Legal provisions of COM(2020)261 - Conduct of clinical trials with and supply of medicinal products for human use containing or consisting of GMOs intended to treat or prevent coronavirus disease

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dossier COM(2020)261 - Conduct of clinical trials with and supply of medicinal products for human use containing or consisting of GMOs intended to ...
document COM(2020)261 EN
date July 15, 2020

Contents

Article 1

For the purposes of this Regulation, the following definitions apply:

(1)‘clinical trial’ means clinical trial as defined in point (a) of Article 2 of Directive 2001/20/EC;

(2)‘sponsor’ means sponsor as defined in point (e) of Article 2 of Directive 2001/20/EC;

(3)‘investigational medicinal product’ means investigational medicinal product as defined in point (d) of Article 2 of Directive 2001/20/EC;

(4)‘medicinal product’ means medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC;

(5)‘genetically modified organism’ or ‘GMO’ means genetically modified organism as defined in point (2) of Article 2 of Directive 2001/18/EC.

Article 2

1. All operations related to the conduct of clinical trials, including packaging and labelling, storage, transport, destruction, disposal, distribution, supply, administration or use of investigational medicinal products for human use containing or consisting of GMOs intended to treat or prevent COVID-19, with the exception of the manufacturing of the investigational medicinal products, shall not require a prior environmental risk assessment or consent in accordance with Articles 6 to 11 of Directive 2001/18/EC or Articles 4 to 13 of Directive 2009/41/EC when these operations relate to the conduct of a clinical trial authorised in accordance with Directive 2001/20/EC.

2. Sponsors shall implement appropriate measures to minimise foreseeable negative environmental impacts resulting from the intended or unintended release of the investigational medicinal product into the environment.

3. By way of derogation from point (a) of Article 6(2) of Regulation (EC) No 726/2004 and from the second indent of the fourth paragraph of point 1.6 of Part I of Annex I to Directive 2001/83/EC, in applications for marketing authorisation for medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19, the applicant shall not be required to include a copy of the competent authority’s written consent to the deliberate release into the environment of GMOs for research and development purposes in accordance with Part B of Directive 2001/18/EC.

Article 3

1. Articles 6 to 11 and 13 to 24 of Directive 2001/18/EC as well as Articles 4 to 13 of Directive 2009/41/EC shall not apply to operations related to the supply and use of medicinal products containing or consisting of GMOs that are intended to treat or prevent COVID-19, including packaging and labelling, storage, transport, destruction, disposal, distribution or administration, with the exception of the manufacturing of the medicinal products, in any of the following cases:

(a)where such medicinal products have been excluded from the provisions of Directive 2001/83/EC by a Member State pursuant to Article 5(1) of that Directive;

(b)where such medicinal products have been temporarily authorised by a Member State pursuant to Article 5(2) of Directive 2001/83/EC; or

(c)where such medicinal products are made available by a Member State pursuant to Article 83(1) of Regulation (EC) No 726/2004.

2. Where feasible, Member States shall implement appropriate measures to minimise foreseeable negative environmental impacts resulting from the intended or unintended release of the medicinal product into the environment.

Article 4

1. This Regulation shall apply as long as WHO has declared COVID-19 to be a pandemic or as long as an implementing act by which the Commission recognises a situation of public health emergency due to COVID-19 in accordance with Article 12 of Decision No 1082/2013/EU of the European Parliament and of the Council (7) applies.

2. The Commission shall, when the conditions for the application of this Regulation referred to in paragraph 1 are no longer fulfilled, publish a notice in the Official Journal of the European Union to that effect.

3. Clinical trials within the scope of Article 2 of this Regulation that have been authorised under Directive 2001/20/EC prior to the publication of the notice referred to in paragraph 2 of this Article may validly continue and be used in support of an application for marketing authorisation in the absence of an environmental risk assessment or consent in accordance with Articles 6 to 11 of Directive 2001/18/EC or Articles 4 to 13 of Directive 2009/41/EC.

Article 5

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.