Contract Responsible Person (RP)
The roles and responsibilities of a Responsible Person (RP) are defined in the EU Good Distribution Practice Guide and apply to both an employed or a contracted RP i.e. a Contract Responsible Person (RP).
Chapter 2, Clause 2.2 of the guide defines the qualifications and conditions which should be complied with when nominating any individual for the role:
The wholesale distributor must designate a person as responsible person. The responsible person should meet the qualifications and all conditions provided for by the legislation of the Member State concerned (1). A degree in pharmacy is desirable. The responsible person should have appropriate competence and experience as well as knowledge of and training in GDP.
The final decision to award the RP status to any individual who is named on a WDA Licence application rests solely with the MHRA.
It is rare for new startups and organisations taking their first steps into the Wholesale Distribution of Medicines to employ a company based Responsible Person due to the high costs involved and/or lack of experience.
An ideal solution is to have a Contract Responsible Person (RP) from a reputable company such as Pharma Experts Limited.
Our Senior Consultants are approved by the MHRA to act as a Contract Responsible Person for Wholesale Distribution of Medicines the UK and are also registered as Pharmacists with the GPhC.
What are the benefits of a Contract Responsible Person?
There are several benefits to contracting out the services of the RP to a external Contract Responsible Person (RP).
In many cases, businesses do not have experienced or qualified people to act as RP and the expertise of a Contract Responsible Person (RP) from the onset adds value to the organisation. This can free up time so that the management can focus on business developmental activities instead of managing GDP activities.
There is always an element of financial risk with any new venture and a Contract Responsible Person (RP) can be cost-effective solution as it takes away the need of hiring a permanent employee, resulting in substantial savings.
Contract RP’s can also provide valuable support for on-site staff and assist in their development.
How does the scheme work?
If you are thinking of applying for a Wholesale Dealers Licence this is an ideal way to start.
Our Contract Responsible Person will be named on your existing Wholesale Dealers Licence.
A Technical Agreement is drawn up between both party’s and outlines the duties of each organisation including the roles and responsibilities of the Contract Responsible Person.
If you are ready to work with us, or would like to discuss in further detail about how we can help you and your organisation please contact our office and send us your request, or schedule a free initial half an hour telephone consultation.