Wholesale Distributor Licence / Authorisation
So, you now have a business plan and are ready to take the world over with your new venture. The cash flow projections look good and you are ready to activate your network and announce the news that you will soon be trading after applying for the all-important Wholesale Distributor Licence / Authorisation.
Pound signs flash in front of your mind’s eye and distract you from preparing for the impending MHRA inspection.
Then, all hell breaks loose as someone mentions the importance of bona-fides, quality systems and the responsibilities of an RP.
Suddenly, the elation wears off and the stress kicks in.
Fear not, Pharma Experts Limited is here to help.
Good Distribution Practice
To start, it is imperative you get to grips with the EU Good Distribution Practice Guidelines 2013/C 343/01 for the distribution of human medicinal products.
Your Wholesale Distributor Licence / Authorisation business should be based around the chapters and clauses in this important document. Download it from here and make yourself familiar with its 10 chapters.
We highly recommend as a minimum that you attend one of our Good Distribution Training courses which will give you an insight both regulatory and statutory requirements for those who want to acquire a Wholesale Distributor Licence / Authorisation.
As a holder of a Wholesale Distributor Licence / Authorisation trading in the EU, you will be required to maintain a quality system setting out of full responsibilities, processes and risk management in order to meet these guidelines.
With the increasing complexity within the supply chain, compliance is essential in order maintain product integrity and prevent falsified medicine reaching the end user, the patient.
As a part of the supply chain you are obligated to protect the public from harm and danger which can easily result from non-compliance to this directive.
Plan to Succeed
Making the application is easy; having robust systems in place can appear to be simple till things go wrong. Often issues stem from the lack of knowledge which can be acquired by consulting experts in the field of Good Distribution Practice.
There are a multitude of things to consider and we can help you put together a customised project plan together covering, for example:
- Risk Management
- Quality Management Systems (procedures, forms and registers)
- Warehouse design
- Technical Agreements (or third party logistics, contract RP, and contract warehouses)
- Temperature Mapping and journey validation
- Dealing with Complaints, recalls and Falsified Medicines
In fact, all that you will require regarding the application for a Wholesale Distributor Licence / Authorisation !