SPONSOR FAQs
The following frequently asked questions are intended to assist patients and sponsors by answering common questions about Post-Approval Named Patient Programs (PA-NPPs). If you have any additional questions be sure to reach out to us for more information here.
A PA-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 PA-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.
PHYSICIAN FAQs
The list provided below answers some of the questions frequently asked by physicians or healthcare providers regarding the Post-Approval Named Patient Program. If you are looking for more information, please don’t hesitate in contacting us directly here.
A PA-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 PA-NPP.
Information can usually be found on manufacturer websites, if they have an approved PA-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 through a PA-NPP, the physician will need to complete the necessary importation documentation, on behalf of the patient. 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.