Category: MHRA

13
Mar 17

Paradigm are offering monthly GDP training sessions at their offices in Rushden, Northants, NN10. Training sessions include; 1) GDP Training for Managers and RP Teams, covering all 10 chapters of the EU Guidelines for Good Distribution Practice for Medicines for Human use 2013/C 343/01 2) Audit training – A day of training on auditing a…

24
Feb 17

Many wholesalers have been found to be deficient during their GDP MHRA inspections, especially with their Chapter 30 Commodity codes, when exporting pharmaceutical products. Many have exported pharmaceutical products either using a “blanket” code that they believe suits finished products, or in some cases not even coding their products at all. In some circles the…

30
May 16

Home Office List of Controlled Substances

Posted by admin Comments off   -   MHRA

Well, it has been a long time coming, but the Home Office have now re-posted the list of controlled substances which has been down for over a year.   https://www.gov.uk/government/publications/controlled-drugs-list–2/list-of-most-commonly-encountered-drugs-currently-controlled-under-the-misuse-of-drugs-legislation   This list shows drug classifications as well as schedules, and although not exhaustive is a useful tool. To supply controlled drugs a site needs…

23
May 16

Do you supply medicines as stock to other healthcare providers or other legal entities by way of wholesale dealing? You may be aware you need to hold a Wholesale Distribution Authorisation or WDA (H) if you supply medicines as stock to another legal entity, but do you supply Controlled Drugs too? If yes, you will…

The Falsified Medicines Directive is a key focus for the UK Competent Authority, the MHRA, and it is expected that as a UK Pharmaceutical wholesaler that you are aware of this emerging regulation. The FMD comes into effect 09 Feb 2019, “Brexit” or not. For more information around Falsified Medicines and the coding, see our…

An update on the Falsified Medicines Directive from 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). “With the Falsified Medicines Directive coming (slowly) to fruition, it will be pharmacies and wholesalers bearing the brunt of the changes…

For those who do not know already the “5% rule” for pharmacies disappeared some time ago, and to purchase products from a site without a WDA (Wholesale Distribution Authorisation) is a critical deficiency in Good Distribution Practice. Prior to 14 August 2012, section 10(7) of the Medicines Act 1968 provided a pharmacist in a registered pharmacy (or…

3
Nov 15

What is Pharmacovigilance?

Posted by admin Comments off   -   MHRA

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…

24
Jun 15

MHRA Inspectorate Blog – New and helpful?

Posted by admin Comments off   -   MHRA

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 and our work with the MHRA…

14
May 15

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?…

4
May 15

Broker? Yes or no?

Posted by admin Comments off   -   MHRA

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 a legal entity, accidentally…

We see frequently that sites share their wholesale Standard Operating Procedures aka SOPs, which in some cases 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 wholesale SOPs for a different business model, or out of date. A…

10
Feb 15

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…

29
Jan 15

MHRA Website relocation to .gov.uk

Posted by admin Comments off   -   MHRA

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…

11
Oct 14

Paradigm Shift Consulting are a third-party provider of the PharmaDoctor suite of services. Whether you are looking to provide travel health solutions, from anti-malarials to yellow fever vaccinations, we can arrange full training and marketing support to get your clinic up and running, and to become a success. Want to provide Erectile Dysfunction, Hair Loss,…

22
Aug 14

Posted by admin Comments off   -   MHRA

Paradigm shift consulting Is Here To Help In essence, we are a service to the pharmacy and wholesale sectors, specialising in streamlining operations and increasing profitability. We have many satisfied customers who have used our service to take advantage of innovations in a quickly developing pharmacy market. Whether this is setting up assisting in managing a Wholesale Dealers…

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