On May 28, RDC 390/2020 was published in Brazilian Federal Register (D.O.U), which establishes rules for the operation of analytical laboratories, the procedures for their qualification in Brazilian Network of Analytical Health Laboratories (REBLAS) and their accreditation for conducting guidance, control and fiscal analyzes on products subject to sanitary regulation.

Firstly, it is important to explain that this legislation aims at structuring a network of public and private laboratories that, together with official laboratories, can provide more effective tools for monitoring and inspecting the quality of products subject to health surveillance marketed in the country.

Check below the main points covered by the new legislation.

THE FUNCTIONING OF ANALYTICAL LABORATORIES

This topic cover technical and legal requirements for the operation of laboratories, with emphasis on:

• Self-assessment provided for in item IV, which may be carried out following the guide published by Anvisa for Elaboration of the Evaluation Report of Analytical Laboratories. Link: https://bit.ly/36lkvQr (updated 7th July)

• As to item VII, those laboratories that perform quality control tests (ECQ) as an inherent part of their licensed activities are considered regular and do not depend on a specific health license

• Service provider laboratories must be qualified at REBLAS to carry out quality control tests on finished products.

• All analytical laboratories covered by this resolution are subject to the obligation to transmit data from quality control tests to Anvisa via webservice. This obligation will be implemented gradually, so that products, terms and data will be defined in specific normative instructions.

Still on the transmission of analytical data, it is worth remembering that if the quality control analysis is carried out by a service provider laboratory, the data transmission can be done alternatively by the MAH.

QUALIFICATION IN THE BRAZILIAN NETWORK OF ANALYTICAL LABORATORIES IN HEALTH – REBLAS

The license is the act of Anvisa issued in favor of an analytical laboratory, which becomes part of REBLAS for a defined scope of product categories subject to health surveillance. Topic brings the documents to be filed for REBLAS qualification application, with emphasis on:

• Qualification at REBLAS has as its scope of action the following categories of finished products: Personal Hygiene Products, Cosmetics and Perfumes; Blood products; APIs; Medicines; Medical devices; Sanitizing; Vaccines; Food/Dietary Supplements and Cannabis Products.

ACCREDITATION

Permission for the laboratory to perform orientation, control – AC – and fiscal analyzes, which are configured in material acts that precede the sanitary action, that is, to delegate preparatory activity for the purposes of inspection and monitoring of the products subject to the sanitary surveillance by the National Sanitary Surveillance System (SNVS); Accreditation is the permission for the laboratory to carry out orientation, control and physical analysis, which are configured in material acts that precede the sanitary action. This topic brings the requirements and procedures for registration, with emphasis on:

• Analytical laboratories belonging to manufacturers, importers, fractionators and distributors are not eligible for accreditation.

• Accreditation has as scopes the following categories of finished products: Personal Hygiene Products, Cosmetics and Perfumes; Blood products; APIs; Medicines; Medical Devices; Sanitizing; Vaccines; Food/Dietary Supplements and Cannabis Products.

• Pharmaceutical Equivalence Centers (EQFAR) are automatically accredited for the categories of medicines and pharmaceutical supplies.

Note: does not apply to EQFAR belonging to MAH, manufacturers, importers, fractionators and distributors of medicines or APIs.

PUBLICATION, EFFECTIVENESS AND RENEWAL OF QUALIFICATION IN REBLAS AND ACCREDITATION

• The REBLAS qualification and accreditation are published in the D.O.U, valid for 4 years, except for EQFAR laboratories that fall under the criteria of automatic accreditation.

• Renewal protocol must be between 6 and 3 months from expiration.

This Resolution takes effect on August 3, 2020.

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