Document:GBR Directive 2001/20/EC 04-Apr-2001: Difference between revisions
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| Document information | |
|---|---|
| Reference | GBR Directive 2001/20/EC 04-Apr-2001 |
| Validity area | GBR |
| Scope(s) | HM |
| Document name | Directive 2001/20/EC |
| Version / Revision | 04-Apr-2001 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - of 4 April 2001
on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use The European Directive (2001/20/EC) no longer applies in the UK. The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 to enable the MHRA to operate as a regulator outside the EU. |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (a) | HM | Article 2 (a) | EN | Definitions For the purposes of this Directive the following definitions shall apply: (a)âclinical trialâ: any investigation in human subjects intended to discover or verify the clinical, ... |
| Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (c) | HM | Article 2 (c) | EN | (c)ânon-interventional trialâ: a study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the ... |
| Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (l) | HM | Article 2
(l) || EN || (l)âinspectionâ: the act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the ... | ||
| Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m) | HM | Article 2
(m) || EN || (m)âadverse eventâ: any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this ... | ||
| Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (o) | HM | Article 2
(o) || EN || (o)âserious adverse event or serious adverse reactionâ: any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires hospitalisation or prolongation of ... | ||
| Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (n) | HM | Article 2
(n) || EN || (n)âadverse reactionâ: all untoward and unintended responses to an investigational medicinal product related to any dose administered; | ||
| Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (p) | HM | Article 2
(p) || EN || (p)âunexpected adverse reactionâ: an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. investigator's brochure for an unauthorised ... | ||
| Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 16 | HM | Article 16 | EN | Notification of adverse events 1. The investigator shall report all serious adverse events immediately to the sponsor except for those that the protocol or investigator's brochure identifies as not ... |
| Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 17 | HM | Article 17 | EN | Notification of serious adverse reactions 1.(a)The sponsor shall ensure that all relevant information about suspected serious unexpected adverse reactions that are fatal or life-threatening is ... |
| Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-001 | HM | Article 10
(b) || EN || Conduct of a clinical trial [âŚ] (b)without prejudice to point (a), in the light of the circumstances, notably the occurrence of any new event relating to the conduct of the trial or the development ... | ||
| Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-002 | HM | Article 10
(b) || EN || Conduct of a clinical trial [âŚ] (b)without prejudice to point (a), in the light of the circumstances, notably the occurrence of any new event relating to the conduct of the trial or the development ... | ||
| Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 3 | HM | Article 3 | EN | Protection of clinical trial subjects [âŚ] 2. A clinical trial may be undertaken only if, in particular: [âŚ] (f) provision has been made for insurance or indemnity to cover the liability of the ... |
| Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (c) | HM | Article 10
(c) || EN || Conduct of a clinical trial [âŚ] (c)within 90 days of the end of a clinical trial the sponsor shall notify the competent authorities of the Member State or Member States concerned and the Ethics ... |
