We assist pharmaceutical companies in making their products available across European countries prior to and after marketing authorisation (MA) has been granted. We have a specialised knowledge in all steps of the product lifecycle.

Alongside Clinical Trials

Does your pharmaceutical company have a new medicine you want to test in the market alongside clinical trials? Specific Pharma can help you in the distribution of your medicine alongside clinical trials to patients who have tried all other marketed medicines.

Post-trial Access

Specific Pharma can help you distribute your medicine to patients after the clinical trial has ended but prior to MA in order to maintain patient access. Specific Pharma maintains agreements with pharmaceutical companies to distribute medicinal products to patients on a named patient basis or compassionate use basis. This allow physicians and patients access to pre-approved, investigational medicine outside of the clinical trial setting.

Staggered Global Launch

Do you want to market/commercialise your product in some countries in Europe but not all? Specific Pharma can be your partner in new markets on an unlicensed basis.
Throughout our extensive global network, we are a trustworthy partner in providing assistance for pharmaceutical companies with a product approved in all European countries, but prioritising which markets to commercialise in. This allows pharmaceutical companies not willing to invest in international sales to focus on their main markets, while Specific Pharma provides assistance and support in the remaining countries.
When this is the case, Specific Pharma assists the company by making the product available to patients on a named patient basis/compassionate use permit. This allows physicians and patients to access commercially approved medicines that are not marketed in their own country.

Temporary Supply Problems & Drug Shortages

Specific Pharma can be your partner in moving your company’s medicines between countries in order to avoid shortages and no-delivery-fines.

Discontinuation Management

The costs of maintaining marketing authorisation of certain products can often be very high for pharmaceutical companies if the sales are not high enough.
Therefore, the companies can choose to partially withdraw the MA, however, it will have an impact upon patients and patient access will be compromised. This is where Specific Pharma steps in as a partner and continue to supply your products to countries where MA has been withdrawn.

If you have a product on the market you no longer want to maintain and withdrawal of marketing authorisation has been considered, please contact Specific Pharma. Together we can find a solution whereupon both you and the patients will win.

Why choose Specific Pharma as a partner?

Expanded and early access in Europe

A full global launch may not be part of the market access strategy, but patient demand may still need to be met. During this time, we assist the pharmaceutical company in making their product available on an unlicensed basis. This allows pharmaceutical companies not willing to invest in international sales to focus on their main markets (e.g. the big 5), while we provides assistance and support in the remaining countries.

Market insight

By making your product available on an unlicensed basis, it will provide you with an insight in patient forecasting, regulatory landscape, mapping of treatment site and KOLs.

Real world data

Unlicensed medicine is an opportunity to collect data outside the confines of a clinical trial setting, providing valuable information about medicines in the real world population well ahead of launch and commercialisation.

Informed and loyal Key Opinion Leaders before commercialisation

When KOLs are familiar with a certain product, even before MA and commercialisation, it can ensure easier uptake when you decide to commercialise your product.

Seamless transition from unlicensed to licensed/commercialised stage

Providing access to unlicensed medicines can form a critically important part of an access strategy.

Social responsibility

Your company will be socially responsible when making your products available to patients in need even before commercialisation.

Additional revenue

When you make your product available before commercialisation on an unlicensed basis, it ensures revenue earlier than planned.

If you want to know more about how we can help your company to ensure patient access prior to and after MA has been granted, click here to contact us.