European importing rules could spark UK drug shortage
Supply chain Short supply of medicines ingredients could spark a UK drug shortage if non-EU countries do not comply with new importing rules by July, the Association of British Pharmaceutical Industry (ABPI) has warned.
A short supply of medicines ingredients could spark a UK drug shortage if non-EU countries do not comply with new importing rules by July, the Association of British Pharmaceutical Industry (ABPI) has warned.
Countries importing pharmaceutical ingredients into the EU must obtain a certificate by July 2 to show they have complied with EU standards, under legislation introduced by the European Commission in January. But the ABPI said that only seven countries – including Australia, Brazil, Japan and the USA – had applied for a certificate and the situation was becoming urgent.
Just seven countries have applied for a certificate to import medicines ingredients into the EU, with the July deadline looming |
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ABPI technical affairs manager Mike Murray said the organisation was working with other European pharmaceutical bodies to "ensure that there is no interruption of the pharma supply chain". |
"The number of certificates obtained so far appears to be low, although good progress has been made in India and China following discussions between them and the European Commission," Mr Murray told C+D earlier this month. But the ABPI was still concerned that the certificates for these countries would not be finalised before the July deadline.
The ABPI had raised its concerns with the MHRA to help the medicines watchdog find a solution, Mr Murray said, but stressed that the extent to which UK medicine manufacturers would be affected would depend on which countries they sourced their ingredients from.
"The MHRA is keeping the situation and the potential implications under review and considering what action may have to be taken to avoid any shortages due to the new legislative requirements," an MHRA spokesperson told C+D last Wednesday (March 13).
What could UK pharmacy bodies do to avoid a drug shortage resulting from these measures? Comment below or email us at [email protected] You can also find C+D on Twitter, LinkedIn and Facebook |