Pharmaceutical products (HS 30); Essential oils and resinoids; perfumery, cosmetic or toilet preparations (HS 33); Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wicks and candles, and fly-papers) (HS 3808)

Borrador de Decreto Ejecutivo, Que reglamenta la Ley 1 de 10 de enero de 2001, Sobre Medicamentos y otros Productos para la Salud Humana (Draft Executive Decree implementing Law No. 1 of 10 January 2001 on medicines and other human health products) (131 pages, in Spanish)

The notified Executive Decree sets out the implementing regulations for Law No. 1 of 10 January 2001, which regulates all aspects relating to the functions of the National Pharmacy and Drugs Directorate; the charging of fees for the Directorate's services; and all aspects relating to the registration of the following pharmaceutical products:

·         Topical antiseptics

·         Bactericides and disinfectants

·         Biological and biotechnological products

·         Cosmetics

·         Herbal medicines

·         Chemically synthesized medicines

·         Homeopathic medicines

·         Orphan medicines

·         Pesticides for household and public health use

·         Household and hospital cleaning products with antiseptic and fungicidal properties

·         Radiopharmaceuticals

·         Vitamin or dietary supplements

It also sets out implementing regulations for all aspects relating to the accelerated registration procedure; labelling; stability; interchangeability; manufacture, control and inspection and other provisions; marketing; prior and post- verification of pharmaceutical products; the National Pharmacovigilance System; pharmacotherapy; regulation and inspection of pharmaceutical establishments; good manufacturing practices for cosmetic, antiseptic and disinfectant products and household pesticides; registration requirements for raw materials, excipients and packaging inputs in industries producing medicines, cosmetics, disinfectants, pesticides and other products; product distribution; good pharmaceutical practices; prescriptions; and government procurement of human health products.