- 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
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