Overview
Special Access Schemes, which allow the importation or use of innovative medicines to treat patients with life-threatening diseases, are officially called Named Patient Programs (NPP) in Malaysia. Under Malaysia’s Medicine Sales Act 1952 and the Medicine and Cosmetics Control Regulations 1984, hospitals or doctors who import or manufacture products solely for the treatment of patients with life-threatening diseases can apply to the Director of Pharmaceutical Services, Ministry of Health, for registration of an exemption permit.
Doctors are fully responsible and must fully inform patients and obtain their prior consent for the use of next-generation medicines. The Named Patient Programme specifically allows for the use of breakthrough medicines by patients enrolled in approved trials. Applicants for exemptions must be assessed by the Pharmaceutical Services Programme and the decision is at their discretion. Applicants are required to provide clinical evidence to support the safety and efficacy of their products.
Physician Eligibility
Exemption from license registration may be applied for by qualified medical practitioners who are not under the Ministry of Health Malaysia
Patients Eligibility
Exemption from license registration may be applied for by qualified medical practitioners who are not under the Ministry of Health Malaysia
Before your request
1.Requests for next-gen medicines can only be used for the treatment of life-threatening conditions.
2.Confirm the registration status of the medicine you need beforehand.
3.A healthcare professional must complete each request form.
Completion guidelines
All applicants must ensure that the form is completed in a complete, clear and legible manner.
The form consists of several sections requiring detailed information about the requesting institution, the patient’s identity, the treatment plan, details of the medicine, dosage and duration of treatment, quantity and price, pharmacist’s confirmation and method of obtaining exemption letters, etc.
Before starting treatment with cutting-edge drugs, obtain the patient’s consent.
Submit the application to the Director of Pharmaceutical Services, Ministry of Health Malaysia, for review and approval.
Just follow the related documents’ guidelines to complete the whole Special Access Schemes/Named Patient Programs Project application.
