National implementation

The status of implementation of Directive 2001/83/EC varies considerably in the 27 Member States of the EU.

Article 14 - simplified registration

Since the implementation of Article 14 became mandatory after the extensive revision of Directive 2001/83/EC in 2003/4, the legal and regulatory provisions for the special simplified registration procedure have been implemented in all 28 Member States.

Mutual recognition

The same applies to the option to make an application for such a registration in more than one Member State at once, by means of mutual recognition, in accordance with Articles 28 and 29 (1-3) of Directive 2001/83/EC.

Article 16(2) - marketing authorisation

However, according to Directive 2001/83/EC, the implementation of Article 16(2) (marketing authorisation of homeopathically manufactured medicinal products) is optional for a Member State. Article 16(2) foresees that a Member State may establish specific national rules for pre-clinical tests and clinical trials.

There are currently twelve Member States which have established Article 16(2), including the publication of specific rules for preclinical tests and clinical trials. In six Member States, Article 16(2) has not been implemented at all; in these countries Article 16(1) (full marketing authorisation in accordance with Articles 8, 10, 10a, b, c and 11) applies for homeopathic medicinal products. In ten Member States, the optional Article 16(2) is given in the national drug law but no specific rules for pre-clinical and clinical testing are provided. This means that in practice in these countries Article 16(2) cannot be considered as fully implemented.

Article 13 - grandfathered products

In addition, Article 13 of Directive 2001/83/EC  allows Member States to keep on the national market homeopathic medicinal products which are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In some countries these products are known as ‘grandfathered products’.

Further information

• Questions and answers document on regulatory and legal issues concerning homeopathic medicinal products in the European framework,  Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Medicines Agencies, 2020
• HMPWG Report on the regulatory status of homeopathic medicinal products for human use in EU and EFTA countries, 2017