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Wholesale Medicines Licensing Consultancy & Responsible Person Support

Wholesale Medicine Dealers Licensing & Responsible Person Support Consultancy

Pharmacy Consulting Ltd (PCL) has been offering services to new UK wholesale distributors of medicines since 2006.

These services are primarily:

  • Supporting new medicines wholesalers in obtaining an appropriate MHRA Wholesale dealers license (WDL) in order to permit wholesale dealing to commence
  • Acting thereafter on an ongoing basis as a contract Responsible Person for the wholesaler

Taking these services in turn:

Companies wishing to become wholesale distributors of medicines (including pharmacies) need to apply to the MHRA to obtain a Wholesale dealers license covering the category, or categories of medicines they wish to distribute. If they also intend to import medicines the appropriate type of licence application must be made relevant to the source country/ies from which such medicines will come. Before making an application, applicants need to have suitable secure premises for the storage of medicines and have developed a set of written standard operating procedures (SOPs) that detail exactly how the various company medicines handling processes and procedures will work. These must comply with Good distribution practice (GDP) guidelines for medicines. PCL can advise on premises requirements and suitability and help customers to prepare a set of suitable SOPs. PCL also send their senior consultant along to the MHRA pre-licensing inspection to help deal with questions from the MHRA inspector.

Unless the customer already has an employee who has more than a year’s practical experience of wholesale handling of medicines, the customer must employ or engage the services of a Responsible Person, who already has such experience. This person is legally answerable to the MHRA and the customer for overseeing the upholding of the standards of Good Distribution Practice within the business. PCL offer this service to customers on a contract basis, usually involving customer site visits at 2 or 3 monthly intervals supported by and interspersed with regular Skype and e-mail communications in order to maintain a close proximity to company medicines distribution activities. This RP work is done under a technical agreement which spells out both the responsibilities of the contract RP and the customer’s responsibilities.

Case Studies

Entering the UK Medicine Distribution Market

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 License application and attending the MHRA inspector’s visit which was 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 unforeseen absence of the employed RP there was still a back up to allow trading in medicines to continue.

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.

Customer benefits

By following the adopted approach, the company have trained an employee to take over the RP role, thus developing an employee. At the same time they have retained an external advisor and contract deputy to cover any unexpected eventualities. The initial license application was obtained at first attempt and the company were thus able to meet a commercial challenge and begin distributing a range of medicines containing products, within their desired timescale.

Becoming Distributors and Importers of Radio-Pharmaceuticals

A Radiopharma equipment distribution company approached Pharmacy Consulting Ltd (PCL) for support and advice concerning how they could become distributors, and importers of radio-pharmaceuticals. Due to the specialist nature of the products, it was decided that the company would not handle or store the products, and instead would engage specialist shippers and distributors on a sub-contract basis to handle the products between manufacturer and UK hospital customer.

The Pharmacy Consulting solution

A visit to the customer’s proposed office facilities was followed by providing practical assistance in drafting a set of working procedures that would meet UK requirements.

PCL made two contemporaneous MHRA License applications on the customer’s behalf, one to cover imports from outside the EU and one to cover imports from inside the EU, and attended the MHRA inspector’s visit which was successful.

PCL was then pleased to support the client’s management in establishing the UK business, in particular establishing the routines for non-EU imports where each individual importation has to be pre-notified to the MHRA.

Customer benefits

Using PCL’s experience and expertise the initial MHRA license application was obtained at first attempt and the company were thus able to begin licensed UK based trading at the earliest possible juncture.



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