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Parliamentary questions
20 June 2018
E-002513/2018
Answer given by Mr Andriukaitis on behalf of the Commission

EU legislation on homeopathic medicines was introduced in 1992 with the aim of ensuring their quality and safety whilst at the same time providing a clear indication of their homeopathic nature(1). At the time of adoption of the legislation, it was considered that despite the differences in recognition between Member States, consumers across the EU should be adequately protected, if they choose to use homeopathic medicines.

Under the current simplified registration procedure, homeopathic medicines must not mention specific therapeutic indications and be diluted to a sufficient degree to ensure their safety. Furthermore, their labelling must clearly mention that they are ‘homeopathic medicinal products’.

Regarding the second question, the regulatory framework for homeopathic medicines and vaccines is different under Directive 2001/83/EC(2). Vaccines can only be authorised subject to an in-depth assessment of quality, safety and efficacy.

(1)https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31992L0073&from=EN
(2)http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF

Last updated: 21 June 2018Legal notice