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Mutual Recognition Fair  Form

Mutual Recognition Fair Form

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Instructions and help about Mutual Recognition Fair

now we will thoroughly discuss main authorization and related procedures in a visit by the rules of granting marketing authorization and assessment of medicinal products for human use we will start with the mutual cognition procedure as it is the first procedure described in the rules within a mutual recognition procedure the common Authority of the reference member state should complete granting marketing authorization and assessment of the marketing authorization application dossier within 210 days within the first 14 days upon submission the competent authority should validate the dossier should any questions arise the competent authority will furnish the applicant with a notice to provide additional information or clarification applicants should respond to such notice within 90 days where the competent authority considered the application to the invalid having taken into account response provided by an applicant where the applicant doesn't respond in a timely manner the competent a

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