The first ever abortion pill has been approved for use in Ireland.
The Health Products Regulatory Authority (HPRA) confirmed to the Irish Examiner last night that it has “received and approved Mifepristone for termination of pregnancy”.
The tablet was authorised on November 30.
The tablet is taken as a single 600 mg oral dose, followed 36 to 48 hours later by the administration of prostaglandin analogue.
The Nordic Group BV, with an address in the Netherlands, is listed by the HPRA as the marketing authorisation holder.
The Irish Examiner asked if the HPRA was confident that the company will have supplies available in time for the January 1 deadline from which the Health Minister Simon Harris has promised an abortion service will be available for the first time in Ireland.
The HPRA said it could only comment that “the application has met the sufficient quality, safety and efficacy standards for a marketing authorization and not on the precise availability of this medicinal product”.
In a statement, the HPRA said “our understanding is that the company is working with relevant stakeholders with a view to have the necessary product available in time for this scheme”.
Last night, Dr Peter Boylan, former chair of the Institute of Obstetricians and Gynaecologists, who was appointed by the Government to help implement the new abortion service, said he believed it could be introduced by January 1, if the legislation, currently working its way through the Dáil, is passed.
Family doctors have expressed concern that this date is not achievable.
However Dr Boylan said he expects it can be done, although it is likely to have teething problems.
“I don’t think people should have undue expectations. People should anticipate that there will be difficulties because it takes time to get used to a new service,” he said.
However Mary Favier, vice president of the Irish College of General Practitioners said family doctors have “yet to see the evidence” that systems will be in place to allow the delivery of an abortion service from January.
“It’s a deadline constructed by the minister [Simon Harris] and it’s his deadline. There is a huge amount to be put in place, such as referral pathways. The minister has assured us it will happen, but we have yet to see the evidence. We are concerned,” Dr Favier said.
Separately a meeting organised by Start, the Southern Taskgroup on Abortion and Reproductive Rights, a group of up to 80 doctors drawn from general practice, obstetrics, and gynaecology and psychiatry in Munster, may not now go ahead tonight due to security concerns.
Mike Thompson, a GP member of Start, said the educational meeting is due to take place in Limerick. However it’s understood a high ranking staff member within the University of Limerick hospital group has been sent posters labelling them a “serial killer”.