Anavex Life Sciences Corp (AVXL)

[Steady_T]

The EMA is setting the schedule. Anavex needs to have the MAA ready for whenever the EMA tells them that they will accept the MAA.

Notification of intention to submit an application
Applicants should consider the date of submission carefully, referring to the published submission dates and the guidance below:

Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines
Update: To notify the Agency of the intended submission date, applicants should send the pre-submission request form via EMA service desk, selecting the tab 'Business Services', category 'Human Regulatory'. The subcategory to be selected is 'Pre-Submission Phase - Human', followed by the sub-option 'Letter of Intent Request'.

If you do not have an EMA account, please create it via the EMA Account Management portal. For further information or guidance about how to create an EMA Account reference the guidance 'Create an EMA Account'.

Presubmission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application
When: 7 months before submission of marketing authorisation application

More information: Pre-authorisation guidance – section 2: Steps prior to submitting the application

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Appointment of rapporteurs
The Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC) appoints (co-)rapporteurs to conduct the scientific assessment.

For advanced therapy medicinal products, (co-)rapporteurs are also appointed from members of the Committee for Advanced Therapies (CAT), who will lead the assessment.

More information: Pre-authorisation guidance - section 2: Steps prior to submitting the application

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Pre-submission meetings (recommended)
Pre-submission meetings are the best opportunity for applicants to obtain procedural and regulatory advice from the Agency:

Marketing authorisation application (MAA) - pre-submission interactions form
Successful pre-submission meetings along with the information in the guidance should enable applicants to submit applications in line with legal and regulatory requirements. This speeds up the validation process.

When: 6 to 7 months before submission of marketing authorisation application

More information:Pre-authorisation guidance – section 2: Steps prior to submitting the application

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Re-confirmation of communicated submission date
Applicants should re-confirm the submission date initially communicated to EMA, or inform EMA of any delays or cancellations, following the guidance below:

Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines
Update: If the planned submission date is changed, applicants must inform EMA by re-sending the completed pre-submission request form, stating the new intended submission date in the corresponding field. It must be sent via EMA Service Desk, selecting the category 'Business Services' category 'Human Regulatory'. The subcategory to be selected is 'Pre-Submission Phase - Human', followed by the sub-option 'Notification of Change Request'.

If you do not have an EMA account, please create it via the EMA Account Management portal. For further information or guidance about how to create an EMA Account reference the guidance 'Create an EMA Account'.

Holding successful pre-submission meetings and following this guidance should enable applicants to submit applications in line with legal and regulatory requirements, speeding up the validation process.

When: 2-3 months before submission of marketing authorisation application

More information:Pre-authorisation guidance – section 2: Steps prior to submitting the application


Submission of the application
Submission of the application
Applicants should use the electronic common technical document (eCTD) format and submit the application through the eSubmission gateway or web client.

If EMA needs additional information to complete its validation of the application, it will ask the applicant to supply this by a deadline.

More information:

What is eSubmission?
Pre-authorisation guidance - section 4: Submission, valiadation and fees

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/obtaining-eu-marketing-authorisation-step-step