WRITTEN QUESTION E-0647/03

by Jules Maaten (ELDR) to the Commission

(5 March 2003)

Subject: Obligation to register homeopathic medicines

1. Is the Commission aware that because of the different registration requirements in the Member States, homeopathic remedies can be sold in pharmacies in the Germany, while this has been forbidden in the Netherlands since 1 June 2002?

2. Does the Commission take the view that a company can market homeopathic products in the Netherlands that are registered in Germany, although they are not registered in the Netherlands?

3. If not, is a company also forbidden to put a product on the market in the Netherlands if it has demonstrated that the product meets European safety requirements? The reason for this question is that registration is very expensive, and difficult for small companies and importers to obtain.

4. Dutch patients have to order most of the German homeopathic remedies prescribed by their doctors themselves, and collect them from Germany. This is because the Netherlands is the only Member State to have applied, since 1 June 2002, the European registration requirements. Medicines produced in Germany meet the German registration requirements, but do not yet meet the European ones (which will not be introduced in Germany until 2008). Is the Commission aware of this practical problem, and how does it intend to solve it?

5. In the opinion of the Commission, does this situation not constitute an unacceptable barrier to the European single market?

6. Does the Commission intend to remedy this situation?

Answer given by Mr Liikanen on behalf of the Commission

(9 April 2003)

1. The Commission is aware of differences that exist between the national rules on the registration and distribution of homeopathic medicinal products in various Member States. The reason for these differences is that the European legislation does not fully harmonise this area. Homeopathic medicinal products covered by a registration or an authorisation granted under national law on or before 31 December 1993 are excluded, according to Article 13 paragraph 1 of Directive 2001/83/EC of the Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(1), from the harmonised registration requirements of that Directive. In addition, the rules on the retail trade and in particular whether medicinal products have to be sold in pharmacies, are not covered by the existing European legislation.

2. Article 6 paragraph 1 of Directive 2001/83/EC provides that no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with that Directive or an authorisation has been granted in accordance with Council Regulation (EEC) No 2309/93 of 22 July 1993 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(2). This provision applies to all medicinal products including homeopathic medicinal products. Hence a homeopathic medicinal product may not be marketed in the Netherlands, if it has not obtained a national marketing authorisation/registration in the Netherlands or a Community marketing authorisation.

3. The requirement set out in Article 6 paragraph 1 of Directive 2001/83/EC is a strict and necessary condition for the marketing of a medicinal product. Therefore, the answer given to the second question applies, irrespective of whether European safety requirements are met.

4. The situation described in the fourth question is not correct according to the information that is available to the Commission. The harmonised legislation for the authorisation and registration of homeopathic medicinal products as set out in Directive 2001/83/EC is applied in all Member States including Germany. However, as explained in the answer to the first question, this legislation is obligatory only for authorisations/registrations after 31 December 1993. For authorisations or registrations that were existing at that date, the European legislation does not contain obligatory provisions. It is up to the Member States therefore to decide what rules to apply to such authorisations or registrations. The Commission does not have the competence to impose any binding rules in this area.

5. As a result of Article 6 of Directive 2001/83/EC, there is no entirely free circulation of nationally approved medicines as a separate approval is needed for each Member State where the product is marketed. However, it is one of the key objectives of that Directive to facilitate the free movement of the medicinal products concerned, in particular by providing for a mutual recognition of marketing authorisations. For authorisations or registrations granted before 31 December 1993, Article 13 paragraph 1 of Directive 2001/83/EC obliges the Member States to take due account of such approvals, when an authorisation or registration for the same product is sought in another Member State. This system promotes the Single Market while taking account of existing divergences between the Member States.

6. As the answers given to the other questions indicate, the Commission is not entitled to stipulate how the Member States should deal with the authorisations or registrations for homeopathic medicinal products existing on the 31 December 1993. For authorisations and registrations granted after that date, the European legislation provides for largely harmonised rules. No specific problems with the application of these rules have been brought to the attention of the Commission. It is not foreseen, therefore, to take any particular measure in this area.

(1) OJ L 311, 28.11.2001.

(2) OJ L 214, 24.8.1993.