by John Finey | Aug 21, 2018 | Blog, Brexit, Training
I am sure plenty has been written and said about what I am sure many will see as an additional burden on wholesalers, this simple post is to help provide clarity about the scope of the regulations…
by Dean Tinklin | Aug 17, 2018 | Behind the scenes, Blog, Good Distribution Practice - GDP, RP, Training
Despite the MHRA’s guidance note 6 there is a lack of a clearly defined and standardised route into becoming a trained, experienced, and effective Responsible Person (RP), and consequently the MHRA are now placing a greater emphasis on the suitability of a licence holder’s RP, perhaps in an attempt to ensure that all roads eventually lead to the same destination or to gradually develop and define the necessary route, or maybe both…
by Jackie (née Heneghan) Peck | Jun 19, 2018 | Brexit, GDP/RP, MHRA, WDA(H)
How well do you know them? Ten Questions which you need to ask yourself about your QP (Qualified Person) Are they involved enough in the changes and decisions made in your organisation ? Do they report to the decision makers ? Can they easily communicate with the...
by Jackie (née Heneghan) Peck | Jun 1, 2018 | Analyisis, Behind the scenes, Blog, Brexit, Business, GDP/RP
Changes to the way data is held and processed are now in place since the adoption of GDPR legislation which came into force on the 25th May. Unless you have been living on a desert island somewhere, you could hardly have failed to notice this given the plethora of...
by Jackie (née Heneghan) Peck | Jan 23, 2018 | Consultancy, EudraGMDP, Export Training, GDP/RP, Good Distribution Practice - GDP, MHRA, NHS, Pharmacist, WDA(H), WDA(H)
Are you a Wholesaler exporting Controlled Drugs or are planning to expand your product range to include Controlled Drugs? Do you hold a valid United Kingdom Controlled Drug Licence from the Home Office – if not you should and your WDA (H) may need to be varied to...
by Adel Nagy | Sep 29, 2017 | Blog, Consultancy, GDP/RP, Good Distribution Practice - GDP, MHRA, RP, Training
The European GDP Guideline of 5 November 2013 requires that wholesale distributors have to appoint a Responsible Person (RP) for GDP. The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices. According to...
