FAQ  1 – What is the Brazilian Good Manufacturing Practices (BGMP) Certificate? Who does the BGMP Certificate apply to?  BRISA ADVISORS: The Brazilian Good Manufacturing Practices Certificate is the document issued by ANVISA attesting that a given establishment complies with Good Manufacturing Practices. The Certificate is issued per manufacturing unit, covering the production lines, pharmaceutical forms, special therapeutic classes and/or risk classes of products for which the company was inspected, and applies to companies manufacturing Medicines, Health Products, Cosmetics, Perfumes, Personal Hygiene Products and Pharmaceutical Supplies located in the national territory, in Mercosur or in other countries, as defined in specific norms.  2 – What ANVISA norm regulates the BGMP Certificate for products subject to sanitary surveillance?  BRISA ADVISORS: RDC No 665/2022: Consolidates the technical regulation  of Good Manufacturing Practices and Distribution and Storage of medical products and products for in vitro diagnosis.  RDC No 687/2022: Provides the criteria for granting or renewing of BGMP Certificate for Medical Devices.  The norm that regulates the GMP and Distribution and/or Storage Certificate is RDC No 497/2021. This resolution aims to establish administrative procedures for granting GMP Certificate for Medicines, Health Products, Cosmetics, Perfumes, Personal Hygiene Products, Sanitizing Products, Active Pharmaceutical Inputs and Food and also the Good Distribution and/or Storage Practices of Medicines, Health Products and Active Pharmaceutical Inputs.  3 – Is the Brazilian Good Manufacturing Practices Certificate mandatory for the operation of a company?  BRISA ADVISORS: It depends. Companies manufacturing products subject to sanitary surveillance must, obligatorily, comply with Good Practices, following the practices and procedures established in specific ANVISA rules.   If the company is manufacturing medical devices classified in class III or IV, the BGMP Certificate is mandatory  4 – What is the validity of a BGMP Certificate?  BRISA ADVISORS: The Brazilian Good Manufacturing Practices Certificate will be valid for two years, counting from the date of its publication in the Federal Official Gazette (DOU).  5 – What are the procedures adopted for granting the Certificate?  BRISA ADVISORS:  NACIONAL CERTIFICATE  In the case of national companies, the inspection is carried out by the Health Surveillance Offices of the States, Municipalities or Federal District.  1st STEP – Upon receiving the certification request, ANVISA’s technical area will consult the internal database to verify if there is a recent inspection carried out for that company.  2nd STEP – If no inspection is planned, the Agency sends an official letter to the Health Surveillance Office requesting an inspection.  3rd STEP – After the letter arrives at the local Health Surveillance, it will be up to it, according to its schedule and planning, to define the date of the inspection.  4th STEP – For the Certification, technical items from all sectors of the companies are evaluated. In the case of manufactures, for example, the warehouse, utilities (water and air systems, etc.), production, quality control, quality assurance, among other points addressed in the specific norms published by ANVISA, area analyzed.  5th STEP – Generally, the inspection team meets at the end of the inspection to consolidate the information and observations to support the preparation of the inspection report and conclusion regarding the inspection result.  6th STEP – After reaching a consensus, the report is delivered to the company, either at the inspected company or at the Health Surveillance, depending on local procedures.  7th STEP – Health Surveillance will send the inspection report to ANVISA according to its own procedures and schedules. The report is then evaluated by the Agency to support the analysis of the Certification petition.  ‘’ANVISA recommends that the interested party contact Health Surveillance, which will carry out the inspection in order to speed it up, informing: details of the company to be inspected; file number of the certification request at ANVISA; and lines, pharmaceutical forms, special therapeutic classes and/or risk classes of the products to be inspected.’’  MERCOSUR  In the case of companies headquartered in Mercosur countries that wish to sell medicines, biological inputs or health products in Brazil, the inspection is carried out only as a last resort, as there is a cooperation agreement in which the authorities exchange reports to be evaluated. If in doubt, questions are asked. If not answered, they are reiterated. Thus, only as a last resort is a joint inspection carried out with the health authority of the country where the manufacturer is headquartered.   Despite the exchange of information and reports between Mercosur member countries, there is no mutual recognition of certificates.  INTERNATIONAL  1st STEP – Upon receiving the certification request, ANVISA will analyze the requested documents, verifying if the documentation is sufficient to allow planning the inspection.  2nd STEP – If so, the inspection is scheduled. Otherwise, companies requesting inspection are required.  3rd STEP – Once the inspection can be carried out, a date for the inspection is negotiated. After that, the responsible area at ANVISA will set up the schedule and start defining inspection teams, usually composed of two technicians. The composition of the team and the performance of the inspection must be approved by the Collegiate Board of ANVISA (Dicol).  4th STEP – Once the inspection is approved, the teams are summoned and the removal process begins, that is, flight planning, hotel reservations, among others. After the inspection is planned, the team heads to the country where the company to be inspected is located.  5th STEP – During the inspection, technical items from all sectors of the companies are evaluated. In the case of manufactures, for example, the warehouse, utilities (water and air systems, etc.), production, quality control, quality assurance, among other points addressed in the specific norms published by ANVISA, are analyzed.  6th STEP – After the inspection, the report is delivered to the requesting company after the inspection team returns to Brazil, with one of the following technical opinion:  I – Satisfactory, being forwarded to Certification;  II – On demand, the deadlines set forth in RDC No 497/2021 must be complied with; or  III – Unsatisfactory. In this case, imports may be interrupted (in the case of products already registered) or

Being the registration holder itself, or having a company specialized in hosting these registrations in markets where it operates is strategic for any manufacturer of Medical Devices. In Brazil, it is fundamental to have a competent and reliable company that can defend the manufacturer’s interests with ANVISA regarding regulatory issues. An eventual dispute of commercial interests between distributors and the manufacturer can result in the loss of ‘’marketshare’’ by having to stay months or even years off the market until registration are reestablished. Since 1995, acting as consultants in regulatory matters, we have seen it all. Companies that were expelled from competition by purchasing the distributor in Brazil who was the registration holder for the entire product line of their main competitor, commercial conflicts that resulted in the cancellation of registrations and also companies that act as registration holders, but are more bureaucratic than ANVISA and make the simple issuance of an import authorization letter a barrier to the commercialization of products. It is for these and other situations that changes the daily routine of foreign manufacturers in a real challenge that the BRISA ADVISORS group – through its host registration company BIHS – launched the service of Business Process Outsourcing-BPO – which includes a full service through a simple service subscription. It is the embodiment of the One-Stop Shop term, with the advantage of previsibility of the annual budget that the subscription club model provides. To promote these services, we will publish the main doubts of our clients regarding different topics, starting with transferring ownership of registrations that allows you to guarantee and maintain access to the market safely and quickly! Brazilian legislation allows registers to be transferred to another company for reasons of corporate operations such as merger, spin-off, incorporation or even for the sale of assets. RDC No. 102/2016 which deals with transferring ownership of products subject to Sanitary Surveillance regulated the commercial operation defined as ‘’operation between companies resulting in the sale of assets or group of assets, without the occurrence of any corporate operation between the companies involved.’’ For more information on the subject, visit our FAQ on the subject.