RE: Interims30 Sep 2025 07:55
Thanks. It was actually May 2025 it seems but my points stand.
The amendment removed the restriction that only one holder of a hospital exemption authorisation could manufacture an advanced therapy for up to 10 patients under that route. 
That said it is still not “unlimited” by default: Each application still defines the patient group, medical need, and scope. The Estonian Medicines Agency decides case by case. So while the 10-patient statutory cap is gone, practical limits still exist and regulators will not authorise open-ended mass production under a hospital exemption.
Under the new rules, a hospital exemption authorisation is still valid for up to 2 years (so no that isn’t rubbish as you put it) but may be renewed for up to 5 years per renewal (and it may be renewed repeatedly) if quality, safety, and requirements are met.
Some AI for you - Hospital exemption remains “non-routine, custom-made, for an individual patient.” It is not meant for industrial-scale roll-out. Every treated patient must still meet criteria (no other therapy available, standard options exhausted, etc.), and pharmacovigilance and GMP obligations remain. Reimbursement by Estonia’s Health Insurance Fund is a separate negotiation. Even if manufacturing limits are relaxed, financial barriers remain.