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Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014
On clinical trials on medicinal products for human use,
and repealing Directive 2001/20/EC (Text with EEA relevance)- Recitals
CHAPTER I — GENERAL PROVISIONS- CHAPTER II — AUTHORISATION PROCEDURE FOR A CLINICAL TRIAL
- Article 4 — Prior authorisation
- Article 5 — Submission of an application
- Article 6 — Assessment report — Aspects covered by Part I
- Article 7 — Assessment report — Aspects covered by Part II
- Article 8 — Decision on the clinical trial
- Article 9 — Persons assessing the application
- Article 10 — Specific considerations for vulnerable populations
- Article 11 — Submission and assessment of applications limited to aspects covered by Part I or Part II of the assessment report
- Article 12 — Withdrawal
- Article 13 — Resubmission
- Article 14 — Subsequent addition of a Member State concerned
- CHAPTER III — AUTHORISATION PROCEDURE FOR A SUBSTANTIAL MODIFICATION OF A CLINICAL TRIAL
- Article 15 — General principles
- Article 16 — Submission of application
- Article 17 — Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report
- Article 18 — Assessment of a substantial modification of an aspect covered by Part I of the assessment report
- Article 19 — Decision on the substantial modification of an aspect covered by Part I of the assessment report
- Article 20 — Validation, assessment and decision regarding a substantial modification of an aspect covered by Part II of the assessment report
- Article 21 — Substantial modification of aspects covered by Parts I and II of the assessment report
- Article 22 — Assessment of a substantial modification of aspects covered by Parts I and II of the assessment report — Assessment of the aspects covered by Part II of the assessment report
- Article 23 — Decision on the substantial modification of aspects covered by Parts I and II of the assessment report
- Article 24 — Persons assessing the application for a substantial modification
- CHAPTER IV — APPLICATION DOSSIER
- CHAPTER V — PROTECTION OF SUBJECTS AND INFORMED CONSENT
- Article 28 — General rules
- Article 29 — Informed consent
- Article 30 — Informed consent in cluster trials
- Article 31 — Clinical trials on incapacitated subjects
- Article 32 — Clinical trials on minors
- Article 33 — Clinical trials on pregnant or breastfeeding women
- Article 34 — Additional national measures
- Article 35 — Clinical trials in emergency situations
- CHAPTER VI — START, END, TEMPORARY HALT, AND EARLY TERMINATION OF A CLINICAL TRIAL
- Article 36 — Notification of the start of a clinical trial and of the end of the recruitment of subjects
- Article 37 — End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results
- Article 38 — Temporary halt or early termination by the sponsor for reasons of subject safety
- Article 39 — Update of the contents of the summary of results and summary for laypersons
- CHAPTER VII — SAFETY REPORTING IN THE CONTEXT OF A CLINICAL TRIAL
- Article 40 — Electronic database for safety reporting
- Article 41 — Reporting of adverse events and serious adverse events by the investigator to the sponsor
- Article 42 — Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency
- Article 43 — Annual reporting by the sponsor to the Agency
- Article 44 — Assessment by Member States
- Article 45 — Technical aspects
- Article 46 — Reporting with regard to auxiliary medicinal products
- CHAPTER VIII — CONDUCT OF A CLINICAL TRIAL, SUPERVISION BY THE SPONSOR, TRAINING AND EXPERIENCE, AUXILIARY MEDICINAL PRODUCTS
- Article 47 — Compliance with the protocol and good clinical practice
- Article 48 — Monitoring
- Article 49 — Suitability of individuals involved in conducting the clinical trial
- Article 50 — Suitability of clinical trial sites
- Article 51 — Traceability, storage, return and destruction of investigational medicinal products
- Article 52 — Reporting of serious breaches
- Article 53 — Other reporting obligations relevant for subject safety
- Article 54 — Urgent safety measures
- Article 55 — Investigator's brochure
- Article 56 — Recording, processing, handling and storage of information
- Article 57 — Clinical trial master file
- Article 58 — Archiving of the clinical trial master file
- Article 59 — Auxiliary medicinal products
- CHAPTER IX — MANUFACTURING AND IMPORT OF INVESTIGATIONAL MEDICINAL PRODUCTS AND AUXILIARY MEDICINAL PRODUCTS
- Article 60 — Scope of this Chapter
- Article 61 — Authorisation of manufacturing and import
- Article 62 — Responsibilities of the qualified person
- Article 63 — Manufacturing and import
- Article 64 — Modification of authorised investigational medicinal products
- Article 65 — Manufacturing of auxiliary medicinal products
- CHAPTER X — LABELLING
- Article 66 — Unauthorised investigational and unauthorised auxiliary medicinal products
- Article 67 — Authorised investigational and authorised auxiliary medicinal products
- Article 68 — Radiopharmaceuticals used as investigational medicinal products or as auxiliary medicinal products for a medical diagnosis
- Article 69 — Language
- Article 70 — Delegated act
- CHAPTER XI — SPONSOR AND INVESTIGATOR
- CHAPTER XII — DAMAGE COMPENSATION
- CHAPTER XIII — SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS
- CHAPTER XIV — IT INFRASTRUCTURE
- CHAPTER XV — COOPERATION BETWEEN MEMBER STATES
- CHAPTER XVI — FEES
- CHAPTER XVII — IMPLEMENTING ACTS AND DELEGATED ACTS
- CHAPTER XVIII — MISCELLANEOUS PROVISIONS
- Article 90 — Specific requirements for special groups of medicinal products
- Article 91 — Relation with other Union legislation
- Article 92 — Investigational medicinal products, other products and procedures, free of charge for the subject
- Article 93 — Data protection
- Article 94 — Penalties
- Article 95 — Civil and criminal liability
- CHAPTER XIX — FINAL PROVISIONS
- Final
- ANNEX I — APPLICATION DOSSIER FOR THE INITIAL APPLICATION
- ANNEX II — APPLICATION DOSSIER FOR SUBSTANTIAL MODIFICATION
- ANNEX III — SAFETY REPORTING
- ANNEX IV — CONTENT OF THE SUMMARY OF THE RESULTS OF THE CLINICAL TRIAL
- ANNEX V — CONTENT OF THE SUMMARY OF THE RESULTS OF THE CLINICAL TRIAL FOR LAYPERSONS
- ANNEX VI — LABELLING OF INVESTIGATIONAL MEDICINAL PRODUCTS AND AUXILIARY MEDICINAL PRODUCTS
- ANNEX VII — CORRELATION TABLE