第34条 製造業者の義務が輸入業者及び販売業者に適用される場合

Importers or distributors shall be considered manufacturers for the purposes of this Regulation where they:

(a)place a product covered by a delegated act adopted pursuant to Article 4 on the market under their name or trademark; or

(b)modify such a product already placed on the market in a way that affects compliance with the requirements set out in the applicable delegated acts adopted pursuant to Article 4.