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LifeSciences in Brazil No. 114 - Pinheiro Neto Advogados...Ruling No. 01 of January 7, 2015...

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LifeSciences in Brazil No. 114 November 2015 -1- 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 Life Sciences group of Pinheiro Neto Advogados in English and Portuguese. If you do not wish to receive this publication by electronic mail, please answer to this e-mail with the word “UNSUBSCRIBE” in the subject. With the compliments of Angela Fan Chi Kung [email protected]
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Page 1: LifeSciences in Brazil No. 114 - Pinheiro Neto Advogados...Ruling No. 01 of January 7, 2015 (Approves the phytosanitary requirements for importation of in vitro seeds and seedlings

LifeSciences in Brazil No. 114

November 2015

-1-

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 Life Sciences group of Pinheiro Neto Advogados in English and Portuguese. If you do not wish to receive this publication by electronic mail, please answer to this e-mail with the word “UNSUBSCRIBE” in the subject. With the compliments of

Angela Fan Chi Kung

[email protected]

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MEDICAL DEVICES

SÃO PAULO STATE BILL No. 1,503 OF 2015

(published on November 20, 2015) Manufacturing and expiration date on a standard place

Provides for information relating to placement of the manufacturing and expiration date on a standard place of packages of products sold in the State of São Paulo.

RESOLUTION RDC ANVISA No. 52 OF NOVEMBER 27,

2015 Registration of in vitro diagnostic devices aimed at self-testing for HIV

Provides for rules on registration of in vitro diagnostic devices used as self-testing for HIV - Human Immunodeficiency Virus, for screening purposes, and makes other provisions.

PHARMACEUTICALS SANTA CATARINA STATE LAW No. 16,751 OF

NOVEMBER 09, 2015 Prohibition of drug advertising in the state of Santa Catarina

Prohibits the advertising of drugs and similar in sound, audiovisual and written media in the state of Santa Catarina.

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RESOLUTION RDC ANVISA No. 49 OF NOVEMBER 11,

2015 Update of the Lists of Narcotic, Psychotropic, Precursor and other Controlled Substances

Provides for the update of Annex I, Lists of Narcotic, Psychotropic, Precursor and other Controlled Substances of Ordinance SVS/MS No. 344/98 of May 12, 1998.

RESOLUTION RDC ANVISA No. 50 OF NOVEMBER 11,

2015 Indications for treatment with Thalidomide

Provides for update of Annex III (Indications for treatment with Thalidomide) to RDC No. 11 of March 22, 2011.

RESOLUTION RDC ANVISA No. 51 OF NOVEMBER 27,

2015 Inclusion, exclusion and rectification of the Common Brazilian Denominations (DCB)

Provides for amended to RDC No. 64 of 2012 for inclusion, exclusion and rectification of the Common Brazilian Denominations (DCB) in the full list of ANVISA DCB.

VACCINES RESOLUTION RDC ANVISA No. 48 OF NOVEMBER 9,

2015 Composition of influenza vaccines

Provides for the composition of influenza vaccines to be used in Brazil in 2016.

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FOODS DECREE No. 8,552 OF NOVEMBER 3, 2015 Regulation of the sales of foods for infants and young children

Regulates Law No. 11,265 of January 3, 2006, which provides for sales of foods for infants and young children and childcare-related products.

DECREE No. 8,553 OF NOVEMBER 3, 2015 National Plan for Healthy Food

Creates the “Gluten Free” state seal for products manufactured or sold without gluten in their composition.

SÃO PAULO STATE BILL No. 1,449 OF 2015

(published on November 6, 2015) Obligation to expressly inform on the use of agrochemicals in food products marketed in State of São Paulo

Establishes the obligation to expressly inform on the use of agrochemicals in food products marketed in State of São Paulo.

ANIMAL, PLANT, AGRICULTURAL AND

CATTLE BREEDING PRODUCTS NORMATIVE RULING SDA No. 41 OF OCTOBER 29,

2015 (published on November 5, 2015) Criteria and requirements for the accreditation and monitoring of laboratories

Amends Normative Ruling No. 57 of December 11, 2013 (establishes criteria and requirements for the accreditation and monitoring of laboratories by MAPA, under such Normative Ruling).

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SÃO PAULO STATE BILL No. 1,451 OF 2015

(published on November 6, 2015) Location of the warehouses of agrochemicals resellers and/or distributors

Provides for location of the warehouses of agrochemicals resellers and/or distributors.

ORDINANCE MAPA No. 238 OF NOVEMBER 11, 2015 Extends the term of effectiveness of the authorizations for urgent use of pesticides to control the pest Helicoverpa armigera in the cultures of soybean, corn and cotton

Extends the term of effectiveness set out in article 1 of Normative Ruling No. 3 from March 18, 2015 to November 6, 2016 (Extends up to March 18, 2016, the authorizations for urgent use of pesticides to control the pest Helicoverpa armigera in the cultures of soybean, corn and cotton, referred to in Act No. 15 of March 14, 2013, of the General Coordination of Agrochemicals and Related Products, of the Agricultural Input Inspection Department of MAPA).

ORDINANCE SDA No. 89 OF NOVEMBER 11, 2015 Institution of the Technical Commission for Management of Biological Risks and Biosafety (CTGRB)

Institutes in the ambit of Department of Inspection of Livestock Inputs (DFIP/SDA) the Technical Commission for Management of Biological Risks and Biosafety (CTGRB) in establishments that manufacture or carry out quality control of vaccines, antigens and hyperimmune serum for veterinary use.

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RESOLUTION SDA No. 6 OF OCTOBER 6, 2015 Importation of in vitro seeds and seedlings of Phalaenopsis

Provides for a new word to article 3 of Normative Ruling No. 01 of January 7, 2015 (Approves the phytosanitary requirements for importation of in vitro seeds and seedlings of Phalaenopsis spp. (Category 4, Class 1) produced in Taiwan, Republic of China.)

NORMATIVE RULING SDA No. 1 OF NOVEMBER 6,

2015 Reference specifications of phytosanitary products approved for use in organic agriculture

Amends item 9 of Annex I and item 20 of Annex II to Joint Normative Ruling SDA/SDC No. 2 of July 12, 2013 (Establishes reference specifications of phytosanitary products approved for use in organic agriculture).

RESOLUTION SDA No. 7 OF NOVEMBER 20, 2015 Changes the phytosanitary requirement relating to the mandatory previous authorization for shipment (RO)

Revokes Resolution No. 5 of September 30, 2015 (Revokes Resolution No. 1 of February 27, 2015 (Changes the phytosanitary requirement relating to the mandatory previous authorization for shipment (RO), making it optional for products classified under category 2 and 3 listed in the Normative Rulings) and Resolution No. 2 of March 2, 2015 (Changes the phytosanitary requirement relating to the mandatory previous authorization for shipment (RO), making it optional for products classified under category 2 and 3 listed in the Normative Rulings No. 28, of July 31, 2006 (apple - Malus sp.) and No. 21 of July 31, 2006 (pear - Pyrus sp)).

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RESOLUTION SDA No. 8 OF NOVEMBER 23, 2015 Work Plan for implementation of the integrated system for reducing the risk associated with Cydia pomonella

Approves the Work Plan for implementation of the integrated system for reducing the risk associated with Cydia pomonella in shipments of imported apple (Malus spp), pear (Pyrus spp) and guince (Cydonia oblonga) from Republic of Argentina.

HEALTH CARE SERVICES RIO DE JANEIRO STATE LAW No. 7,110 OF

NOVEMBER 19, 2015 Access to public and private properties by health care and epidemiological surveillance agents

Regulates the access to public and private properties by health care and epidemiological surveillance agents in situations of imminent risk of epidemic outbreaks or actual epidemic outbreaks in the State of Rio de Janeiro.

HEALTH CARE PROFESSIONALS RESOLUTION CFO No. 160 OF OCTOBER 2, 2015

(published on November 6, 2015) Acupuncture, Homeopathy and Sports Dentistry as dental specialties

Recognizes Acupuncture, Homeopathy and Sports Dentistry as dental specialties.

RESOLUTION CFO No. 161 OF OCTOBER 2, 2015

(published on November 6, 2015) Amends the Consolidation of Rules for Procedures in Dentistry Councils

Amends the articles, items and paragraphs in the Consolidation of Rules for Procedures in Dentistry Councils.

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SÃO PAULO STATE BILL No. 1,464 OF 2015

(published on November 13, 2015) Compulsory placement of Boards with names of the physicians and nursing chiefs and their respective schedules in Hospitals, Health Care Centers, Laboratories and Health Care Units

Establishes that Hospitals, Health Care Centers, Laboratories and Health Care Units must exhibit Boards with names of the physicians and nursing chiefs and their respective schedules.

DECISION COFEN No. 203 OF NOVEMBER 18, 2015 More Inspection Program 2

Institutes in the ambit of the Federal Council of Nurses (COFEN) and the Regional Council of Nurses (COREN) the More Inspection Program 2 (Programa

Mais Fiscalização 2), and makes other provisions. NORMATIVE RESOLUTION CFQ No. 261 OF

NOVEMBER 18, 2015 Amounts to be paid to CFQ/CRQs System

Establishes the amounts to be paid to CFQ/CRQs System by professionals and companies of the Chemistry area, pursuant to prevailing law, for 2016.

RESOLUTION CFO No. 163 OF NOVEMBER 9, 2015 Conceptualizes Hospital Dentistry

Conceptualizes Hospital Dentistry and defines the qualification of the dentist that will exercise it.

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SUS SÃO PAULO STATE BILL No. 1,423 OF 2015

(published on November 4, 2015) Disclosure of hospital infection rate

Establishes that hospitals of the public and private network in the State of São Paulo must disclose information on the hospital infection rate.

ORDINANCE MS No. 1,800 OF NOVEMBER 9, 2015 Guidelines on Pharmaceutical Assistance in the Indigenous People Health Care Subsystem

Approves the Guidelines on Pharmaceutical Assistance in the Indigenous People Health Care Subsystem (SASISUS).

ORDINANCE SCTIE No. 65 OF NOVEMBER 9, 2015 Approves the Clinical Protocol and Therapeutic Guidelines to prevent the Vertical Transmission of HIV, Syphilis and Viral Hepatitis in the ambit of SUS

Makes public the decision of approving the Clinical Protocol and Therapeutic Guidelines to prevent the Vertical Transmission of HIV, Syphilis and Viral Hepatitis in the ambit of SUS.

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RESOLUTION SS No. 116 OF NOVEMBER 11, 2015 Revokes the Protocol to treat Persons with Severe Chronic Obstructive Pulmonary Disease (DPOC)

Revokes Resolution SS No. 278 of July 26, 2007, which approved the Protocol to treat Persons with Severe Chronic Obstructive Pulmonary Disease (DPOC) in the ambit of SUS in the State of São Paulo.

RESOLUTION SS No. 117 OF NOVEMBER 12, 2015 Revokes the Resolution approving the Protocol to treat Persons with Pulmonary Arterial Hypertension (HAP)

Revokes Resolution SS No. 321 of October 30, 2007, which approved the Protocol to treat Persons with Pulmonary Arterial Hypertension (HAP), in the ambit of SUS in the State of São Paulo.

SÃO PAULO STATE BILL No. 1,463 OF 2015

(published on November 13, 2015) Oral Health Week Creates the Oral Health Week in the State of São

Paulo, and makes other provisions.

ORDINANCE CCD No. 32 OF NOVEMBER 16, 2015 Creates the Committee on Visceral Leishmaniasis (LV)

Creates the Committee on Visceral Leishmaniasis (LV) of the Health State Office in the State of São Paulo.

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ORDINANCE SAS No. 1,158 OF OCTOBER 21, 2015

(published on November 19, 2015) Clinical Protocol and Therapeutic Guidelines on Non-Infectious Posterior Uveitis

Approves the Clinical Protocol and Therapeutic Guidelines for Non-Infectious Posterior Uveitis.

SÃO PAULO STATE BILL No. 1,471 OF 2015

(published on November 13, 2015) Visiting of domestic animals and pets in public and private within SUS

Provides for visiting of domestic animals and pets in public and private hospitals within SUS, in the State of São Paulo, and makes other provisions.

ORDINANCE SAS No. 1,159 OF NOVEMBER 18, 2015 Isotretinoin in the treatment of severe acne

Approves the Protocol to use isotretinoin in the treatment of severe acne.

ORDINANCE SAS No. 1,160 OF NOVEMBER 18, 2015 Approves the Clinical Protocol and Therapeutic Guidelines of Hyperprolactinemia

Approves the Clinical Protocol and Therapeutic Guidelines for Hyperprolactinemia.

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ORDINANCE SAS No. 1,161 OF NOVEMBER 18, 2015 Approves the Clinical Protocol and Therapeutic Guidelines for Congenital Hypothyroidism

Approves the Clinical Protocol and Therapeutic Guidelines for Congenital Hypothyroidism.

ORDINANCE SAS No. 1,162 OF NOVEMBER 18, 2015 Approves the Clinical Protocol and Therapeutic Guidelines for Hereditary Ichthyosis

Approves the Clinical Protocol and Therapeutic Guidelines for Hereditary Ichthyosis.

ORDINANCE SAS No. 1,169 OF NOVEMBER 19, 2015 Approves the Clinical Protocol and Therapeutic Guidelines for Myasthenia Gravis

Approves the Clinical Protocol and Therapeutic Guidelines for Myasthenia Gravis.

ORDINANCE SAS No. 1,170 OF NOVEMBER 19, 2015 Approves the Clinical Protocol and Therapeutic Guidelines for Congenital Adrenal Insufficiency

Approves the Clinical Protocol and Therapeutic Guidelines for Congenital Adrenal Insufficiency.

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ORDINANCE SAS No. 1,171 OF NOVEMBER 19, 2015 Approves the Clinical Protocol and Therapeutic Guidelines for Guillain-Barré Syndrome

Approves the Clinical Protocol and Therapeutic Guidelines for Guillain-Barré Syndrome.

JOINT RESOLUTION SF/SS No. 1 OF NOVEMBER 19,

2015 Guidelines to be observed as regards expenses incurred with hospital food

Creates a Working Group in order to promote studies for the establishment of guidelines to be observed as regards expenses incurred with hospital food in the ambit of Health State Office, and makes other related provisions.

JOINT RESOLUTION SF/SS No. 2 OF NOVEMBER 19,

2015 Guidelines to be observed as regards expenses incurred with medical gases

Creates a Working Group in order to promote studies for the establishment of guidelines to be observed as regards expenses incurred with medical gases in the ambit of Health State Office, and makes other related provisions.

JOINT RESOLUTION SF/SS No. 3 OF NOVEMBER 19,

2015 Guidelines to be observed as regards expenses incurred with hospital laundry

Creates a Working Group in order to promote studies for the establishment of guidelines to be observed as regards expenses incurred with hospital laundry in the ambit of Health State Office, and makes other related provisions.

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JOINT RESOLUTION SF/SS No. 4 OF NOVEMBER 19,

2015 Guidelines to be observed as regards expenses incurred with hospital cleaning technique

Creates a Working Group in order to promote studies for the establishment of guidelines to be observed as regards expenses incurred with hospital cleaning technique in the ambit of Health State Office, and makes other related provisions.

JOINT RESOLUTION SF/SS No. 5 OF NOVEMBER 19,

2015 Guidelines to be observed as regards expenses incurred with solid waste.

Creates a Working Group in order to promote studies for the establishment of guidelines to be observed as regards expenses incurred with solid waste in the ambit of Health State Office, and makes other related provisions.

ORDINANCE SCTIE No. 66 OF NOVEMBER 19, 2015 Treatment of Chronic Genotype 1 chronic HCV infection

Makes public the decision of not including veruprevir, ritonavir, ombitasvir and dasabuvir to treat genotype 1 chronic HCV infection in the ambit of SUS.

ORDINANCE SCTIE No. 67 OF NOVEMBER 19, 2015 Treatment of cutaneous and mucosal leishmaniasis

Makes public the decision of expand the use of pentoxifylline 400 mg in association with antimony for the treatment of cutaneous and mucosal leishmaniasis in the ambit of SUS.

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SÃO PAULO STATE BILL No. 1,502 OF 2015

(published on November 20, 2015) No need of medical prescription for certain blood tests

Establishes that no medical prescription is required for certain blood tests.

RIO DE JANEIRO STATE LAW No. 7,111 OF

NOVEMBER 23, 2015 Eye exams for newborns

Amends the summary and article 1 of Law No. 4,582 of July 25, 2005, which deals with eye exams for newborns.

ORDINANCE MS No. 1,898 OF NOVEMBER 24, 2015

Redefines the criteria for accreditation of Child Friendly Hospital Initiative - Iniciativa Hospital Amigo da Criança (IHAC)

Extends the term established in Ordinance No. 1,153/GM/MS of May 22, 2014 (Redefines the criteria for accreditation of Child Friendly Hospital Initiative - Iniciativa Hospital Amigo da Criança (IHAC), as an strategy to promote, protect and support breastfeeding and comprehensive health care for children and women, within SUS).

SÃO PAULO STATE BILL No. 1,511 OF 2015

(published on November 25, 2015) Medical exams and appointments for persons over 60 years

Provides for the time period to schedule medical exams and appointments for persons over 60 years old at the Public Health Units belonging to the Government of the State of São Paulo.

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RESOLUTION SS No. 121 OF NOVEMBER 27, 2015 Aripiprazole in the list of drugs for treating Schizophrenia

Revokes Resolution SS-295 of September 4, 2007, which approved the Technical Rule for inclusion of aripiprazole in the list of drugs for treating Schizophrenia, in the ambit of SUS, in the State of São Paulo.

ANVISA RESOLUTION RDC ANVISA No. 47 OF NOVEMBER 6,

2015 Internal Rules of ANVISA

Amends Resolution RDC No. 29 of July 21, 2015, which approves and enacts the Internal Rules of ANVISA.

ORDINANCE ANVISA No. 1,454 OF NOVEMBER 27,

2015 Changes in the Permanent Committee on Haemovigilance

Updates the duties, powers and composition of the Permanent Committee on Haemovigilance.

ORDINANCE ANVISA No. 1,455 OF NOVEMBER 27,

2015 Designates the sitting members to compose the Permanent Committee

Designates the sitting members appointed by the institutions invited to compose the Permanent Committee on Haemovigilance, dealt with in Ordinance No. 1,454 of November 27, 2015.

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NATIONAL HEALTH COUNCIL ORDINANCE MS No. 1,897 OF NOVEMBER 24, 2015 Changes of the sitting members and alternates of the National Health Council

Amends Ordinance GM/MS No. 2,814 of December 12, 2012, published in the Official Gazette of the Federal Executive No. 240, Section 2, p. 32 of December 13, 2012, concerning the sitting members, 1st and 2nd alternates of the National Health Council (CNS) for 2012-2015 triennium.

MISCELLANEOUS SÃO PAULO STATE BILL No. 1,435 OF 2015

(published on November 5, 2015) Manufacture, production and distribution of synthetic phosphoethanolamine to patients with cancer

Provides for the manufacture, production and distribution of synthetic phosphoethanolamine to patients with cancer.

SÃO PAULO STATE BILL No. 1,456 OF 2015

(published on November 10, 2015) Obligation to place on labels information on the use of nanotechnology in products and their by-products

Regulates and provides for the obligation to place on labels information on the use of nanotechnology in products and their by-products.

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ORDINANCE MS No. 1,813 OF NOVEMBER 11, 2015 Declares Public Health Emergency of National Concern in view of the changing in the pattern of occurrence of microcephaly

Declares Public Health Emergency of National Concern (ESPIN) in view of the changing in the pattern of occurrence of microcephaly in Brazil.

SÃO PAULO STATE BILL No. 1,462 OF 2015

(published on November 12, 2015) Child Obesity Awareness Week

Creates the Child Obesity Awareness Week in the State of São Paulo.

ORDINANCE MS No. 1,826 OF NOVEMBER 11, 2015 CNS Board 2015-2018 triennium

Designates the entities and social movements elected to compose the CNS Board – for 2015-2018 triennium.

FEDERAL LAW No. 13,186 OF NOVEMBER 11, 2015 Educational Policy on Sustainable Consumption

Creates the Educational Policy on Sustainable Consumption.

RESOLUTION SES No. 1,296 OF NOVEMBER 18, 2015 Prompt notification of cases involving pregnant women with rash syndrome

Establishes the obligation to promptly notify cases involving pregnant women with rash syndrome.

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SÃO PAULO STATE BILL No. 1,494 OF 2015

(published on November 19, 2015) Lipodystrophy Day Creates the Lipodystrophy Day in the State of São

Paulo. SÃO PAULO STATE BILL No. 1,495 OF 2015

(published on November 19, 2015) Acromegaly Day Creates the Acromegaly Day in the State of São

Paulo. SÃO PAULO STATE BILL No. 1,496 OF 2015

(published on November 19, 2015) Amyloidosis Day Creates the Amyloidosis Day in the State of São

Paulo. RIO DE JANEIRO STATE LAW No. 7,108 OF

NOVEMBER 19, 2015 "Red December" campaign

Institutes in the State of São Paulo the "Red December" campaign.

SÃO PAULO STATE BILL No. 1,509 OF 2015

(published on November 24, 2015) Week for Fighting and Preventing Microcephaly

Creates the Week for Fighting and Preventing Microcephaly, and makes other provisions.

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RIO DE JANEIRO STATE LAW No. 7,115 OF

NOVEMBER 24, 2015 Breastfeeding right in the State of Rio de Janeiro

Provides for the breastfeeding right in the State of Rio de Janeiro, and makes other provisions.

SÃO PAULO STATE BILL No. 1,525 OF 2015

(published on November 30, 2015) Implementation of photovoltaic solar panels in hospitals of the State of São Paulo

Provides for implementation of photovoltaic solar panels in hospitals of the State of São Paulo.

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PUBLIC CONSULTATIONS (CP)

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.

Rule / Public

Consultation (CP) Subject Publication Date Term

ANVISA – CP No. 96 of November 11, 2015

Initial term for submission of comments and suggestions on the proposed Resolution, which provides for active ingredient H16 - (Z)-7-HEXADECENAL, listed in the Compendium of Active Ingredients of Agrochemicals, Household Cleaning Products and Wood Preservers.

November 12, 2015 30 days

ANVISA – CP No. 97 of November 11, 2015

Initial term for submission of comments and suggestions on the proposed Resolution, which provides for active ingredient I10 - IMAZETHAPYR, listed in the Compendium of Active Ingredients of Agrochemicals, Household Cleaning Products and Wood Preservers.

November 12, 2015 30 days

ANVISA – CP No. 98 of November 11, 2015

Initial term for submission of comments and suggestions on the proposed Resolution, which provides for active ingredient E04 - SULFUR, listed in the Compendium of Active Ingredients of Agrochemicals, Household Cleaning Products and Wood Preservers.

November 12, 2015 30 days

ANVISA – CP No. 99 of November 11, 2015

As from publication of this Public Consultation, the period of 30 days starts running for submission of comments and suggestions on the proposed Resolution which provides for inclusion of active ingredient B41 - BOSCALID in the Compendium of Active Ingredients of Agrochemicals, Household Cleaning Products and Wood Preservers.

November 12, 2015 30 days

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Rule / Public Consultation (CP)

Subject Publication Date Term

ANVISA – CP No. 100 of November 11, 2015

As from publication of this Public Consultation, the period of 30 days starts running for submission of comments and suggestions on the proposed Resolution which provides for inclusion of active ingredient T33 - TEFLUBENZURON in the Compendium of Active Ingredients of Agrochemicals, Household Cleaning Products and Wood Preservers.

November 12, 2015 30 days

ANVISA – CP No. 101 of November 11, 2015

As from publication of this Public Consultation, the period of 30 days starts running for submission of comments and suggestions on the proposed Resolution which provides for inclusion of active ingredient B49 - BACILLUS AMYLOLIQUEFACIENS in the Compendium of Active Ingredients of Agrochemicals, Household Cleaning Products and Wood Preservers.

November 12, 2015 30 days

ANVISA – CP No. 102 of November 11, 2015

As from publication of this Public Consultation, the period of 30 days starts running for submission of comments and suggestions on the proposed Resolution which provides for inclusion of active ingredient B50 - BACILLUS METHYLOTROPHICUS in the Compendium of Active Ingredients of Agrochemicals, Household Cleaning Products and Wood Preservers.

November 12, 2015 30 days

SCTIE – CP No. 34 of November 4, 2015

Initial term for the civil society to submit comments and suggestions on the recommendation of the Brazilian Committee on Technology Incorporation to include, in SUS, antiangiogenics (bevacizumab and ranibizumab) for the treatment of diabetic macular edema, as presented by SAS/MS.

November 5, 2015 20 days

SDA – CP No. 88 of November 6, 2015

Initial term for submission of comments and suggestions on the Normative Ruling Bill which approves the technical regulation on antiparasitic products for veterinary use, and establishes criteria and procedures for their registration and obtaining of commercial license in Brazil.

November 9, 2015 60 days

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Rule / Public Consultation (CP)

Subject Publication Date Term

MAPA – CP No. 246 of November 16, 2015

Initial term for submission of comments and suggestions on the Normative Ruling Bill and its Annexes, which establishes rules for the accreditation of entities that provide pre-slaughter and slaughter management training with the purpose of issuing a qualification certificate to those in charge of animal well-being in commercial slaughterhouses.

November 17, 2015

60 days

ANVISA – CP No. 103 of November 27, 2015

Initial term for submission of comments and suggestions on the proposed Resolution, which provides for active ingredient B51 - BACULOVIRUS SPODOPTERA FRUGIPERDA, listed in the Compendium of Active Ingredients of Agrochemicals, Household Cleaning Products and Wood Preservers.

November 30, 2015

30 days

ANVISA – CP No. 104 of November 27, 2015

Initial term for submission of comments and suggestions on the proposed Resolution, which provides for active ingredient I27 - INDAZIFLAM, listed in the Compendium of Active Ingredients of Agrochemicals, Household Cleaning Products and Wood Preservers.

November 30, 2015

30 days

ANVISA – CP No. 105 of November 27, 2015

Initial term for submission of comments and suggestions on the text of the proposed Public Consultation on Compendium of Surgical Sutures to be included in the Brazilian Pharmacopeia, 6th edition.

November 30, 2015

60 days

Page 24: LifeSciences in Brazil No. 114 - Pinheiro Neto Advogados...Ruling No. 01 of January 7, 2015 (Approves the phytosanitary requirements for importation of in vitro seeds and seedlings

LifeSciences no Brasil No. 114

November 2015

24

GLOSSARY

ANVISA – National Public Health Agency CCD –Disease Control Coordination CFQ – Chemistry Federal Council CFO – Federal Council of Odontology COFEN – Federal Council of Nurses MAPA – Ministry of Agriculture, Cattle Breeding and Supply MF – Ministry of Finance MS – Ministry of Health SF – Treasury Office of the State of São Paulo SS – São Paulo Health Office SAS – Health Support Office SES – State Health Office SCTIE - Office of Science, Technology and Strategic Inputs SDA – Agricultural and Stockbreeding Defense Office SUS – Integrated Health System SVS – Health Surveillance Office This issue was compiled by the LifeSciences team of Pinheiro Neto Advogados Angela Fan Chi Kung ([email protected]), Nicole Recchi Aun ([email protected]), Lydia Mauler Lobo ([email protected]), Guilherme Gieron Fonseca ([email protected]) and Júlia de Castro Kesselring ([email protected]).


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