“The drugs ofself-medication have been the subject of a marketing authorization (AMM); they have a favorable benefit / risk ratio, in the same way as prescription drugs. They are therefore governed by the same rules of safety, monitoring and dispensing, ”recalls the Ministry of Health on its site dedicated to drugs (www.medicaments. Gouv.fr). “Efficacy is not linked to whether a drug is prescribed or not by the doctor,” adds Professor Jean-Paul Giroud, clinical pharmacologist. The proof: some accessible without a prescription are reimbursed by Social Security as soon as they are prescribed by the doctor. “
What is the Marketing Authorization?
It is the sesame of the drug: it is essential to be marketed. It is requested by the pharmaceutical laboratory for each drug on the basis of a file containing pharmaceutical quality, efficacy and safety data (particularly from experiments in animals and clinical trials in humans) , in the claimed indication.
