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In this respect it should be mentioned that the owner of a product can allow it to beprepared in whole or in part by any manufacturer, provided that the requirements laidout in the LGS and other applicable provisions are complied with.4.3. Sanitary Authorization for EstablishmentsAccording to the LGS, only establishments engaged in the following activities require asanitary authorization:a) The processing of medicines containing narcotics and psychotropic substances;vaccines; toxoids; serums and antitoxins of animal origin and hemo-derivatives;b) The production, manufacture, or preparation of medicines, pesticides, plant nutrients,or toxic or hazardous substances;c) The application of pesticides;d) The use of sources of radiation for medical or diagnostic purposes;e) Establishments that engage in surgical or obstetric activities.Other establishments that do not require a sanitary authorization must only give anoperating notice to the SSA, 8 which is to say that they only need to advise the Ministrythat they have commenced operations and do not need a permit prior to operating.4.4. Importation AuthorizationThe SSA establishes what products or raw materials require an authorization prior toimportation. The products that may require an importation authorization are food, nonalcoholicbeverages, alcoholic beverages, perfumery, beauty and bath products, tobacco,and the materials used in their preparation. The above is determined based on the healthrisks such products may produce.Furthermore, a sanitary authorization issued by the SSA is required for the importationof medicines and their raw materials, medical equipment, prosthesis, orthotics, functionalaids, diagnostic agents, odontologic use materials, surgical, and healing materials andhygienic products specified by the Ministry of Health. Finally, a sanitary authorization of__________8These notices must be filed in writing before the SSA or the governments of the states within 10 days followingthe initiation of operations. They should contain the following information:a) Name and domicile of the individual or entity that owns the establishment;b) Domicile of the establishment where the process is carried out and the date of initiation of operations;c) Processes used and product line or lines;d) Declaration under oath that the requirements and provisions applicable to the establishment have beencomplied with;e) Code of activities of the establishment;f) Professional license number of the person responsible for sanitary matters, if applicable.183Special Regulations for the Sale of Products

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