A clinical investigation on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set out in Article 62(4), all of the following conditions are met:
Ní fhéadfar imscrúdú cliniciúil a dhéanamh ar mhná torracha ná ar mhná atá ag cothú linbh ar an gcíoch ach amháin má chomhlíontar na coinníollacha seo a leanas ar fad, de bhreis ar na coinníollacha a leagtar amach in Airteagal 62(4):