European Union regulations regarding ozone therapy

Roberto Quintero, Legal Advisor of AEPROMO e ISCO3

 

  • The European Union does not have specific legislation on ozone therapy, but there are some provisions that are applicable to ozone therapy. 
  • European Parliament resolution on non-conventional medicines. 
  • European Union Directive applicable to ozone medical equipment.

  

Complementary and alternative therapies

The European Parliament, since 1997, has asked the European Commission to adopt legislation on non-conventional medicines and establish the difference between complementary and alternative medicines. Legislation that has not yet been adopted. (A4-0075/97 Resolution on the regime of non-conventional medicines. Official Journal of the European Communities No. C 182/67, May 29, 1997).

Ozone therapy is a complementary therapy. This is stated in the Madrid Declaration on Ozone Therapy. https://isco3.org/madrid-declaration-on-ozone-therapy-3rd-edition-isco3/

 

Medical ozone equipment in the European Union

European companies manufacturing medical ozone equipment are obliged to apply Council Directive 93/42/EEC (now the European Union) which includes this equipment in class IIb.

This content is also available in: Spanish