1E9Ct5D

Authorization: Granted exclusively by the health department of the relevant state or localgovernment or the Federal District to authorize establishments carrying out any businessactivities subject to sanitary surveillance to operate.Certificate of Compliance with Good Manufacturing and Control Practices: A documentissued by the federal sanitary authority attesting that the establishment is in compliance withgood manufacturing and control practices.Company: A legal entity that, according to the prevailing trade laws, is engaged in a businessactivity or industrializes a product that is subject to sanitary laws.Establishment: the Company’s unit where the activity subject to sanitary surveillance iscarried out.Any operating permit issued will be valid nationwide and will be renewed on an annual basis.Authorizations, in turn, must be issued to each establishment separately (an independent, specificauthorization), even when there is more than one establishment for the same company at the samelocation.In terms of operation, whenever an establishment industrializes or markets different types of productsor products for different uses, then such establishment must use different premises to manufactureand store materials, substances and finished products.In relation to the requirements that must be met in order for an establishment to carry out the businessactivities subject to the above laws, if an establishment wishes to manufacture, industrialize or importproducts subject to sanitary laws, it must operate under the assistance and responsibility of a legallyqualified technician (technically responsible professional).This is why companies engaged in the business activities subject to sanitary surveillance are requiredto have and keep, in each establishment, a sufficient number of technically responsible professionalswith proper skills, so that all different types of productions are covered for every establishment.Besides the operation permit and the relevant authorizations, the company must check if it is requiredto register its products with the competent authority. None of the products covered by the above laws– not even imported products – can be industrialized, offered for sale or provided for consumptionwithout proper registration.In particular, drugs, medicine and pharmaceuticals coming from abroad must first be registered in theircountry of origin in order to be registered in Brazil. It is important to point out that if a drug is not112