Regulatory Focus™ > News Articles > Updated: MHRA Suspends UK Company's MS License

Updated: MHRA Suspends UK Company's MS License

Posted 15 September 2015 | By Zachary Brennan 

Updated: MHRA Suspends UK Company's MS License

Late last month, the UK's Medicines & Healthcare products Regulatory Agency (MHRA) suspended the manufacture specials (MS) license of a UK company that recently made a push into the US.

The MHRA did not reveal what caused it to suspend Bionical Limited's license, but according to MHRA's most recently updated list of suspensions, the license is suspended until 18 February 2016.

Jonathan Hughes, business development director of Bionical, told RAPS that the suspension came because the company stopped using the license and doesn't have a need for it. He added that between 2009 and 2012, Bionical supplied medicinal products to hospitals and ministries in the Middle East and North Africa but the company has exited that part of its business.

He also clarified that the suspension of this license will not have any impact on the company's Wholesale Distribution Authorization (WDA) license, which it uses to distribute medicinal products within the European Economic Area and to store products in the UK. The WDA license was re-approved back in late August following a successful MHRA inspection in April, according to documents provided to RAPS by Bionical.

Bionical joins four other companies on the list of suspensions, including Roya Health Limited, Pars Ram Dhanda, Octavian Pharma Limited, and Relonchem Limited, which has a partial suspension until 17 December.

In certain circumstances, MHRA will permanently revoke a license. The list of revocations includes seven companies, with the most recent action taken against Acomed Limited in May.  The list is updated on the same day that the suspension or revocation takes place.

The suspension for Bionical comes almost a month after the company announced that it's expanding operations into the US via the acquisition of McCallan Health, which the offers customized patient education materials.

MHRA Decision


Categories: Regulatory News

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