De mange vanskeligheder og forsinkelser, de tydelige kompetencekonflikter og den overdrevne bureaukratisering af procedurerne har ført til, at der kun er fastlagt kriterier for 12 produktgrupper, hvorfra indtil slutningen af september 1997 kun 22 fabrikanter havde modtaget 40 tilladelser.
The many difficulties and delays in implementation, obvious problems of conflicting jurisdiction and the excessive red tape involved in the procedures have meant that criteria have been defined for just 12 product groups. For this reason, only 40 licences had been granted to 22 manufacturers up to September 1997.