Publication of new Ordinance on Pharmacovigilance
The new Ordinance on Pharmacovigilance was published on the 19th October 2009 in the Official Gazette No. 125/09.
This Ordinance comes into effect on the eight day after its publication in the Official Gazette. The link to the Ordinance can be found on the ALMP website, in the Legislation section.
The Ordinance on Monitoring Adverse Reactions to Medicinal Products and Medical Devices (Official Gazette No. 29/05), ceases to be valid as of the day of commencement of the above mentioned Ordinance on Pharmacovigilance.