AND GENETIC HERITAGE AND PROFESSIONALS … - NOVO...˙PHOTO: AMAURI AMˆ ... ANVISA – PC No. 546 of September 3, 2018 Establishes a deadline for submission of comments and suggestions

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nº 147septermber, 2018

HUMAN HEALTH HEALTHCARE SERVICES AND PROFESSIONALS

PUBLICCONSULTATIONS

ANIMAL HEALTH, PLANT PRODUCTS AND GENETIC HERITAGE

This bulletin is meant for general informational purposes only and should not be relied upon as legal advice on any specifi c deal or matter. If you need more information, please contact our lawyers or visit our website www.pinheironeto.com.br.

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SUS

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.

PUBLICATION FREQUENCY

Monthly

SUPERVISING PARTNER

Angela Fan Chi Kung

CONTRIBUTORS

Camila Martino Parise, Nicole Recchi Aun, Júlia de Castro Kesselring e Marina Baptista de Andrade

CONTACT

[email protected]

Ordinance SAS No. 1,368 of August 31, 2018, published on September 5, 2018Includes procedures in the List of Procedures, Drugs, Ortheses, Prostheses and Special Materials of the Integrated Health System - SUS (everolimus).

(PHOTO: RAWPIXEL)

▫ SUS ▫ Pharmaceuticals ▫ Others

▫ Professionals ▫ Animal Health and Plant Products ▫ Heathcare Professionals

Ordinance SCTIE No. 24 of September 11, 2018Makes public the decision to include in the Integrated Health System - SUS the procedure for electrical stimulation of the vagus nerve for adjuvant therapy of patients with drug-resistant epilepsy, without indication of resective surgery for the treatment of epilepsy.


nº 147september, 2018

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PUBLICCONSULTATIONS


(PHOTO: SAMUEL ZELLER)

Ordinance MS No. 2,976 of September 19, 2018Amends article 46 of Annex XCIII to the Consolidation Ordinance GM/MS No. 5 of September 28, 2017 (Consolidation of the rules on healthcare actions and services of the Integrated Health System - SUS).

Ordinance SAS No. 1,416 of September 6, 2018, published on September 19, 2018Changes and included procedure in the List of Procedures, Drugs, Ortheses, Prostheses and Special Materials of the Integrated Health System - SUS (hearing aids).

Ordinance SAS No. 1,506 of September 20, 2018, published on September 24, 2018Changes attributes and includes procedures belonging to the Pharmaceutical Assistance Specialized Component in the List of Procedures, Drugs, Ortheses, Prostheses and Special Materials of the Integrated Health System - SUS (Topiramate, Penicillamine, Latanoprost, Bimatoprost, Travoprost, Octreotide Lar, Insulin, Laronidase and Tofacifitinibe Citrate). Lar, Insulina, Laronidase E Citrato De Tofacifitinibe).

Ordinance SCTIE No. 37 of September 11, 2018Makes public the decision to extend the indication of alteplase for the treatment of acute pulmonary embolism in the scope of the Integrated Health System - SUS.

Ordinance SCTIE No. 39 of September 11, 2018Makes public the decision to include in the Integrated Health System - SUS the electronic larynx for malignant neoplasm of larynx.

Ordinance MS No. 2,895 of September 12, 2018Defines, to 2018, the strategy to expand the access to Elective Surgical Procedures in the scope of the Integrated Health System - SUS.

Ordinance SAS No. 1,414 of September 6, 2018, published on September 13, 2018Changes the characteristic of a procedure in the List of Procedures, Drugs, Ortheses, Prostheses and Special Materials of the Integrated Health System - SUS (surgery for the review the bone-anchored hearing aid and surgery for re-implantation of bone-anchored hearing aids).






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PUBLICCONSULTATIONS


Resolution RDC ANVISA No. 247 of September 3, 2018Provides for the update of the Brazilian Common Denominations (DCBs).

Order No. 211 issued by the Head of ANVISA on September 3, 2018Proposed Resolution RDC – which deals with Pharmacovigilance Good Practices for Holders of Registration of Pharmaceutical for human use and Proposed Normative Ruling – IN, which deals with Periodic Report for Assessment of Benefit-Risk Assessment (RPBR) to be submitted to ANVISA by the Holders of Registration of Pharmaceutical.

Communiqué CMED No. 12 of August 23, 2018, published on September 14, 2018Discloses the updated and consolidated list of the economic groups operating in the Brazilian pharmaceutical market, which will be considered by CMED for the calculation of the Z factor.

Communiqué CMED No. 13 of August 23, 2018, rectified on September 17, 2018Discloses the market concentration index per therapeutic subclass to establish the Factor Z three levels to be adopted for 2019 price adjustment.

Communiqué CMED No. 14 of September 12, 2018, rectified on September 17, 2018Instructions for completing the marketing report relating to the first half of 2018.

Communiqué CMED No. 15 of September 21, 2018Discloses the new Coefficient for Adjustment of Prices (CAP).

Communiqué CMED No. 16 of September 24, 2018Discloses on ANVISA website the list of new presentations of pharmaceuticals, recognized by the Technical Executive Committee as similar to those included in the list of Resolution No. 5 of October 9, 2003, which are also exempted from the criteria of adjustment or establishment of Factory Price dealt with in article 6, IV of Law No. 10,742 of October 6, 2003.

PHARMACEUTICALS

(PHOTO: RAWPIXEL)






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PUBLICCONSULTATIONS


Order No. 210 issued by the Head of ANVISA on September 3, 2018Proposed initiative for reviewing/amending Resolution ANVISA No. 25/2001 – which provides for the importation, sale and donation of used and reconditioned medical devices.

OTHERS

São Paulo City Bill No. 594 de 2018, published on September 5, 2018Authorizes the prescription of ozone therapy as supplementary medical treatment.

Federal Decree No. 9,493 de September 5, 2018Approves the Regulation for the Supervision of Controlled Products.

Provisional Measure No. 851 of September 10, 2018Authorizes the public administration to sign partnership instruments and instruments for implementation of programs, projects and other purposes of public interest with endowment fund management organizations, and providV es for other measures.

Ordinance MS No. 2.894 of September 12, 2018Revokes item III of article 5 of Ordinance GM/MS No. 2,814 of May 29,1998 (Establishes procedures to be observed by companies producing, importing, distributing and marketing pharmaceuticals, aiming at proving, as a matter of urgency, the identity and quality of pharmaceuticals subject to complaint for possible falsification, adulteration and fraud).

(PHOTO: AMAURI AM)






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PUBLICCONSULTATIONS


Normative Ruling MAPA No. 46 of August 28, 2018, published on September 3, 2018Establishes the Technical Regulation for the export of live bovine, bubaline, ovine and caprine animals, for slaughter or breeding purposes.

Normative Ruling MAPA No. 47 of August 30, 2018, published on September 6, 2018Establishes the Technical Regulation on Sugar, defining its official classification standard, including its identity and quality standards, sampling, presentation form, marking or labeling, in the aspects relating to product classification.

Normative Ruling MAPA No. 48 of August 31, 2018, republished on September 10, 2018Amends Normative Ruling No. 14 of February 8, 2018 (Establishes the Supplementation of Identity and Quality Standards for Wine and Products Made of Grape and Wine).

Ordinance MAPA No. 1,329 of August 13, 2018, published on September 10, 2018Amends Annex I to Ordinance No. 266 of February 28, 2018, which defines the coverage area of Services in connection with the Inspection of Products of Animal Origin.

Normative Ruling SDA No. 30 of September 13, 2018, published on September 26, 2018Approves the Technical Regulation on Collection of Samples and Submission of Results of Official Quality and Control of Products for Veterinary Use.

Normative Ruling MAPA No. 49 of September 26, 2018Establishes throughout the Brazilian territory the supplementation of the Identity and Quality Standards of Juice and Fruit Pulp, pursuant to this Normative Ruling.

Normative Ruling MAPA No. 50 of September 12, 2018, published on September 27, 2018Amends Annex to Normative Ruling No. 19 of April 16, 2018 (Makes public the reference list of animal species introduced in the Brazilian territory), to include aquatic animal species.

ANIMAL HEALTH AND PLANT PRODUCTS

(PHOTO: THOMAS VERBRUGGEN)






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PUBLICCONSULTATIONS


Normative Ruling SDA No. 35 of September 25, 2018, published on September 27, 2018Approves procedures for recognizing systems of healthcare inspection and accreditation of foreign establishments by the Department of Inspection of Products of Animal Origin – DIPOA of the Agricultural and Stockbreeding Defense Office - SDA/MAPA, of the Ministry of Agriculture, Cattle Breeding and Supply – MAPA.

Normative Ruling SDA No. 36 of September 25, 2018, published on September 27, 2018Amends the annex to Normative Ruling SDA/MAPA No. 30 of September 9, 1999 (Approves the Technical Regulation for Establishment of Identity and Quality Requirements for diet and low calorie beverages).

Normative Ruling SDA No. 34 of September 25, 2018, published on September 27, 2018Approves the procedures for previous authorization of importation, re-inspection and special controls applicable to the importation of edible products of animal origin by the Department of Inspectionof Products of Animal Origin – DIPOA of the Agricultural and Stockbreeding Defense Office - SDA/MAPA, of the Ministry of Agriculture, Cattle Breeding and Supply – MAPA.

(PHOTO: CHUTTERSNAP)






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PUBLICCONSULTATIONS


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.

HEALTHCARE PROFESSIONALS

(PHOTO: MARTIN BROSY)

PUBLIC CONSULTATIONS

Rule / Public Consultation (PC)

Subject Publication Date Term

ANVISA – PC No. 546 of September 3, 2018

Establishes a deadline for submission of comments and suggestions to the text of RDC that deals with the requirements for manufacturing, marketing, importation and exposure to the use of customized and patient-specific medical devices.

September 5, 2018 60 days


EEstablishes a deadline for submission of comments and suggestions to the text of RDC that deals with Pharmacovigilance Good Practices for Holders of Registration of Pharmaceutical for human use.



Establishes a deadline for submission of comments and suggestions to the text of Normative Ruling - IN that deals with the Periodic Report for Assessment of Benefit-Risk Assessment (RPBR) to be submitted to ANVISA by the Holders of Registration of Pharmaceutical.


MAPA – Ordinance No. 103 of September 20, 2018

Submits to public consultation the Normative Ruling Bill that seeks to establish throughout the Brazilian territory the identity and quality standards of kombucha.


Normative Resolution CFQ No. 270 of August 23, 2018, published on September 5, 2018Regulates the practice of the Chemistry professional in relation to the production chain of medical gases.

Resolution CFM No. 2,180 of February 23, 2018, published on September 5, 2018Establishes the physicians’ data to be made available in electronic consultations related to the records of the medical professionals enrolled in the System of Councils of Medicine, and makes other provisions.






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PUBLICCONSULTATIONS


GLOSSARY

ANVISA – National Public Health Agency

CFN – Federal Council of Medicine

CFQ – Federal Council Of Chemistry

CMED – Medication Market Regulation Chamber

MAPA –Ministry of Agriculture, Cattle Breeding and Supply

MS – Ministry of Health

SAS – Health Support Office of the National Public Health Agency

SCTIE - Office of Science, Technology and Strategic Inputs of the Ministry of Health

SDA – Agricultural and Stockbreeding Defense Office of the Ministry of Agriculture, Cattle Breeding and Supply

(PHOTO: ANI KOLLESHI).




Documents

AND GENETIC HERITAGE AND PROFESSIONALS … - NOVO...˙PHOTO: AMAURI AMˆ ... ANVISA – PC No. 546 of September 3, 2018 Establishes a deadline for submission of comments and suggestions