Keywords

Summary



Keywords

1. Approximation of laws – Medicinal products for human use – Directive 2001/83

(European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 1(2)(b))

2. Free movement of goods – Quantitative restrictions – Measures having equivalent effect

(Arts 28 EC and 30 EC)

3. Free movement of goods – Exceptions – Procedure for the exchange of information on national measures derogating from the principle of the free movement of goods – Concept of a measure hindering the free movement or marketing of goods

(Art. 10 EC; European Parliament and Council Directive 3052/95, Arts 1 and 4)

Summary

1. In order to determine whether a product falls under the definition of medicinal product by function within the meaning of Directive 2001/83, as amended by Directive 2004/27, on the Community code relating to medicinal products for human use, the national authorities, subject to review by the courts, must decide on a case‑by‑case basis, taking account of all the characteristics of the product, in particular its composition, its pharmacological, immunological and/or metabolic properties, to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail.

However, the mere fact that one or more medicinal herbs are among the constituents of a product is not sufficient to permit the conclusion that that product contributes to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action or to making a medical diagnosis, within the meaning of Article 1(2)(b) of Directive 2001/83.

It is possible that, having regard, in particular, to the small amount of the active substance contained in it and/or the manner in which it is used, a product based on medicinal herbs will have no effect on physiological functions or that its effects will not suffice for it to be a medicinal product by function.

Accordingly, the consequence of an administrative practice in a Member State which systematically classifies as medicinal products all products based on medicinal herbs not listed in the special register of medicinal herb-based preparations may be that some of those products are classified as medicinal products even when they are not capable of restoring, correcting or modifying human physiological functions.

(see paras 72,74-76)

2. A Member State fails to fulfil its obligations under Articles 28 EC and 30 EC when that State, on the ground that products based on medicinal herbs, lawfully produced and/or marketed in another Member State are deemed to be medicinal products marketed without the requisite marketing authorisation, withdraws from the market, under an administrative practice, any product based on medicinal herbs not included either in that Member State’s special register of medicinal herb-based preparations or in the list of plants sale of which to the public is prohibited or restricted because of their toxicity, other than a preparation the constituents of which are exclusively one or more medicinal herbs or whole parts of such herbs, or crushed or powdered parts of such herbs.

While Community law does not, in principle, preclude a Member State requiring prior marketing authorisation before it is possible to market products based on medicinal herbs on its territory, since it is for the Member States, in the absence of harmonisation, to decide on the level of protection of human health and life they wish to ensure, the Member State must, when exercising that discretion, comply with the principle of proportionality. Such an authorisation must actually be necessary, in each case, to safeguard public health; which implies a detailed assessment, on a case‑by‑case basis, of the risk to public health which the marketing of a product based on medicinal herbs might entail.

However, the systematic nature of the administrative practice at issue which requires that marketing authorisation be obtained, solely by reason of the fact that the medicinal herb on which the manufactured product is based is not listed in the national legislation on herbal based preparations, does not allow, on the basis of the most recent scientific data, account to be taken of the actual risk to public health presented by such products, and consequently does not satisfy the condition that there be a detailed assessment, on a case‑by‑case basis, of the supposed risks to public health.

(see paras 91-95, 116, operative part)

3. A Member State fails to fulfil its obligations under Articles 1 and 4 of Decision No 3052/95 establishing a procedure for the exchange of information on national measures derogating from the principle of the free movement of goods within the Community when it does not communicate such a measure to the Commission.

The obligation to notify laid down in Article 1 of Decision No 3052/95 falls on the Member State concerned not only where products produced or marketed in another Member State are withdrawn from the market, but also where products produced in its own territory are withdrawn from the market while products of the same model or of the same type are lawfully produced and/or marketed in another Member State and would also be subject to withdrawal from the market if they were imported into the Member State concerned.

The mere existence of legislation or of a practice in a Member State applicable without distinction to domestic and imported products is likely to deter traders from importing into that Member State goods lawfully produced or marketed in another Member State and therefore has the effect of restricting the free movement of those goods.

However, that obligation falls on the Member State concerned only if it knows, or could reasonably be expected to know, that the measure adopted by it has the effect of hindering the marketing in its territory of products lawfully produced or marketed in another Member State. The onus is on the Commission to provide evidence to that effect.

When the authorities of the Member State concerned were informed that products based on medicinal herbs not included in the national register had been imported from another Member State, it was their duty, if they considered the evidence that those products were lawfully produced and/or marketed in that other Member State to be insufficient, to check the facts with the authorities of that Member State, in accordance with the duty of genuine cooperation laid down in Article 10 EC.

(see paras 107-109, 114, 116, operative part)