Provision of unapproved medicines for unmet medical needs

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We recognise that there may be instances when Healthcare Professionals seek an unapproved medicine or vaccine for a patient that has no other satisfactory alternative treatment options. GSK has established programs that may provide an option for providers faced with these challenges.

Provision of unapproved medicines under these circumstances may be referred to by various names depending country regulations (e.g. single patient use, named patient use, compassionate use, expanded access, special access, managed access, importation of unlicensed medicine, etc.).

 

Scientist Using Syringe Behind Protective Screen Cover

Policy

Please read our policy on treatment use of unlicensed medicines

Treatment use of unlicensed medicines (PDF, 217.4KB)


If you are a Healthcare Professional who would like to request a GSK medicine that is not approved, licensed or available in your country for treatment of a patient, please use the GSK Managed Access Request Portal. Only Healthcare Professionals can submit a request, which requires creation of a profile.

In order to handle your enquiry, GSK is required to record and maintain the personal information provided, including your name and contact details. This personal information will be processed solely for the purpose of dealing with this enquiry. More detailed information on the processing of your personal information is available from our Privacy Notice.

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The importation of unlicensed medicines programme may provide a mechanism for a physician to treat a patient with a GSK medication that has been approved in a major market but is not yet approved in their country for the same indication.

Patient eligibility includes: 

  • Serious or life threatening disease 
  • No alternative treatments available
  • Inability to participate in a clinical trial 
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For oncology, please contact MedicineAccess@Clinigengroup.com

For any other request please connect with your local GSK entity via Worldwide | GSK 

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