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You may be surprised at the number of enquiries we receive from prospective clients who want to get a WDA (H) (wholesale dealer authorisation for medicines for human use) and start what they think is an “easy” business. Everyone needs drugs, right? A safe investment for the future is medication wholesale? Well, sadly, it’s not…

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  We think that £55 + Postage and packing is a fair price for such a critical publication, but not everyone will agree. If you do agree, click the link above and buy it from the Pharmaceutical Press. We meet many who do invest, but there are also many more who cannot or will not…

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The European Medicines Agency database of good manufacturing practice and good distribution practice compliance continues to be populated as more sites are inspected. GMP and GDP compliance certificates will be uploaded to the site, and will allow prospective customers or suppliers (or other interested third parties, including competitors) view them at will. What does this…

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Have you subscribed to the MHRA email alerting service? Any and all staff involved in GDP related activities should take advantage of this free and essential resource. https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/email-signup Whether you are involved in Good Distribution Practice, Good Manufacturing Practice, Pharmacy or just like to keep up to date with the news. How can this help…

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With the updates to EU GDP last year many small pharmacy wholesale operations are still catching up and coming to terms with the impact that it has on their business, but is there a bigger problem ahead? For years pharmacies have been audited by the RPSGB and now the GPhC, yet how many are still…

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Most of you will be aware of the classes of deficiency that may be discovered during your risk based inspection, but for those who do not, here is a brief summation Critical deficiency • A “Critical” is deficiency which causes, or leads to a significant risk of causing, a product to be harmful to a…

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How do the MHRA carry out inspections? Those of us who have been lucky enough to attend more than a few know that it can vary slightly, depending on which inspector is leading. Although the framework remains the same, some inspectors may have particular areas of interest or expertise which can then colour the inspection…

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The MHRA regularly find that self inspections, which are required for GDP compliance, are either not carried out or are insufficient in their scope. The new regulations advise that third party inspections could be considered helpful, but cannot replace self inspection protocols. It is also agreed that the self inspection does not need to be…

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Many companies are unable to provide their own Responsible Person and turn to a Contract Responsible Person to help manage and support their GDP Quality management system. When selecting your Contract Responsible Person, how should you go about it? Opinions vary, but many will pick a person they know, or is known by a trusted friend…

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The MHRA are still issuing the new WDA(H) to licence holders, and after the next inspection cycle all licences and GDP compliance certificates will be found here; http://eudragmdp.ema.europa.eu/ The site allows you to search by WDA number, address and more. You are now responsible for ensuring that anyone you outsource work to is compliant, and…

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What are the costs associated with gaining and retaining your wholesale licence? A lot depends upon your business model, but your average pharmacy stock skimming models costs half for the initial inspection as a “normal” wholesaler, as long as they trade 15% or less of their turnover. Small wholesalers trading in less than £35,000.00 per…

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The full day rate for an MHRA Good Distribution Practice inspection is £1936.00 This rate is reduced for wholesalers who only supply GSL (General Sales List) products, or for small wholesaler dealers where wholesaling of licensed products does not exceed 15% or £35,000 of total turnover, but ONLY where the inspector spends less than 3.5…

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Well, you should already be… but many are not. The updates came into force in September last year. For those who haven’t yet caught up, or are still not completely sure about what they are doing, we recommend purchasing the Green Guide 2014, Rules and Guidance for Pharmaceutical Distributors. But for those of you who…

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There are some companies offering coaching on how to “handle” an MHRA inspector. If you think this is of interest to you then I suggest you STOP and think again. If you have to pay to be coached on handling an inspector/inspection then there is something wrong. These simple, common sense rules will help anyone…

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We are often asked for assistance pre-inspection, and to help prepare a site in advance of the regulator’s visit. How can we help you to help yourself? If you don’t want to engage us to assist directly, then we recommend; read our free and helpful blogs. Check your compliance against the EU GDP Guidance update of November…

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An MHRA (other competent authorities are available!) Wholesale Distribution Authorisation (for medicines for human use) aka WDA(H) is the revised name for the MHRA “wholesale dealers licence” which is the licence issued by the MHRA (Medicines and Healthcare Products Regulatory Agency) to wholesalers. If we don’t seem to be able to make up our mind re what it…

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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,…

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The new guidance for Good Distribution Practice was published March 7th 2013, and came into law in September 2013. Some of the updated guidance and legislation will potentially leave you at risk of major or critical failings in your next inspection, if you don’t catch up. Significant changes are noted around the following areas; 1)…

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Firstly… what is an RP? In terms of wholesale and GDP (Good Distribution Practice, NOT Gross Domestic Product!) the letters RP stand for “Responsible Person.” So… what is a Contract RP? Not all holders of a WDA(H) (Wholesale Dealers Authorisation for medicines of human use) will either be capable, or desire, to be the Responsible…

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6
Feb 14

Paradigm are proudly partnered with Discount Specials, a provider of quality unlicensed medicines. Discount Specials supply quickly, efficiently, and cost effectively, avoiding the dubious “rebate” model that some companies have been shown to be using. How does it work? We set you up a new account, and you order online or by placing a call. Tariff…

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Paradigm Shift Consulting Ltd, and Smartway Pharmaceuticals have, on request, been given a deal for their customer bases on the newly published MHRA Green Guide – Rules and guidance for Pharmaceutical Distributors 2014 The MHRA and Pharmaceutical Press have kindly agreed to extend their FREE DELIVERY offer on the Green Guide – offer now extended to…

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