From now on, the MEB will issue calls for registration of medicines in urgent demand. This concerns medicines facing an anticipated long-term shortage or permanent discontinuation. The calls apply to medicines that are essential for public health. With these calls, the MEB seeks a permanent solution to the prolonged shortages of these medicines.
Marketing authorisation holders and companies are invited to contact the MEB if they wish to register listed medicines for the Dutch market.
The MEB will work with applicants to determine the most appropriate regulatory pathway to bring the medicine to market.
First call
The first issued call concerns the lithium carbonate tablets in strengths of 200 mg, 300 mg and 400 mg. With this call, the MEB seeks a permanent solution to the persistent shortage of lithium carbonate. Lithium carbonate is a medicine used to stabilise mood swings and treat and prevent manic and depressive episodes. It is mainly prescribed for people with bipolar disorder.