The document summarizes new Brazilian regulations for pharmaceutical patent applications. Key points:
- Regulation RDC #21 of 2013 amends previous regulations and takes effect immediately.
- Patent applications will be denied if considered against public health policies of access to medicines or do not meet patentability requirements.
- Applications covering products on the Ministry of Health lists are considered against these public policies.
Doing business with medical cannabis
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Doing business with medical cannabis
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1. This Circular provides for:
a) Documentation requirements, procedures for issuance, renewal, revision and revocation of the marketing authorization of modern medicines, vaccines, biologicals, herbal drugs and medicinal materials (including active ingredients, semi-finished herbal ingredients, excipients, and capsule shells) for human use in Vietnam;
b) Required clinical data for assurance of safety and efficacy in the application;
c) Requirements for exemption from clinical trial or certain stages thereof in Vietnam; drugs that have to undergo Stage 4 clinical trial;
d) Rules for validation of marketing authorization applications (hereinafter referred to as “marketing application”) for drugs/medicinal materials, renewal and revision thereof;
đ) Rules for validation of applications for license to import drugs that are yet to be approved for marketing authorization (hereinafter referred to as “unapproved drugs”) in the cases specified in Point a Clause 43 Article 5 of Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on business conditions under state management of the Ministry of Health of Vietnam (hereinafter referred to as “Decree No. 155/2018/ND-CP”);
e) Rules for organization and operation of Marketing Authorization Advisory Board (hereinafter referred to as “the Advisory Board”);
g) Procedures for validation of marketing applications, renewal and revision thereof; Procedures for validation of applications for the license to import unapproved drugs.
Circular 23/2021/TT-BYT , issued December 09, 2021: Amendments to some legislative documents on medical equipment, pharmacy and population issued by the Minister of Health
This Circular provides for emergency marketing authorization of COVID-19 vaccines (hereinafter referred to as “vaccines"), specifically:
1. Applications and procedures for vaccine marketing authorization issuance, renewal and amendment.
2. Requirements for clinical data in applications to ensure vaccine safety and effectiveness.
3. Exemption from one or more than one clinical trial phase and vaccines required to undergo phase 4 clinical trial in Vietnam.
On March 3, 2023, the Government issued Decree 07/2023/ND-CP amending Decree 98/2021/ND-CP on medical equipment management.
Accordingly, the content of medical equipment price listing is regulated as follows:
- Organizations and individuals producing and trading medical equipment shall list prices of medical equipment at locations as prescribed in Article 17 of Decree 177/2013/ND-CP guiding the Price Law or on the Electronic Information Portal of the Ministry of Health.
- In case of listing medical equipment prices on the Ministry of Health's Electronic Information Portal, the following minimum information must be included:
+ Name and type of medical equipment.
+ Manufacturing company and country; firm, owner country.
+ Unit of calculation.
+ Configuration and technical features of medical equipment.
+ Listed price of medical equipment.
Circular 10/2023/TT-BYT, issued May 11, 2023: Amendments to Article 3 of Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health on templates of documents and reports on implementation of Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices
Medical Consumer Product Protection LegislationJoseph Curtis
Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.
All matters relating to NPPA including its functions of price control and monitoring.
Responsible for development of infrastructure, manpower and skills for the pharmaceutical sector.
Work for the promotion and coordination of basic, applied and other research in areas related to the pharmaceutical sector and for international co-operation in pharmaceutical research.
1. This Circular provides for:
a) Documentation requirements, procedures for issuance, renewal, revision and revocation of the marketing authorization of modern medicines, vaccines, biologicals, herbal drugs and medicinal materials (including active ingredients, semi-finished herbal ingredients, excipients, and capsule shells) for human use in Vietnam;
b) Required clinical data for assurance of safety and efficacy in the application;
c) Requirements for exemption from clinical trial or certain stages thereof in Vietnam; drugs that have to undergo Stage 4 clinical trial;
d) Rules for validation of marketing authorization applications (hereinafter referred to as “marketing application”) for drugs/medicinal materials, renewal and revision thereof;
đ) Rules for validation of applications for license to import drugs that are yet to be approved for marketing authorization (hereinafter referred to as “unapproved drugs”) in the cases specified in Point a Clause 43 Article 5 of Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on business conditions under state management of the Ministry of Health of Vietnam (hereinafter referred to as “Decree No. 155/2018/ND-CP”);
e) Rules for organization and operation of Marketing Authorization Advisory Board (hereinafter referred to as “the Advisory Board”);
g) Procedures for validation of marketing applications, renewal and revision thereof; Procedures for validation of applications for the license to import unapproved drugs.
Circular 23/2021/TT-BYT , issued December 09, 2021: Amendments to some legislative documents on medical equipment, pharmacy and population issued by the Minister of Health
This Circular provides for emergency marketing authorization of COVID-19 vaccines (hereinafter referred to as “vaccines"), specifically:
1. Applications and procedures for vaccine marketing authorization issuance, renewal and amendment.
2. Requirements for clinical data in applications to ensure vaccine safety and effectiveness.
3. Exemption from one or more than one clinical trial phase and vaccines required to undergo phase 4 clinical trial in Vietnam.
On March 3, 2023, the Government issued Decree 07/2023/ND-CP amending Decree 98/2021/ND-CP on medical equipment management.
Accordingly, the content of medical equipment price listing is regulated as follows:
- Organizations and individuals producing and trading medical equipment shall list prices of medical equipment at locations as prescribed in Article 17 of Decree 177/2013/ND-CP guiding the Price Law or on the Electronic Information Portal of the Ministry of Health.
- In case of listing medical equipment prices on the Ministry of Health's Electronic Information Portal, the following minimum information must be included:
+ Name and type of medical equipment.
+ Manufacturing company and country; firm, owner country.
+ Unit of calculation.
+ Configuration and technical features of medical equipment.
+ Listed price of medical equipment.
Circular 10/2023/TT-BYT, issued May 11, 2023: Amendments to Article 3 of Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health on templates of documents and reports on implementation of Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices
Medical Consumer Product Protection LegislationJoseph Curtis
Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.
All matters relating to NPPA including its functions of price control and monitoring.
Responsible for development of infrastructure, manpower and skills for the pharmaceutical sector.
Work for the promotion and coordination of basic, applied and other research in areas related to the pharmaceutical sector and for international co-operation in pharmaceutical research.
1. This Circular provides for information on labels, methods for labeling and package inserts of drugs and medicinal ingredients sold on the market; change of expiry dates of labeled drugs because of national defense and security, epidemic control or disaster recovery need.
2. This Circular does not apply to labels of:
a) Drugs and medicinal ingredients which are used for export but not yet registered in Vietnam;
b) Drugs imported for non-commercial purposes as regulated in Clause 1 Article 75 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy (hereinafter referred to as “Decree No. 54/2017/ND-CP”);
c) Drugs imported to meet urgent need of national defense and security, epidemic control or disaster recovery as regulated in Clause 1 Article 67 of the Decree No. 54/2017/ND-CP.
The Drug Enforcement Administration is raising the production quota for marijuana that is ordered by the federal government.
The National Institute on Drug Abuse produces marijuana for the purpose of research. The DEA is giving the agency permission to produce up to 600 kilograms of marijuana this year.
"The aggregate production quota for marijuana should be increased in order to provide a continuous and uninterrupted supply of marijuana in support of DEA-registered researchers who are approved by the federal government to utilize marijuana in their research protocols," the agency wrote.
This Circular provides for application and promulgation of Good Manufacturing Practices for pharmaceutical products and pharmaceutical starting materials (hereinafter referred to as “GMP”) and inspection of GMP compliance.
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Client alert anvisa new resolution 21 of 2013 on 229-c prior approval of pharmaceutical applications
1. NEW REGULATIONS FOR PHARMACEUTICAL PATENTS IN BRAZIL
ANVISA’s regulation RDC #21 of 2013 - effective today - amending RDC #45 of 2008
Regarding the prior approval under article 229-C of Statute #9.279 of 1996
RDC #45 of 2008 of June 24, 2008, as amended by RDC #21 of 2013, published on the Brazilian Federal Gazette of April 15, 2013.
Patent applications shall be denied when considered of interest to the public policies of access to
medicines and pharmaceutical assistance of the Public Healthcare System and do not meet patentability
requirements. Public policies of access to medicines and pharmaceutical assistance include all patent
applications covering products listed in the ordinances published by the Ministry of Health.
Please refer to the enclosed patent workflow to understand how changes affect patent prosecution in Brazil
ANVISA’s Board of Directors of the National Sanitary Surveillance Agency, by the power invested in them by item IV of
art.11 of the Regulation approved by Decree # 3,029, of April 16, 1999, and given the provisions of item II and
paragraphs 1 and 3 of art. 54 of the Internal Guide Rule approved in the terms of Annex I of ANVISA’s Ordinance # 354,
of August 11, 2006, republished in the Official Gazette of August 21, 2006, in the meeting held on June 17, 2008, and:
considering that the direct and indirect public administration of any of the Powers of the Union, States, Federal District
and Municipalities will obey the principles of legality, impersonality, morality, publicity and efficiency, pursuant to
Article 37 of the Federal Constitution of 1988;
considering that the public administration will also obey, amongst others, the principles of purpose, motivation,
reasonability, proportionality, full-defense, due process system, vested rights and public interest, pursuant to Article 2
of Statute #9,784, of January 29, 1999, regulating the administrative proceedings within the Federal Government,
seeking, especially, the protection of the rights of the administered and the better execution of the Administration’s
purposes;
considering that ANVISA’s activity must be judicially conditioned by the principles of validity, celerity, finality,
reasonability, impersonality, impartiality, publicity, morality and economical proceedings, pursuant to Article 29 of its
Regulation approved by Decree #3,029, of April 16, 1999;
considering the dispositions of the Agreement on Trade Related Aspects of Intellectual Property Rights – TRIPS – of the
World Trade Organization, especially in the part that it refers to the right of the members of organizing themselves
administratively in their best judgment for the execution of the Agreement;
considering ANVISA’s institutional purpose of promoting the protection of the population’s health and its legal
attributions established in Statute # 9,782, of January 26, 1999;
considering that the granting of patents of pharmaceutical products and processes by the Brazilian PTO – INPI depends
on prior approval from ANVISA, pursuant to article 229-C of Statute# 9,279, of May 14, 1996, that regulates rights and
obligations in industrial property, amended by Statute #10,196, of February 14, 2001;
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2. NEW REGULATIONS FOR PHARMACEUTICAL PATENTS IN BRAZIL
ANVISA’s regulation RDC #21 of 2013 effective today amending RDC #45 of 2008
Regarding the prior approval under article 229-C of Statute #9.279 of 1996
considering the guidelines, the priorities and the responsibilities established in the National Medicine Policy
established by the Ordinance #3,916/MS/GM, of October 30, 1998, that seeks to guarantee conditions for the safety
and quality of the medicines consumed in the country, promote the reasonable use and the population’s access to
those considered essential;
considering the Resolution #338, of May 6, 2004, of the National Counsel for Health, that approves the National Policy
of Pharmaceutical Assistance of the Ministry of Health; and
considering the need to improve the procedure of prior approval of ANVISA for the granting of patents for
pharmaceutical products and processes, decides to adopt the following Resolution of the Full Board of Directors and I,
Director-President, determine its publication:
Art. 1st ANVISA’s prior approval for the granting of patents for pharmaceutical products and processes is
subject to the rules and procedures established in this Resolution and other rules in force.
Sole paragraph - The disposition established in this article applies to the applications for patents of
invention of pharmaceutical products and processes that on December 15, 1999, were in course or were
filed from that date on before the Brazilian PTO – INPI.
Art. 2nd For the purposes of this Resolution the following definitions are adopted:
I – prior approval: ANVISA’s deliberative act issued taking into account the compliance regarding article 229-
C of Patent Statute #9,279, 1996, in which the Agency must verify if the object of the patent application is
against public health;
II – applicant: any individual or company that filed a patent application before the INPI;
III – interested party: any person, individual or company, that holds interest, pursuant to Statute #9,784, of
1999, or that holds relevant information for the examination of a patent application;
Art. 3rd The prior approval procedure will take place with the sending by the INPI of the application to
ANVISA for acknowledgement and manifestation, being the Agency able to conclude regarding the approval
or not, through motivated decision.
Art. 4th After receiving the patent application sent by the INPI, ANVISA will perform its examination in light
of public health, through a decision in the technical opinion submitted by competent area department inside
the Agency.
Paragraph 1st - The patent application shall be considered against public health when:
I - The pharmaceutical product or process in the patent application presents risk to health; or
II - The patent application of pharmaceutical product or process is of interest to the public policies of access
to medicines and pharmaceutical assistance of the Public Healthcare System (SUS) and does not meet
patentability requirements and further criteria established by Patent Statute #9,279 of 1996.
Paragraph 2nd - The risk to health will be characterized when the pharmaceutical product comprises, or the
pharmaceutical process results in, substance which the use may have been prohibited in the country.
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3. NEW REGULATIONS FOR PHARMACEUTICAL PATENTS IN BRAZIL
ANVISA’s regulation RDC #21 of 2013 effective today amending RDC #45 of 2008
Regarding the prior approval under article 229-C of Statute #9.279 of 1996
Paragraph 3rd – The patent application for pharmaceutical product or process will be deemed as interest to
the public policies of access to medicines and pharmaceutical assistance of the Public Healthcare System
(SUS) when comprises, or results in, substance established in the Ordinances published by the Ministry of
Health establishing the strategic products, for SUS, and your regular updates, as well as comprises, or results
in, substance established to the therapeutic purpose listed in the mentioned Ordinances.
Paragraph 4th – The guidelines for the analysis of risk to health and interest to the public policies of access to
medicines and pharmaceutical assistance of SUS will be established in the proper act.
Paragraph 5th - The applicant shall present to the ANVISA, always when requested, all the necessary
documents to answer the doubts raised during the examination.
Paragraph 6th - Until the end of the examination mentioned by this Resolution, the interested parties will be
able to present documents and other information to assist ANVISA’s examination.
Art. 5th When the technical report states, preliminarily, for the denial of the prior approval or formulates any
office action, the applicant or his legal representative will be notified through registered letter, to reply,
within ninety days, starting from the date of the official notification or from the notice given to the
interested party in the proceeding.
Paragraph 1st - If a reply to the office action is filed, even if it is not fulfilled, or if its formulation is objected,
and having or not any manifestation concerning its merits, ANVISA shall proceed with the analysis.
Paragraph 2nd – Prior approval will not be granted to patent application that have unanswered office action.
Art. 6th When the assessment performed within ANVISA concludes for approval, the application will return
to INPI for the conclusion of the patent granting proceeding. (revoked)
Art. 7th The decisions concerning the conclusion of the prior approval examination will be published in the
Brazilian Federal Gazette.
Paragraph 1st - An appeal to the Full Board of Directors of ANVISA can be filed within sixty days against the
decision that denies the prior approval to the application, pursuant to art. 15, paragraph 2nd, of Statute
#9,782, of 1999, art. 11, paragraph 1st, of Decree #3,029, of April 16, 1999, art. 212 of Statute #9,279, of
1996, complying with the specific regulation that establishes the proceedings of administrative appeals
within ANVISA.
Paragraph 2nd - After ANVISA’s final decision, the application shall return to the INPI for administrative
proceedings conclusion.
Art. 8th The petitions and documents dealt by this Resolution shall be received according to the specific
regulation on the ANVISA’s protocol.
Art. 9th This Resolution will enter into force on the date of its publication.
DIRCEU BRÁS APARECIDO BARBANO
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