By: Roxana Bermúdez
To comply with 1068 Law “Law Creating the National Health Regulation Authority”, Article 4 of its functions states that the authority may elaborate and approve regulations, norms, and administrative provisions aimed at updating the regulatory framework in the Nicaraguan territory.
The National Health Regulation Authority (ANRS), attached to the Health Ministry, issued Administrative Resolution No. 004-2023 “Over-the-counter Drugs list 2023”, which was communicated its approval in circular MS-ARNS-KVM-1634-05-2023 issued by the Pharmacy Directorate, an instance attached to the Health Regulation Authority.
The resolution has a general section, specific provisions, and aspects related to the concentrations and vehicles of the drugs, where the parameters or criteria taken into account for this readjustment of over-the-counter drug list are explained.
Having said the above, the list of drugs to be marketed under the ” over-the-counter” modality has been updated, the product categories affected are pharmaceuticals, natural medicinal products, and nutritional supplements.
Consequently, the holders whose products were affected by this update must comply with the post-registration changes corresponding to the “sales modality” complying with the requirements established in the current regulations. Additionally, they must consider if the product has an authorized medical sample (MM) presentation, when making the change of modality they must add a notification B3 “discontinuation of presentations” since it is not allowed for an over-the-counter 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 OTC listing. What is not mentioned is why it was not updated.
The administrative resolution is published on the Health Ministry’s web page. To download it, please go to the Health Regulation / Pharmacy Department / Nicaragua over-the-counter drug list folder.
This list came into force as of its signature on May 10, 2023.
ANNEX I
OVER-THE-COUNTER DRUG LIST 2023 NICARAGUA
| THERAPEUTIC CLASSIFICATIONS CONCERNED | ACTIVE INGREDIENTS/CONCENTRATION INCLUDED OR MODIFIED |
| A) EXPECTORANT AND ANTIHISTAMINE ANTITUSSIVES | Desloratadine up to 5mg Oral Solids / 0.5 mg/mL oral liquids.Fexofenadine from 60 to 180mg Oral Solids. Hederá Hé l ix Oral Liquids and Capsules.N-acetylcysteine up to 100mg oral liquids. |
| B) ANALGESICS, ANTI-INFLAMMATORY AND MUSCLE RELAXANTS | Acetaminophen up to 250mg Suppository.Flurbiprofen 8.75mg Oral Solids.Lbuprofen up to 100mg/5ml Oral FluidsMethocarbamol 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. Benzidamine up to 5%. |
| D) ANTIACIDOS Y AGENTES GASTROINTESTINALES | Calcium carbonate up to 750mg Oral SolidsOral Solid Probiotics and Oral LiquidsOral Rehydration Serum Oral Solution and PowderSucralfate up to 1g suspension and powderPsyllium Plantago powderSimethicone (dimethicone or dimethylpolysiloxane) up to 250mg Oral SolidsSimethicone (dimethicone or dimethylpolysiloxane) up to 100mg/ml DropsOmeprazole up to 20mg Oral SolidsPetrolatum Liquid or Mineral Oil up to 30g/100ml Suspension / Emulsion |
| E) LOCAL ANESHETICS | Lidocaine up to 10mg solutions.Lidocaine up to 3mg buccal tablet / Chewable Tablet.Lidocaine up to 10% semisolid. |
| H) OPHTHALMIC USE | All healing and tissue regenerating products containing Vitamin A, D, E, Panthenol, Zinc Oxide, Zinc Dioxide, Allantoin, and Sulfadiazine are approved. Topical preparations containing the following essential oils are approved: Menthol, camphor, gomenol, eucalyptus, balsam, methyl salicylate, terpine, turpentine, thymol. |
| l) DERMATOLOGICAL USE | Derivatives of Methylcellulose, Hydroxypropylmethylcellulose, and 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) ASTRINGENTS FOR TOPICAL USE | Diphenhydramine up to 1% Gel/Cream/Ointment/Lotion |
| N) ANTITHROMBOTICS FOR TOPICAL USE | 1. Polyester Mucopolysaccharide Sulfuric Acid 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) ANTIPARASITICS | Albendazole up to 400mg/10ml Suspension Nitazoxanide 100mg/5ml Oral LiquidsPyrantel Pamotao 250mg Oral LiquidsSecnidazole up to 500mg Oral SolidsSecnidazole 100mg/5ml Suspension |
| V) VITAMINS AND MINERALS | Malt extract up to 1 g/5ml. |
| W) ESSENTIAL OILS | All healing and tissue regenerating products containing 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. |