Regulation 2020/1043 - Conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19)

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1.

Current status

This regulation has been published on July 17, 2020 and entered into force on July 18, 2020.

2.

Key information

official title

Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19)
 
Legal instrument Regulation
Number legal act Regulation 2020/1043
Original proposal COM(2020)261 EN
CELEX number i 32020R1043

3.

Key dates

Document 15-07-2020; Date of signature
Publication in Official Journal 17-07-2020; OJ L 231 p. 12-16
Signature 15-07-2020
Effect 18-07-2020; Entry into force Date pub. +1 See Art 5
End of validity 31-12-9999; See Art. 4

4.

Legislative text

17.7.2020   

EN

Official Journal of the European Union

L 231/12

 

REGULATION (EU) 2020/1043 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 15 July 2020

on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

After consulting the European Economic and Social Committee,

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure (1),

Whereas:

 

(1)

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. On 30 January 2020, the World Health Organization (WHO) declared the outbreak a public health emergency of international concern. On 11 March 2020, WHO characterised COVID-19 as a pandemic.

 

(2)

Directive 2001/83/EC (2) and Regulation (EC) No 726/2004 (3) of the European Parliament and of the Council require that applications for authorisation to place a medicinal product on the market, in a Member State or in the Union, be accompanied by a dossier containing the results of clinical trials carried out on the product.

 

(3)

It follows from Directive 2001/20/EC of the European Parliament and of the Council (4) that, before commencing any clinical trial, sponsors are required to request authorisation from the competent authority of the Member State in which the clinical trial is to be conducted. The purpose of the authorisation is to protect the rights, safety and well-being of clinical trial subjects and to ensure the reliability and robustness of the data generated by the clinical trial.

 

(4)

Under Directive 2001/20/EC, the authorisation for a clinical trial is issued without prejudice to the application of Directives 2001/18/EC (5) and 2009/41/EC (6) of the European Parliament and of the Council.

 

(5)

Directive 2001/18/EC provides that a deliberate release into the environment of genetically modified organisms (‘GMOs’) for any purpose other than for placing on the market is subject to a notification to and to written consent by the competent authority of the Member State within whose territory the release is to take place. The notification is to include an environmental risk assessment performed in accordance with Annex II to Directive 2001/18/EC and a technical dossier supplying the information specified in Annex III to that Directive.

 

(6)

Directive 2009/41/EC provides that the risks to human health and the environment associated with the contained use of genetically modified micro-organisms are to be assessed on a case-by-case basis. To that end, that Directive provides that the user is to assess the risks to human health and the environment that the specific type of contained use may pose, using as a minimum the elements of assessment and the procedure set out in Annex III to that Directive.

 

(7)

Clinical trials necessitate the performance of multiple operations, including the manufacture, transport and storage of the investigational medicinal products, packaging and labelling, the administration thereof to clinical trial subjects and subsequent monitoring of the subjects, and the disposal of waste and unused investigational medicinal products. Those operations may fall within the scope of Directive 2001/18/EC or 2009/41/EC in cases where the investigational medicinal product contains or consists of GMOs.

 

(8)

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This text has been adopted from EUR-Lex.

5.

Original proposal

 

6.

Sources and disclaimer

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7.

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