New Applications

Content of the Dossier

Chemical Purity and Microbiological Quality

The Quality Overall Summary (QOS) should discuss the ability of the European Pharmacopoeia monograph to control the quality of the active substance and in particular the declared potential impurities or the need for alternative methods. The purpose of the QOS is to provide the assessor with a summary of the content of the dossier.
Please refer to the 'Content of the dossier for chemical purity and microbiological quality (PA/PH/CEP 04 1 4R)' for more detailed information.

TSE Risk Assessment

An applicant can apply for a CEP for all material(s) derived from animals which are susceptible to the transmission of TSE agents, as described in general chapter 5.2.8 of the European Pharmacopoeia which is verbatim the EMEA Notes for Guidance on 'Minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products'. The certification procedure requires the presentation of a dossier as described in 'Content of a dossier for a substance for TSE risk assessment (PA/PH/CEP (06) 2)'.

Herbal Drugs and Herbal Drug Preparations

The certification procedure requires the presentation of a dossier as described in 'Content of the dossier for herbal drugs and herbal drugs preparation quality evaluation (PA/PH/CEP 026)'.

Sterile Substances

An applicant can apply for a CEP for a sterile active ingredient. The certification procedure requires the presentation of a dossier as described in 'Certificates of suitability for sterile active substances (PA/PH/Exp. CEP/T (06) 13, 1R)'. This applies also for CEPs which have already been granted with the subtitle "sterile" and for which the validation of the sterilisation process has not yet been assessed.  An additional fee will be applied in all cases and the manufacturing site will be inspected before or after granting of the CEP (at the latest 18 months after granting the CEP).

Submitting a New Application

Applicants are encouraged to submit electronic versions of their applications, in addition to paper copies.  This will allow a better and more efficient management of the applications. For more information, please click HERE.

The applicant should send the following documentation to the EDQM:

•   a complete application form (preferably in English) including the fee form,
•   a single copy of a dossier in CTD format, and
•   a single copy of the Quality Overall Summary (QOS) in Word format.
  

For CEP on chemical purity and microbiological quality evaluation, detailed information on the manufacturing method of the substance and the impurities that are associated with it so that the reference to the corresponding European Pharmacopoeia monograph can be validated.

For CEP on TSE evaluation, information on the source of animals and tissues used, manufacturing method, traceability and quality system in force.

The application is sent to the Certification Division of the EDQM.  It is validated and listed for assessment.  After it is assessed, the EDQM may send queries to the applicant. When the queries have been resolved, the EDQM sends the applicant a CEP.

Submission of electronic documentation for applications for CEPs

Applicants are encouraged to submit electronic versions of their applications, in addition to paper copies.  This will allow a better and more efficient management of the applications. For more information, click HERE.

New policy for mentioning manufacturing sites on CEPs

The policy concerning the manufacturing sites mentioned on the CEPs was changed in 2007 and applies to new and revised CEPs. For more information about this policy click HERE.