Monday 10 December 2018

Dublin pharmaceutical firm allegedly broke medicinal regulations over the sale of cancer drugs, court hears

Photo: Stock Image
Photo: Stock Image

Tom Tuite

A Dublin pharmaceutical firm and three of its directors have been given four weeks to decide how they will plead to breaking medicinal regulations over the sale of cancer treatment drugs.

The case against Taj Accura Pharmaceutical Ltd had its second listing at Dublin District Court on Monday. The firm and three named directors are being prosecuted by the Health Products Regulatory Authority (HPRA), the agency which regulates medicines in Ireland.

Solicitor Ronan O’Neill, for the HPRA, Judge John Brennan that they had complied with an order for disclosure of prosecution evidence to the defence and it could be adjourned until March 20 next.

Judge Brennan said the case was listed for them to say how they will plead on the next date.

The firm with an address at Trinity Street, Dublin 2, faced charges relating to the sale of suspected falsified products and breaching medicinal product regulations.

It was alleged that from Nov. 16 until Dec. 22, 2015 they sold by wholesale a medicinal product name Fluourouracil 50 injections containing the prescription only substance Fluourouracil in circumstances where there was sufficient grounds to suspect it was a falsified medicinal product.

The prosecuting agency also alleged that on March 5, 2016, the defendants imported into the State a product named Afhlan (Melphalan injections USP 50mg) knowing it to be a falsified product. It was also alleged they exported it, sold it by wholesale and placed the product, which contained a prescription only substance, in circulation.

The HPRA alleged that between Aug. 11, 2015 and Jan. 29, 2016 they brokered and sold by wholesale the product BICNU containing the prescription only substance Carmustine and sold the product.

It was also alleged they sold by wholesale Melphalan injections which contained a prescription only product between March 23, 2016 and April 5, 2016.

Directors James Madden, of Upper Pembroke Street, Dublin 2, Emma Madden of the Waterfront, Hanover Quay, Dublin 2 and Orna Madden of Hanover Dock, Hanover Quay, Dublin 2 were the co-defendants with the company.

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