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Written Answers — Department of Health: Medicinal Products (11 Jun 2024)

Stephen Donnelly: ...the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list. Only medicines with licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority can be added to the reimbursement list. In making a relevant...

Written Answers — Department of Health: Medicinal Products (11 Jun 2024)

Stephen Donnelly: ...the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list. Only medicines with licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority can be added to the reimbursement list. In making a relevant...

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