Court litigation against the Medicines Evaluation Board on amending marketing authorisations for pharmaceuticals (Utrecht District Court, case numbers: SBR 10/2689 and SBR 10/2825) (2012).

Over-the-counter medicines Revised marketing authorisations Change of dispensing status. Dutch Medicines Act. Medicines Act Regulation. Ban on restricting the free movement of goods. 

Sections of the law: Medicines Act 58 paragraph 3, 59 paragraph 1, Medicines Act Regulation 4.1; Treaty on the Functioning of the European Union 34, 36. 

 

Summary: 

The Dutch Medicines Evaluation Board issued revised marketing authorisations for medicines containing ibuprofen which the plaintiffs market as manufacturers. Pharmacy Only dispensing status was awarded to products containing ibuprofen 200mg with more than 48 tablets and ibuprofen 400 mg with more than 24 tablets. Products containing ibuprofen 200mg with a maximum of 48 tablets and ibuprofen 400mg with a maximum of 24 tablets were awarded the dispensing status Pharmacy or Drugstore Only. These medicines had initially been provisionally classified as Pharmacy or Drugstore Only medicines when the Dutch Medicines Act entered into force, without their content being assessed.