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Medicines Approval Section

The Medicines Approval Section (MAS) staff at the One-Stop-Shops is responsible for the co-ordination of the entitlement procedure in order to ensure conformity and guarantee that entitlement is universal in application. In addition to the same day service offered at the One-Stop-Shop MAS receive and process requests from Mater Dei and Health Centres for regulated formulary items and protocol regulated items. These are reviewed as per indications, prescriber criteria, conditions qualifying patients for receiving treatment, investigations required prior to starting treatment, objective indicators of efficacy and any need for any other declarations and then approved or rejected. Whenever a request for an item is rejected a not entitled form letter is sent to the patient stating the reason for which the request was rejected. 

 
A Consultant is requested to fill in correctly the Protocol Regul​ated Application Form including the patients details and address, drug/s requested, dosage form and regimen, duration of therapy, reason/s for the drug being requested and any further documentation. The form should be endorsed by the consultants signature, name, date, e-mail and telephone number. 
 
Once a request is accepted the new SCHV document with or without permit depending on the medicinal is sent to the patient by post (when applications are received electronically or by post). SCHV documents are handed out there and then when the patients visit the one-stop-shop. 

Entitlement to free medication through the public health sector outside a Maltese government hospital setting is based on the principle of social solidarity and occurs through a system based on criteria linked to disease or means by virtue of the Social Security Act Cap 318 Article 23 and the amendment of this act - Act No. I of 2012 ​and the Fifth Schedule of the same Act. Those patients suffering from chronic conditions usually fall underSchedule V (Yellow Card), whilst those with limited means generally pertain to the Schedule II (Pink Card).

Pink card holders are only entitled to a limited number of medicinal products, which are specifically marked as pink card positive on the Government Formulary List.​ ​​

Medicines Approval Menu