BeneluxA collaboration joint pricing negotiations fail

Eveline Van Keymeulen

The first joint pricing negotiations for a medicinal product in the context of the BeneluxA collaboration with respect to health technology assessment and pricing and reimbursement have failed. On 23 May 2017, the Belgian Minister of Health announced that the Belgian National Institute for Health and Disability Insurance (RIZIV), joined by the Dutch competent authorities, Read More

Dutch Medicines Evaluation Board publishes assessment criteria for combination packages

Iradj Nazaryar

The Dutch Medicines Evaluation Board (MEB) recently published the “Assessment criteria for combination packages” policy document (MEB 47).  The MEB 47 sets out the conditions that the MEB applies for assessing and authorising combination packages, i.e. packages with more than one medicinal product that are marketed under a single trade name and marketing authorisation. The Read More

The Attorney-General’s opinion on Swiss-form claims in the Dutch ribavirin case: MSD v Teva

Jin Ooi

The Dutch courts are on a roll this year in clarifying the scope of protection of Swiss-form claims.  Earlier this month, Attorney-General Wissink delivered his opinion in the long-running ribavirin case involving Merck Sharp & Dohme and Teva, concerning a Swiss-form claim for the use of ribavirin (a known substance) for treating a specific selection Read More

Dutch Council of State upholds administrative fine for unauthorised preparation and marketing of a medicinal product

Iradj Nazaryar

On 3 May 2017, the Dutch Council of State upheld a EUR12,000 fine against Biodent B.V. (Biodent) for preparing, storing and marketing a medicinal product (EC40) against caries without authorisation. Biodent’s appeal that the product does not qualify as a medicinal product within the meaning of the Dutch Medicines Act and Directive 2001/83/EC was denied Read More

Dutch Health Care Inspectorate launches online questionnaire on pharmacovigilance

Elise Troll

The Health Care Inspectorate (IGZ) has developed a risk model to gather information about the risks that may derive from the pharmacovigilance system managed by marketing authorisation holders. To complete the model, IGZ will send a mandatory online questionnaire in May 2017 to all marketing authorisation holders (MAH) of medicinal products authorised for the Dutch Read More