On May 11, 2020 Brazil’s ANVISA announces that the General Management of Drugs and Biological Products (GGMED) of Anvisa has a new flow for requesting and supplying copies of the registration process of drugs and active pharmaceutical ingredients (APIs). Henceforth, requests must be made through electronic petition, by means of subject codes. The objective of the measure is to provide greater agility to the fulfillment of requests, as well as to standardize the procedure.
Applicable Documents for Petition:
This measure applies to the following requests:
- clinical research
- registration and post-registration changes of generic, similar and new/innovative drugs
- safety and efficacy evaluation of new medicines
- registration and post-registration changes of specific, notified drugs, herbal medicines, dynamised drugs and medicinal gases
- registration and post-registration changes of biological drugs
- registration and post-registration changes of active pharmaceutical ingredients
Documents Required in the Petition:
- Digitalization of the power of attorney indicating that whoever issued it has powers before the company;
- Digitalization of the social contract with the last alteration or bylaws of the company;
- Digitalization of the Form for Request for Copies of processes signed, according to the Anvisa model. In this form it is essential that the applicant informs who is responsible for requesting the copy, as well as his/her e-mail (it must coincide with that of the power of attorney), ensuring that the information is made available to the authorized person.
GGMED Petition Evaluation Process:
After the evaluation of the request, an electronic letter will be sent to the company’s mailbox, informing about the approval or not of the copy request. In case of consent, a link will be provided to access the requested copies, as well as the appropriate instructions for access. The link will be available for 20 days from the sending of the letter.* It may be possible that GGMED may request additional information or clarification on the documentation submitted.
Total or partial dismissal may occur if the file contains confidential information. In such cases, access to the information is conditional upon proof of its legitimacy. In such cases, the applicant shall be informed of the possibility of appeal, time limits and conditions for your interposition.
In the event that access to copies is denied or the reasons for denial are not provided, the applicant may appeal within 10 (ten) days of being informed of the decision. The competent authority shall review the decision within five (5) days of its submission.
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.. To learn more, please contact us at email@example.com
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