Document:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
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| Document information | |
|---|---|
| Reference | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| Validity area | EU |
| Scope(s) | HM |
| Document name | Regulation (EU) 536/2014 - clinical trials |
| Version / Revision | 05-Dec-2022 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | 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 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 17 | HM | ANNEX I
Section D No. 17 | EN | PROTOCOL
[...] 17.The protocol shall at least include: [...] (ah) a statement from the sponsor (either in the protocol or in a separate document) conf… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 19 | HM | ANNEX I
Section D No. 19 | EN | 19. With regard to the notification of adverse events, the protocol shall identify the categories of: (a) adverse events or laboratory anomalies that… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No.17 ; No. 22 | HM | ANNEX I
Section D No.17 ; No. 22 | EN | PROTOCOL
[...] 17. The protocol shall at least include: [...] (m) a description of the measures taken to minimise bias, including, if applicable, rand… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section K No. 59-60 | HM | ANNEX I
Section K No. 59-60 | EN | RECRUITMENT ARRANGEMENTS (INFORMATION PER MEMBER STATE CONCERNED) 59. Unless described in the protocol, a separate document shall describe in detail … |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1 | HM | ANNEX III Section 2.1 | EN | Adverse Events and Causality 2. Medication errors, pregnancies and uses outside what is foreseen in the protocol, including misuse and abuse of the p… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section 2.5 No. 17-22 | HM | ANNEX VI
Section 2.5 No. 17-22 | EN | Unblinding treatment allocation 17. The investigator shall only unblind the treatment allocation of a subject in the course of a clinical trial if un… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section D No. 8 | HM | ANNEX VI
Section D No. 8 | EN | REPLACING OF INFORMATION 8. The particulars listed in sections A, B and C, other than those particulars listed in paragraph 9, may be omitted from th… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 10 | G | Article 10 | EN | Specific considerations for vulnerable populations 1. Where the subjects are minors, specific consideration shall be given to the assessment of the… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 11 | G | Article 11 | EN | Submission and assessment of applications limited to aspects covered by Part I or Part II of the assessment report Where the sponsor so requests, the… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 12 | G | Article 12 | EN | Withdrawal The sponsor may withdraw the application at any time until the reporting date. In such a case, the application may only be withdrawn with … |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 13 | G | Article 13 | EN | Resubmission This Chapter is without prejudice to the possibility for the sponsor to resubmit, following the refusal to grant an authorisation or the… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 14 | G | Article 14 | EN | Subsequent addition of a Member State concerned 1. Where the sponsor wishes to extend an authorised clinical trial to another Member State (‘additi… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 15 | HM | Article 15 | EN | General principles A substantial modification, including the addition of a clinical trial site or the change of a principal investigator in the clini… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 16 | HM | Article 16 | EN | Submission of application In order to obtain an authorisation, the sponsor shall submit an application dossier to the Member States concerned through… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 17 Paragraph 1-3 | HM | Article 17 Paragraph 1-3 | EN | Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report 1. The rep… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 17 Paragraph 4-5 | HM | Article 17 Paragraph 4-5 | EN | 4. Where the reporting Member State, taking into account considerations expressed by the other Member States concerned, finds that the application d… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 18 Paragraph 1-3 | HM | Article 18 Paragraph 1-3 | EN | Assessment of a substantial modification of an aspect covered by Part I of the assessment report 1. The reporting Member State shall assess the app… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 19 Paragraph 1 | HM | Article 19 Paragraph 1 | EN | Decision on the substantial modification of an aspect covered by Part I of the assessment report 1. Each Member State concerned shall notify the sp… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 19 Paragraph 2-4 | HM | Article 19 Paragraph 2-4 | EN | 2. Where the conclusion of the reporting Member State is that the substantial modification is acceptable or acceptable subject to compliance with sp… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 | HM | Article 2 | EN | Definitions
[...] (30) ‘Good clinical practice’ means a set of detailed ethical and scientific quality requirements for designing, conducting, perform… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 13 | HM | Article 2 Paragraph 13 | EN | (13) ‘Substantial modification’ means any change to any aspect of the clinical trial which is made after notification of a decision referred to in Ar… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 32-34 | HM | Article 2
Paragraph 2 No. 32-34 | EN | (32) ‘Adverse event’ means any untoward medical occurrence in a subject to whom a medicinal product is administered and which does not necessarily hav… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 26 - 29 | HM | Article 2 Paragraph 26 - 29 | EN | (26) ‘End of a clinical trial’ means the last visit of the last subject, or at a later point in time as defined in the protocol; (27) ‘Early terminat… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 1 | HM | Article 2
Paragraph 2 No. 1 | EN | Definitions
For the purposes of this Regulation, the following definitions also apply: (1) ‘Clinical study’ means any investigation in relation to h… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 2 | HM | Article 2
Paragraph 2 No. 2 | EN | (2) ‘Clinical trial’ means a clinical study which fulfils any of the following conditions: (a) the assignment of the subject to a particular therapeu… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 3 | HM | Article 2
Paragraph 2 No. 3 | EN | (3) ‘Low-intervention clinical trial’ means a clinical trial which fulfils all of the following conditions: (a) the investigational medicinal product… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 4 | HM | Article 2
Paragraph 2 No. 4 | EN | (4) ‘Non-interventional study’ means a clinical study other than a clinical trial;… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 20 Paragraph 1-3 | HM | Article 20 Paragraph 1-3 | EN | Validation, assessment and decision regarding a substantial modification of an aspect covered by Part II of the assessment report 1. Within six day… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 20 Paragraph 4-7 | HM | Article 20 Paragraph 4-7 | EN | 4. For the purpose of this Article, the date on which the sponsor is notified in accordance with paragraph 1 or 3 shall be the validation date of th… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 21 | HM | Article 21 | EN | Substantial modification of aspects covered by Parts I and II of the assessment report 1. Where a substantial modification relates to aspects cover… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 22 | HM | Article 22 | EN | 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 … |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 23 Paragraph 1-2 | HM | Article 23 Paragraph 1-2 | EN | Decision on the substantial modification of aspects covered by Parts I and II of the assessment report 1. Each Member State concerned shall notify … |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 23 Paragraph 3-6 | HM | Article 23 Paragraph 3-6 | EN | 3. Where, regarding the substantial modification of aspects covered by Part I of the assessment report, the substantial modification is acceptable o… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 24 | HM | Article 24 | EN | Persons assessing the application for a substantial modification Article 9 applies to assessments made under this Chapter.… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 1 | HM | Article 28 Paragraph 1 | EN | General rules
1. A clinical trial may be conducted only where all of the following conditions are met: (a) the anticipated benefits to the subject… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 1 (f) | HM | Article 28
Paragraph 1 (f) | EN | General rules (f) the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate,… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 2-3 | HM | Article 28 Paragraph 2-3 | EN | 2. Without prejudice to Directive 95/46/EC, the sponsor may ask the subject or, where the subject is not able to give informed consent, his or her l… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 1 | HM | Article 29 Paragraph 1 | EN | Informed consent 1. Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragrap… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 2 | HM | Article 29 Paragraph 2 | EN | 2. Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 3-5 | HM | Article 29 Paragraph 3-5 | EN | 3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 6-8 | HM | Article 29 Paragraph 6-8 | EN | 6. The subject shall be informed that the summary of the results of the clinical trial and a summary presented in terms understandable to a layperso… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 31 Paragraph 1 | HM | Article 31 Paragraph 1 | EN | Clinical trials on incapacitated subjects 1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consen… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 31 Paragraph 2-3 | HM | Article 31 Paragraph 2-3 | EN | 2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those clinical trials on inca… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 1 | HM | Article 32 Paragraph 1 | EN | Clinical trials on minors 1. A clinical trial on minors may be conducted only where, in addition to the conditions set out in Article 28, all of th… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 2-3 | HM | Article 32 Paragraph 2-3 | EN | 2. The minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity. 3. If during a clinical tr… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 33 | HM | Article 33 | EN | Clinical trials on pregnant or breastfeeding women A clinical trial on pregnant or breastfeeding women may be conducted only where, in addition to th… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 34 | HM | Article 34 | EN | Additional national measures Member States may maintain additional measures regarding persons performing mandatory military service, persons deprived… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 1 | HM | Article 35 Paragraph 1 | EN | Clinical trials in emergency situations 1. By way of derogation from points (b) and (c) of Article 28(1), from points (a) and (b) of Article 31(1) … |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 2-3 | HM | Article 35 Paragraph 2-3 | EN | 2. Following an intervention pursuant to paragraph 1, informed consent in accordance with Article 29 shall be sought to continue the participation o… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 37 Paragraph 1 – 7 | HM | Article 37 Paragraph 1 – 7 | EN | End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results 1. The sponsor shall notify each Me… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 37 Paragraph 4 | HM | Article 37 Paragraph 4 | EN | End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results 4. Irrespective of the outcome of a… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 38 | HM | Article 38 | EN | Temporary halt or early termination by the sponsor for reasons of subject safety 1. For the purposes of this Regulation, the temporary halt or early… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 4 | G | Article 4 | EN | Prior authorisation
A clinical trial shall be subject to scientific and ethical review and shall be authorised in accordance with this Regulation. T… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-002 | HM | Article 41 | EN | Reporting of adverse events and serious adverse events by the investigator to the sponsor 1. The investigator shall record and document adverse eve… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-001 | HM | Article 41 | EN | Reporting of adverse events and serious adverse events by the investigator to the sponsor 1. The investigator shall record and document adverse eve… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 42 | HM | Article 42 | EN | Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency 1. The sponsor of a clinical trial performed in at least o… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 43 | HM | Article 43 | EN | Annual reporting by the sponsor to the Agency 1. Regarding investigational medicinal products other than placebo, the sponsor shall submit annually… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-003 | HM | Article 47 | EN | Compliance with the protocol and good clinical practice The sponsor of a clinical trial and the investigator shall ensure that the clinical trial is … |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-001 | HM | Article 47 | EN | Compliance with the protocol and good clinical practice The sponsor of a clinical trial and the investigator shall ensure that the clinical trial is … |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-002 | HM | Article 47 | EN | Compliance with the protocol and good clinical practice The sponsor of a clinical trial and the investigator shall ensure that the clinical trial is … |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 48 | HM | Article 48 | EN | Monitoring In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and t… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 49 | HM | Article 49 | EN | Suitability of individuals involved in conducting the clinical trial The investigator shall be a medical doctor as defined in national law, or a pers… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 5 | G | Article 5 | EN | Submission of an application 1. In order to obtain an authorisation, the sponsor shall submit an application dossier to the intended Member States … |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 50 | HM | Article 50 | EN | Suitability of clinical trial sites The facilities where the clinical trial is to be conducted shall be suitable for the conduct of the clinical tria… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 51 | HM | Article 51 | EN | Traceability, storage, return and destruction of investigational medicinal products 1. Investigational medicinal products shall be traceable. They … |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 52 | HM | Article 52 | EN | Reporting of serious breaches 1. The sponsor shall notify the Member States concerned about a serious breach of this Regulation or of the version o… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 53 | HM | Article 53 | EN | Other reporting obligations relevant for subject safety 1. The sponsor shall notify the Member States concerned through the EU portal of all unexpe… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 54 | HM | Article 54 | EN | Urgent safety measures 1. Where an unexpected event is likely to seriously affect the benefit-risk balance, the sponsor and the investigator shall … |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 56 | HM | Article 56 | EN | Recording, processing, handling and storage of information 1. All clinical trial information shall be recorded, processed, handled, and stored by t… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 57 | HM | Article 57 | EN | Clinical trial master file The sponsor and the investigator shall keep a clinical trial master file. The clinical trial master file shall at all time… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 58 | HM | Article 58 | EN | Archiving of the clinical trial master file Unless other Union law requires archiving for a longer period, the sponsor and the investigator shall arc… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 6 | G | Article 6 | EN | Assessment report — Aspects covered by Part I
1. The reporting Member State shall assess the application […] (a) Whether the clinical trial is a l… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 66 | HM | Article 66 | EN | Unauthorised investigational and unauthorised auxiliary medicinal products 1. The following information shall appear on the outer packaging and on … |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 67 | HM | Article 67 | EN | Authorised investigational and authorised auxiliary medicinal products 1. Authorised investigational medicinal products and authorised auxiliary me… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 68 | HM | Article 68 | EN | Radiopharmaceuticals used as investigational medicinal products or as auxiliary medicinal products for a medical diagnosis Articles 66 and 67 shall n… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 69 | HM | Article 69 | EN | Language The language of the information on the label shall be determined by the Member State concerned. The medicinal product may be labelled in sev… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 7 | G | Article 7 | EN | Assessment report — Aspects covered by Part II 1. Each Member State concerned shall assess, for its own territory, the application with respect to … |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 76 | HM | Article 76 | EN | Damage compensation 1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation i… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 77 | HM | Article 77 | EN | Corrective measures to be taken by Member States 1. Where a Member State concerned has justified grounds for considering that the requirements set … |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 78 | HM | Article 78 | EN | Member State inspections 1. Member States shall appoint inspectors to perform inspections in order to supervise compliance with this Regulation. Th… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 8 | G | Article 8 | EN | Decision on the clinical trial 1. Each Member State concerned shall notify the sponsor through the EU portal as to whether the clinical trial is au… |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 9 | G | Article 9 | EN | Persons assessing the application 1. Member States shall ensure that the persons validating and assessing the application do not have conflicts of … |
