By: Graciela Gutierrez
Paralegal – Life Sciences
The promotion and advertising of medicines in El Salvador is regulated by the Medicines Law through the National Directorate of Medicines through the Promotion and Publicity Unit.
It is important to mention that the law only regulates the drug and not the brand of the drug manufacturer.
Based on the drug law, these are defined as follows:
Art 13
Promotion: all informative and advertising activities carried out by manufacturers, distributors and dispensers with the aim of inducing the prescription, supply, acquisition and rational use of medicines.
The promotion of medicines will be oriented to inform about its rational use and prevention of its abuse.
Advertising: advertising of pharmaceutical specialties and products is understood to be that which is done by any form or means of dissemination, such as: printed, radio broadcast, telecast, drawn, painted, projected or broadcast advertising through the Internet, audio system, fixed or mobile, as well as the free distribution of samples.
The Promotion and Advertising may be directed to the general public and exclusively to health professionals, as follows:
When permission for Promotion and Advertising directed to the public is requested, it must meet the following requirements:
- Be classified in over-the-counter drugs.
- That it has a valid health registry in the country.
- Offer reliable, accurate, updated and verifiable information.
- It should be aimed at promoting rational use, as well as the prevention of its abuse.
- You should not use phrases that exaggerate the benefits of the product, such as: wonderful, magical, unsurpassed, number one, the most effective and other similar ones that imply unfair competition.
- Make an express and clearly visible invitation to carefully read the instructions that appear on the bullets of the medication and mention the phrase "in case of doubt consult your doctor or pharmacist"
To request permission for promotion and advertising aimed exclusively at health professionals, the requirements are:
- Have a valid health registry in the country.
- The information will be made through written, audiovisual or electronic media where only health professionals have access.
- The information must include the name of the laboratory and drug, chemical, pharmaceutical, medical and technical information to be reported and must be compatible with the monograph approved for the drug.
- The essential information of the product, according to the data contained in the data sheet, including the name of the drug, qualitative and quantitative composition, complete clinical data, incompatibilities, instructions for use/handling, name and address of the authorization holder.
- Its prescription and dispensing regime, different presentations of the product, in its case the dosage and pharmaceutical form; and
- Date of the last update and revision of the information provided.
The Medicines Law in article 63 prohibits the public promotion of psychotropic and narcotic drugs, however, as an exception to the rule, we can request a special permit where we mention the reason for the Promotion and Publicity, whether we are in the launch or medicine seminar, and we know that only professionals who are experts in the subject and who will serve as support will be there.
The Unit also approves patient benefit plans, which consist of delivering through the doctor a 2+1, 3+1 or discount coupon for the purchase of the medication, whose benefit is in accordance with the provisions of article 1 of the Medicines Law, which seeks to ensure greater accessibility of medicines to the population.
In addition, to deliver promotional items such as: t-shirts, caps, pencils, among others, the Unit authorizes such delivery only to health professionals and not to the general public, since many times people are conditioned purchase of the medication and the aim is lost, which is the rational use of the medication.
In case of non-compliance with the requirements, the Promotion and Advertising Unit may prevent or deny advertising and in case of promoting or advertising without prior permission, the Directorate will open a sanctioning process where it may cancel the health registration of the drug.
Currently, the issue of promotion and advertising in El Salvador is very complex, since there is no guide that clarifies the granting of permits for promotion and advertising, so it is advisable to always have the advice of a highly trained team and specialized in the subject; At LatinAlliance we are known for always providing the necessary support to our clients.