3.11 Efficient licensing of pharmaceutical products

New medicines should become available to patients as rapidly as possible. Lif urges that the new available possibilities to get a medicine fast on the market for the benefit of the patients are used.

Therefore the licensing process for medicines ought to take as little time as possible and be of the highest possible quality, whether carried out by the Danish authorities (the Danish Medicines Agency), the European Medicines Agency (EMEA) or an authority in one of the other EU countries.

It is also important that the Danish Medicines Agency plays a central role in the European work in this area, including the continued development of the body of rules, to ensure the highest possible degree of competence within the Danish Medicines Agency, so that it is among the most frequently used of the European licensing authorities.

Lif supports the harmonisation process that the Danish Medicines Agency has initiated with regard to product information relating to identical medicinal products, so that the information on the package leaflet will be the same for products with the same active ingredient.

Lif believes:
  • that applications constitute part of a company’s intellectual property, and should therefore be exempted from the Danish Act on Access to Public Information Files,  

  • that an open and ongoing dialogue with the authorities is necessary in order to obtain rapid, efficient and safe processing of applications and service to the industry,

  • that it is important that the Danish Medicines Agency gives priority to the international world and has sufficient professional resources to take an proactive part in the international work,

  • that the Danish Medicines Agency has sufficient resources to process all types of applications within the set deadlines,

  • that medicinal product licence fees should be negotiated with the industry and should reflect the actual costs associated with the application under consideration,

  • that the procedures of the Danish Medicines Agency's procedures conform with EU procedures and that national special demands should be avoided,

  • that there is a need for further simplification of the procedures for processing variations