SPONSOR FAQs

A NPP provides access to post-approval drugs that are approved and commercially available in one or more country, other than the patient’s home country.

No. Companies are not required to provide their products through a formal NPP.

  • Dealing with unsolicited patient request for drug in an ethical and regulatory controlled manner
  • Providing exposure to, and experience with, company products to physicians in additional countries and build a larger KOL network and future advocates
  • Providing new products to patients who would move to commercial drug when it becomes available in these countries
  • Generating additional revenues in countries that allow you to charge for drugs supplied on a named patient basis

Companies can provide drug to patients in any country in which they have not yet received marketing approval. This includes countries in which a company plans to seek marketing approval, as well as those countries in which a company does not plan to seek marketing approval.

PATIENT FAQs

A NPP provides access to post-approval drugs that are approved and commercially available in one or more country, other than the patient’s home country.

Companies are not required to provide their products through a formal NPP.

Information can usually be found on manufacturer websites, if they have an approved NPP. Additionally, WEP Clinical is always happy to help research potential options on your behalf, and even starting a dialogue with the manufacturer.

To import a drug into a patient’s home country through a NPP, the patient’s physician will have to complete the necessary importation documentation. This documentation will be reviewed by the FDA, or the equivalent regulatory body, when the drug arrives in the patient’s home country. Without this documentation, the drug will not be allowed to pass through customs and will most likely be sent back to the origin country.

WEP Clinical can help provide support in obtaining the correct permits and can assist physicians with the completion of the right documentation.

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