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both a type IA and type IB variation), please only raise a single query.
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please provide as much relevant information as possible, including the name of the product.To help the service deal with your query efficiently: It allows MAHs to receive specific regulatory guidance on planned applications and to discuss any pre-submission questions with an EMA procedure manager before submitting an application. The service aims to provide timely pre-submission guidance to facilitate the validation of these post-authorisation applications. Post-authorisation safety studies (PASS) for nationally authorised products
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Periodic safety update reports (PSURs) for nationally authorised products Select 'Question' / 'Post-authorisation queries' / 'Article 61(3) notification' Select 'Question' / 'Post-authorisation queries' / 'MAH transfer'Īrticle 61(3) notifications (labelling and package leaflet) Select ‘Question’ / ‘Post-authorisation queries’ / ‘ Type II variation (Non-clin/Clin/RMP scopes)' Type-II variations (clinical, non-clinical and risk management plan variations) Select 'Question' / 'Post-authorisation queries' / ' Variation IB A&B scopes' or ' Variation IB C scopes' Select 'Question' / 'Post-authorisation queries' / ' Variation IA' If you do not have one, you can create one via the EMA Account Management portal. You need an EMA account to use EMA Service Desk. Type-II variations: questions and answers: 'Who is my contact at the European Medicines Agency during a type II variation, including extension of indications?'ĮMA has a pre-submission queries service to respond to questions about specific post-authorisation procedures.EMA pre-authorisation guidance, section 5.1: 'What is the role of the EMA product team?' and 'Who is my contact at EMA during an application evaluation procedure?'.When the applicant corresponds with other members of the EMA product team, the Product Lead should always be copied on the correspondence.įor certain procedures (type IA and IB variations, type II variations, transfers of marketing authorisation and Article 61(3)notifications), EMA has a dedicated pre-submission queries service and will nominate a procedure manager upon receipt of those applications. They may contact the MAH directly to facilitate discussion on specific aspects of the evaluation.įor specific procedures (post-authorisation safety studies (PASS) and periodic safety update single assessments (PSUSA) for nationally authorised products (NAPs), the MAH should contact the Risk Management Specialist who works in close collaboration with the Product Lead. Other members of the product team may be involved during the evaluation as needed, depending on the type, scope and complexity of the application. You should contact the Product Lead for any questions regarding the evaluation procedure. The EMA Product Lead assigned to your product is the marketing authorisation holder's (MAH) primary contact point.
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