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National OTC Medicines List

List to be filled by pharmaceutical agents according to Decision NB. 1292 Date 10/10/2016: Please complete the list by the missing information related to your OTC products in culums L/M/N/O. An example is given in row 2

Decision Nb. 941 Date 18/5/2018
Decision Nb. 1292 Date 10/10/2016
National OTC Medicines List

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:
  • ATC code
  • Brand or Generic status
  • Ingredients
  • Code
  • Registration number
  • Brand name
  • Strength
  • Presentation
  • Form
  • Agent
  • Manufacturer
  • 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:

National OTC Medicines List-2018
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