Separation of the Licence Holder and Responsible Person – The last paragraph on page 128 of the 2017 Green Guide contained the following sentence:
‘In the case of small companies, the licensing authority may accept the licence holder as the nominated RP.’
In the updated 2022 Green Guide this 18 word sentence has been omitted. Further clarification from the MHRA has yielded the following information:
‘MHRA guidance on the appointment of the Responsible Person has been updated in the 2022 Green Guide to remove the option for small companies to have the Licence Holder and the RP as the same person.
Evidence has shown that companies where the Director / owner of the company is also the RP are significantly more at risk of failing to meet the requirements of GDP and The Human Medicines Regulations’.
This means that there now needs to be separation of the Licence Holder and Responsible Person within a WDA holder’s business. This will have significant impact on small companies, such as independently owned retail pharmacies, who wish to obtain a WDA(H) licence and have the Pharmacist Owner/Superintendent acting as both the Licence Holder and the RP.
The updated Green Guide also changes the experience requirements for the Responsible Person (page 75). Previously, Pharmacists and QPs were exempt from requiring at least 1 year’s practical experience of the activities authorised on a WDA licence (i.e. procurement, holding, supplying or exporting) and maintaining a quality management system.
The updated guidance makes no mention of any exemptions for Pharmacists and QPs – effectively therefore requiring that all RPs have at least 1 year’s experience, regardless of professional background or qualifications.
At PCL we are experts at navigating would-be WDA holders through the regulatory requirements imposed by the MHRA, and can provide all the help and support required to set up your Wholesaling business, including contact RP support whilst in-house personnel obtain the required experience.
We can also support your training needs for all staff, from introductory training in GDP to the full MHRA approved Cogent Gold Standard training for Responsible Persons.
We also run a short (two hour) Green Guide update training session to cover all the changes to the new MHRA guidance and a regular monthly RP forum to discuss issues affecting all aspects of GDP Quality and Regulatory compliance.
Contact us for further information using the link below:https://pharmacyconsulting.co.uk/contact/