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Sharp has received Wholesale Distribution Authorisation (WDA) and Investigational Medicinal Product (IMP) licensing approvals to support clinical activities from its facility in Heerenveen, Netherlands. 

  1. What licences have been awarded to the Heerenveen facility

Sharp has received Investigational Medicinal Product (IMP) and Wholesale Distribution Authorisation (WDA) licensing approvals to support clinical activities from its existing facility in Heerenveen, Netherlands. 

2. When will this European-based clinical facility become operational?

The licenses have been awarded and the facility will be ready to receive clinical material in October, 2019.

3. Can you explain the QP to QP agreement between Sharp sites in Heerenveen and Rhymney?

The QP to QP agreement that is now in place between our UK and EU Sharp facilities gives us the infrastructure necessary for the seamless transfer of all the required regulatory and support information associated with each protocol.  For our clients, it will mean the timely and on-going delivery of fully-compliant QP IMP services between the UK and the EU.

4. Is this a new facility for Sharp?

No.  The facility has been in operation as a commercial packaging site for many years and recently underwent an extensive renovation in support of a strategic client of Sharp Packaging.  The clinical services infrastructure will be accommodated in what was previously a fallow area of the facility.  Both clinical and commercial activities will co-exist at the site, in dedicated and segregated areas. More specific details of the site can be found here.

5. Exactly what clinical services are now being offered in Heerenveen?

Sharp will now offer QP release services and dedicated temperature-controlled warehousing as well as shipping, from this wholly-owned European-based depot. 

Existing Sharp Clinical clients will now have this additional option of releasing and distributing their drug product in this European facility, which will provide them with a regulatory solution in the context of Brexit. Sharp clients will continue to be fully supported by our project management and operations teams as normal from our facility in Rhymney, South Wales.

The Netherlands facility will operate on the SAP ERP platform as so our other clinical facilities. This standardization allows for smoother movement of both data and materials.  Sharp Clinical clients will also have the benefit of having access to the on-line inventory portal.

6. How does this additional facility offer Sharp clinical clients a solution to the challenges of Brexit?

As the facility is based in the EU and offers EU-recognised QP services to client’s clinical drug product can be inspected and released to the EU market. Sharp-employed Qualified Persons can provide the necessary regulatory releases from this facility. 

7. When will the Heerenveen facility be available to audit?

This facility is now open and available for client audit.

8. Where exactly is the facility located?

Sharp Heerenveen is located at:
Neptunus 12
8448 CN Heerenveen
The Netherlands

Tel: +31 513 433 947


 

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