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Technical Advice
Scope
The procedure is intended to give applicants advice by answering questions connected with the requirements for demonstrating the suitability of the monograph for their substance, prior to or during the submission of an application for a new Certificate of Suitability (CEP), or for its subsequent revision or renewal. Advice may be requested for all substances. Questions can be of a technical nature, on matters concerning the content of an application or planning the submission of applications for complex or multiple changes.
The procedure
The applicant should submit the Technical Advice meeting form to the EDQM. Relevant documentation should either be attached or sent separately (no later than one month before the planned meeting). The request should be sent by regular mail or e-mail to: cep@edqm.eu. The EDQM may provide advice in writing, via telephone conferencing or at a meeting. The meeting is held at the premises of the EDQM and lasts generally one hour. During the meeting, notes are kept by the EDQM. Minutes from the applicant may be submitted to the EDQM.
Note: Obtaining technical advice does not replace the submission or assessment of a CEP application, or the granting of a CEP. It does not relieve the applicant from their responsibilities.
Fees
The fee for technical advice is 1,000 Euros. The fee should be paid upon receipt of the invoice. Applicants can pay online via the EDQM Online Store.
One-to-One meetings
Scope
The scope is similar to a technical advice meeting except that the meeting is organised during a conference or an exhibition.
The procedure
The applicant can register online or by sending the completed one-to-one registration meeting form to the EDQM at the latest one week before the event. The meeting lasts generally 15 to 30 minutes.
Fees
Payment is made according to specific instructions.
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5 & 19 June |
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3 July |
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11 & 25 September |
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9 & 23 October |
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6 & 20 November |
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4 December |
PAPHExpCEPT04274R: Technical Advice to Applicants of CEP (June 2007)
7 allée Kastner, CS 30026, F67081 Strasbourg, France - Tel. +33 (0)3 88 41 30 30 - Fax +33 (0)3 88 41 27 71
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