The pilot project ran for 18 months until August 2022. They will be also asked to provide feedback on challenges and limiting factors they face in ensuring the availability of their medicines in the EU. The pilot aims to help regulators understand why delays may occur in the marketing of certain medicines in EU Member States after they receive a marketing authorisation.ĮMA will invite marketing authorisation applicants to share this information via an online survey at the time of validation or when they receive the CHMP opinion. More information: Pre-authorisation guidance – section 2: Steps prior to submitting the applicationįrom 25 March 2021, marketing authorisation applicants for orphan medicines and medicines to treat cancer will be invited to take part in a pilot project by declaring their market launch intentions on a voluntary and confidential basis. When: 2-3 months before submission of marketing authorisation application 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. ![]() The subcategory to be selected is 'Pre-Submission Phase - Human', followed by the sub-option 'Notification of Change Request'. 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'. Re-confirmation of communicated submission dateĪpplicants should re-confirm the submission date initially communicated to EMA, or inform EMA of any delays or cancellations, following the guidance below: More information: Pre-authorisation guidance – section 2: Steps prior to submitting the application When: 7 months before submission of marketing authorisation application pre-submission request form (intent to submit MA).For further information or guidance about how to create an EMA Account reference the guidance ' Create an EMA Account'. If you do not have an EMA account, please create it via the EMA Account Management portal. The subcategory to be selected is 'Pre-Submission Phase - Human', followed by the sub-option 'Letter of Intent Request'. 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'. Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines.Notification of intention to submit an applicationĪpplicants should consider the date of submission carefully, referring to the published submission dates and the guidance below:
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