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New Rule on Importing Active Pharmaceutical Ingredients (API) to the EU

With the enforcement of the European Directive 2011/62/EU relating to medicinal products for human use regarding falsified medicinal products, new requirements are introduced for active substances. The new regulation requires among other things, documentation of the supply chain traceability.

When purchasing from Novo Nordisk Pharmaceuticals, you are purchasing from a European company based in Denmark. All the manufacturing activities are located in Denmark at our facility in Koege.

In due time before 1st of March 2013 we will register Novo Nordisk Pharmaceuticals as a manufacturer of Active Substances at the Danish Health and Medicines Authority.

The supply chain at Novo Nordisk Pharmaceuticals is fully traceable and you need neither to be concerned about APIs imported from non-EU countries, nor to get a written confirmation from a competent authority in foreign countries.

Do not hesitate to contact us if you have questions or require more information.

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