Siden begyndelsen af 1998 har nye lægemidler ikke kunnet opnå markedsføringstilladelse via et nationalt godkendelsessystem, medmindre det pågældende lægemiddel kun skal markedsføres i landet selv.
Since the beginning of 1998, it has no longer been possible for a new medicine to be given market authorisation under a national system of approval unless it is to be marketed only in that country.