Year: 2015

What is Pharmacovigilance? By Joan Mwanaka, BSc Did you know that every drug has a side effect? It has been reported that a drug without a side effect will not work! So, if drugs are supposedly causing side effects, why are they on the market, and how are these drugs monitored? Pharmacovigilance is the answer…

Consultants from Paradigm Shift have supported a number of companies in their journey out of MHRA licence suspension, some of whom had taken legal advice, or had engaged solicitors to fight their case, in advance of contacting us. Quite often by the time Paradigm are contacted it’s too late. Typically we receive notice from people just…

Import tax minimisation and planning Import taxes include customs duty and VAT and these represent high costs within international supply chains. They impact EU manufacturers and distributors that source raw materials or finished products from overseas. Even UK/EU suppliers can also be a source of opportunity, should they have previously imported products that are being…

Preparing for your initial or return MHRA GDP inspection? Do you know what you need to do prior to the visit? At Paradigm we prescribe always being inspection/audit ready. Despite being given a two week notice of MHRA inspection it is essential that you remain as up to date as you can at any given…

Yesterday the MHRA released their first two blogs; https://mhrainspectorate.blog.gov.uk/2015/06/23/welcome/ https://mhrainspectorate.blog.gov.uk/2015/06/23/join-our-talented-and-dynamic-team-protecting-public-health/ Written by Mark Birse, Group Manager for the MHRA Inspectorate, the first blog covers the plan to bring blogs from all areas of GxP, including; – Compliance management approaches – Data integrity – Preventing drug shortages – Significant findings from our inspections – Supporting innovation…

As many of you will know, manufacturers do NOT need a WDA(H) (Wholesale Distribution Authorisation for medicines for human use) if they are distributing their own products. What many manufacturers do not realise is that they are now operating illegally by procuring, supplying, invoicing etc. UK Manufacturers; Are you conducting wholesaling activities in other countries?…

Quality can be built in to your systems… and it should be. For those of us who want to build and run a successful and consistent wholesale business, standard operating procedures are a good start… but not everything. If you have Standard Operating Procedures (aka SOPs) do you follow them? Are they reflective of the…

Brokering and GDP   With the release of new legislation around brokering, do you know what you are doing? Many are still misunderstanding the term “broker” and are brokering illegally, or without knowingly doing so. This post from Senior Associate Bernard Lawlor may help enlighten you. Are you, while acting as a Pharmacist or as…

We see frequently that sites share their wholesale Standard Operating Procedures aka SOPs. This can be a good thing if the wholesale SOPs are of a high quality and are tailored for the specific site, or a significant problem if they are for a different business model or out of date (not following current guidelines). A…

Every wholesaler should be actively subscribed to the medicine recall and drug alerts and be aware of their responsibilities for carrying out recalls within the time limits required. If no recall happens during the year the licence holder must carry out a dummy recall. This has historically been a big part of non-compliance with GDP, however…

With the “New” GDP guidelines now having been in effect since September 2013, and the requirement for registration of brokers of pharmaceutical products the Paradigm team are quite surprised at how few brokers are registered. At last check (4th Feb 2015) count there are only seventeen/17 pharmaceutical brokers registered, whether as companies or individuals. Why…

With the Falsified Medicines Directive coming (slowly) to fruition, it will be pharmacies and wholesalers bearing the brunt of the changes in the continual pursuit of patient safety. Sultan “Sid” Dajani, Chairman of the Falsified Medicines Directive at the Royal Pharmaceutical Society,  and UK Representative for the Pharmacy Group of the European Union (PGEU), has kindly written…

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Jan 15

The MHRA website originally sat on the domain www.mhra.gov.gsi.uk but was moved recently to www.mhra.gov.uk Aside from breaking lots of our web links much content was archived, and the new site is “light” on content. Many of the links that still sit on Google will take you to the archive, which is a snapshot of…

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