Recently, Anvisa announced that it identified the need to include and change the subject codes for the Import Licensing petition, through the Request System, originating from the registration of LPCO – Licenses, Permissions, Certificates and Other Documents, in the Single Foreign Trade Portal, TA/LPCO module. After continuous monitoring of the Contingency Plan, this measure proved necessary because of the analysis.
What is the Contingency Plan?
The Contingency Plan started on December 20, 2021, on an emergency basis for requesting import licensing. The measure was necessary thanks to the intermittent and recurring unavailability of the Electronic Import Petition (PEI). Therefore, the continuity of the import process of products of interest to health was ensured. According to Anvisa, these failures occur in the petition and in the processing, generating files without them reaching the responsible technical area for consent.
What changed in the codes?
Regarding the changes, there is, as an example, subject code 90352, which corresponded to code 9566 of the Electronic Import Petition (PEI), and had its text changed also to include the replacement of subject 9563. In this same context, subject code 90422 was included to allow import petition corresponding to PEI subject 9907.
Thus, the other changes and additions were made to break down the subjects corresponding to the PEI codes 90105, 90106 and 90153, and depending on the imported substance, there are different analysis flows. Note what the changes were:
PEI subject Petition type LPCO subject
90105 Primary 90408
Description of the petition subject
Consent to Import a chemical or environmental reference standard containing substance from procedure 1 or 1A by legal entity.
90105 Primary 90423
Consent to Import a reference standard of a chemical or environmental nature containing a substance of the procedure 3by a legal entity.
90106 Primary 90409
Consent of Importation of drug samples under Clinical Research containing substance of procedure 1 or 1A.
90106 Primary 90424
Consent for Importation of drug samples under clinical research containing substance of the procedure 3.
90153 Primary 90419
Import consent for drugs and substances subject to special control, part of procedure 1 and 1A not regularized at Anvisa, by institutions that are part of SUS, linked to mandatory compliance.
90153 Primary 90223
Consent for the importation of products derived from Cannabis by institutions that are part of the SUS, linked to the obligation to comply with legal action. These changes were added to the other guidelines and those of the petition, according to the Contingency Plan. To access this document, click here. Still on this subject, Anvisa warns that the PEI must make the petition under the terms of this Contingency Plan exclusively for cases in which it is not possible to file a regular petition. Another important point is that the process must start and end in the same petition system, making it impossible to start it in one system and continue in another. Petitioning in both systems should also be avoided, as it increases the time for approving petitions.
To learn more about the regulation of import and export processes, contact Licempre. We are prepared to offer you the best service in regulation and bureaucracy with the competent bodies.