The Health Products Regulatory Authority (HPRA) says it does not have the authority to withdraw the licence for a vaccine against cervical cancer.
The High Court is hearing a legal action from a Westmeath woman, who claims her teenage daughter suffered "horrendous adverse effects" after taking it.
Gardasil is used as part of the Health Service Executive's HPV vaccination programme, and is currently offered to the parents of girls aged between 11 and 16 to protect against cervical cancer.
Fiona Kirby, a nurse from Kilbeggan in Co Westmeath, claims her daughter developed severe flu-like symptoms after receiving it in 2011.
She told the court her condition got worse after a second shot, and she was hospitalised the following year.
She is now 16-year-old and needs to be schooled from home and cared for on a permanent basis.
Ms Kirby claims more than 100 other girls have also been affected and she wants the licence to be withdrawn pending a full investigation.
Counsel for the HPRA, which monitors health products in Ireland, says that can only be done at European level.
The court heard a review is already underway and while a final decision will not be made until Spring next year, the authority claims it has so far found no evidence to warrant such a withdrawal.
