Technical advice meetings are intended to answer applicants questions related to the requirements for demonstrating the suitability of the monograph for their substance, prior to or during 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 in a telephone conference.
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. If the required documentation is not provided, your request cannot be accepted nor progressed.
Requests should be sent by regular mail or preferably by e-mail to: email@example.com. The meeting minutes shall be prepared by the applicant and submitted to the EDQM for approval. The fee for technical advice is 1,000 Euros.
These face-to-face discussions allow participants the opportunity to meet with DCEP 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.
Search for a list of granted CEPs, their type, the name of the substance, the full CEP number, the issue date and validity status, using the Certification Database (updated daily).