Importers or distributors take on the obligations of a manufacturer in the following situations:
They make a product available on the market under their own name, trademark, or registered trade name, even if they do not manufacture it, as long as the manufacturer's data is not present on the product label.
They modify the intended purpose of a product that is already on the market or in use.
They modify the product already placed on the market in a way that could impact its compliance with regulatory requirements.
However, this does not include the release or translation of information provided by the manufacturer for a product already on the market, nor does it include the provision and translation of information or changes to the outer packaging necessary to market the product in a relevant member state.
Distributors and importers are required to establish a quality management system to ensure reliable and up-to-date translations. They must also ensure that any repackaging does not compromise the original condition of the product and that the new packaging is free from defects. They should notify the manufacturer and the authority in the member country at least 28 days before making the modified product available on the market.