{"product_id":"mocra-serious-adverse-event-reporting-service","title":"MoCRA Serious Adverse Event Reporting Service","description":"\u003cp\u003eUnder MoCRA, the responsible person must report serious adverse events from US cosmetic use to FDA within 15 business days and keep records for 6 years. Our managed annual plan covers intake, triage and record keeping, from £2,250 a year for 1–10 products. Each serious event report on MedWatch Form 3500A is £450.\u003c\/p\u003e\u003ch2\u003eWhat is MoCRA adverse event reporting?\u003c\/h2\u003e\u003cp\u003e\u003cstrong\u003eMoCRA\u003c\/strong\u003e added \u003cstrong\u003esection 605\u003c\/strong\u003e to the \u003cstrong\u003eFD\u0026amp;C Act\u003c\/strong\u003e. The \u003cstrong\u003eresponsible person\u003c\/strong\u003e for a cosmetic must report any \u003cstrong\u003eserious adverse event\u003c\/strong\u003e associated with its use in the US to \u003cstrong\u003eFDA\u003c\/strong\u003e within \u003cstrong\u003e15 business days\u003c\/strong\u003e of receiving the report, usually on \u003cstrong\u003eMedWatch Form 3500A\u003c\/strong\u003e, and send any new medical information received within one year. Adverse event records must be kept for \u003cstrong\u003e6 years\u003c\/strong\u003e, or 3 years for small businesses. Small businesses are not exempt from this duty.\u003c\/p\u003e\u003ch3\u003eWhat's included in your adverse event service?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eIntake\u003c\/strong\u003e: Reports received at our US contact and logged\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTriage\u003c\/strong\u003e: Each report assessed against the MoCRA definition of a serious adverse event\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA report\u003c\/strong\u003e: Serious events reported on MedWatch Form 3500A within 15 business days (per-event fee)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFollow-up\u003c\/strong\u003e: New medical information received within a year sent to FDA\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecords\u003c\/strong\u003e: Adverse event records kept for 6 years\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this service for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands whose responsible person needs an adverse event process\u003c\/li\u003e\n\u003cli\u003eBrands using our US Responsible Person service\u003c\/li\u003e\n\u003cli\u003eUS brands without in-house regulatory staff\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this service not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eMedical advice or treatment.\u003c\/strong\u003e We do not advise consumers medically.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct recalls.\u003c\/strong\u003e Handled separately with you.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eLegal defence of claims.\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSerious event reports on the annual plan alone.\u003c\/strong\u003e Each FDA report is charged per event.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does MoCRA Serious Adverse Event Reporting Service work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSet up\u003c\/strong\u003e: We agree the intake contact and the information you must send us.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIntake\u003c\/strong\u003e: Reports are logged and triaged.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReport\u003c\/strong\u003e: If an event is serious, we prepare and file the MedWatch report within 15 business days.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecords\u003c\/strong\u003e: All reports are kept for 6 years.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch3\u003eWhat US law and FDA rules apply?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 605(a)\u003c\/strong\u003e — definition of serious adverse event\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 605(b)\u003c\/strong\u003e — report to FDA within 15 business days; new information within 1 year\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 605(e)\u003c\/strong\u003e — records kept for 6 years (3 for small businesses)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 612\u003c\/strong\u003e — the small business exemption does not cover adverse event reporting\u003c\/li\u003e\n\u003cli\u003eOfficial sources:\u003c\/li\u003e\n\u003cli\u003e[Modernization of Cosmetics Regulation Act of 2022 (FDA)](https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/modernization-cosmetics-regulation-act-2022-mocra)\u003c\/li\u003e\n\u003cli\u003e[Registration and Listing of Cosmetic Product Facilities and Products (FDA)](https:\/\/www.fda.gov\/cosmetics\/registration-listing-cosmetic-product-facilities-and-products)\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eRelated services\u003c\/h3\u003e\u003cp\u003eBrowse \u003ca href=\"\/fr\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/fr\/products\/us-responsible-person-for-cosmetics-12-months\"\u003eUS Responsible Person for Cosmetics (12 Months)\u003c\/a\u003e, \u003ca href=\"\/fr\/products\/us-cosmetic-safety-substantiation-file-mocra\"\u003eUS Cosmetic Safety Substantiation File (MoCRA)\u003c\/a\u003e, \u003ca href=\"\/fr\/products\/mocra-essentials-annual-package\"\u003eMoCRA Essentials Annual Package\u003c\/a\u003e.\u003c\/p\u003e\u003cp\u003ePrepared by \u003cstrong\u003ePhoenix Compliance Services\u003c\/strong\u003e and reviewed by \u003cstrong\u003e\u003ca href=\"https:\/\/www.linkedin.com\/in\/shamuelshees\" rel=\"author\"\u003eSyed Muhammad Shamuel Shees\u003c\/a\u003e, US Regulatory Lead\u003c\/strong\u003e, with US agent and responsible person roles provided by Phoenix Safety Consultants LLC (USA), a sister company of Phoenix Compliance Services. FDA fees are not included and are passed through where they apply.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Annual plan, 1–10 products","offer_id":67824691478605,"sku":null,"price":2250.0,"currency_code":"GBP","in_stock":true},{"title":"Annual plan, 11–25 products","offer_id":67824691511373,"sku":null,"price":2950.0,"currency_code":"GBP","in_stock":true},{"title":"Annual plan, 26–50 products","offer_id":67824691544141,"sku":null,"price":3950.0,"currency_code":"GBP","in_stock":true},{"title":"Annual plan, 51–100 products","offer_id":67824691576909,"sku":null,"price":4950.0,"currency_code":"GBP","in_stock":true},{"title":"Per serious event report","offer_id":67824342073421,"sku":null,"price":450.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/mocra-serious-adverse-event-reporting-service.webp?v=1793176385","url":"https:\/\/phoenixcosmeticsafety.com\/fr\/products\/mocra-serious-adverse-event-reporting-service","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}