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Food, Drug, Agriculture, Health Care, Biotechnology and Biodiversity Life Sciences in Brazil is an electronic newsletter with information on recent legislation in the areas of Agriculture, Health Care, Innovation, Biotechnology and Biodiversity. This monthly publication is prepared by the LifeSciences practice group of Pinheiro Neto Advogados in English and Portuguese languages. If you do not wish to receive this publication by electronic mail, please return this e-mail with the word “UNSUBSCRIBE” in the subject area. With the compliments of MS/MCTI JOINT MINISTERIAL ORDINANCE No. 686 of Establishes a partnership with the Ministries of Health and of Science, Technology and Innovation for technical cooperation regarding the creation of policies to support the development of scientific, technological and innovation in connection with human health areas by means of integration of the Health Science and Technology National Policy with the Science and Technology National Strategy with the creation of the Joint Ministerial Technical Committee. RDC RESOLUTION No. 52 of SEPTEMBER 28, 2012 Provides for influenza vaccines to be used in Brazil in 2013. RDC RESOLUTION No. 53 of OCTOBER 2, 2012 Provides for MERCOSUR Technical Regulation – Analytical Methodologies, Acceptable Daily Intake and Maximum Residue Levels for Veterinary Pharmaceuticals in Food of Animal Origin. Hanseniasis and Eradicating Diseases of the Health Surveillance Office of the Ministry of Health (CTA-HDE/SVS/MS), with the purpose of giving support to the Health Surveillance Office in the technical and scientific aspects necessary for the epidemiological inspection, eradication of hanseniasis as a public health problem, health control and assistance to patients with such eradicating diseases. Adds the drug sildenafil for the treatment of Raynaud Phenomenon in the Systemic Sclerosis within SUS. ORDINANCE No. 32 of SEPTEMBER 27, 2012 Adds the drug naproxen for the treatment of ankylosing spondylitis within SUS. ORDINANCE No. 33 of SEPTEMBER 27, 2012 Adds the drug Clobetasol for the treatment of Psoriasis within SUS. ORDINANCE No. 34 of SEPTEMBER 27, 2012 Adds the drug Biotin for the treatment of Biotinidase Deficiency within SUS. ORDINANCE No. 35 of SEPTEMBER 27, 2012 Adds the drug tacrolimus for the treatment of Primary Nephrotic Syndrome within SUS. ORDINANCE No. 36 of SEPTEMBER 27, 2012 Adds the immunoglobulin for treatment of acute antibody-mediated examination of research of C4d marker within SUS. ORDINANCE No. 37 of SEPTEMBER 27, 2012 Adds the dose of antigen CA125 for treatment monitoring and post-treatment follow-up of epithelial ovarian malignancy within SUS. ORDINANCE No. 38 of SEPTEMBER 27, 2012 Establishes the non addition of the following biological drugs: ustekinumab for the treatment of moderate to severe psoriasis in adults within SUS and recommend that the association of patients and specialists in the area be consulted and, if applicable, that a new procedure for evaluation of the subject be carried out. ORDINANCE No. 39 of SEPTEMBER 27, 2012 Establishes the non addition of the drug roflumilast for Severe Chronic Obstructive Pulmonary Disease (DPOC) associated with Chronic Bronchitis within SUS. ORDINANCE No. 40 of SEPTEMBER 27, 2012 Establishes the non addition of the drug Botox® for the treatment of overactive bladder within SUS and recommend the preparation of the Clinical Protocol and Therapeutic Guidelines of such condition, including the therapeutic clinic and surgery. ORDINANCE No. 41 of SEPTEMBER 27, 2012 Establishes the non addition of the drug Daivobet® (calcipotriol + betamethasone dipropionate) for the treatment of psoriasis within SUS. ORDINANCE No. 42 of SEPTEMBER 27, 2012 Excludes ICD K51.4 of the Clinical Protocol and Therapeutic Guidelines (PCDT) of the Ulcerative Colitis of the Ministry of Health. ORDINANCE No. 44 of OCTOBER 23, 2012 Adds ORDINANCE No. 45 of OCTOBER 23, 2012 Adds the drug lanreotide acetate for the treatment of acromegaly within SUS. Institutes the Managing Committee for the analysis, issuance of conclusive opinion and follow-up on Production Development Partnerships (PDP), dealing with transfer of technology for drugs and pharmaceutical inputs and establishes their acting and alternate members. ORDINANCE No. 51 of OCTOBER 23, 2012 Institutes the Managing Committee for the analysis, issuance of conclusive opinion and follow-up on Production Development Partnerships (PDP), dealing with transfer of technology for medical products - medical equipment and materials and establishes their acting and alternate members. Institutes the Managing Committee for the analysis, issuance of conclusive opinion and follow-up on Production Development Partnerships (PDP), dealing with transfer of technology for serums, vaccines and diagnostic reagents and establishes their acting and alternate members. Approves the Clinical Protocol and Therapeutic Guidelines of the Chronic Pain. RESOLUTION No. 1999 of SEPTEMBER 27, 2012 The lack of scientific evidence of benefits and risks as well as harms caused to health do not allow the use of hormonal therapies aimed at delaying, interfering with or preventing the aging process. Provides for air spraying of active ingredients imidacloprid, clothianidin, fipronil and thiamethoxam. NORMATIVE RULING No. 21 of OCTOBER 1, 2012 Approves the phytosanitary requirements for importation of grains (Category 3, Class 9) of soybean (Glycine max) produced in Bolivia. NORMATIVE RULING No. 22 of OCTOBER 5, 2012 Revokes Normative Ruling No. 12 of June 6, 2012, which establishes previous authorization for importation of apple, pear and quince (Category 3, Class 4: Fruit for consumption) from Republic of Argentina. NORMATIVE RULING No. 24 of OCTOBER 30, 2012 Amends article 2-A of SDA Normative Ruling No. 36 of December 30, 2010, which provides for the phytosanitary requirements for importation of seeds. Before a regulation comes into force, MS, ANVISA or MAPA publishes the proposed regulation for “Public Consultation”. Comments and suggestions can be submitted by any interested party within a certain period of time as from the publication date of the Public Consultation in the Official Gazette of the Federal Executive. During such period, the Public Consultations are available at www.anvisa.gov.br or www.agricultura.gov.br, the ANVISA and MAPA websites, respectively. A regulation only comes into force after it is published as a “Resolution”, “Normative Ruling”, “Ordinance” or the like. Criticism and suggestions related to the Resolution proposal providing for E29 – ETIPROLE active ingredient to be included in the Roster of Monographs Agrochemicals, Household Cleaning and Wood Preservers. Criticism and suggestions related to the Resolution CHLORANTRANILIPROLE active ingredient to be included in the Roster of Monographs of Active Ingredients of Agrochemicals, Household Cleaning and Wood Preservers. Criticism and suggestions related to the Resolution proposal providing for P46 - PYRACLOSTROBIN active ingredient to be included in the Roster of Monographs Agrochemicals, Household Cleaning and Wood Preservers. Criticism and suggestions related to the Resolution proposal providing for F43 - FIPRONIL active ingredient to be included in the Roster of Monographs Agrochemicals, Household Cleaning and Wood Preservers. Criticism and suggestions related to the Resolution proposal providing for T14 - THIOPHANATE- METHYL active ingredient to be included in the Roster of Monographs of Active Ingredients of Agrochemicals, Household Cleaning and Wood Preservers. Criticism and suggestions related to the Resolution proposal providing for P52 – PYMETROZINE active ingredient to be included in the Roster of Monographs Agrochemicals, Household Cleaning and Wood Preservers. Criticism and suggestions related to the Resolution proposal providing for Z60 - ZETA-CYPERMETHRIN active ingredient to be included in the Roster of Monographs Agrochemicals, Household Cleaning and Wood Preservers. Criticism and suggestions related to the Resolution proposal providing for F46 – FLUMIOXAZIN active ingredient to be included in the Roster of Monographs Agrochemicals, Household Cleaning and Wood Preservers. Criticism and suggestions related to the Resolution proposal providing for T48 – THIAMETHOXAM active ingredient to be included in the Roster of Monographs Agrochemicals, Household Cleaning and Wood Preservers. Criticism and suggestions related to the Resolution proposal providing for E32 - SPINETORAM active ingredient to be included in the Roster of Monographs Agrochemicals, Household Cleaning and Wood Preservers. Criticism and suggestions related to the Resolution proposal providing for B35 – BENFURACARB active ingredient to be included in the Roster of Monographs Agrochemicals, Household Cleaning and Wood Preservers. Criticism and suggestions related to the Resolution approving the Mercosur Technical Regulation on paper and carton packaging and equipment to be used in contact with food during the procedures of cooking or heating in oven. Resolution proposal providing for administrative procedure related to prior consent from Anvisa to grant patents for pharmaceutical products and processes. Introduces the National Program for Cytopathology Quality (PNQC) in cervix cancer prevention. recommendation from the National Committee for Implementation of Technologies to the Integrated Health System (CONITEC/SCTIE) related to the proposal for introduction of drug omalizumab to SUS, a pharmaceutical used in the treatment of non-controlled severe allergic asthma filed by Novartis Biociências S.A., headquartered in the city of São Paulo/SP. recommendation from the National Committee for Implementation of Technologies to the Integrated Health System (CONITEC/SCTIE) related to the proposal for introduction of the Nucleic-Acid Amplification Test (NAT) to detect the Human Immunodeficiency Virus (HIV) and the Hepatitis C Virus (HCV) to SUS, filed by the Health Care Office of the Ministry of Health. recommendation from the National Committee for Implementation of Technologies to the Integrated Health System (CONITEC/SCTIE) related to the proposal for introduction of the drug tadalafil to SUS, a pharmaceutical used in the treatment of Pulmonary progress in the records of proceeding MS/SIPAR No. 25000.051405/2012-89, filed by Eli Lilly do Brasil Ltda., headquartered in the city of São Paulo/SP. recommendation from the National Committee for Implementation of Technologies to SUS related to the proposal for introduction of the sweat test based on chloride dosage used to diagnose Cystic fibrosis (CF). recommendation from the National Committee for Implementation of Technologies at SUS related to the proposal for introduction of the drug indicaterol to SUS used in the treatment of chronic obstructive pulmonary disease. ophthalmologic exams and procedures as well as cardiologic diagnosis exams to organize the proper cares to be taken with patient with chronic diseases at the Health Care Office for People with Chronic Diseases of SUS. Draft of Ordinance approving the Guidelines on Health Care to Patients with Spinal Cord Injury. Normative Ruling project approving the procedures for control of aging of liquor and other products GLOSSARY MS – Ministry of Health ANVISA – National Public Health Agency SDA – Agricultural and Stockbreeding Defense Office SCTIE – Science, Technology and Strategic Inputs Office SAS – Health Care Office SUS - Integrated Health System CFM – Federal Medicine Council This issue was compiled by the LifeSciences team of Pinheiro Neto Advogados Angela Fan Chi Kung (akung@pn.com.br), Camila Martino Parise (cparise@pn.com.br), Luiza Sato Pereira Dias, Nicole Recchi Aun (naun@pn.com.br) and Gabriela Kavaguti (gkavaguti@pn.com.br).

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