GtDRA online

Decline Chapter C

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

User Name:
Password: