Distribution date: 03 June 2013

<p style="margin:6pt 0cm;"><span lang="ES">El Reglamentos establece la clasificación y los procedimientos para la solicitud y el otorgamiento de la Autorización de Seguridad Biológica.</span></p><span lang="ES" style="font-family:'Times New Roman','serif';font-size:11pt;">Se aplica a las personas naturales y jurídicas vinculadas con todas las actividades relacionadas con el uso, la investigación, el ensayo, la producción, la liberación, la importación y la exportación de agentes biológicos y sus productos, organismos y fragmentos de éstos con información genética así como, a las diferentes etapas del proceso constructivo de las instalaciones con riesgo biológico, que se realicen en el territorio nacional.</span>

Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); NUCLEAR REACTORS, BOILERS, MACHINERY AND MECHANICAL APPLIANCES; PARTS THEREOF (HS code(s): 84)

Regulation Type: Regular notification

Distribution date: 03 June 2013

<p style="margin:6pt 0cm;"><span lang="ES">El Reglamentos establece la clasificación y los procedimientos para la solicitud y el otorgamiento de la Autorización de Seguridad Biológica.</span></p><span lang="ES" style="font-family:'Times New Roman','serif';font-size:11pt;">Se aplica a las personas naturales y jurídicas vinculadas con todas las actividades relacionadas con el uso, la investigación, el ensayo, la producción, la liberación, la importación y la exportación de agentes biológicos y sus productos, organismos y fragmentos de éstos con información genética así como, a las diferentes etapas del proceso constructivo de las instalaciones con riesgo biológico, que se realicen en el territorio nacional.</span>

Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); NUCLEAR REACTORS, BOILERS, MACHINERY AND MECHANICAL APPLIANCES; PARTS THEREOF (HS code(s): 84)

Regulation Type: Regular notification

Distribution date: 03 June 2013

<span lang="ES" style="font-family:'Verdana','sans-serif';font-size:9pt;">Establece como requisito para el movimiento transfronterizo de <span>&nbsp;</span>muestras de material biológico contar con una<span>&nbsp; </span>autorización de importación o exportación<span>&nbsp; </span>emitida por el Buró Regulatorio para la Protección de la Salud Publica del Ministerio de Salud Pública, sin perjuicio de las autorizaciones que, de forma previa, corresponda otorgar al centro nacional de seguridad Biológica, del Ministerio de Ciencia, Tecnología y Medio Ambiente en relación con el material biológico que pudiera estar involucrado en dichas muestras, según lo previsto en la legislación vigente. </span>

Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002)

Regulation Type: Regular notification

Distribution date: 03 June 2013

<span lang="ES" style="font-family:'Verdana','sans-serif';font-size:9pt;">Establece como requisito para el movimiento transfronterizo de <span>&nbsp;</span>muestras de material biológico contar con una<span>&nbsp; </span>autorización de importación o exportación<span>&nbsp; </span>emitida por el Buró Regulatorio para la Protección de la Salud Publica del Ministerio de Salud Pública, sin perjuicio de las autorizaciones que, de forma previa, corresponda otorgar al centro nacional de seguridad Biológica, del Ministerio de Ciencia, Tecnología y Medio Ambiente en relación con el material biológico que pudiera estar involucrado en dichas muestras, según lo previsto en la legislación vigente. </span>

Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002)

Regulation Type: Regular notification

Distribution date: 03 June 2013

<span style="text-decoration:underline;"><span lang="ES" style="font-family:'Times New Roman','serif';font-size:11pt;mso-fareast-font-family:'Times New Roman';mso-fareast-language:ES;mso-ansi-language:ES;mso-bidi-language:AR-SA;">Establece los requisitos técnicos y administrativos que rigen el proceso de Notificación y Autorización de las prácticas y las actividades asociadas al empleo de fuentes de<br />radiaciones ionizantes.</span></span>

Products Covered: Natural uranium and its compounds; alloys, dispersions, incl. cermets, ceramic products and mixtures containing natural uranium or natural uranium compound [Euratom] (HS code(s): 284410); Uranium enriched in U 235 and its compounds: plutonium and its compounds; alloys, dispersions, incl. cermets, ceramic products and mixtures containing uranium enriched in U 235, plutonium or compounds of these products [Euratom] (HS code(s): 284420); Uranium depleted in U 235 and its compounds; thorium and its compounds; alloys, dispersions, incl. cermets, ceramic products and mixtures containing uranium depleted in U 235, thorium or compounds of these products (HS code(s): 284430); Radioactive elements, isotopes and compounds, and alloys and dispersions, incl. cermets, ceramic products and mixtures, containing these elements, isotopes and compounds; radioactive residues (excl. natural uranium, uranium enriched and depleted in U 235; plutonium, thorium and compounds of these products) (HS code(s): 284440); Spent "irradiated" fuel elements "cartridges" of nuclear reactors [Euratom] (HS code(s): 284450); Computer tomography apparatus (HS code(s): 902212); Apparatus based on the use of X-rays for dental uses (HS code(s): 902213); Apparatus based on the use of X-rays, for medical, surgical or veterinary uses (excl. for dental purposes and computer tomography apparatus) (HS code(s): 902214); Apparatus based on the use of X-rays (other than for medical, surgical, dental or veterinary uses) (HS code(s): 902219); Apparatus based on the use of alpha, beta or gamma radiations, for medical, surgical, dental or veterinary uses (HS code(s): 902221); Apparatus based on the use of alpha, beta or gamma radiations (other than for medical, surgical, dental or veterinary uses) (HS code(s): 902229); X-ray tubes (HS code(s): 902230); X-ray generators other than X-ray tubes, high tension generators, control panels and desks, screens, examination or treatment tables, chairs and the like, and general parts and accessories for apparatus of heading 9022, n.e.s. (HS code(s): 902290)

Regulation Type: Regular notification

Distribution date: 03 June 2013

<span style="text-decoration:underline;"><span lang="ES" style="font-family:'Times New Roman','serif';font-size:11pt;mso-fareast-font-family:'Times New Roman';mso-fareast-language:ES;mso-ansi-language:ES;mso-bidi-language:AR-SA;">Establece los requisitos técnicos y administrativos que rigen el proceso de Notificación y Autorización de las prácticas y las actividades asociadas al empleo de fuentes de<br />radiaciones ionizantes.</span></span>

Products Covered: Natural uranium and its compounds; alloys, dispersions, incl. cermets, ceramic products and mixtures containing natural uranium or natural uranium compound [Euratom] (HS code(s): 284410); Uranium enriched in U 235 and its compounds: plutonium and its compounds; alloys, dispersions, incl. cermets, ceramic products and mixtures containing uranium enriched in U 235, plutonium or compounds of these products [Euratom] (HS code(s): 284420); Uranium depleted in U 235 and its compounds; thorium and its compounds; alloys, dispersions, incl. cermets, ceramic products and mixtures containing uranium depleted in U 235, thorium or compounds of these products (HS code(s): 284430); Radioactive elements, isotopes and compounds, and alloys and dispersions, incl. cermets, ceramic products and mixtures, containing these elements, isotopes and compounds; radioactive residues (excl. natural uranium, uranium enriched and depleted in U 235; plutonium, thorium and compounds of these products) (HS code(s): 284440); Spent "irradiated" fuel elements "cartridges" of nuclear reactors [Euratom] (HS code(s): 284450); Computer tomography apparatus (HS code(s): 902212); Apparatus based on the use of X-rays for dental uses (HS code(s): 902213); Apparatus based on the use of X-rays, for medical, surgical or veterinary uses (excl. for dental purposes and computer tomography apparatus) (HS code(s): 902214); Apparatus based on the use of X-rays (other than for medical, surgical, dental or veterinary uses) (HS code(s): 902219); Apparatus based on the use of alpha, beta or gamma radiations, for medical, surgical, dental or veterinary uses (HS code(s): 902221); Apparatus based on the use of alpha, beta or gamma radiations (other than for medical, surgical, dental or veterinary uses) (HS code(s): 902229); X-ray tubes (HS code(s): 902230); X-ray generators other than X-ray tubes, high tension generators, control panels and desks, screens, examination or treatment tables, chairs and the like, and general parts and accessories for apparatus of heading 9022, n.e.s. (HS code(s): 902290)

Regulation Type: Regular notification

Distribution date: 31 May 2013 | Final date for Comment: 30 July 2013

<p style="margin:6pt 0cm;">This draft Technical Regulation has the objective to establish requirements to commercialize traditional Chinese medicine products in Brazil.</p><p style="margin:6pt 0cm;">It is established a period of three years from the date of publication of this Resolution for the monitoring of the use of traditional Chinese medicine products in the country.<span>&nbsp;&nbsp; </span></p><p style="margin:6pt 0cm;">For the purposes of this Resolution traditional Chinese medicine products are formulations obtained from vegetable and mineral raw materials in accordance with traditional Chinese medicine techniques and part of the Chinese Pharmacopoeia. </p><p style="margin:6pt 0cm;">It is forbidden the use of animal origin raw material in the formulations to be commercialized in Brazil. </p>

Products Covered: Traditional Chinese Medicine products (HS:30.00)

Regulation Type: Regular notification

Distribution date: 31 May 2013 | Final date for Comment: 30 July 2013

<p style="margin:6pt 0cm;">This draft Technical Regulation has the objective to establish requirements to commercialize traditional Chinese medicine products in Brazil.</p><p style="margin:6pt 0cm;">It is established a period of three years from the date of publication of this Resolution for the monitoring of the use of traditional Chinese medicine products in the country.<span>&nbsp;&nbsp; </span></p><p style="margin:6pt 0cm;">For the purposes of this Resolution traditional Chinese medicine products are formulations obtained from vegetable and mineral raw materials in accordance with traditional Chinese medicine techniques and part of the Chinese Pharmacopoeia. </p><p style="margin:6pt 0cm;">It is forbidden the use of animal origin raw material in the formulations to be commercialized in Brazil. </p>

Products Covered: Traditional Chinese Medicine products (HS:30.00)

Regulation Type: Regular notification

Distribution date: 31 May 2013 | Final date for Comment: 22 July 2013

<p style="margin:6pt 0cm;">This draft Normative Instruction determines the publication of the List of herbal medicines that requires simplified registration at Anvisa and the List of herbal medicines of traditional use that requires simplified registration at Anvisa to be commercialized in Brazil.<span>&nbsp;&nbsp; </span></p><p><span>This Normative Instruction will enter into force on the date of its adoption. It will revoke Normative Instruction n. 5, December 11^th 2008.</span></p>

Products Covered: Herbal medicines (HS:30.04)

Regulation Type: Regular notification

Distribution date: 31 May 2013 | Final date for Comment: 22 July 2013

<p style="margin:6pt 0cm;">This draft Normative Instruction determines the publication of the List of herbal medicines that requires simplified registration at Anvisa and the List of herbal medicines of traditional use that requires simplified registration at Anvisa to be commercialized in Brazil.<span>&nbsp;&nbsp; </span></p><p><span>This Normative Instruction will enter into force on the date of its adoption. It will revoke Normative Instruction n. 5, December 11^th 2008.</span></p>

Products Covered: Herbal medicines (HS:30.04)

Regulation Type: Regular notification