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) (2024)
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)
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Article 74U.K.Legal representative of the sponsor in the Union
1.Where the sponsor of a clinical trial is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication to that legal representative shall be deemed to be a communication to the sponsor.
2.Member States may choose not to apply paragraph 1 as regards clinical trials to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that clinical trial who shall be the addressee for all communications with the sponsor provided for in this Regulation.
3.As regards clinical trials to be conducted in more than one Member State, all those Member States may choose not to apply paragraph 1 provided that they ensure that the sponsor establishes at least a contact person in the Union in respect of that clinical trial who shall be the addressee for all communications with the sponsor provided for in this Regulation.
It introduces an authorisation procedure based on a single submission via a single EU portal, an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements.
On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No.2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU until the Regulation's entry into application.
The purpose of this Regulation is to lay down a Community procedure for the designation of medicinal products as orphan medicinal products and to provide incentives for the research, development and placing on the market of designated orphan medicinal products.
Annex VI to the Clinical Trials Regulation (EU) 536/2014 1 introduces a change to the rules under the Clinical Trials Directive (2001/20/EC) 2 for the labelling of unauthorised investigational and auxiliary medicinal products.
Regulation 536/2014 will replace Directive 2001/20/EC. For clinical trials with medicinal products it is important that the rights, safety, dignity and well-being of the subjects are protected and that the trial data are complete and reliable.
On 31 January 2022, the new Clinical Trial Regulation (CTR) entered into force. The new regulation requires that all clinical trial applications and assessments be managed through a new, unified online portal known as the Clinical Trial Information System (CTIS).
On 4 April 2001, the European Parliament and Council enacted Directive 2001/20/EC, which had to be implemented in the national law of the European Union member states by May 2004. Its aim was to improve the quality of clinical trials and to assure the safety and well-being of trial subjects.
The CTR replaces Directive 2001/20/EC, the first EU-wide legislation for clinical trials of medicinal products which applied from 01 May 2004. In the EU, legal texts called “directives” are not immediately applicable.
Regulation (EC) No 1333/2008 lays down rules on food additives used in foods with a view to ensuring the effective functioning of the internal market whilst ensuring a high level of protection of human health and a high level of consumer protection, including the protection of consumer interests and fair practices in ...
Council Regulation (EC) 1346/2000 on insolvency proceedings (Insolvency Regulation 2000) imposes, in EU member states except Denmark, conflicts of law rules for insolvency proceedings concerning debtors based in the EU with operations in more than one member state, giving particular prominence to insolvency proceedings ...
The EU rules (Regulation (EC) 561/2006) apply to drivers of most vehicles used for the carriage of goods (including dual purpose vehicles) where the maximum permissible weight of the vehicle, including any trailer or semi-trailer, exceeds 3.5 tonnes and where the vehicle is used within the UK or between the UK and EU ...
The new EU Regulation No 536/2014 (Clinical Trials Regulation, CTR) came into force on 31 January 2022. It concerns the new way in which clinical drug research is conducted in the European Union (EU).
Article 58Archiving of the clinical trial master file
Unless other Union law requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial.
The sponsor shall notify the Member States concerned about a serious breach of this Regulation or of the version of the protocol applicable at the time of the breach through the EU portal without undue delay but not later than seven days of becoming aware of that breach.
This Regulation lays down requirements for the carrying out of the statutory audit of annual and consolidated financial statements of public-interest entities, rules on the organisation and selection of statutory auditors and audit firms by public-interest entities to promote their independence and the avoidance of ...
The Legal Representative serves as liaison between the Regulatory bodies (Competent Authority and the Ethic Committee) and sponsors, ensuring prompt and appropriate communication flow. Any communication to the Legal Representative shall be deemed to be a communication to the sponsor.
The Clinical Trials Information System (CTIS) supports the flow of information between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries and the European Commission.
European Medicines Agency (EMA) : EMA is a decentralized body of the European Union, located in Amsterdam in the Netherlands. It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use in the EU.
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