Named Patient Supplies

Named Patient Supplies enable healthcare professionals, on behalf of their patients, to access medicines approved or nearing approval in other countries before marketing authorisation has been granted in their home country.

The treating healthcare professional makes the clinical judgment that no comparable or satisfactory alternative approved therapy is currently available for a given patient and that the probable risks from the investigational drug are not greater than the probable risks from the condition itself.

In the UK, provision for granting access to investigational drugs for patients is governed by The Medicines and Healthcare Regulatory Agency (MHRA), who are responsible for ensuring the safe supply of medicines to patients. The MHRA may provide licenses to companies who demonstrate the capabilities and facilities to manage the provision of unlicensed medicines in accordance with MHRA guidelines. In the US, the Food and Drug Administration (FDA) governs the equivalent process.

Often grouped under the labels of compassionate use, special access, expanded access, or named patient supply, these provisions allow companies to provide patients with access to their medicines while the drugs are still in the preapproval phase. Strict regulations governing such access define access criteria, data collection, non-promotion, and control of drug distribution.

Examples of circumstances where such access may be granted include:

  • A medicine for which no clinical alternative exists is still undergoing clinical trials;
  • A licensed medicine existed, but is discontinued, and an unlicensed alternative that does exist is still in development;
  • A product is awaiting approval in a particular country, but is licensed elsewhere in the world;
  • A local shortage exists for an essential medication; or
  • A patient has an immediate clinical need, but is not eligible for a trial, and the treating healthcare professional believes that the patient might benefit from taking the drug. 

Companies such as BTG which are authorised to distribute on a named patient basis merely distribute and are not involved in the patient doctor relationship. All information regarding patients is controlled under specific privacy and data protection legislation. BTG can only distribute where permitted to do so and only in response to an unsolicited information or product supply request.

Our list of Named Patient Distributors is organised according to territory.

Please note: this contact information is intended for healthcare professionals only.

Please note: to order products in territories where they are licensed, please visit the Contact Us page.

EFFECTIVE 17TH JANUARY 2022 - BTG is changing suppliers for DigiFab® and Voraxaze® in Europe and other territories


Country
DIGIFab
Voraxaze
CroFab

Australia 

Licensed

orders@phebra.com
+61 (0)2 9420 9199 or +1 800 720 020

productsupplies@btgsp.com
+44 (0)1239 851 122

France

atu@serb.eu
+33 1 73 03 20 00
For emergency orders, contact is:
astreinte@serb.eu
+ 33 1 44 62 55 17

atu@serb.eu
+33 1 73 03 20 00
For emergency orders, contact is:
astreinte@serb.eu
+ 33 1 44 62 55 17

productsupplies@btgsp.com
+44 (0)1239 851 122

Italy 

orderentry-italy@serb.eu
+39 376 0316227
For emergency orders, contact is:
astreinte@serb.eu
+ 33 1 44 62 55 17

orderentry-italy@serb.eu
+39 376 0316227
For emergency orders, contact is:
astreinte@serb.eu
+ 33 1 44 62 55 17

productsupplies@btgsp.com
+44 (0)1239 851 122

Germany

service@pharmore.de
+49 (0) 54 51 - 96 90 0

service@pharmore.de
+49 (0) 54 51 - 96 90 0

productsupplies@btgsp.com
+44 (0)1239 851 122

New Zealand 

orders@phebra.com
+61 (0)2 9420 9199 or +1 800 720 020

orders@phebra.com
+61 (0)2 9420 9199 or +1 800 720 020

productsupplies@btgsp.com
+44 (0)1239 851 122

Nordics and Baltics

logistics@specificpharma.com
+46 79 0792750 

atu@serb.eu
+33 1 73 03 20 00
For emergency orders, contact is:
astreinte@serb.eu
+ 33 1 44 62 55 17

productsupplies@btgsp.com
+44 (0)1239 851 122

Saudi Arabia 

medical@al-hobail.com
+96 692 000 6647

atu@serb.eu
+33 1 73 03 20 00
For emergency orders, contact is:
astreinte@serb.eu
+ 33 1 44 62 55 17

productsupplies@btgsp.com
+44 (0)1239 851 122

Spain 

pedidos.manuales@movianto.com
+34 91875.35.04 – opción 1

pedidos.manuales@movianto.com
+34 91875.35.04 – opción 1

productsupplies@btgsp.com
+44 (0)1239 851 122

Portugal

encomendaslgf@alloga-distrifarma.pt
+351 21 961 4610

encomendaslgf@alloga-distrifarma.pt
+351 21 961 4610

productsupplies@btgsp.com
+44 (0)1239 851 122

Poland 

zamowienia@komtur.com
+48 22 56 62 613

zamowienia@komtur.com
+48 22 56 62 613

productsupplies@btgsp.com
+44 (0)1239 851 122

United Kingdom

Licensed

ops.orders@oxfordhealth.nhs.uk
+44 1865 904 141
For emergency orders, contact is:
+44 1865 901 000

productsupplies@btgsp.com
+44 (0)1239 851 122

All other countries  

atu@serb.eu
+33 1 73 03 20 00
For emergency orders, contact is:
astreinte@serb.eu
+ 33 1 44 62 55 17

atu@serb.eu
+33 1 73 03 20 00

For emergency orders, contact is:
astreinte@serb.eu
+ 33 1 44 62 55 17

productsupplies@btgsp.com
+44 (0)1239 851 122