Medicines List to be filled by Medicine Importers and Local Manufacturers in accordance with the decision number 1292/2016 related to the completion of the medicine lists allowed to be dispensed without a prescription (OTC medicines list).
To be able to prepare and update the national OTC medicines list 2022, and based on the decision 1292/2016 related to the completion of the medicine lists allowed to be dispensed without prescription (OTC), the Medicine distributors and local manufacturers having OTC products in their portfolio, are requested to complete the below excel sheet by filling the missing information related to their OTC products in columns (L), (M), (N), and (O).
An Example is given in row 2.
Upon filling the excel sheet, kindly send it to the Quality Assurance of Pharmaceutical Products Department at the Ministry of Public Health at the following email addresses: otc@moph.gov.lb and otc.moph@gmail.com.
Kindly note that the maximum period to complete the submission is 1 month from today’s date, 01/03/2022
NB: The title of the excel to be used is: (name of the agent)-OTC list 2022.
Example: Mersaco-OTC list 2022
Reference to the previous communication related to the preparation and update of the national OTC medicines list 2022, this is to remind Medicine distributors and local manufacturers having OTC products in their portfolio, to complete the previously communicated excel sheet.
In case there are no OTC in a Company's portfolio, please also confirm by email.
Foreword
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: otclist@moph.gov.lb