INFORMATIVES >> CLIENT ALERTS

Go back
Life Sciences & Healthcare 23/05/2022

The Ministry of Health Ordinance GM/MS 913, which entered into force on May 22nd, declared the end of the Public Health Emergency Related to Covid.

 

The end of the emergency period would bring the sudden revocation of rules edited to improve the managing of goods and services and distribution of devices, medicines, and vaccines during the pandemic.

 

To avoid destabilizing the supply and health services systems, on May 18, ANVISA published RDC 683/2022, which sets forth transition measures for the rules issued during the Pandemic.

 

In a nutshell, 18 of the Resolutions approved in this period will be extended until May 23, 2023, to preserve the underlying policy to combat Covid-19.

 

ANVISA’s decision guarantees legal certainty and adds administrative effectiveness and efficiency by allowing the Agency to meticulously assess the need to implement these special rules within the current regulatory framework.

 

RDC 683/2022 came into force on May 22.

 

The table below lists the RDCs that are extended until May 23, 2023:

 

1. RDC 357/2020: Temporarily extends the maximum quantities of medicines subject to special control and allows, temporarily, remote delivery defined by a specific public program and home delivery of those products.

 

2. RDC 364/2020: Stays the effects of RDC 302/2005, on a temporary and exceptional basis, for Federal Agricultural Defense Laboratories that will carry out analyzes for the diagnosis of COVID-19.

 

3. RDC 373/2020: Amends article 29 of RDC 72/2009, which sets forth the Technical Regulation to promote sanitary control in ports installed in the national territory, and vessels that transit through them during the Public Health Emergency of International Importance of COVID-19.

 

4. RDC 377/2020: Authorizes, on a temporary and exceptional basis, the use of “rapid tests” (immunochromatographic assays) for COVID-19 in pharmacies, stays the effects of § 2 of articles 69 and 70 of RDC 44/2009

 

5. RDC 384/2020: Sets forth the temporary inclusion of a procedure for issuing a health certificate by document analysis, regulated in RDC 72/2009, to vessels.

 

6. RDC 400/2020: Defines the extraordinary criteria and procedures for applying exceptionalities to specific requirements for labeling and drug package inserts.

 

7. RDC 402/2020: Establishes the temporary opening of entry and exit points for substances subject to special control.

 

8. RDC 415/2020: Defines extraordinary new criteria and procedures for handling Marketing Authorizations (“MA”) petitions and post-registration changes of medicines and biological products.

 

9. RDC 465/2021: Establishes the exemption from MA and authorization for emergency use and the procedures to import and monitor vaccines against Covid-19 acquired by the Ministry of Health within the scope of the Covax Facility[1].

 

10. RDC 479/2021: Sets forth prohibitions for imports carried out by individuals for their use by any import modalities during the pandemic.

 

11. RDC 522/2021: Sets forth the procedure for the assessment and debate on administrative appeals through a deliberative circuit.

 

12. RDC 533/2021: Establishes exceptional and temporary procedures for importing vaccines against Covid-19 regularized at Anvisa and its inputs.

 

13. RDC 534/2021: Extraordinarily and temporarily sets forth for the continuous submission of clinical development dossiers for vaccines against Covid-19 by Brazilian public universities or publicly funded institutions.

 

14. RDC 568/2021: Sets forth the permission to use medicines and biological products used in the treatment and prevention of Covid-19 from the remaining stock of clinical trials conducted or in progress on an extraordinary and temporary basis in Brazil.

 

15. RDC 573/2021: Amends RDC 9/2015, which approves the regulation for conducting clinical trials with drugs in Brazil.

 

16. RDC 574/2021: Sets forth the sanitary requirements for the embarkation, disembarkation, and transport of travelers on cruise ships located in Brazilian jurisdictional waters, including those with travelers from other countries.

 

17.RDC 584/2021: Sets forth sanitary measures for operating platforms located in Brazilian waters and cargo vessels.

 

18. RDC 601/2021: Sets forth the simplified analysis of petitions for consent in the clinical research process, changes to the Clinical Drug Development Dossier (CDDD), a substantial amendment to the clinical protocol, and consent in the CDDD process referring to the Experimental Drug Dossier.

 

The above extensions seek to promote stability and predictability in the sector, ensuring timely adaptation to a possible return to normality.

 

As an exception, RDC 606/2022, which establishes the extraordinary and temporary criteria and procedures for certifying good manufacturing practices for MA and post-registration changes of APIs, medicines, and devices, was extended until 17 November 2022 (180 days).

 

Our Life Sciences & Healthcare team is available to answer questions about RDC 683/2022 through the email lifesciences@soutocorrea.com.br.

 

____________________________________________________

[1] An international alliance established through non-governmental organizations, such as the WHO, to promote the production and equal access to vaccines against COVID-19.