Directive 2001/83/EC of the European Parliament and of the Council [15] applies in cases where a product, taking into account all its characteristics, may fall both within the definition of ‘medicinal product’ as laid down in that Directive and within the definition of a product covered by this Regulation.
Tá feidhm ag Treoir 2001/83/CE ó Pharlaimint na hEorpa agus ón gComhairle [15] i gcásanna ina dtagann táirge, agus a airíonna uile á gcur san áireamh, faoin sainmhíniú “táirge míochaine” faoi mar a leagtar síos sa Treoir sin agus laistigh de shainmhíniú táirge atá cumhdaithe ag an Rialachán seo araon.