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US EU Mutual Recognition Agreement Pharmaceutical Quality Congress June 16, 2017Presentation and Panel DiscussionPANEL I. Howard Lambert, Esq., Principal, Lambert Strategies LLC FDA, 20102017 o Last
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01
Begin by identifying which sector or industry your business operates in that is covered by the US-EU Mutual Recognition Agreement.
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Research and familiarize yourself with the specific requirements and procedures for obtaining mutual recognition within that sector.
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Ensure that your business meets all the necessary eligibility criteria and qualifications specified by the agreement.
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Gather all the required documentation and information needed to support your application for mutual recognition.
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Fill out the application form accurately and provide detailed information regarding your business operations, products, and compliance with relevant regulations.
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Submit the completed application along with all the supporting documents to the designated authority or regulatory body responsible for processing mutual recognition applications.
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Pay any applicable fees or charges associated with the application process.
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Await the review and evaluation of your application by the regulatory body.
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Comply with any additional requests for information or clarification that may arise during the application review process.
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If your application is approved, ensure ongoing compliance with the agreed-upon standards and requirements outlined in the Mutual Recognition Agreement.

Who needs us eu mutual recognition?

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Companies or businesses operating in sectors that are covered by the US-EU Mutual Recognition Agreement.
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Businesses looking to expand their operations or export products between the United States and the European Union.
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Regulatory bodies or authorities responsible for overseeing and enforcing compliance within specific sectors covered by the agreement.
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Consumers who rely on the safety and quality standards established through mutual recognition for products and services imported from the United States or European Union.

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