Tag Archives: COMPASSIONATE USE

Belgium Amends Compassionate Use and Medical Need Program Rules to Expand Access

On 13 December 2020, Belgium amended its rules regarding compassionate use and medical need programs to confirm that authorized programs can continue to operate after the marketing authorization for the concerned product has been granted but while the decision on reimbursement is still pending. The Law of 25 March 1964 (“Medicines Law”) regulates the use … Continue Reading

Italian Council of State Improves Access to Investigational Medicines

Recently, the Council of State (i.e., the Italian supreme administrative court and consultative body) adopted an important advisory opinion, which allows for improved access to investigational medicines by patients in Italy.  In particular, the Council of State found that patients may be enrolled in compassionate use programmes or supplied with a medicine listed in the … Continue Reading
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