By: Roxana Bermudez
In compliance with Law 1068 "Creating Law of the National Sanitary Regulation Authority" article 4, as functions it establishes that the authority may prepare and approve regulations, standards and administrative provisions whose purpose is to update the regulatory framework in Nicaraguan territory. The National Health Regulation Authority (ANRS) attached to the Ministry of Health, issued Administrative Resolution No. 004-2023 "List of Free-Sale Medicines 2023", which was communicated its approval in circular MS-ARNS-KVM-1634-05 -2023 issued by the Department of Pharmacy instance attached to the Health Regulation Authority.
The resolution has a general section, specific provisions, aspects related to drug concentrations and vehicles, where the parameters or criteria taken into account for this readjustment of the over-the-counter list are explained.
Having said the above, the list of medicines that will be marketed under the "over the counter" modality has been updated, the categories of products that are affected are pharmaceutical products, natural medicinal products and nutritional supplements.
Consequently, the holders whose products were affected by this update, must comply with post-registration changes corresponding to the "sale modality", complying with the requirements established in current regulations. Additionally, they must consider if the product has the authorized medical sample (MM) presentation, when making the change of modality, they must add a B3 notification "discontinuation of presentations", since it is not allowed for a free-sale product to have an MM presentation.
In Annex I, you will find the therapeutic classifications that specifically underwent changes, as well as the active ingredients, combinations or concentrations that were included or modified, compared to the previous over-the-counter list. What is not mentioned is why it did not undergo an update.
The administrative resolution is published on the website of the Ministry of Health. To download it, you must access the Health Regulation tab / Pharmacy Directorate / Nicaragua free-sale medication list folder.
Said list entered into force as of its signature on May 10, 2023.
ANNEX I
FREE SALE LIST 2023 NICARAGUA
| THERAPEUTIC CLASSIFICATIONS AFFECTED | ACTIVE PRINCIPLES/CONCENTRATION INCLUDED OR MODIFIED |
| A) EXPECTORANT AND ANTIHISTAMINIC ANTITUSSIVES | Desloratadine up to 5mg Oral Solids / 0.5mg/mL oral liquids. Fexofenadine from 60 to 180mg Oral Solids. Hederá Hé l ix Oral Liquids and CapsulesN-acetylcysteine up to 100mg oral liquids |
| B) ANALGESICS, ANTI-INFLAMMATORY AND MUSCLE RELAXANTS. | Acetaminophen up to 250mg Suppository.Flurbiprofen 8.75mg Oral SolidsLbuprofen up to 100mg/5ml Oral LiquidsMethocarbamol up to 500mg Oral Solids |
| C) ANALGESIC, ANTI-INFLAMMATORY, ANTIPYRETIC IN COMBINATION IN ITS SOLID AND ORAL LIQUID FORMS: | Butylhioscine bromide up to 10 mg Benzydamine up to 5%. |
| D) ANTACIDS AND GASTROINTESTINAL AGENTS | Calcium carbonate up to 750mg Oral SolidsProbiotics oral solids and Oral LiquidsOral rehydration serums oral solution and powderSucralphate up to 1g suspension and powderPsyllium Plántago powderSimethicone (dimethicone or dimethylpolysiloxane) up to 250mg Oral SolidsSimethicone (dimethicone or dimethylpolysiloxane) up to 100mg /ml DropsOmeprazole up to 20mg Solid Oral Petrolatum Liquid or Mineral Oil up to 30g/100ml Suspension / Emulsion |
| E) LOCAL ANESTHETICS | Lidocaine up to 10mg solutions. Lidocaine up to 3mg Buccal Tablet / Chewable Tablet. Lidocaine up to 10% semi-solids. |
| H) OPHTHALMOLOGICAL USE | Derivatives of Methylcellulose, Hydroxypropylmethylcellulose, Carboxymethylcellulose up to 1% Ophthalmic Solution. Sodium hyaluronate up to 0.4% Ophthalmic Solution. Polyethylene glycol 0.40% Ophthalmic Solution Propylene glycol 0.60% Ophthalmic Solution |
| l) DERMATOLOGICAL USE | Neomycin up to 1% Gel, Cream, Ointment and SolutionBacitracin 30.000 IU per 100g Gel, Cream, Ointment and solution Hydrocortisone up to 1% Gel, Cream and Ointment Benzoyl Peroxide 5% |
| L) ASTRINGENTS FOR TOPICAL USE | Diphenhydramine up to 1% Gel/Cream/Ointment/Lotion |
| N) ANTITHROMBOTICS FOR TOPICAL USE | Sulfuric Acid Polyester Mucopolysaccharide up to 0.445% Gel |
| S) ORAL CARE PRODUCTS | Salicylic acid 1% + Rhubarb hydroalcoholic extract 5% Solution. |
| T) SLEEP INDUCERS | Melatonin up to 5mg Tablets |
| U) ANTIPARASITIC | |
| V) VITAMINS AND MINERALS | Malt extract up to 1 g/5ml. |
| W) ESSENTIAL OILS | All healing and tissue regenerators that contain Vitamin A, D, E, Panthenol, Zinc Oxide, Zinc Dioxide, Allantoin, Sulfadiazine are approved. Topical preparations containing the following essential oils are approved: menthol, camphor, gomenol, eucalyptus, balsam, methyl salicylate, terpine, turpentine, thymol. |