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Experimental drugs to be used under medical supervision are exempt from registration as well, aslong as all specific legal requirements are met. Such drugs may even be imported, if expresslyauthorized by the relevant agency.Drug registrations with ANVISA are valid for five (5) years and are subject to revalidation for equal,successive periods, in which case the original registration will be renewed.According to the prevailing laws, a holder of a drug registration must necessarily be a legal entityholding the registration of the product, i.e., the rights in such product. Such legal entity will beresponsible for the product until it reaches the end consumerFor a drug registration to be granted, an assessment of legal, administrative, technical and scientificcompliance must first be made in relation to the efficacy, safety and quality of such products beforethey enter – and are marketed and consumed in – the Brazilian market.Another important point is that ANVISA’s registrations and revalidations will only start producingeffects on the date they are published in the federal gazette (Diário Oficial da União – DOU).Requests for revalidation must be filed with ANVISA within the period of time determined in the law;otherwise, such requests will be considered null. In addition, industrialization of the product in the firstvalidity period must be proved.It is important to mention that in case trademarks or product names are transferred betweencompanies, the assignee is not automatically entitled to the assignor's registration. In this case, theassignor must cancel the registration with ANVISA and the assignee must apply for a new registration.Both the cancellation of the old registration and the granting of the new registration will be published inthe DOU at the same time.22.4 - Violations of sanitary lawsThis subject is generally regulated by Law 6,437 of 20 August 1977, which contains provisionsconcerning the violation of federal sanitary laws and the relevant penalties, among other things.Under such law, violations of sanitary laws are subject to the following penalties – in addition to anyapplicable civil or criminal penalties that may be imposed on an alternative or cumulative basis:- Warning;- Fine;- Seizure of products;- Product destruction;- Product ban;115