1E9Ct5D

This Act seeks to regulate the manufacturing, elaboration, partition, quality control, distribution,prescription, dispensation, trading, representation, import, export, storage, rational usage, priceregime, information, publicity and evaluation, authorization and registry of medical products forhuman use, drugs and chemical products, reagents and all other products used and applied in humanmedicine, as well as products considered as cosmetics and cleansing products.The Ministry of Health is the national authority in charge of verifying the compliance of the normscontained in the Act hereof, issuing regulations in accordance with the Act, and the application ofsanctions. The National Department of Sanitary Surveillance (Dirección Nacional de VigilanciaSanitaria), dependent on the Ministry of Health, is the executive organ.The manufacturing, import, trading and sales of pharmaceutical specialties shall be subject toauthorization from the national sanitary authority (Dirección de Vigilancia Sanitaria- DVS).Pharmaceutical specialties authorized for expenditure within the national territory shall be, uponmanufacturer and representative’s request, registered in a specific registry at the Ministry of Health.The latter shall also apply to any amendment, transfer or cancellation of the authorizations granted tothe pharmaceutical specialties.In order to guarantee the quality of the raw materials, semi-elaborated products, products in processand final products, the DVS shall set the type of control required. Such controls shall be extendedduring commercialization and production. Any modification in regards to technological or scientificdevelopments shall be informed to the DVS.The Ministry of Health shall regulate, according to the Act hereof and its corresponding decree, theevaluation procedure, concession and denial of authorization as well as the registration in thepharmaceutical registry.The authorization or registration certificate of pharmaceutical specialties shall extend to five years andmay be renewed according to the Act. To such effect, the proprietor shall file the correspondingapplication and, if required, a previous update of the technical documentation.The Act also states that the authorizations granted may be temporarily suspended by the nationalsanitary authority for reasons similar to the ones stated above with regard to the grounds for denial ofauthorization, including the case when an international health organisms such as the World HealthOrganization or the Pan-American Health Organization recommends the suspension. Likewise, thenational sanitary authority, may, for public health reasons, modify or restrict the conditions of theauthorization due to the composition, indications or adverse reactions. The national sanitary authoritymay limit the validity of the authorization and restrict the commercialization and use for hospitalsonly.A special provision has been included for cases in which the medicine is well known and itseffectiveness, safety in usage and adverse reactions have been sufficiently tried nationally orinternationally. Consequently, the national sanitary authority may require an extract of the documentsavailable, exempting applicable requirements from compliance, adopting a simplified process ofauthorization.18Berkemeyer Attorneys and Counselors | Asunción - Paraguay