ED Decision 2018/009/R
This provision is necessary to ensure that enforcement measures will be taken also in cases where the competent authority may not act on the licence, certificate or attestation. The type of enforcement measure will depend on the applicable national law and may include for example the payment of a fine or the prohibition from exercising.
It covers two cases:
(a) persons subject to the requirements laid down in Regulation (EC) No 216/2008 and its Implementing Rules who are not required to hold a licence, certificate or attestation - for example general medical practitioners (GMPs); and
(b) persons who are required to hold a licence, rating, certificate or attestation, but who do not hold the appropriate licence, rating, certificate or attestation as required for the activity they perform.
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