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 matter of coding your products has been something of a “dark art” with hints and allusions from the MHRA inspectorate over the last years, but nothing solid has been published.
Those who have worked with the Department of International Trade (formerly known as UKTI) may have been lucky enough to be involved in their training courses, and be aware of what they should be doing.
Others have not been so lucky. Or knowledgeable.
Wholesalers need to remember that our regulator is not here to show us how to do things, but to see that we are compliant with the regulations.
The GDP Symposia, held annually in December, has seen Senior Inspector Cheryl Blake presenting on exports in 2014 and 2015.
This 2016 GDP Symposia saw a change from this, with Cheryl presenting with Terry Madigan an excellent interactive session on “Errors, Event Chains and Deviation Management,” but exports and customs procedures again held a spot.
Jane Sewell, International Trade Development Liaison Officer at HMRC presented on “International Trade and Export.” This was a partly useful presentation, however the presenter had to provide examples that were not related to pharmaceuticals, to prevent people being able to suggest that “this is what HMRC said we should do.”
Helpful? Not quite sure… but we have a breakthrough.
Cheryl Blake herself, who has been the MHRA lead on exports and introduction, has written an extremely useful blog post, which spells out in much clearer fashion.
This MHRA blog on exports and customs procedures removes much of the mystery that surrounds exports… but not all.
Where our government agencies are working closer together, and reporting to each other, we have to ensure that all protocols are in place and followed.
The Inspectors will be looking to see that you have used the right codes for the export of your products, and if not may refer you to HMRC.
A company was recently hit with significant charges for using incorrect coding for their exported products, in this case shoes. Instead of coding for rubber heels with wooden inserts, they coded rubber heels. A very nasty surprise of a bill of £150,000 is not what a company wants. Nor do you want a visit from Her Majesty’s Revenue and Customs.
Do you understand that products that are exported must be evidenced as having left the Union?
Have you got the relevant import permits and documentation for the country you wish to export to?
Have a Responsible Person with export experience?
Did you know export is outside of the EU… and EU trade is parallel trade?
Did you know you cannot export paracetamol to Ghana, or Botox to the USA?
Realise you cannot accept returns of exported goods?
Struggling with the concept? Want to know more?
Read the blog and do your research. Buy the Green Guide and maybe call in a friendly GDP consultancy!
We can help.
Contact us for more information!
2 Apr 2019
2 Apr 2019
12 Feb 2019
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