Named Patient Supply
When there is unmet clinical need within the UK then a product may be imported into the UK without the requirement of a Marketing Authorisation upon a written order from a Healthcare Professional such as a doctor or dentist. Copea Pharma can submit the required documentation and work with you to ensure that the project is managed compliantly.
Copea Pharma can import unlicensed medicines from outside the EU to meet the unmet clinical needs of the patient, whilst working closely with the Healthcare Professional who are requesting the medication.
Bona Fide Checks
As part of the requirement to supply unlicensed medicines Bona Fide checks are required to occur to ensure that requests have only been received from those authorised to request unlicensed medicines. Copea Pharma has the ability to perform these checks and retain the required documentation to meet the Regulatory Authorities requirements.