Requisitos para Licencia Sanitaria: Qué es la Licencia Sanitaria, funciones de COFEPRIS y quiénes deben tramitarla

Todo producto consumido por los seres humanos tendrá un efecto en su organismo, favorable o desfavorable, y si no lo crees entonces a qué te parece que alude el dicho popular que reza que el pez muere por la boca.

Cuando se trata de sustancias determinadas como medicinas, drogas, sueros, vacunas, u otros medicamentos que llevan compuestos químicos determinados que pueden ocasionar severos daños al ser humano, es necesario que quien los fabrica y expide cuente con los permisos necesarios para llevar a cabo esta actividad.

Por la importancia que representa este tema te traemos los Requisitos para Licencia Sanitaria, además te explicamos cómo tramitar la licencia sanitaria, por qué y dónde.

ESTO ENCONTRARÁS AQUÍ

Requisitos para Licencia Sanitaria

  • Uno de los primeros requisitos para tramitar la licencia sanitaria es tener el título de propiedad del lugar en el que funcionará el negocio o en su defecto el contrato de arrendamiento del local, si es el caso.
  • Luego, ya podrá dirigirse a la Secretaria de Salud con los documentos necesarios, siempre que no haya restricciones por la pandemia de Covid-19 y amerite una cita previa llamando al teléfono de la institución o dirigiendo una misiva por la página web.

Las oficinas están en el Paseo de la Reforma #42, Colonia Centro o a los módulos en las sedes de las delegaciones del Distrito Federal y Central Abasto.

Requisitos para Licencia Sanitaria

La autoridad establecerá qué medidas de protección anti Covid-19 deben seguir los solicitantes.

Si la Secretaría de Salud suspende temporalmente  la emisión de licencias o acepta el trámite por vía online, probablemente tendrás que escanear los documentos que nombraremos a continuación y enviarlos.

Respecto a los papeles que se necesitan para tramitar, difieren según sea para el funcionamiento de un banco de órganos, un hospital o la instalación de una droguería, pero en general como mínimo son los siguientes:

  • Boleta o comprobante de cancelación de los derechos de licencia.
  • El acta constitutiva del negocio o empresa, razón social, y marca.
  • Un poder debidamente firmado y sellado por la Notaria Pública.
  • Fotocopia de documento de identidad del representante legal de la empresa.
  • La Constancia de inscripción en el SAT (Servicio de Administración Tributaria) de México.
  • El formato de autorización a llenar.
  • Una vez entregada la solicitud de licencia sanitaria, debe aguardar al menos 15 días hábiles para recibir o no la resolución.
  • Los datos serán evaluados por la COFEPRIS como una nueva solicitud o como un tipo de actualización de una licencia ya entregada.
  • Se hará una visita al lugar del negocio para verificar que cumple con las condiciones sanitarias y otras normativas y dependiendo del lugar en el que funcionará puede exigírsele el pago de algunos derechos determinados.
  • Finalmente se emite la resolución o veredicto positivo (aprobatorio) o negativo sobre la expedición de la licencia sanitaria.
  • La licencia sanitaria no tiene exactamente un carácter indefinido, sino que se mantiene sujeta a comprobación periódica en el ente oficial que la autorizó y que, verificará el cumplimiento de las condiciones impuestas al titular del negocio.
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¿Qué es la Licencia Sanitaria?

Una licencia sanitaria es una autorización emanada de la máxima autoridad sanitaria de un lugar o país para que un negocio, comercio o expendio pueda vender, comprar o fabricar total o parcialmente determinados productos de consumo humano, y por tanto entre en la categoría de riesgo.

Para emitir dicha autorización se tienen que cumplir ciertas condiciones de seguridad sanitaria en el sitio de elaboración e incluso cualquier modificación o cambio de lugar, amerita tramitar una nueva solicitud.

Con la orden sanitaria se podrán vender aquellos medicamentos o tratamientos como vacunas, sueros, plaguicidas, u otras sustancias de cierto riesgo para la salud; asimismo, llegar a funcionar como centro de salud, servicio de ambulancia terrestre, importar, exportar, almacenar, aplicar aditivos, entre otros, a elementos líquidos, sólidos, gaseosos, consumibles por personas.

¿Qué es COFEPRIS?

La abreviatura COPEFRIS quiere decir Comisión Federal para la Protección contra Riesgos Sanitarios, dependencia federal descentralizada, pero bajo la dependencia  del gobierno de México.

COFEPRIS

La COPEFRIS es la encargada de regular, controlar, coordinar y establecer la normativa general materia de salud pública.

Como cualquier otro organismo oficial, tiene demarcada sus funciones, entre las que resulta notable la de vigilar y regir todo lo que tiene que ver con la compra, venta y fabricación de sustancias de carácter médico o de salud general en el país.

En ello entran las clínicas, farmacias, droguerías, hospitales, servicios de ambulancia, exportación e importación de materia prima y aditivos, material de aseo, entre otros.

Funciones de COFEPRIS

Entre las funciones que tiene COFEPRIS cabe mencionar las siguientes:

  • En este momento tan dramático que vive México, su función principal es contribuir a implementar las medidas de protección ciudadana contra la pandemia de Covid-19.
  • Si es necesario, elaborará mapas de riesgo posible de contraer la pandemia, para información de los ciudadanos.
  • Evaluar los peligros que tienen para la salud, la venta y fabricación de sustancias sólidas, líquidas, o gaseosas de cualquier tipo que puedan dañar la salud y proponer lugares adecuados para su manipulación.
  • Proponer al Secretario de Salud la política sanitaria destinada a controlar la venta y fabricación de medicamentos en el país, su exportación o importación.
  • Regir el tema de la donación, banco de órganos y trasplantes de órganos, células humanas, tejidos y demás componentes así como alimentos y bebidas, productos de aseo, cosméticos, plaguicidas, tabaco, nutrientes vegetales o sustancias toxicas, productos biotecnológicos, materias primas, suplementos alimenticios, aditivos, entre otros.
  • Prevenir y controlar los efectos nocivos derivados de factores ambientales sea de tipo ocupacional o de salubridad pública.
  • Suspender temporalmente la emisión de licencias o establecer las modalidades alternativas de trámite de las mismas, incluyendo la vía online, las medidas para presentarse en oficinas, entre otras, dadas las condiciones de riesgo por Covid-19 en México.
  • Vigilar, controlar, y expedir la normativa oficial para el funcionamiento de los establecimientos o negocios destinados a la compra venta de los productos antes nombrados.
  • Establecer los pagos o aranceles que deben pagar los comercios dedicados a la compra venta de productos antes señalados, según su tipo, categoría o nivel de riesgo.
  • Examinar, vigilas, y controlar la Publicidad de los establecimientos que expenden estos productos, su contenido, servicios y calidad de los mismos, según lo que establezca la ley y disposiciones oficiales. trasplantes de los órganos y sus tejidos.
  • Imponer las sanciones a que dé lugar la violación de algunas disposiciones oficiales e imponer las medidas de seguridad de su competencia.
  • Mantenerse al día en materia de sanidad y salud internacional emanadas de las autoridades mundiales como la OMDS u otras derivadas de convenios con el gobierno de México.
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¿Quiénes deben tramitar la Licencia Sanitaria?

La Licencia Sanitaria tiene que ser tramitada por distintas empresas, entre ellas: droguerías,  farmacias, proveedurías de medicamentos, botiquines de Emergencia, centros de salud como clínicas, consultorios, tiendas de Estética, centros de Nutrición, centros odontológicos,  hospitales, servicios de ambulancias terrestres.

QUIENES DEBEN TRAMITAR LA LICENCIA SANITARIA

Entran también en esta línea los  fabricantes de sueros, vacunas, nutrientes vegetales, medicamentos naturistas,  plaguicidas, sustancias tóxicas o de sumo riesgo para la salud,  entre otras.

Importante que tengas en consideración que deben tramitar la Licencia Sanitaria “todos aquellos que producen, procesan o venden productos para consumo y/o uso humano”.

Costos de una Licencia Sanitaria

El costo dependerá del tipo de negocio, pues cada uno conlleva a determinadas diligencias y nivel de permisología.

Al gestionar la licencia por primera vez, por ejemplo, para una droguería o farmacia,  muy probablemente tendrá que derogar un estimado de 1.285 pesos o más. Y tal cantidad disminuirá cuando se trate de renovarla  y oscilará en unos 964 pesos.

En cambio cuando se trata de centros médicos en los que se efectúan operaciones, entonces puede alcanzar un monto estimado de 18.772 pesos la primera vez, y la renovación puede llegar a pagos de 14.079 pesos.

¿Qué podemos decirte al final? Que mantengas las medidas de protección anti Covid-19. Asimismo, entérate de las disposiciones emanadas por el gobierno a través de las autoridades de salud.

Ahora sí terminamos; no queda más que invitarte a seguir con nosotros para que realices la búsqueda de todos los temas de tú interés.

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