If you are a distributor and importer of pharmaceutical products, medical devices and reagents, a legal representative of company that provides such services or part of the staff, surely you are aware of the provisions contained in the “Standard of Good Practices for Storage, Distribution and Transportation of Medical Supplies”, approved through the Ministerial Agreement No. 32-2020 on February 4, 2020, which has as a General Purpose to establish and implement the relevant provisions and requirements, so that health sector establishments that import, export, store, transport, distribute and market medical supplies, comply with the guidelines established for the storage, distribution and transportation of medical supplies, and guarantee the maintenance of their characteristics and properties; and the one that significantly updated the “Standard for Storage and Distribution of Medicines” that was in force since 1996.
Such Standard specified as General Provisions (among others), that warehouses should have defined the areas of dispatch, reception and delivery, cold, psychotropic products and flammable and toxic products, without establishing dimensions.
In this sense, the Distributors and Importers of pharmaceutical products, medical devices and reagents registered and authorized for their operation before the entry into force of the updated Standard, met the objectives required in the 1996 Standard and the warehouses with the established conditions in the same; as well as the provisions of the Act of Supervision and Inspection of Distributors and Importers of Pharmaceutical Products, but now we must highlight the novelty of such new Standard: the dimensions and delimitations and identifications of the areas of the establishment, the conditions of the transport of the products, quality management system and information system.
The foregoing is extremely important and in practice, the Legal Representatives and Regents of local Distributors and Importers of Pharmaceutical Products have made approaches to the authority to evacuate consultations on its proper implementation, as a result, the authority approved an extension of the term of its implementation by a period of time of three (3) months, starting on the eleventh day of June of the year two thousand twenty-one. Since we are close to the end of this period, our Firm recommends keeping these regulations in mind and guaranteeing their compliance as soon as possible to avoid affecting your operations in Nicaragua.