INFO LIFE SCIENCES | JUNE 2021
New administrative procedures for GMP and GDP certification
On 26 May 2021, the National Health Surveillance Agency (Anvisa) published Resolution RDC No. 497/2021 (Portuguese language) which revokes Resolution RDC No. 39/2013 (Portuguese language) and introduces new administrative procedures for granting Good Manufacturing Practices (GMP) and Good Distribution and Storage Practices (GDP) certification. The new Resolution aims to simplify, optimise and provide more transparency to administrative procedures related to certification of GMP and GDP.
The Resolution applies to companies that: (i) manufacture drugs, health products, cosmetics, perfumes, personal care products, sanitising products, active pharmaceutical ingredients, and foods and are located in Brazil or other countries; and (ii) store, distribute or import drugs, health products and active pharmaceutical ingredients and are located in Brazil.
The Resolution amends existing rules by:
- Introducing an administrative procedure for granting GMP for food.
- Making mandatory the provision of certain information and reports by companies to support Anvisa’s decision-making regarding certification requests.
- Extending the validity of the GDP certificate from two to four years.
- Explicitly defining the situations in which certification requests may be dismissed.
- Disclosing, through Anvisa’s website, an establishment’s GMP status and the legal justification that motivated the final granting or refusal of a certificate.
Resolution RDC No. 497/2021 entered in force on 1 June 2021 (except the rule on disclosing an establishment’s GMP status which will enter in force within six months from publication of the Resolution). Requirements for certifications filed before 1 June 2021 will also follow the procedure introduced by the new Resolution.
COVID 19: CMED publishes rule on pricing for drugs and vaccines
By Kestener & Vieira Advogados
On 1 June 2021, the Drug Market Regulation Chamber (CMED) published Resolution No. 5/2021 (Portuguese language), regulating the procedure for determining the price of new COVID-19 drugs and vaccines. The Resolution is intended to address the public health emergency caused by COVID-19 and to fulfil the Ministry of Health’s national plan for rolling out vaccinations for the disease.
According to the Resolution, price information documents that refer to requests for pricing of new COVID-19 drugs and vaccines for registration purposes are categorised as an “omitted case” and must be analysed and decided on only by CMED’s Technical-Executive Committee.
As soon as the price information document for the pricing request has been filed with the CMED’s Executive Secretariat, the requesting pharmaceutical company can market the product at the proposed price, while awaiting CMED’s final decision.
Products with no registration and with temporary authorisation for emergency use under Law No. 13,979/2020 (Portuguese language) are not subject to CMED’s price analysis.
Anvisa releases new regulation on advanced therapy products
By Kestener & Vieira Advogados
On 31 May 2021, the National Health Surveillance Agency (Anvisa) published eight Normative Instructions and thirteen RDC Resolutions, in compliance with Decree No. 10,139/2019 (Portuguese language) which determines that the federal regulatory bodies must review and consolidate normative acts, to improve and simplify regulations and exclude any obsolete provisions.
Among other subjects, Anvisa reviewed the following Resolutions on advanced therapy products:
Advanced therapy products subject to registration are defined by the Resolutions as “new drugs that encompass advanced cellular therapy, engineered tissue products and gene therapy products”.
The Resolutions determine specific requirements for testing and obtaining MA for advanced therapy products and set forth some changes to the previous rules regarding document requirements. Both Resolutions enter into force on 1 July 2021.
“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”
