The Authorization for the placing on the market of a drug (AIC) is a coding system that uniquely identifies each pharmaceutical package sold in Italy, also distinguishing it based on the number of tablets/units, the percentage of active ingredient, the route of administration, etc. These codes are issued by the Italian Medicines Agency (AIFA) after the completion of all the study phases of the clinical trials and the positive opinion of the Technical Scientific Commission (CTS). The CTS, together with a group of internal and external experts and the Health Authorities Institution (ISS), carries out all the necessary assessments (chemical-pharmaceutical, biological, pharmaco-toxicological and clinical) on each drug to be placed on the Italian market in order to ensure the safety and efficacy requirements. The results of researches conducted by the manufacturer of the drug itself are also examined.
AIC use according to the DPCM on EHR:
In accordance with the Technical Regulation attached to the DPCM on the EHR, the AIC codes, together with the ATC codes, have to be used within the PS for coding:
- adverse reactions to drugs and/or foods as regards the therapeutic, pharmacological or chemical class;
- pharmacological therapies of the patient;
- vaccinations of the patient.