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Provision of unlicensed medicines for unmet medical needs

We unite science, talent and technology to get ahead of disease together.

We recognise that there may be instances when it is appropriate for Healthcare Professionals to seek an unapproved medicine or vaccine for treatment use for a patient where no satisfactory alternatives exist. Our policy and programmes may provide an option for providers and patients faced with these challenges.

Provision of unlicensed medicines for unmet medical needs in various places and circumstances may be referred to as single patient use, named patient use, compassionate use, expanded access, special access, managed access, importation of unlicensed medicine, or other names.

Scientist Using Syringe Behind Protective Screen Cover

Policy

Please read our policy on treatment use of unlicensed medicines

Treatment use of unlicensed medicines (PDF, 194.6KB)

Healthcare professional requests for compassionate use

If you are a Healthcare Professional who would like to request compassionate use of a GSK investigational medicine for a patient, please use the GSK Compassionate Use Request Portal.  You will need to create a profile before you can submit your request.

In order to handle your enquiry, we are required to record and maintain the personal information that you have provided to us.  This may include your name and contact details. This personal information will be processed solely for the purpose of dealing with your enquiry.  More detailed information on the processing of your personal information is available from our Privacy Notice.

Patients themselves cannot make a request for compassionate use and need to contact their Healthcare Professional.

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Importation of Unlicensed Medicines programme

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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Requesting use of an unlicensed GSK medicine

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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