6. INVESTORS GUIDE HN - 2021 SPECIAL PERMISIONS

6. SPECIAL PERMITS

HONDURAS INVESTOR´S GUIDE 2020-2021

j. Recovery fee for services rendered. *Sanitary license for establishments of sanitary interest, at the option of the interested party, shall be valid for two (2), four (4), or six (6) years, from the date of its granting. * Application for a sanitary license shall be performed for each manufacturing plant, even if located on the same site. *Renewal of a sanitary license is only applicable when applying 3 months before the expiry date. A request for an overdue renewal can be made up to 6 months after the expiry date. * Payment will be made for each modification requested. FOOD AND BEVERAGE SANITARY REGISTER The Sanitary Registry is the authorization for a product of sanitary interest to be manufactured, imported, packaged, or ordered once all the technical and legal requirements are met. They are products of sanitary interest: food and beverages, drugs, cosmetics, hygiene products, dangerous substances, medical devices and equipment, natural products, laboratory reagents and others which are considered by the sanitary authority. Who performs the procedure? The Legal representative Where Is It Done? The Health Regulatory Agency (ARSA), Directorate of Food and Beverage Cost: It varies according to the type of product to register REQUIREMENTS: a. Submit application with the following information: • Data of the Holder: Name of the holder, identification document number, name of the legal representative, identification document number of the legal representative, address, telephone, fax number, e-mail of the applicant; address, telephone, fax number, e-mail of the warehouse or distributor, signature of the holder of the applicant company • Manufacturer’s data: Name of the factory (as shown in the license; indicate if it is local or foreign, number and validity of the permit or license of the factory or warehouse, address, telephone, fax number, e-mail of the factory.) • Product data: Name of the product to be registered, trademark, type, net content, Sanitary Registry number (in case of renewal), country of origin. b. Original Power of Attorney and copy, duly authenticated (where applicable)

6.6.3 SANITARY LICENSE FOR FOOD AND BEVERAGE FACTORIES AND WAREHOUSES Who performs the procedure? The Legal representative Where Is It Done? The Health Regulatory Agency (ARSA), Directorate of Food and Beverage REQUIREMENTS: a. Request to the Health Regulatory Agency including the following information: • Name and business name of the factory and its warehouses • Name of owner or legal representative (for legal entities) • Address of the factory and its warehouses • Phone, fax number and e-mail from the factory and its warehouses • Address of headquarters in case they are different from the factory and its warehouses • Central office phone, fax number and e-mail • Number of employees (excluding administrative) • Type of food produced or stored • Duration of the license for which the application is submitted (2, 4 or 6 years) • Number of previous sanitary license (renewal) b. Power of Attorney, original and copy, duly authenticated (where applicable) c. Affidavit of factory and warehouse new sanitary license duly authenticated and signed by the company’s legal representative. d. Authorization for the location and construction of the factory and its warehouse granted by the competent authority (this requirement only applies for the granting of the sanitary license), where applicable. e. Comply with the environmental requirements established in accordance with the current legislation of each State Party (environmental license, when applicable). f. Sketch map and distribution plans of the factory areas: How to get to the factory or warehouses, as well as the internal and external areas, according to the type of factory or warehousescand photographs of these. g. Company or Merchant´s Articles of Incorporation, and copy of it duly registered, or in its absence, duly authenticated copy. h. List of products to be manufactured in the factory. i. Comply with good manufacturing practices for working factories in accordance with Central American regulations.

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