| Authority involved |
Ministarstvo zdravlja (Ministry of Health) and The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) |
National Organization for Medicines |
Malta Medicines Authority |
Instituto Nacional da Farmacia e do Medicamento (INFARMED) |
Javna agencija RS za zdravila in medicinske pripomočke - Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (JAZMP) |
| Laws and regulations |
Pursuant to Article 73 of the Medicinal Products Act (Official Gazette 71/07 and 45/09) ordinance on pharmacovigilance |
Information unavailable (may be in progress) |
Though there is a pharmaceutical regulatory procedure, no official national legislation exists Unlicensed medicinal products as directed in DH Circular 137/2004 (updated version DH Circular 270/06 - Health concerning the “Guidelines Governing the Use of Medicinal Products for Human Use without a Marketing Authorization” is different from CUP Further information unavailable |
Articles 92–93 of the Decreto Lei no. 176 of 30th August 2006 INFARMED'S Decision 105/CA/2007, of 1 March 2007 Nominative |
83 Article 6 Medicines Act (Official Gazette of RS, no. 17/14) |
| Overview |
It is possible to adopt compassionate use from diagnosis to the approval to use the drug Compassionate use facilitates access to unauthorized medicinal products for chronic, serious, or a life-threatening diseases which cannot be treated satisfactorily by an authorized medicinal product |
Compassionate use of medicines for individual patients exists. However, information on access for a group of patients is unavailable Literature shows that there are high implementation barriers such as lack of infrastructure to support early access programs in the country |
There is a regulatory procedure for CUP to use medicinal products consistent with EU regulations The product applied for under CUP must be under evaluation in the centralized authorization procedure at the EMA |
Medicines, including the ones for compassionate use without a marketing authorization, under special and exceptional circumstances, can be used to treat patients in always under an authorization granted with a temporary and transitory nature by the INFARMED |
In Slovenia, in line with the EU regulation, CUP is:
The administration of a new active ingredient, constituting a significant therapeutic, scientific and technical innovation For drugs obtaining marketing authorization or clinical testing of medicines For a group of patients with a chronically or seriously debilitating disease that cannot be satisfactorily treated with medicines that have marketing authorization The sponsor/manufacturer of a CUP must provide the product free of charge, which includes the costs of supply and wholesale distribution.
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