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ABPI supply chain warning

pharmafile | March 7, 2013 | News story | Manufacturing and Production, Sales and Marketing ABPI, API, EFPIA 

The ABPI is warning of supply chain problems which may cause a bottleneck in UK pharma manufacture this summer.

The issue has arisen because of June 2011’s Falsified Medicines Directive, which requires written confirmation that active pharmaceutical ingredients (APIs) imported into the EU meet appropriate standards.

Directive 2011/62/EU will take until 2017-2020 to implement fully but one key part of it comes into force on 2 July.

From that date, API shipments must be accompanied by written confirmation from the competent authority of the exporting third country that they comply with “standards of good manufacturing practice and control of the plant are equivalent” to those in the EU.

“There are concerns about the ability and readiness of some third states to do this,” explains ABPI technical affairs manager Mike Murray.

“It is in encouraging countries to become authorised that there may be problems,” he goes on. “There is potentially quite an acute situation between now and July.”

The EU rules have been opposed by some major API exporting countries, including India and China – from whom a sizeable proportion of bulk APIs used in the EU are sourced. 

That means there is concern that pharma firms, particularly generic manufacturers, could find that some APIs are scarce once the regulations are in place.

“We don’t want on 30 June a potential backlog of people waiting for certificates,” Murray suggests. “The worst case scenario is that companies wouldn’t have access to APIs to be imported.”

“Effectively, that means you won’t be able to manufacture drugs,” Murray says bluntly.

The UK’s Medicines & Healthcare products Regulatory Agency has sent a letter to the EC outlining its concerns, suggesting that “exporting countries may be unwilling to participate in the scheme as it increases their regulatory burden”.

However, the Commission has not given any sign that it’s willing to change the July deadline, according to the ABPI.

“We have made representations to the EC through [European pharma trade body] EFPIA to push back the date,” Murray says. “But we haven’t received any positive feedback.”

In December, Switzerland became the first country to be classed as having equivalent standards for the manufacture of APIs under the new EU rules, which allows it to sidestep this certification issue.

Adam Hill

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