The abortion pill known as RU-486 has been approved in Italy despite opposition by the Vatican.
The 4-1 vote at the Italian Drug Agency's executive branch comes about two years after the agency first looked into the issue.
The agency said there will be restrictions on administering the pill.
RU-486 cannot be sold in pharmacies, only prescribed by doctors in a hospital. And it can only be given to women up to the seventh week of pregnancy.
The Catholic Church, which opposes abortion and contraception, protested the approval immediately.
"That's not how you alleviate human suffering, that's not how you help women, that's not how you help mankind," Monsignor Elio Sgreccia, a senior church bioethicist, said in an interview Friday with Associated Press Television News.
The Vatican announced that women taking the pill or doctors administering will be excommunicated under church law.
Source: The Associated Press