#named patient program

The Named Patient Program (NPP) provides access to medications not yet approved in a patient's home country but available elsewhere, particularly for those with serious conditions and limited treatment options. Key features include global access, Regulatory Compliance, Patient-Centric Approach, Collaboration with Healthcare Providers, and Quality Assurance.

InviMeds ensures regulatory compliance when importing unregistered medicines through its Named Patient Import by adhering to stringent protocols and regulations at every step of the process. 

Firstly, our Named Patient Access Program team meticulously evaluates the eligibility of patients and healthcare providers, ensuring that only those meeting regulatory criteria are considered for the program.

Secondly, we meticulously handle all documentation requirements, ensuring that all necessary paperwork is accurately completed and submitted. This includes obtaining import licenses, CDEC, and any other relevant permits required by regulatory authorities.

Thirdly, we collaborate closely with authorized distributors and regulatory bodies to ensure that the importation process complies with all local laws and regulations. This includes adhering to importation guidelines, quality control standards, and safety protocols.

Additionally, our team remains vigilant throughout the importation process, conducting thorough checks and audits to ensure that all imported medicines meet regulatory standards and requirements.

Named Patient Program (NPP) provide controlled, pre-approval access to drugs in response to requests by physicians on behalf of specific, or “named”, patients before those medicines are licensed in the patient’s home country. Through these programs, patients are able to access drugs in late-stage clinical trials or approved in other countries for a genuine, unmet medical need, before those drugs have been licensed in the patient’s home country.

What is Named Patient Program (NPP)?

It is common in certain cases, that drugs are already discovered, but not marketed in every global region due to ongoing approval processes or products are under the late-stage of clinical research. Named Patient Program breaks the gap between such medication accessibility to physicians and patients. Named Patient Program gives the freedom to the physician to prescribe medication that is available in well-established pharma- markets. Both physicians and patients can order these medications by providing necessary documentation required to prove the actual need of the drug/s.

Named Patient Program has the accessibility to all well-established pharma- markets and sponsors for sourcing the necessary medications. Named Patient Program brings the global marker under one umbrella for physicians, patients as well as for sponsors. Named Patient Program maintains all the regulatory and logistics requirements to provide hassle-free service to all the consumers.

Uses Of Named Patient Program

Named Patient Program is useful for all the pharma sponsors also. Usually, sponsors want to launch their products in the popular markets where they get more patients and well-established pharma markets of the USA, Europe, and Japan or other such vast markets. But Name Patient Program gives them a scope to market their products beyond commercialization.

The patient from any country who is recognized as ‘the Named Patient’ and suffering from the chronic, serious, or life-threatening disease has the right to access, procure, and import medicines which have life-saving potentiality or improve the quality of life of the patient. But rules and regulations for importing innovative medications are different in every country. Every country has to follow its own regulation to import such medications.  Different programs are already existed such as Named Patient Import, Early Access Program, and Compassionate Use Program specifically available to import such medications. However, every country follows its own program.

A Named Patient Program (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 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.