Furthermore, in order to create greater legal certainty it is necessary to define the responsibilities regarding the transparency rules for the Agency's work, to set certain conditions for the marketing of medicinal products authorised by the Community, to confer on the Agency powers to monitor the distribution of medicinal products authorised by the Community and to specify the sanctions and the procedures for implementing them in the event of failure to observe the provisions of this Regulation and the conditions contained in the authorisations granted under the procedures it establishes.
Da bi poleg tega dosegli večjo pravno varnost, je treba opredeliti odgovornosti glede pravil transparentnosti pri delu agencije, postaviti nekatere pogoje za trženje zdravil, ki jih odobri Skupnost, pooblastiti agencijo za spremljanje distribucije zdravil, ki jih odobri Skupnost, navesti kazni in postopke za njihovo izvajanje, če se ne upoštevajo določbe te uredbe, ter pogoje, vsebovane v izdanih dovoljenjih za promet po postopkih, ki jih vzpostavlja.