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MHRA averts UK drugs shortage by relaxing EU importing rules

Sort Out Stocks The MHRA has averted a UK drugs shortage by temporarily relaxing new European rules on importing pharmaceutical ingredients.

The MHRA has averted a UK drugs shortage by temporarily relaxing new European rules on importing pharmaceutical ingredients.


The Association of the British Pharmaceutical Industry (ABPI) praised the MHRA's decision to temporarily allow manufacturers to continue to import ingredients from countries that could not prove they had met EU standards and said the medicines regulator had ensured the supply of drugs would not be disrupted.


Countries exporting pharmaceutical ingredients to the EU must obtain a certificate to show they have complied with EU standards, under European Commission legislation that came into force yesterday (July 2).


Countries that export medicines must now obtain EU certification to show they have complied with standards

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Implementing the new rules had been more problematic than expected and the MHRA's contingency plan would prevent a shortage of ingredients from India and China, who had decided to issue their own letters of compliance, ABPI technical affairs manager Mike Murray said.

"All parties are striving to resolve the issue as quickly as possible and we very much welcome the approach adopted by the MHRA in the interim," he told C+D.


Last month, the MHRA announced that, if UK manufacturers were worried that countries from which they imported ingredients would not have a certificate in time, they could vouch that their manufacturing sites within the country had been inspected within the past three years and met with EU guidance.


Mr Murray said the European Federation of Pharmaceutical Industries and Associations (EFPIA) had called on other EU states to adopt a similar approach to avoid unnecessary drugs shortages.


Switzerland, the USA, Australia and Japan have been added to a list of nations who do not require a certificate. Other countries, such as India and China, have set up their own systems to issue letters of confirmation.


These systems had only been set up recently and it could take some time before the countries were able to produce a letter for each ingredient they manufactured, Mr Murray added.


C+D has launched a petition as part of its Sort Out Stocks campaign, calling for the government to accept that prescription medicine shortages are still a problem for both pharmacists and patients in the UK. Pharmacists can back the campaign and sign the petition here.



Have you signed C+D's petition to sort out stocks?

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6 Comments

Paula Henderson, Hospital nurse

Thanks for this interesting post. Medication producers are facing crippling shortages of raw materials, leading to <a
title="Adderall among prescription drug shortages" href="http://www.newsytype.com/">drug shortages</a> nationwide. Adderall, a popular Attention deficit hyperactivity disorder medication, is in dangerously short supply. This is not good especially to those with maintenance medications.

Dani Daniels, Non healthcare professional

Drug shortage is experience not only in the European region but also worldwide. Various drugs are in critically short supply. Dwindling raw materials among other problems are causing several narcotics to not be produced in sufficient amounts. One of the most substantial medication shortages is that of Adderall, a popular medication for treating Attention Deficit/Hyperactivity Disorder. Source of article: <a title="Adderall among prescription drug shortages" href="http://www.newsytype.com/14225-adderall-shortages/">Adderall among prescription drug shortages</a>

Medicine Master, Primary care pharmacist

Just shows you the state of the british pharmaceutical industry and how impotent europe really is when faced with countries who don't care two hoots about them.
We have out sourced to the far east and then expect to impose import restrictions on them when the indigenous pharma industry has been massacred only politicians could do this, when the developing countries are getting richer and demanding better healthcare who needs to sell in europe.

Oliver Staunton, Locum pharmacist

PI generics.

Z ZZzzzz, Information Technology

Is this the same China where the population trust their regulators that much that the people of China are buying up baby milk fomula from anywhere but China thus forcing restrictions on the number of cans customers can buy of some products in UK supermarkets. Honestly.......

C W, Dispensing assistant

Yep.

I don't understand why there are so many shortages/MCSs etc. Whats worse, potentially dodgy drugs from abroad or no drugs at all?

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