Como proceder diante do indeferimento da AFE/AE?

Atualmente é a resolução RDC 17/2013, da Anvisa, a norma que trata dos critérios para peticionamento de Autorização de Funcionamento (AFE) e de Autorização Especial (AE) de farmácias e drogarias, elencando diversos motivos de indeferimento dos pedidos de renovação da AFE/AE, como por exemplo:

  • A não apresentação da licença sanitária ou relatório de inspeção emitidos pela vigilância sanitária local do ano corrente;
  • O protocolo de petição antes de 180 dias ou depois de 60 dias anteriores à data de vencimento da AFE/AE, bem como o não pagamento da taxa da Anvisa em até 30 dias da emissão da GRU (Guia de Recolhimento da União).

Contudo, uma vez indeferido, o que pode a farmácia ou drogaria fazer? A resposta se encontra na própria RDC 17/2013, que apresenta três condutas a serem tomadas pelo agente regulado:

1) O pedido de retificação de publicação
2) O pedido de reconsideração
3) O recurso administrativo

1 – Pedido de retificação de publicação

O Pedido de retificação (art.16) pode ser apresentado em dois casos: quando o erro na publicação do Diário Oficial da União (D.O.U) foi causado pela ANVISA ou quando o erro se deu pela própria empresa – neste caso, haverá a incidência da cobrança de taxa.

2 – Pedido de reconsideração

O Pedido de reconsideração do indeferimento (art. 16) pode ser apresentado para tentar reverter a situação, solicitando que o próprio setor que indeferiu o pedido reanalise os fundamentos de tal rejeição. Deve-se apresentar uma justificativa objetiva e comprovar as alegações, juntando documentos virtualmente.

3 – Recurso administrativo

O recurso administrativo, na minha opinião o melhor a ser feito, possui fundamento no artigo 11 da resolução RDC 17/2013 e remete à Resolução 25/08.

Ele deve ser interposto no prazo de 10 dias das decisões oriundas de análises técnicas da Anvisa e será decidido não pelo próprio setor que deferiu a decisão de indeferimento (como ocorre com o pedido de reconsideração), mas pela Diretoria Colegiada da Anvisa, embora o setor responsável pelo indeferimento possa reconsiderar sua decisão no prazo de 05 dias.

Ao contrário do que ocorre com os pedidos de retificação de publicação e de reconsideração, em relação ao recurso administrativo a situação é mais confortável à empresa, na medida em que a Lei nº 9.782/99 diz claramente no parágrafo 2º de seu artigo 15 que “dos atos praticados pela Agência caberá recurso à Diretoria Colegiada, com efeito suspensivo, como última instância administrativa”.

Assim, enquanto pendente o julgamento do recurso administrativo, deve-se considerar o indeferimento da renovação da AFE/AE como inexistente – situação esta favorável ao estabelecimento farmacêutico.

Gustavo Semblano é advogado e consultor jurídico da ASCOFERJ (Associação do Comércio Farmacêutico do Estado do Rio de Janeiro) e da ANFARMAG -RJ (Associação Nacional de Farmacêuticos Magistrais do Estado do Rio de Janeiro). Atualmente, cursa a pós-graduação em Direito da Farmácia e do Medicamento na Faculdade de Direito de Coimbra (Portugal). 

Fonte: Guia da Farmácia



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