{"id":1639,"date":"2025-06-02T11:27:00","date_gmt":"2025-06-02T11:27:00","guid":{"rendered":"https:\/\/pharmilab.likealot.pt\/?p=1639"},"modified":"2025-07-14T10:04:35","modified_gmt":"2025-07-14T09:04:35","slug":"us-agent-vs-pessoa-responsavel","status":"publish","type":"post","link":"https:\/\/pharmilab.likealot.pt\/en\/2025\/06\/02\/us-agent-vs-pessoa-responsavel\/","title":{"rendered":"US Agent VS Responsible Person"},"content":{"rendered":"

Responsible Person<\/strong><\/p>\n\n\n\n

The Responsible Person may be the manufacturer, packer, or distributor of a cosmetic product whose name and address are listed on the label and is not required to be based in the U.S. Under MoCRA, it is mandatory to designate a Responsible Person for each cosmetic product marketed in the U.S., who is responsible for:<\/p>\n\n\n\n

\u2022 Listing each cosmetic product and making annual updates;<\/p>\n\n\n\n

\u2022 Reporting adverse effects associated with the use of the cosmetic product to the FDA and maintaining records of these reports;<\/p>\n\n\n\n

\u2022 Keeping records with product information that substantiates its safety;<\/p>\n\n\n\n

\u2022 Ensuring compliance with labeling requirements;<\/p>\n\n\n\n

\u2022 Ensuring cosmetic products comply with MoCRA requirements.<\/p>\n\n\n\n

When the Responsible Person is not based in the U.S., it is necessary to designate a U.S. Agent.<\/p>\n\n\n\n

U.S. Agent<\/strong><\/p>\n\n\n\n

The U.S. Agent is a person or legal entity residing in or having a place of business in the U.S., whose purpose is to serve as the legal representative in the U.S. for companies not based there. <\/p>\n\n\n\n

Their responsibilities differ from those of the Responsible Person and include:<\/p>\n\n\n\n

\u2022 Acting as the point of contact between the FDA and the foreign company;<\/p>\n\n\n\n

\u2022 Responding to FDA inquiries about products imported into the U.S.;<\/p>\n\n\n\n

\u2022 Assisting the FDA in scheduling inspections on the foreign company<\/p>\n\n\n\n

\u2022 Receiving information or documents from the FDA on behalf of the company when the FDA is unable to contact it directly.<\/p>\n\n\n\n

If you are not based in the U.S. and intend to export your cosmetic products, Pharmilab can act as your U.S. Agent and provide all the necessary support. Contact us for more information.<\/p>","protected":false},"excerpt":{"rendered":"

Pessoa Respons\u00e1vel A Pessoa Respons\u00e1vel pode ser o fabricante, embalador ou distribuidor de um produto cosm\u00e9tico cujo nome e endere\u00e7o constam no r\u00f3tulo, n\u00e3o sendo obrigat\u00f3rio estar sediado nos EUA. Ao abrigo do MoCRA, \u00e9 obrigat\u00f3rio designar uma Pessoa Respons\u00e1vel para cada produto cosm\u00e9tico colocado no mercado dos EUA, sendo esta respons\u00e1vel por: \u2022 Listar […]<\/p>","protected":false},"author":3,"featured_media":1640,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1639","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cosmeticos"],"_links":{"self":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/posts\/1639","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/comments?post=1639"}],"version-history":[{"count":1,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/posts\/1639\/revisions"}],"predecessor-version":[{"id":1641,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/posts\/1639\/revisions\/1641"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/media\/1640"}],"wp:attachment":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/media?parent=1639"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/categories?post=1639"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/tags?post=1639"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}