Post-Approval Named Patient Programs

A Post-Approval Named Patient Program (PA-NPP) allow Sponsors to make their approved medicines available in countries where they are not yet approved or commercially available.

Sponsors can make their product available through a PA-NPP after they have received regulatory approval in at least one country. 

Contact us for Consultation

These programs are for patients suffering from a serious or debilitating illness and who have no locally approved alternative treatments available. This means that:

  • There are no locally approved treatments available for the specific type of disease in the patient’s home country
  • There are locally approved treatments available, however, the physician has tried them without success
  • The patient cannot enroll in an active clinical trial for their specific stage of disease

How Sponsors Benefit

  • Manage unsolicited requests for your medicine worldwide while maintaining the highest quality, regulatory and safety standards for patients
  • Provide physicians with early experience of your new medicine through local access schemes prior to commercial approval
  • Develop an expert KOL network and Real World Evidence (RWE) in new countries critical for future Market Access and Regulatory agency interactions
  • Generate revenue from the PA-NPP to fund the program and re-invest in bringing new medicines to market

Our PA-NPPs

Here is a list of some of the products for which we currently have a PA-NPP in place. If you are a healthcare professional, please click on each to access the appropriate contact details and information about each program.

Annual
Lifetime

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For Emergency Product Orders and Enquiries:

Please note, the contact information provided above is intended for healthcare professionals only.

For information on this PA-NPP, check out our program announcement using the link below:

For Emergency Product Orders and Enquiries:

Please note, the contact information provided above is intended for healthcare professionals only.

For information on this PA-NPP, check out our program announcement using the link below:

For Emergency Product Orders and Enquiries:

Please note, the contact information provided above is intended for healthcare professionals only.

For information on this PA-NPP, check out our program announcement using the link below:

For Emergency Product Orders and Enquiries:

Please note, the contact information provided above is intended for healthcare professionals only.

For information on this PA-NPP, check out our program announcement using the link below:

For Emergency Product Orders and Enquiries:

Please note, the contact information provided above is intended for healthcare professionals only.

For information on this PA-NPP, check out our program announcement using the link below:

 

For Emergency Product Orders and Enquiries:

Please note, the contact information provided above is intended for healthcare professionals only.

For information on this PA-NPP, check out our program announcement using the link below:

For Emergency Product Orders and Enquiries:

Please note, the contact information provided above is intended for healthcare professionals only.

For information on this PA-NPP, check out our program announcement using the link below:

For Emergency Product Orders and Enquiries:

Please note, the contact information provided above is intended for healthcare professionals only.

For information on this PA-NPP, check out our program announcement using the link below:

Our PA-NPP Services

  • Regulatory Approval Management
  • Patient Advocacy Engagement
  • Real World Data Collection
  • Product Warehousing & Distribution
  • Market Access services and transition to commercial supply
  • Local access scheme and reimbursement support
  • Dedicated Project Management
  • Medical Oversight
  • SAE Reporting
  • Physician Training and On-Going Support
  • Physician Request Management covering > 120 countries
  • WEP cross-functional team

If you are receiving requests for your commercial medicine from countries where it is not yet launched, or you are considering the benefits of making your medicine available globally following first commercial launch, then please complete the form to the left or contact us at:

Our PA-NPP Case Studies

SUPPORTING A MEDICINE THROUGHOUT THE DEVELOPMENT JOURNEY

Condition: Rare autoimmune disease Approved in: US and Europe

USING A PA-NPP TO CREATE ACCESS FOR A CANADIAN-APPROVED PRODUCT IN EUROPE

Condition: Genetic metabolic disorder Approved in: Canada

PROVIDING SITE TRAINING AS PART OF A PA-NPP FOR A SPECIALIZED PRODUCT

Condition: Pediatric cancer Approved in: US

Our PA-NPP Case Studies

USING A PA-NPP TO CREATE ACCESS FOR A CANADIAN-APPROVED PRODUCT IN EUROPE

Condition: Genetic metabolic disorder Approved in: Canada

SUPPORTING A MEDICINE THROUGHOUT THE DEVELOPMENT JOURNEY

Condition: Rare autoimmune disease Approved in: US and Europe

PROVIDING SITE TRAINING AS PART OF A PA-NPP FOR A SPECIALIZED PRODUCT

Condition: Pediatric cancer Approved in: US

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