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Questionnaire for preparing a commercial proposal for variations to a medicinal product

Your company name

Trade name of the medicinal product

Dosage form

Dosage

Reference member state

In which concerned member state is the medicinal product registered?

Which variations need to be submitted?

In which states is the submission of variations planned?

Has an application for these variations been submitted previously?

Is there currently an active registration procedure for variations in any EAEU member state?

Do you need assistance in preparing the electronic dossier in XML format?

Do you need assistance in submitting the electronic dossier to the regulatory authority of the reference member state?

Do you need assistance in submitting the electronic dossier to the regulatory authority of the concerned member state?

Desired deadline for document preparation

Additional conditions and requests

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