S.L. 458.34 ст. 20Civil and criminal liability.

An authorisation or licence for placing a medicinal product on the market shall not affect the civil and criminal liability of the manufacturer and, where applicable, of the marketing authorisation holder who has placed such medicinal product on the market in any European Union or European Economic Area state. Such manufacturer or marketing authorisation holder shall in particular remain liable for any deficiencies in quality, safety and efficacy of such medicinal products.