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.
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