According to the French National Agency for Medicines and Health Products Safety (ANSM), Over-the-counter (OTC) drugs are medicines that are accessible to patients in pharmacies, based on criteria set to safeguard patients’ safety.
FDA’s Center for Drug Evaluation and Research (CDER) regulates over-the-counter (OTC) which are drugs that have been found to be safe and appropriate for use without the supervision of a health care professional such as a physician, and they can be purchased by consumers without a prescription.
Due to their therapeutic class, these medicines could be dispensed without physician’s intervention for diagnostic, treatment initiation or maintenance purposes.
According to Article 43 of the Law No.367 issued in 1994 related to the pharmacy practice, and the amendment of Articles 46 and 47 by Law No.91 issued in 2010, pharmacists do not have the right to dispense any medicine that is not requested through a unified prescription, unless the medicine is mentioned in a list which is established by the Orders of Pharmacists and Physicians
In this regards, the Ministry of Public Health (MoPH) developed the National OTC list, presented it in a scientific, objective, reliable and accessible listingand issued by a Ministerial decision.
At this stage, no “convenience size packaging” nor “restriction to a maximum dose” or a “maximum dose per day” or “length of treatment” were considered for some molecules to allow them to be classified as OTC.
The list covers medicines that are intended to relief patients from minor to moderate symptoms for a determined period, and procured with the pharmacist’s assistance without the physician’s intervention.
In developing the OTC Medicines List, reference was made to the French, UK, Switzerland, Canada, FDA and AESGP lists.
The National OTC Medicines List covers medicines, dosage forms, package sizes, drug strengths and other information registered at the MoPH. It is divided into sections based on the Anatomical Therapeutic Chemical (ATC) classification system.
Each medication listing contains the following information:
Brand or Generic status
Country of manufacturing
Responsible Party Name
Responsible Country Name
The list will be updated regularly to include any new additions.The National OTC medicines List welcomes comments from healthcare professionals. Please send comments to: email@example.com