The UK subsidiary of a major French based medical devices manufacturing company approached Pharmacy Consulting Ltd (PCL) for support and advice concerning how they could become distributors of specific medicines to their UK customers, alongside their medical device distribution business.
The Pharmacy Consulting Solution
A visit to the customer’s premises and proposed warehouse facility was followed by providing practical assistance in drafting a set of working procedures for the ordering, receipt, storage and distribution of medicines. Assistance was also provided in making the Authorisation application and attending the MHRA inspector’s visit which were both successful and resulted in the company being complimented upon its pre-inspection preparation.
PCL was then pleased to later be able to support the application of the client’s technical manager to take over the role of Responsible Person having gained the requisite experience and training by working with PCL for 12 months. At that point it was recommended and agreed the senior consultant from PCL should become the deputy RP, so that in the event of an unforeseen absence of the employed RP the company were still compliant, and allowed to continue distributing medicines.
At the present time, the customer is preparing to move their entire business to one combined warehouse/office complex and PCL is advising the company RP on the MHRA aspects of this major investment.
By following the adopted approach, the company have developed an employee’s skill set to assume the responsibility of the RP role. At the same time they have retained an external advisor and contract deputy to cover any unexpected eventualities and to provide regulatory advice without internal conflicts of interest. The initial Authorisation application was obtained at first attempt and the company were thus able to begin distributing a range of medicinal products, within their desired timescale.