company wanting to store and distribute pharmaceutical product
in the UK must apply for and be awarded a Wholesale
Dealer’s Licence (WL).
The Medicines and Healthcare
products Regulatory Agency (MHRA) will inspect a company to
check it has in place the relevant standard of storage and
distribution facilities, training and Standard Operating Procedures
(SOPs) that cover all the aspects of Good Distribution Practice
(GDP) that apply to your situation.
The MHRA are constantly raising
their standards on GDP and topics such as counterfeit and
temperature monitoring during transport have become hot topics
recently. Through our involvement in many recent MHRA inspections
HTF has experience of the current MHRA standards required.
Before you get your application process under way we can work with you to set up a limited company (which is required by the MHRA) and identify and negotiate terms with a suitable pre-wholesaler.
Then, we can
manage your application process, draft all the relevant
SOPs you will need and then fine-tune them with you to fit
the relevant staff within your organisation on GDP and the
SOPs will be required before the inspection and we can either
guide you on this or take care of this for you.
A further requirement for the WL award is to have a suitable
Responsible Person (RP) in place, and this person must be
detailed on the initial application form.
We can provide a high quality
contract RP if you do not have a suitable person in-house
- see Contract
Responsible Person (RP) Services.
The MHRA now have a process where they will re-inspect 9-15 months after the award of the WL. HTF can continue to support you through to this Inspection.
After the award of your WL you will need to perform regular batch recall dummy runs and internal GDP audits and be able to demonstrate to the MHRA the robustness of your systems. We can assist you in handling this work, or, it can be directly managed by your RP – such support is handled through our associate company