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Anvisa

New Codes for Authorization to Operate Companies (AFE) that operate in Related Products and Activities (PAF).

The alterations apply to applications to alter address and register a branch.

Requests for address alterations and branch registrations for companies holding Authorization to Operate (AFE) operating within the area of Ports, Airports, Borders and Customs Enclosures (PAF) now have new subject codes.

 

The purpose of this alteration was to segment the petitions associated with Customs enclosures (in accordance with RDC 346/2002) from the other companies providing services in PAFs (in accordance with RDCs 345/2002 and 61/2004).

 

The former subject codes, “9002 – PAF – Registration of a branch of a company holding an Authorization to Operate – Except Pharmacies and Drugstores” and “9006 – PAF – Alteration of address in AFE – Except Pharmacies and Drugstores”, previously used for any company operating in PAF, have been excluded.

 

The new subject codes are as follows:

 

  1. 90493 – PAF – Registration of a branch of a customs enclosure holding an operating permit for the storage of goods subject to health surveillance;
  2. 90494 – PAF – Registration of branch of company holding RDC 345/02 and RDC 61/04 Operating Authorization;
  3. 90495 – PAF – Alteration of address in AFE / Branch registration RDC 345/02 and RDC 61/04;
  4. 90485 – PAF – Alteration of address in the AFE/AE/Registration of a branch of a provider of storage services in customs enclosures.

 

The importance of rigorously following the protocol for all documentation is emphasized, as indicated in the specific checklist for each subject. Valid and verifiable digital signatures are required from the company’s legal representative, as stated in the Articles of Association, and the technical manager, using a certificate issued by certifying authorities acknowledged by the Brazilian Public Key Infrastructure (ICP/Brasil), as established in Article 10 of RDC 470/2021.

 

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