EU regulatory framework on biosafety: Medicinal GMOs for human or veterinary use

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Graph: Evolution of the European regulatory framework for the deliberate release and the placing on the market of GMO's

Historical steps toward the development of the EU regulatory framework on GMOs

Specific sectoral legislation for the placing on the market of pharmaceutical products was established in the EU in 1993 (Regulation (EEC) No. 2309/93). For medicinal products derived from biotechnology, the authorisation procedure is centralised and managed by the EMA (European Medicines Agency). This European agency was established in 1995 for the evaluation of medicines and is primarily responsible for coordinating scientific assessment of European applications for marketing authorisation of medicinal products.

In 2004, the abovementioned Regulation was replaced by Regulation (EC) No. 726/2004, itself supplemented a few years later by Regulation (EC) No. 1394/2007. The latter established a Committee for Advanced Therapies, including gene therapies aimed at restoring, correcting or modifying physiological functions. In this case too, a central authorisation procedure was put in place under the aegis of the EMA.

In the same way as for GM food and feed, there is a legal link between the sectoral legislation on "medicinal products" and Framework Directive 2001/18/EC. From 1993, a requirement to undertake an environmental risk assessment for medicinal products composed of or containing GMOs, as defined in the GMO Framework Directive, was imposed by law.

(All the links provided below refer to Eur-lex, the electronic Official Journal of the EU - © European Union)

Regulation (EC) 726/2004 requires that an applicant for a marketing authorisation for a biotechnological medicinal product shall submit to the European Medicines Agency (EMA) a dossier which includes all the necessary administrative, quality, nonclinical and clinical data for the medicinal product. These data are assessed in accordance with a Centralised procedure.

REGULATION (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. (OJ L 136, 30.4.2004, p.1)
REGULATION (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. (OJ L 324, 10.12.2007, p.121)

The European Union has established a Community code which brings together, in a single instrument, all the basic provisions in force governing the placing on the market, production, labelling, classification, distribution and advertising of medicinal products for human use.

DIRECTIVE 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. (OJ L 311, 28.11.2001, p.67)
This Directive has been amended several times since its adoption. An informal consolidated version is available from the Eur-Lex website

Similarly to the products for human use, the European Union has combined in a single act all basic legal provisions on production, marketing, distribution and use of veterinary medicinal products.

REGULATION (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43–167)

Clinical trials on medicinal products for human use using GMOs or involving medicinal products containing GMOs fall under the scope of the “Clinical Trial Directive” concretised further by the “Good Clinical Practice Directive”.

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 (OJ L 158, 27/05/2014, p. 1)
COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. (OJ L 91, 09/04/2005, p. 13)

Previous EU legislation

DIRECTIVE 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products. (OJ L 311, 28.11.2001, p.1)
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. (OJ L 121, 1.05.2001, p.34)
COUNCIL REGULATION (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. (OJ L 214, 24.08.1993, p.1)
COUNCIL REGULATION (EC) No 1647/2003 of 18 June 2003 amending Regulation (EEC) No 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of Medicinal Products. (OJ L 245, 29.9.2003, p.19)