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Legislative changes in the field of pharmaceuticals for humans

Bulgaria: Revised legal provisions raise new license- and information duties for producers and merchants of pharmaceuticals for humans.

In March 2014 changes were introduced to the Human Pharmaceuticals Act. In future a special license and a preliminary note will be needed in order to export pharmaceuticals, also in case of intra-Community supply. Producers and merchants will be under a duty to prove in each case that sufficient intra-state supply is secured and there is no risk of drug shortages. In addition, holders of drug approvals and registrations who intend to discontinue offering a product of theirs on the Bulgarian market will be under a duty to report and give their reasons to the State Drugs Agency at least two months in advance.

Source: DV 18/2004