Keywords
Summary

Keywords

1. Free movement of goods Derogations Protection of public health Prior registration procedure for reagents Whether permissible Conditions

(EC Treaty, Art. 36 (now, after amendment, Art. 30 EC))

2. Actions for failure to fulfil obligations Proof of failure to fulfil obligations Burden of proof on the Commission

(EC Treaty, Art. 169 (now Art. 226 EC))

3. Free movement of goods Quantitative restrictions Measures having equivalent effect Obligation to state a registration number on the external packaging of medical reagents and to mention that registration on the accompanying notice Not permissible Justification Protection of public health None

(EC Treaty, Arts 30 and 36 (now, after amendment, Arts 28 EC and 30 EC))

Summary

1. In the absence of harmonising rules it is for the Member States to decide on their intended level of protection of human health and life and on whether to require prior authorisation for the marketing of products liable to create a danger to health. The Member States are therefore authorised in principle to introduce a prior registration procedure, which will by its nature be less strict than prior authorisation before placing on the market, for reagents which, while presenting no danger themselves, are liable, if only indirectly, to expose the health or life of humans to danger if their diagnostic performance is not reliable. Nevertheless, the principle of proportionality requires that the power of the Member States to impose restrictions in trade in products from other Member States should be limited to what is necessary to attain the objectives of protection being legitimately pursued.

( see paras 27-29 )

2. In proceedings under Article 169 of the Treaty (now Article 226 EC) for failure to fulfil an obligation, it is for the Commission to prove the allegation that the obligation has not been fulfilled and to place before the Court the information needed to enable it to determine whether the obligation has not been fulfilled.

( see para. 30 )

3. A Member State fails to fulfil its obligations under Article 30 of the Treaty (now, after amendment, Article 28 EC) if it imposes, in national legislation on medical reagents, the obligation to state on the external packaging the national registration number allocated following registration of the reagent and to mention that registration on the notice accompanying each reagent.

Mentioning the registration merely guarantees the user that the reagent has been registered with the competent authorities, and does not provide any additional information which might effectively protect public health. By contrast, the other requirements of the legislation, namely that the name and address of the distributor and the batch number of manufacture must appear on both the external packaging and the primary packaging of the reagent itself, while the name and address of the manufacturer, distributor and, if any, the importer must appear on the accompanying notice, constitute measures which are sufficient to ensure that reagents are traceable. In view of the existence of less restrictive means, such an obligation does not therefore comply with the principle of proportionality.

( see paras 43, 45-46 and operative part 1 )