15 de julho de 2019

BRAZIL NEWS: Consultation: GMP guideline for drugs

From: www.anvisa.gov.br

Public consultation available on the internalization of a set of Good Drug Manufacturing Practices guidelines of the Pharmaceutical Inspection Co-operation Scheme – PIC/s. 

Public Consultation 653/2019 (Consulta Pública 653/2019), on the internalization of a set of Good Drug Manufacturing Practices of the Pharmaceutical Inspection Co-operation Scheme – PIC/s, was published on the Federal Official Gazette (DOU, in Portuguese) of Monday, 27 May 2019. 

People interested in contributing have up to 60 days to do so, as from Monday, 3 June. It is important to emphasize that it is not about the development of a new guide, but the internalization of a norm already adopted by 47 countries.

Click on the link to know the Public Consultation proposal: proposta de Consulta Pública.

How to contribute?

Contributions may be made in four ways:
  • Improvements in translation and text comprehension, so the text reflects the original meaning of PIC/s guideline.
  • Identification of transience, i.e. the need to extend the timeframe to comply with some new requirements until the proposal enters into force.
  • Questions about the public consultation: doubts regarding the meaning of an article, lack of comprehension of some aspect, Anvisa’s interpretation of a certain item, etc.
  • Draft alteration proposals: suggestions of requirements added to the norm, if it is understood that the set of articles is not enough.
It is important to understand that:
  • A regulation does not have a retrospective effect. Therefore, there is no need to request time extension.
  • Since the public consultation refers to the internalization of a set of guidelines widely adopted worldwide, it is not advisable that divergent requirements are adopted, unless there is a confirmed need to obtain the appropriate level of health protection in Brazil. Therefore, requests of exclusion or substantial alteration of a determined item may not be accepted.
  • The questions will be answered every two days and, depending on their complexity and public interest, will be published on the Q&A list. Simpler questions will be answered by the technical area, via e-mail.
Click on the link to access the Webinar on the Public Consultation to Review the Regulatory Benchmark of Good Drug Manufacturing Practices – Presentation of Consultation Forms and Q&A Mechanism (Consulta Pública de Revisão do Marco Regulatório de Boas Práticas de Fabricação de Medicamentos – Apresentação dos formulários da Consulta e do Mecanismo de Perguntas e Respostas) held in 27 May.

How to participate?

After reading and assessing the texts, suggestions may be sent electronically, through a specific form.

The contributions received are deemed public, and will be available to any interested parties, through tools in the menu “Resultado” (Result) of the electronic form, also during the consultation process.

At the end of form filling, the interested party’s participation registry protocol number will be made available. The interested party will then be exempted from sending paper documents via mail or handing then personally at Anvisa.

Those without access to the internet may also participate. In that case, suggestions and comments may be sent in writing to the address: Agência Nacional de Vigilância Sanitária – Gerência Geral de Inspeção e Fiscalização Sanitária (GGFIS) – SIA, Trecho 5, Área Especial 57, Brasília-DF, CEP 71.205-050. Exceptionally, foreign contributions may be sent physically to the same address, but directed specifically to Assessoria de Assuntos Internacionais – Ainte (Foreign Affairs Office).

After the Public Consultation is finished, the Agency will analyze the contributions and may, when applicable, promote debates with organisms, entities, and those who have shown their interest in the subject, with the objective of providing more inputs for technical discussions and the final decision by the Collegiate Board.