.1.3 Mandatory Scope of the CP
          • A 6.1.3.1 Definition of the Term “Treatment of a Disease” used in No. 3 of the Annex of Reg. 726/2004
          • A 6.1.3.2 Treatment of AIDS
          • A 6.1.3.3 Treatment of Cancer
          • A 6.1.3.4 Neurodegenerative Diseases
          • A 6.1.3.5 Diabetes
        • A 6.1.4 Optional Scope of the CP
          • A 6.1.4.1 Therapeutic Innovation
          • A 6.1.4.2 Scientific Innovation
          • A 6.1.4.3 Technical Innovation
          • A 6.1.4.4 Interest of Patients
          • A 6.1.4.5 Optional Scope for Generic Medicinal Products of the Reference Medicinal Product authorised by the Community
      • A 6.2 Territorial Scope and Validity Period of a Community Marketing Authorisation
        • A 6.2.1 Territorial Scope
        • A 6.2.2 Validity Period
          • A 6.2.2.1 Principle of Validity of 5 Years
          • A 6.2.2.2 Requirement to Actually Introduce the Authorised Product on the Market
          • A 6.2.2.3 The Exception of 1-Year-Validity Period of Conditional MA, Art. 14 (7) of Reg. 726/2004
          • A 6.2.2.4 Validity Period of a MA granted Subject to the Requirement for the Applicant to introduce Specific Procedures, Art. 14 (8) of Reg. 726/2004
      • A 6.3 Condition for Filing the Application - Applicant Must be Established in the European Economic Area
      • A 6.4 Marketing Authorisation Procedure
        • A 6.4.1 Pre-Submission Procedure
          • A 6.4.1.1 Letter of Intent to Submit an Application for Marketing Authorisation – Request for a Pre-Submission Meeting
          • A 6.4.1.2 Application for Eligibility of the Optional Scope of the CP
          • A 6.4.1.3 Multiple Applications
          • A 6.4.1.4 Acceptability of an Invented Name
            • A 6.4.1.4.1 The Invented Name Review Group (NRG)
            • A 6.4.1.4.2 EMA Procedure for identifying Difficulties with Invented Names
            • A 6.4.1.4.3 Criteria for Acceptability of Proposed Invented Names
            • A 6.4.1.4.4 Post-Authorisation Issues
          • A 6.4.1.5 Three Months before Submission
          • A 6.4.1.6 Fees Payable to the EMA
        • A 6.4.2 Submission and Validation of the Application
          • A 6.4.2.1 Documentation to be provided
          • A 6.4.2.2 Submission of Mock-Ups and Specimen
          • A 6.4.2.3 Validation Procedure at the EMA
        • A 6.4.3 Contact Points for the Applicant at the EMA
        • A 6.4.4 Tasks of CHMP, Rapporteur and Co-Rapporteur
        • A 6.4.5 Requirements for Marketing Authorisation
          • A 6.4.5.1 Quality
            • A 6.4.5.1.1 Information relating to the Manufacture and Batch Release
            • A 6.4.5.1.2 Pre-Authorisation GMP-Inspections
            • A 6.4.5.1.3 Analysis of Samples
          • A 6.4.5.2 Efficacy
          • A 6.4.5.3 Safety
        • A 6.4.6 Procedure for CHMP-Opinion
          • A 6.4.6.1 Duration of the Evaluation
          • A 6.4.6.2 Preliminary Assessment Report and Request for Additional Information
          • A 6.4.6.3 Submission of Responses and Oral Explanation
          • A 6.4.6.4 Voting in CHMP
          • A 6.4.6.5 Favourable CHMP Opinion
          • A 6.4.6.6 Negative CHMP Opinion - Appeal Procedure
          • A 6.4.6.7 Transmission of the Opinion to the Commission
        • A 6.4.7 Withdrawal of Marketing Authorisation Application
          • A 6.4.7.1 Art. 11 and Art. 80 of Reg. 726/2004
          • A 6.4.7.2 Reflection Paper on the “Publication of Withdrawals of Marketing Authorisation Applications for Human Medicinal Products”
          • A 6.4.7.3 Withdrawal Public Assessment Report
      • A 6.5 Decision Making Procedure
        • A 6.5.1 Draft of the Commission Decision
        • A 6.5.2 Participation of the Standing Committee on Medicinal Products for Human Use
          • A 6.5.2.1 Different Procedures laid down in the Council Decision No. 1999/468/EC
          • A 6.5.2.2 The Standing Committee – Composition and Rules of Procedure
            • A 6.5.2.2.1 Composition
            • A 6.5.2.2.2 Written Procedure
            • A 6.5.2.2.3 Voting in the Committee
            • A 6.5.2.2.4 Negative Opinion
        • A 6.5.3 Important New Questions of a Scientific or Technical Nature raised by Member State’s Observations
        • A 6.5.4 Adoption of a Commission Decision
      • A 6.6 Accelerated Procedure, Art. 14 (9) of Reg. 726/2004
        • A 6.6.1 Request for Accelerated Procedure
        • A 6.6.2 Procedure as Provided for in CPMP/495/96 rev. 1
        • A 6.6.3 Criteria for Qualification
      • A 6.7 Marketing Authorisation Granted under Conditions
        • A 6.7.1 Conditional MA according to Art. 14 (7) of Reg. 726/2004
          • A 6.7.1.1 Scope of Applicability of the Conditional MA
          • A 6.7.1.2 Request for Conditional MA
          • A 6.7.1.3 Criteria for Granting a Conditional MA
          • A 6.7.1.4 Evaluation Procedure
          • A 6.7.1.5 Renewal
          • A 6.7.1.6 Further Provisions
        • A 6.7.2 MA granted Subject to Conditions and Restrictions for the Safe and Effective Use according to Art. 14 (8) of Reg. 726/2004
          • A 6.7.2.1 Definition of “Exceptional Circumstances“ in the Sense of Art . 14 (8) of Reg. 726/2004
          • A 6.7.2.2 Obligations which may be imposed on the MAH
          • A 6.7.2.3 Validity of the MA
        • A 6.7.3 Follow-up Measures
          • A 6.7.3.1 Processing of Post-Approval Commitments
          • A 6.7.3.2 Handling of Annual Re-Assessment
        • A 6.7.4 Restrictions on the Supply of the Medicinal Product
      • A 6.8 Suspension, Revocation, Withdrawal or Variation of a Community Marketing Authorisation
        • A 6.8.1 Conditions for Suspension, Revocation, Withdrawal or Variation of a Community MA
        • A 6.8.2 Burden of Proof for the Grounds of Suspension, Withdrawal, Revocation or Variation of the Community MA
        • A 6.8.3 Procedure
        • A 6.8.4 The Right to be Heard for the MAH
      • A 6.9 Publication of the Marketing Authorisation
      • A 6.10 The European Public Assessment Report (EPAR)
      • A 6.11 Transfer of the Marketing Authorisation
        • A 6.11.1 Transfer Application and Necessary Documents
        • A 6.11.2 Procedure and Effective Date
      • A 6.12 Renewal of a Community Marketing Authorisation
        • A 6.12.1 Principles
        • A 6.12.2 Documentation to be submitted
        • A 6.12.3 Assessment Procedure and Renewal Decision
          • A 6.12.3.1 Deadline for Submission of the Renewal Application
          • A 6.12.3.2 Timetable for the Renewal Assessment
          • A 6.12.3.3 Scope of Assessment
          • A 6.12.3.4 CHMP Opinion – Request for Re-Examination in Case of an Unfavourable Opinion
          • A 6.12.3.5 Submission of Amended Product Information
          • A 6.12.3.6 Additional 5-Year Renewal
        • A 6.12.4 Renewal of MA granted under Exceptional Circumstances, Art. 14 (8) of Reg. 726/2004
      • A 6.13 Financial Penalties for Infringement of Certain Obligations Resulting from Community Marketing Authorisations
        • A 6.13.1 Principles of Financial Penalties
          • A 6.13.1.1 Catalogue of Obligations/ Infringements
          • A 6.13.1.2 Kinds and Amounts of Financial Penalties
          • A 6.13.1.3 Principles Governing Quantification of Financial Penalties
          • A 6.13.1.4 Principles Governing the Infringement Procedure, Time-Limits
        • A 6.13.2 Infringement Procedure
          • A 6.13.2.1 Initiation of the Infringement Procedure - Stage of Inquiry
          • A 6.13.2.2 Decision-Making Stage
    • A 7 Quality – Required Documentation
    • A 8 Non-clinical Studies – Required Documentation
    • A 9 Clinical Trials - Required Documentation
      • A 9.1 Summary
      • A 9.2 The Objective of Clinical Trials
      • A 9.3 Annex 1 of the Amended Directive 2001/83/EC
      • A 9.4 Directive 2001/20/EC on Clinical Trials
        • A 9.4.1 Subjects
          • A 9.4.1.1 Minors as Subjects
          • A 9.4.1.2 Subjects not Able to Give Informed Legal Consent
        • A 9.4.2 Request for Authorisation before Commencement of a Clinical Trial
          • A 9.4.2.1 Ethics Committee
            • A 9.4.2.1.1 Time Frames for the Ethics Committee
            • A 9.4.2.1.2 Single Opinions
            • A 9.4.2.1.3 Application for a Favourable Opinion
          • A 9.4.2.2 Competent Authority
            • A 9.4.2.2.1 Time Frames for the Authority
            • A 9.4.2.2.2 Request for Authorisation of a Clinical Trial
        • A 9.4.3 Filing an Application for Substantial Amendments
        • A 9.4.4 Notification of the End of a Clinical Trial
        • A 9.4.5 Suspension of the Trial
        • A 9.4.6 Exchange of Information
        • A 9.4.7 Manufacture and Import of Investigational Medicinal Products
          • A 9.4.7.1 Good Manufacturing Practice
        • A 9.4.8 Notification of Adverse Events and Adverse Reactions
          • A 9.4.8.1 Reporting Obligations of the Investigator
          • A 9.4.8.2 Reporting Obligations of the Sponsor
        • A 9.4.9 Verification of Compliance with GCP and GMP and Archiving
      • A 9.5 Important Links
    • A 10 Variations - Provisions and Procedure
      • A 10.1 Legal Basis and Development of Regulations
      • A 10.2 Marketing Authorisations to which the Regulations are Applicable
        • A 10.2.1 Commission Reg. 1084/03/EC
        • A 10.2.2 Commission Reg. 1085/03/EC
      • A 10.3 Definition of "Variation" and Types of Variations
        • A 10.3.1 General Definition of "Variation"
        • A 10.3.2 Types of Variations
          • A 10.3.2.1 Minor Variations of Type IA or IB
          • A 10.3.2.2 Major Variations of Type II
          • A 10.3.2.3 Urgent Safety Restrictions (USR)
      • A 10.4 Changes to Marketing Authorisations which are not Variations in the Sense of the Variation Regulations
        • A 10.4.1 Line Extensions
        • A 10.4.2 Changes to an Aspect of the Labelling or Package Leaflet which do not result in a Change of the SPC
      • A 10.5 Variation Procedures
        • A 10.5.1 Variation Procedures for National MAs according to Reg. No. 1084/03/EC
          • A 10.5.1.1 Allocation of the Mutual Recognition Variation Number (MRVNo)
          • A 10.5.1.2 Notification Procedure for Minor Variations of Type IA
          • A 10.5.1.3 Notification Procedure for Minor Variations of Type IB
          • A 10.5.1.4 Approval Procedure for Major Variations Type II
          • A 10.5.1.5 Procedure for Urgent Safety Restrictions (USR)
        • A 10.5.2 Variation Procedures for Community MAs according to Reg. No. 1085/03/EC
          • A 10.5.2.1 General Approach
          • A 10.5.2.2 Notification Procedure for Minor Variations of Type IA
          • A 10.5.2.3 Notification Procedure for Minor Variations of Type IB
          • A 10.5.2.4 Approval Procedure for Major Variations Type II
          • A 10.5.2.5 Procedure for USR
      • A 10.6 Procedure for Variations to the Terms of a Marketing Authorisation for Human Influenza Vaccines
        • A 10.6.1 Human Influenza Procedure for Variations to National MA
        • A 10.6.2 Human Influenza Procedure for Variations to Community MA
      • A 10.7 New Commission Regulation (EC) No. 1234/2008 Resulting from "EU Better Regulation Strategy"
        • A 10.7.1 Structure and Scope of the New Variations Regulation
        • A 10.7.2 Definitions Contained in the New Commission Regulation
        • A 10.7.3 Classification and Grouping of Variations
        • A 10.7.4 Variation Procedures and Timeframes for Implementation
          • A 10.7.4.1 "Do and Tell"-Procedure for Minor Variations of Type IA
          • A 10.7.4.2 Notification Procedure for Minor Variations of Type IB
          • A 10.7.4.3 Prior Approval Procedure for Major Variations of Type II
          • A 10.7.4.4 Extension Applications
          • A 10.7.4.5 Urgent Safety Restrictions
        • A 10.7.5 Worksharing Procedure
    • A 11 Pharmacovigilance - Requirements for Medicinal Products for Human Use
      • A 11.1 Summary
      • A 11.2 Definitions
        • A 11.2.1 The Term "Pharmacovigilance" / Responsibilities of Member States and of the Marketing Authorisation Holder
        • A 11.2.2 Other Legal Definitions
        • A 11.2.3 Further "Soft-Legal" Definitions on EU Level
      • A 11.3 "Pharmacovigilance Guide" with Interpretation of Directive 2001/83/EC and of Regulation (EEC) 2309/93
      • A 11.4 ICH: New Developments Relating to Pharmacovigilance and their Implementation in European Legislation
      • A 11.5 Notification of Cases of Suspected Adverse Reactions to the Authorities: "Individual Case Safety Reporting - ICSR" (Expedited Reports)
        • A 11.5.1 Suspected Cases occurring in the Territory of the EU and EEA (Spontaneous Reports)
        • A 11.5.2 Suspected Cases occurring in the Territory of a Third Country, i. e. Outside the EU
        • A 11.5.3 Notification of Suspected Unexpected Non-Serious Adverse Reactions
        • A 11.5.4 Adverse Reactions occurring in Post-Authorisation Studies, including Phase IV Clinical Trials
        • A 11.5.5 EudraVigilance and the Implementation of Electronic Transmission of Individual Case Safety Reports (ICSR)
          • A 11.5.5.1 Electronic Reporting to the EudraVigilance Database
      • A 11.6 Periodic Safety Update Reports (PSUR)
        • A 11.6.1 Rules in the EU since 1995
        • A 11.6.2 Objectives of the PSUR
        • A 11.6.3 Structure and Content of the PSUR
        • A 11.6.4 Time Frames for Reporting
        • A 11.6.5 Defining the "Birth Date"
        • A 11.6.6 PSUR for Known Substances
      • A 11.7 Appointment and Responsibilities of a "Responsible Qualified Person" (Person Responsible for Pharmacovigilance)
      • A 11.8 Studies for Evaluating Risks During the Post-Authorisation Period
      • A 11.9 Benefit-Risk Assessment During the Post-Authorisation Period
      • A 11.10 Regulations Concerning Variations and Containing Provisions Relating to Urgent Safety Restrictions (USR)
      • A 11.11 Validity of the EU Regulations Concerning Pharmacovigilance as from the Granting of a Marketing Authorisation
      • A 11.12 EU Risk Procedure
        • A 11.12.1 Procedure according to Article 31 of Directive 2001/83/EC
        • A 11.12.2 National Implementation
        • A 11.12.3 Risk Procedures outside Article 31
        • A 11.12.4 Pharmacovigilance Working Party of the CHMP
      • A 11.13 Rapid Information System in the Field of Pharmacovigilance
        • A 11.13.1 Criteria for Rapid Alert (Pharmacovigilance)
        • A 11.13.2 Procedure for Rapid Alert (Pharmacovigilance)
      • A 11.14 Responsibilities of the Regulatory Authorities with Respect to Pharmacovigilance
      • A 11.15 Pharmacovigilance – Inspections
        • A 11.15.1 New Regulations in Directive 2001/83/EC
        • A 11.15.2 Position Paper on Compliance with Pharmacovigilance Regulatory Obligations
      • A 11.16 Information to the Public
      • A 11.17 Important Links
    • A 12 Parallel Importation and Parallel Distribution
      • A 12.1 Introduction
      • A 12.2 Parallel Importation
        • A 12.2.1 Regulatory Aspect
          • A 12.2.1.1 ECJ Jurisdiction
            • A 12.2.1.1.1 ECJ Case "De Peijper"
            • A 12.2.1.1.2 ECJ Case “Cassis de Dijon”
            • A 12.2.1.1.3 ECJ Case "Smith & Nephew"
            • A 12.2.1.1.4 Further Development of ECJ Jurisdiction
            • A 12.2.1.1.5 Summary of Requirements according to ECJ Jurisdiction
          • A 12.2.1.2 Procedure for Parallel Import Licence - Simplified Licence and "Essential Similarity"
            • A 12.2.1.2.1 Commission Communication of 1982
            • A 12.2.1.2.2 Commission Communication of 2003
        • A 12.2.2 Violation of Trademark Rights
          • A 12.2.2.1 ECJ Case "Hoffmann-La Roche/ Centrafarm"
          • A 12.2.2.2 Subsequent Development of ECJ Jurisdiction
            • A 12.2.2.2.1 Artificial Partitioning of the Market between MS
            • A 12.2.2.2.2 Adverse Effect on the Original Condition of the Product
            • A 12.2.2.2.3 Repackaging must not damage the Reputation of the Trademark
            • A 12.2.2.2.4 Prior Notice
            • A 12.2.2.2.5 Information on the New Packaging
      • A 12.3 Specific Mechanism - Exception from the Rule of Exhaustion of Intellectual Property Rights, Especially Specific Mechanism for the Exhaustion of Patent / Supplementary Patent Certification Rights
      • A 12.4 Parallel Distribution
        • A 12.4.1 Mandatory Notification to the EMA
        • A 12.4.2 Notification Procedure
          • A 12.4.2.1 Documents to be submitted
          • A 12.4.2.2 Timeframe
          • A 12.4.2.3 Special Points of Interest
        • A 12.4.3 ECJ Case "Aventis Pharma Deutschland / Kohlpharma and MTK"
    • A 13 Advertising Law
      • A 13.1 Introduction - Directive (EEC) 92/28
      • A 13.2 Definition of "Advertising of Medicinal Products"
      • A 13.3 General Prohibitions and Obligations
      • A 13.4 Advertising to the General Public
        • A 13.4.1 Medicinal Products for which Advertising to the General Public is Allowed
        • A 13.4.2 Obligations Related to Advertising to the General Public
        • A 13.4.3 Prohibitions Related to Advertising to the General Public
      • A 13.5 Advertising to Persons Qualified to Prescribe or Supply Medicinal Products
        • A 13.5.1 Minimum Information
        • A 13.5.2 Quotations, Tables and Illustrative Matters
      • A 13.6 Advertising which is Intended Solely as a Reminder
      • A 13.7 Medical Sales Representatives
      • A 13.8 Free Samples
      • A 13.9 Gifts, Benefits, Inducements and Hospitality
      • A 13.10 Vaccination Campaigns
      • A 13.11 Monitoring of Advertising
        • A 13.11.1 Scientific Service and Obligations of MAH
        • A 13.11.2 Obligation for Member States
    • A 14 Classification of Medicinal Products for Human Use
      • A 14.1 Introduction
      • A 14.2 General Principles
      • A 14.3 Supply Subject to Medical Prescription
        • A 14.3.1 Criteria for Classification Subject to Medical Prescription
          • A 14.3.1.1 Danger, even in Case of Correct Use, if Used without Prescription
          • A 14.3.1.2 Substances which Require Further Investigations
        • A 14.3.2 Sub-Categories of Prescription
        • A 14.3.3 Exemptions
      • A 14.4 Supply without Medical Prescription
      • A 14.5 "Switch" of Classification
      • A 14.6 Member States Obligations
    • A 15 EU Jurisdiction
      • A 15.1 European Courts Competent in European Pharmaceutical Law
        • A 15.1.1 European Court of Justice (ECJ)
        • A 15.1.2 Court of First Instance (CFI)
      • A 15.2 System of Legal Actions Applicable to the European Marketing Authorisation System
        • A 15.2.1 Overview
        • A 15.2.2 Action for Annulment, Art. 230 (4) of the EC-Treaty
          • A 15.2.2.1 Acts of Institutions
          • A 15.2.2.2 Right to bring Action to the Court
          • A 15.2.2.3 Exclusivity of Reasons on which the Action may be based
          • A 15.2.2.4 Deadlines for Submission of Action for Annulment
          • A 15.2.2.5 Consequences if Action is Well-Founded
        • A 15.2.3 Action for Failure to Act
          • A 15.2.3.1 General Principles
          • A 15.2.3.2 Request to Act
          • A 15.2.3.3 Failure of Response to the Request
          • A 15.2.3.4 Deadline for Submission of the Action for Failure to Act
        • A 15.2.4 Interim Measures
          • A 15.2.4.1 System of Interim Measures
          • A 15.2.4.2 Requirements for the Request for Interim Measures
        • A 15.2.5 References for Preliminary Ruling, Art. 234 of the EC-Treaty
        • A 15.2.6 Claim for Damages, Art. 288 and Art. 235 of the EC-Treaty
      • A 15.3 Decisions in Marketing Authorisation Procedures and Legal Remedies
        • A 15.3.1 Decisions in the Centralised Procedure
          • A 15.3.1.1 Action for Annulment against Commission Decisions in the Centralised Procedure
        • A 15.3.2 Decisions in the MRP/DCP
        • A 15.3.3 Decisions according to the Orphan Drug Regulation
          • A 15.3.3.1 Decision Addressed to the Applicant or Holder of the Orphan Designation/ Orphan Status
          • A 15.3.3.2 Actions of Competitors to Holders of Orphan Designations/ Orphan Status
      • A 15.4 Essential Jurisdiction of the European Court of Justice and the Court of First Instance in European Pharmaceutical Law
        • A 15.4.1 Definition of Medicinal Products – Classification – Member States’ Competences
        • A 15.4.2 Grounds for Suspension, Withdrawal or Revocation of a MA
        • A 15.4.3 Bibliographical Application
        • A 15.4.4 Generic Application
        • A 15.4.5 Advertising
        • A 15.4.6 Application for Annulment of a Commission Decision
        • A 15.4.7 Actions for Failure to Act
        • A 15.4.8 Parallel Importation
        • A 15.4.9 Member States’ Competences to adopt Measures in Relation to the Medicinal Products
    • B 1 Marketing Authorisation Application - Legal Requirements and General Aspects
      • B 1.1 EU Pharmaceutical Legislation - EudraLex
        • B 1.1.1 Legally Binding Pharmaceutical Legislation and Soft Law
        • B 1.1.2 Notice to Applicants for Medicinal Products for Human Use
        • B 1.1.3 Scientific Guidelines Related to Quality, Safety and Efficacy
      • B 1.2 Marketing Authorisation
        • B 1.2.1 Validity and Cessation of a Marketing Authorisation
      • B 1.3 Marketing Authorisation Procedures and Community Referrals
      • B 1.4 Application Types
      • B 1.5 Application for a Marketing Authorisation - CTD Format
    • B 2 General Information about the Common Technical Document (CTD)
      • B 2.1 General Aspects of the Harmonised Common Technical Document (CTD)
      • B 2.2 International Development and Harmonisation of Dossier Format - Historical Milestones
      • B 2.3 Activities of ICH
      • B 2.4 Format and Structure of the CTD
      • B 2.5 Advantages of the CTD
      • B 2.6 Implementation of the ICH-CTD Document in Europe
      • B 2.7 Correlation Table EU-CTD versus EU Dossier (1998)
    • B 3 Administrative and Prescribing Information (Module 1 EU-CTD)
      • B 3.1 Module 1 CTD - General Information
        • B 3.1.1 Languages to be Used and Number of Copies of the Dossier
        • B 3.1.2 Delivery Addresses for Dossiers and Correspondence
        • B 3.1.3 Official Journals of EU Member States, the EMA and the EFTA Member States
      • B 3.2 Table of Contents and Requirements for the Regional Administrative Information in Module 1 CTD
      • B 3.3 How to Fill in the Application Form
    • B 4 Common Technical Document Summaries (Module 2 EU-CTD)
      • B 4.1 Module 2 CTD - Common Technical Document Summaries - General Aspects
        • B 4.1.1 Table of Contents
        • B 4.1.2 Module 2 Introduction
        • B 4.1.3 Quality Overall Summary (QOS)
        • B 4.1.4 Non-clinical Overview
        • B 4.1.5 Clinical Overview
        • B 4.1.6 Non-clinical Summary
        • B 4.1.7 Clinical Summaries
    • B 5 Quality of Drug Substance and Drug Product (Module 3 EU-CTD)
      • B 5.1 Necessary Data to be Presented by the Applicant in Module 3 CTD
      • B 5.2 Quality of Drug Substance
        • B 5.2.1 Requirements of CTD Module 3.2 S - Drug Substance
        • B 5.2.2 European Certificate of Suitability to the Monograph of the European Pharmacopoeia (CEP)
        • B 5.2.3 Active Substance Master File (ASMF)
        • B 5.2.4 Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) or Active Substance Master File (ASMF) - A Comparison
      • B 5.3 Quality of Drug Product - Requirements of CTD Module 3.2.P
      • B 5.4 List of EU Legislation
      • B 5.5 Compilation of a Quality Dossier - What has to be Considered*
        • B 5.5.1 Definition of a Quality Document
        • B 5.5.2 Document Pagination and Segregation
        • B 5.5.3 Table of Contents and Formatting
        • B 5.5.4 When can Separate or Repeated Sections be Appropriate?
        • B 5.5.5 Multiple Containers and Multiple Strenghts
        • B 5.5.6 Bioanalytical Methods
        • B 5.5.7 Multiple Links between Different Sections
        • B 5.5.8 Checklist for CTD-Module 3
        • B 5.5.9 Evaluation of Chemical, Pharmaceutical and Biological Documentation for Chemical Active Substance(s) and Biological Medicinal Products*
      • B 5.6 Frequently Observed Deficiencies
    • B 6 Non-Clinical Study Reports (Module 4 EU-CTD)
      • B 6.1 Non-clinical Study Reports - General Aspects
        • B 6.1.1 Basic Principles and Requirements
        • B 6.1.2 Requirements for and Organisation of "Non-clincial Studies" According to Module 4 CTD
      • B 6.2 Different Kinds of Non-clinical Study Reports (CTD Section 4.2) - General Aspects
        • B 6.2.1 Pharmacology
        • B 6.2.2 Pharmacokinetics
        • B 6.2.3 Toxicology
          • B 6.2.3.1 Single Dose Toxicology
          • B 6.2.3.2 Repeat-Dose Toxicology
          • B 6.2.3.3 Genotoxicity
          • B 6.2.3.4 Carcinogenicity
          • B 6.2.3.5 Reproductive and Developmental Toxicity
          • B 6.2.3.6 Local Tolerance
          • B 6.2.3.7 Other Toxicity Studies
      • B 6.3 List of References for Non-Clinical Guidelines
    • B 7 Clinical Study Reports (Module 5 EU-CTD)
      • B 7.1 Clinical Study Reports - General Aspects and GCP Requirements
        • B 7.1.1 Phases of Clinical Development (Phase I-IV) - An Overview
          • B 7.1.1.1 Clinical Trials Phase I
          • B 7.1.1.2 Clinical Trials Phase II
          • B 7.1.1.3 Clinical Trials Phase III
          • B 7.1.1.4 Clinical Trials Phase IV
      • B 7.2 Prerequisites for Conducting Clinical Studies
        • B 7.2.1 Request for an Authorisation of a Clinical Trial
      • B 7.3 Dossier Requirements for Clinical Trials - General Aspects
        • B 7.3.1 Compilation of a Single Core Clinical Study Report Acceptable to all Regulatory Authorities of the ICH Regions
          • B 7.3.1.1 General Requirements for the Study Protocol
        • B 7.3.2 Requirements for an Organisation of Clinical Study Reports According to Module 5 CTD
        • B 7.3.3 Different Kinds of Clinical Study Reports (CTD Section 5.3) - General Aspects
          • B 7.3.3.1 Reports on Biopharmaceutic Studies (Bioavailability and Bioequivalence)
            • B 7.3.3.1.1 Bioavailability (BA) Study Reports
            • B 7.3.3.1.2 Comparative Bioavailability (BA) and Bioequivalence (BE) Study Reports
              • B 7.3.3.1.2.1 Particularities for Modified Release Products
              • B 7.3.3.1.2.2 Proving Bioequivalence for Several Strengths of a Dosage Form
              • B 7.3.3.1.2.3 ‘Biowaiver’
            • B 7.3.3.1.3 In vitro-In vivo Correlation Study Reports
            • B 7.3.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies
            • B 7.3.3.1.5 Frequently asked Questions and Deficiencies in Biopharmaceutical Study Reports
          • B 7.3.3.2 Reports of Human Pharmacokinetic (PK) Studies
          • B 7.3.3.3 Reports on Human Pharmacodynamic (PD) Studies
          • B 7.3.3.4 Efficacy and Safety Studies
          • B 7.3.3.5 Reports of Post-Marketing Experience
          • B 7.3.3.6 Case Report Forms and individual Patient Listings
          • B 7.3.3.7 Literature References in Module 5 CTD
        • B 7.3.4 Pharmacovigilance
      • B 7.4 Other Useful Information
        • B 7.4.1 List of References to Clinical Studies
        • B 7.4.2 Requirements for Clinical Studies - Checklist
        • B 7.4.3 Classification of Medicinal Products with Examples
    • B 8 Variations to the Terms of a Marketing Authorisation
      • B 8.1 Classification of Variations
        • B 8.1.1 Minor Variation of Type IA and IB
        • B 8.1.2 Major Variation of Type II
        • B 8.1.3 Extension Applications
        • B 8.1.4 Urgent Safety Restrictions
      • B 8.2 Grouping of Variations
      • B 8.3 Worksharing Procedure
      • B 8.4 Application Form for a Variation to a Marketing Authorisation
      • B 8.5 Variations - Guidelines and References
    • B 9 Regulatory Compliance
      • B 9.1 Practical Aspects of Regulatory Compliance
    • B 10 Investigational Medicinal Product Dossier (IMPD)
      • B 10.1 Commencement of Clinical Trials
        • B 10.1.1 Requesting a Clinical Trial Authorisation (CTA)
        • B 10.1.2 Requesting an Opinion of the Ethics Committee
        • B 10.1.3 Notification of Amendments
        • B 10.1.4 Declaration of the End of the Clinical Trial
      • B 10.2 Investigational Medicinal Product (IMP) Related Data
        • B 10.2.1 Investigational Medicinal Product Dossier (IMPD)
          • B 10.2.1.1 Quality Data - Structure and Content of the Chemical and Pharmaceutical Quality Documentation
            • B 10.2.1.1.1 Changes to IMP Quality Data
          • B 10.2.1.2 Non-clinical Pharmacology and Toxicology Data
          • B 10.2.1.3 Previous Clinical Data (including Overall Risk and Benefit Assessment)
        • B 10.2.2 Simplified Investigational Medicinal Product Dossier (IMPD)
        • B 10.2.3 Comparator and Placebo Preparations
      • B 10.3 GMP Requirements for Investigational Medicinal Products (IMP) and Active Pharmaceutical Ingredients (APIs) for Use in Clinical Trials
    • B 11 Special Considerations for Marketing Authorisation Applications in Switzerland
      • B 11.1 Marketing Authorisation Application in Switzerland
        • B 11.1.1 Procedures for Marketing Authorisation Application in Switzerland
        • B 11.1.2 Chronology of the Authorisation Procedure
      • B 11.2 Regional Part of the Marketing Authorisation Application Submitted to Swissmedic
      • B 11.3 Handling Variations in Switzerland
        • B 11.3.1 Notifications
        • B 11.3.2 Approvable Variations
        • B 11.3.3 Essential Changes Resulting in a New Licence
    • B 12 GxP
      • B 12.1 Good Regulatory Practices (GRP)
     BOX_INFORMATION_DRAECTD 
    • C 1 Blood and Blood Products - Special Requirements
      • C 1.1 Definition of “Medicinal Product Derived from Human Blood or Human Plasma” and Applicable Provisions
      • C 1.2 Development of Special Provisions
        • C 1.2.1 Directive 89/381/EC
        • C 1.2.2 Directive 2002/98/EC and Implementing Directives
      • C 1.3 Details of Directive 2002/98/EC
        • C 1.3.1 Scope and Definitions
        • C 1.3.2 Provisions Relating to Blood Establishments
          • C 1.3.2.1 Principle of Prior Authorisation - Requirement of Designation, Authorisation, Accreditation or Licensing – Member States’ Obligations, Chapter II
          • C 1.3.2.2 Designation of a "Responsible Person", Art. 9
          • C 1.3.2.3 Quality System, Arts. 11 - 24; Directive 2005/62
          • C 1.3.2.4 Documentation
          • C 1.3.2.5 Haemovigilance: Traceability and Notification of Serious Adverse Events and Reactions, Arts. 14 and 14; Directive 2005/61/EC
            • C 1.3.2.5.1 Principle of Traceability
            • C 1.3.2.5.2 Notification of Serious Adverse Events and Serious Adverse Reactions
        • C 1.3.3 Provisions to ensure the Quality and Safety of Blood and Blood Components
          • C 1.3.3.1 Donors - Arts. 16 - 29; Directive 2004/33/EC
          • C 1.3.3.2 Testing of Donations, Art. 21
        • C 1.3.4 Provisions for Importation of Blood and Blood Components
        • C 1.3.5 Inspections, Suspension and Revocation, Penalties
        • C 1.3.6 Hospital Blood Banks
        • C 1.3.7 Plasma Master File
    • C 2 Advanced Therapy Medicinal Products
      • C 2.1 Actual Legal Provisions for Advanced Therapy Medicinal Products
        • C 2.1.1 Part IV of the Annex of Dir. 2001/83/EC
          • C 2.1.1.1 Gene Therapy Medicinal Product
          • C 2.1.1.2 Somatic Cell Therapy Medicinal Products
          • C 2.1.1.3 Safety and Efficacy Issues
        • C 2.1.2 Standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells, Directive 2004/23/EC
          • C 2.1.2.1 Accreditation, Designation, Authorisation or Licensing of Tissue Establishments and Tissue and cell Preparation Processes – Supervision and Inspections
          • C 2.1.2.2. Traceability
          • C 2.1.2.3 Obligations of Data Storage and Reporting – Serious Adverse Events and Reactions
          • C 2.1.2.4 Quality Management and Handling of Tissues and Cells
          • C 2.1.2.5 Donor Selection and Evaluation
          • C 2.1.2.6 Import and Export of Human Tissue and Cells
          • C 2.1.2.7 Transposition into National Law
      • C 2.2 Commission´s Approach to Harmonise Legislation on Advanced Therapy Medicinal Products
        • C 2.2.1 Committee for Advanced Therapies (CAT)
        • C 2.2.2 Definition of "Advanced Therapy Medicinal Product"
        • C 2.2.3 Essential Principles
    • C 3 Radioactive Medicinal Products - Radiopharmaceuticals
      • C 3.1 Council Directive 89/343/EEC
        • C 3.1.1 Definitions
        • C 3.1.2 Scope of Application
        • C 3.1.3 Principle of Prior Authorisation
        • C 3.1.4 Additional Requirements for Applications, SPC, Labelling and Package Leaflet
      • C 3.2 Additional Requirements for Applications, SPC, Labelling and Package Leaflet
        • C 3.2.1 Definitions, Scope of Application and Principle of Prior Authorisation
        • C 3.2.2 Additional Documentation to be Included in the Application for Radionuclide Generators, Art. 9 of the Community Code
        • C 3.2.3 Additional Information Contained in the SPC, Art. 11 no. 11 and 12 of the Community Code
        • C 3.2.4 Additional Requirements for Labelling and Package Leaflet
          • C 3.2.4.1 Labelling
          • C 3.2.4.2 Package Leaflet
        • C 3.2.5 Provisions of the Annex to the Community Code
      • C 3.3 Euratom Requirements
        • C 3.3.1 Council Directive 97/43/Euratom on Health Protection in Relation to Medical Exposure
          • C 3.3.1.1 Scope of the Directive
          • C 3.3.1.2 Principles and Definitions
        • C 3.3.2 Council Directive 96/29/Euratom on Basic Safety Standards for the Protection of the Health of Workers and the General Public against the Dangers arising from Ionizing Radiation
        • C 3.3.3 Council Regulation (Euratom) No 1493/93 of 8 June 1993 on Shipments of Radioactive Substances between Member States
    • C 4 Orphan Medicinal Products
      • C 4.1 Texts Governing Orphan Medicinal Products
        • C 4.1.1 European Parliament and Council Regulation No. 141/2000 of 16 December 1999
        • C 4.1.2 Commission Regulation No. 847/2000 of 27 April 2000
        • C 4.1.3 Guidance Documents
        • C 4.1.4 Commission Communication 2003/C 178/02
      • C 4.2 Orphan Designation and Orphan Status – Applicable Marketing Authorisation Procedure
        • C 4.2.1 Orphan Designation and Orphan Status as a Two-Step Procedure
        • C 4.2.2 Application of the Centralised Procedure
      • C 4.3 Provisions for Orphan Medicinal Products – Definitions
        • C 4.3.1 Definition of “Orphan Medicinal Product”
        • C 4.3.2 "Sponsor"
        • C 4.3.3 Similar Medicinal Products
      • C 4.4 Criteria for Designation
        • C 4.4.1 Treatment of a an Orphan Condition
          • C 4.4.1.1 Medical Plausibility
          • C 4.4.1.2 Life-Threatening or Debilitating Nature or Seriously Debilitating or Serious and Chronic Nature of the Condition
          • C 4.4.1.3 Prevalence of the Condition
          • C 4.4.1.4 Potential Return of Investment
        • C 4.4.2 Existence of Other Methods
          • C 4.4.2.1 No Satisfactory Method Authorised in the Community
          • C 4.4.2.2 Significant Benefit
      • C 4.5 Designation Procedure
        • C 4.5.1 Time of Application – Submission before a MA has been applied for
        • C 4.5.2 Different Stages of Procedure
          • C 4.5.2.1 Planning of the ODDA
            • C 4.5.2.1.1 Deadlines for Submission
            • C 4.5.2.1.2 Pre-Submission Activities
            • C 4.5.2.1.3 Preparation of the Application
          • C 4.5.2.2 Submission of the Application
          • C 4.5.2.3 Validation and Evaluation Phase
          • C 4.5.2.4 COMP Opinion
          • C 4.5.2.5 Adoption of the Decision on Orphan Designation
          • C 4.5.2.6 Negative COMP Opinion
      • C 4.6 Annual Report
      • C 4.7 Removal from the Register
      • C 4.8 Market Exclusivity and Further Incentives
        • C 4.8.1 Scope of the Market Exclusivity
          • C 4.8.1.1 "Similarity"
          • C 4.8.1.2 Same Therapeutic Indication
        • C 4.8.2 No Marketing Authorisation for a Similar Product
        • C 4.8.3 Procedural Aspects
          • C 4.8.3.1 Application for a Community Authorisation for the 2nd Medicinal Product
          • C 4.8.3.2 Application for a National MA for the 2nd Medicinal Product
          • C 4.8.3.3 Time for Submission of the respective Documentation
        • C 4.8.4 Reduction of Market Exclusivity to 6 Years
          • C 4.8.4.1 Draft Guideline on Aspects of the Application of Article 8 (2) of Reg. 141/2000
          • C 4.8.4.2 Review Procedure of Art. 8 (2) of the Orphan Regulation
        • C 4.8.5 Challenge of Market Exclusivity for "Clinical Superiority"
        • C 4.8.6 Other Incentives
        • C 4.8.7 Transfer of a Designation
    • C 5 Traditional Herbal Medicinal Products - Principles
      • C 5.1 Simplified Procedure – The Traditional-Use Registration (TUR) – Characteristics and Scope
        • C 5.1.1 Subsidiary Character of the TUR
        • C 5.1.2 Restriction to Herbal Medicinal Products
      • C 5.2 Committee for Herbal Medicinal Products (HMPC) – Community Monographs – Community List of Herbal Substances, Preparations and Combinations
        • C 5.2.1 Committee for Herbal Medicinal Products (HMPC)
        • C 5.2.2 Community Herbal Monographs
        • C 5.2.3 Community List of Herbal Substances, Preparations and Combinations
          • C 5.2.3.1 Structure
          • C 5.2.3.2 Documentation to be Submitted
          • C 5.2.3.3 Procedure
      • C 5.3 General Principles
        • C 5.3.1 Establishment within the EEA
        • C 5.3.2 TUR as Requirement for Marketing of Traditional Herbal Medicinal Products
        • C 5.3.3 Application of further Principles by Analogy
        • C 5.3.4 National Procedure, Mutual Recognition and “Due Account”
        • C 5.3.5 Additional Requirements in Relation to Labelling, Package Leaflet and Advertising
      • C 5.4 Criteria for the Eligibility for Traditional-Use Registration (TUR), Art. 16a (1) of the Community Code
        • C 5.4.1 Non-Applicability of Art. 6 or Art. 14 of the Community Code
        • C 5.4.2 Plausibility of Efficacy and Proof of Lack of Harmfulness
        • C 5.4.3 Indications Designed for Use without Supervision of a Medical Practitioner
        • C 5.4.4 Administration Exclusively in Accordance with a Specified Strength and Posology
        • C 5.4.5 Oral, External and/ or Inhalation Preparation
        • C 5.4.6 Period of Traditional Use has Elapsed
      • C 5.5 Definition of Traditional Use
        • C 5.5.1 Period of 30 Years in Medicinal Use, Including at Least 15 Years in the Community
        • C 5.5.2 Requirements for Evidence of Traditional Use
          • C 5.5.2.1 “Medicinal Product in Question”
          • C 5.5.2.2 “Corresponding Product”
          • C 5.5.2.3 Medicinal Use in the Community
          • C 5.5.2.4 Referral to the HMPC
      • C 5.6 Documentation and CTD for Traditional Herbal Medicinal Products
        • C 5.6.1 Catalogue of Documents
        • C 5.6.2 Exceptions
      • C 5.7 Grounds for Refusal – Suspension, Revocation and Withdrawal of a Traditional-Use Registration (TUR)
      • C 5.8 Mutual Recognition
    • D 1 Orphan Medicinal Products / Orphan Drugs
      • D 1.1 General Information about Orphan Medicinal Products
      • D 1.2 Application for Designation as Orphan Medicinal Product (Orphan Drug Designation)
        • D 1.2.1 Common EMA/FDA Application for Orphan Designation for Medicines
      • D 1.3 Marketing Authorisation Application for Orphan Medicinal Products
      • D 1.4 Market Exclusivity and Exemptions from Market Exclusivity for an Orphan Medicinal Product
    • D 2 Paediatric Medicines
      • D 2.1 Introduction
      • D 2.2 Historical Overview
        • D 2.2.1 The EMA Paediatric Working Party
        • D 2.2.2 The Task-Force in Europe for Drug Development for the Young (TEDDY)
        • D 2.2.3 The Legislative Process
      • D 2.3 Regulation 1901/2006/EC as amended
        • D 2.3.1 Key Items of the Regulation
        • D 2.3.2 The Paediatric Committee (PDCO)
        • D 2.3.3 Paediatric Investigation Plan (PIP), Waiver and Deferral
        • D 2.3.4 Incentives and Rewards
        • D 2.3.5 Measures for the Improvement of Data and Information
    • D 3 Advanced Therapy Medicinal Products
      • D 3.1 What are Advanced Therapy Medicinal Products - Definition
      • D 3.2 Key Items of the Advanced Therapies Regulation
      • D 3.3 Advanced Therapy Medicinal Products - Specific Requirements
        • D 3.3.1 ATMPs - Specific Requirements for the Product Information
        • D 3.3.2 Specific Post-authorisation Requirements
      • D 3.4 ATMPs - Incentives for Applicant and Holder of a Marketing Authorisation
      • D 3.5 Committee for Advanced Therapies (CAT)
      • D 3.6 Advanced Therapies Regulation - A Lex Specialis
        • D 3.6.1 Implementation of the Advanced Therapies' Regulation
      • D 3.7 ATMPs - Dossier Requirements in Directive 2009/120/EC
      • D 3.8 Advanced Therapies´ Regulation - Where to find further Information
    • E 1 Electronic Common Technical Document (eCTD)
      • E 1.1 Electronic Submission - Benefits and Challenges
      • E 1.2 The History of Electronic Submissions - 1985 to today
      • E 1.3 Overview Available Guidelines
        • E 1.3.1 ICH eCTD Specification
        • E 1.3.2 EU Module 1 Specification
        • E 1.3.3 Additional EMA guidelines to eCTD and NeeS
        • E 1.3.4 Use of the eCTD in the Mutual Recognition and Decentralised Procedures
      • E 1.4 Current eCTD Implementation Status in Europe
    • F 1 List of Available Application Forms
    • F 2 Important Webpages