What is a Post-Approval Named Patient Program?
A Post-Approval Named Patient Program (PA-NPP) provides patients and physicians access to commercially approved medicines that are not available to them in their own country. These drugs must be approved in at least one country, from which it can be imported into the patient’s country under a PA-NPP.
These may be drugs that are:
Approved but not yet commercially available to be prescribed in the patient’s country
- Approved and available in one country but not approved and available in the patient’s country
Discontinued in the patient’s country but not another
- In shortage in the patient’s country but not another
Please refer to either our Physician or Sponsor section below for further information related to your PA-NPP needs.
A Post-Approval Named Patient Program (PA-NPP) provides patients and physicians access to commercially approved medicines that are not available to them in their own country. These drugs must be approved in at least one country, from which it can be imported into the patient’s country under a PA-NPP.
These may be drugs that are:
Approved but not yet commercially available to be prescribed in the patient’s country
- Approved and available in one country but not approved and available in the patient’s country
Discontinued in the patient’s country but not another
- In shortage in the patient’s country but not another
Please refer to either our Physician or Sponsor section below for further information related to your PA-NPP needs.
Physicians
Because drug companies rarely plan to make their products available in every region of the world, physicians sometimes find they are unable to access certain medicines in their own country. Other times, physicians may find that a drug they have been using is discontinued or is in shortage.
In these circumstances, physicians may be able access needed drugs from another country, in order to treat their patients, through a PA-NPP.
WEP Clinical can source products from all regions of the world, and our team handles the regulatory and logistical processes involved in drug delivery and works with physicians to ensure appropriate and safe use of the drug.
If you are a physician and you wish to gain access to an unavailable medication, please contact us at:
SPONSORS
Sponsors may only be able to focus on specific key markets when seeking approval for their drugs. Often these are well-established markets, like Europe, the US and Japan, as well as other markets which provide large patient populations.
However, sponsors could benefit from allowing access to their products in markets outside of their commercialization plans. This would allow companies to:
Deal with unsolicited patient request for drug in an ethical and regulatory controlled manner
Provide exposure to, and experience with, company products to physicians in additional countries and build a larger KOL network and future advocates
Provide new products to patients who would move to commercial drug when it becomes available in these countries
Generate additional revenues
Because there are numerous restrictions and regulations that apply on a country by country basis, providing access to medicine can be a very complex and daunting task. WEP Clinical has many years of experience helping sponsors supply their products in new regions.
If you are a sponsor and want to make your drugs available in countries where they are currently unavailable or not yet approved, please contact us at:
SPONSORS
Sponsors may only be able to focus on specific key markets when seeking approval for their drugs. Often these are well-established markets, like Europe, the US and Japan, as well as other markets which provide large patient populations.
However, sponsors could benefit from allowing access to their products in markets outside of their commercialization plans. This would allow companies to:
Deal with unsolicited patient request for drug in an ethical and regulatory controlled manner
Provide exposure to, and experience with, company products to physicians in additional countries and build a larger KOL network and future advocates
Provide new products to patients who would move to commercial drug when it becomes available in these countries
Generate additional revenues
Because there are numerous restrictions and regulations that apply on a country by country basis, providing access to medicine can be a very complex and daunting task. WEP Clinical has many years of experience helping sponsors supply their products in new regions.
If you are a sponsor and want to make your drugs available in countries where they are currently unavailable or not yet approved, please contact us at:
WEP Clinical Post-Approval Named pATIENT pROGRAMs
Below 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
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: