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Technical Advice & One-to-One Meetings

Technical Advice Meetings

Technical advice meetings are intended to provide advice to applicants on questions related to the requirements for the submission of a new application for Certificate(s) of Suitability to the monographs of the European Pharmacopoeia (CEPs), or for their subsequent revision or renewal. Questions can be of a technical nature, on matters concerning the content of an application or on the submission of a revision application with complex or multiple changes.

Meetings last one hour and can take place on the EDQM’s premises or by a teleconference.

Technical advice meetings do not replace the submission and assessment processes for applications. They neither grant CEPs nor relieve applicants from their legal obligations.

Applicants should submit the Technical Advice Meeting Form. Remember to propose 2 or 3 dates for a meeting and to submit all the relevant documentation supporting the request. If the required documentation is not provided, the request cannot be accepted nor progressed.

Requests should be sent by e-mail to: cep@edqm.eu.

The fee for a technical advice meeting can be found in the document “Fees and inspection costs”.

The meeting minutes shall be prepared by the applicant and submitted to the EDQM for approval within one month after the meeting.

The advice provided during a technical advice meeting may not be considered valid if they are not implemented within 1 year after the date of the meeting, and the final acceptability will lie with the assessors who evaluate the application.

 

One-to-One Meetings

These face-to-face discussions allow participants the opportunity to meet with Certification of Substances Division staff, exchange points of views and help clarify unanswered questions. They usually take place during EDQM events such as conferences or exhibitions, rather than on the EDQM’s premises or by teleconference. One-to-one meetings generally last 15 to 30 minutes. They vary depending on the event. For more information, go to Events.

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