#edqm

[serresvoice]

Ανάκληση φαρμάκων από τον ΕΟΦ – «Συναγερμός» για καρκινογόνα ουσία

Ανάκληση φαρμάκων από τον ΕΟΦ – «Συναγερμός» για καρκινογόνα ουσία

Στην ανάκληση φαρμάκων προχώρησε ο ΕΟΦ, μετά και τις ενέργειες του ευρωπαϊκού οργανισμού EDQM που απέσυρε το πιστοποιητικό καταλληλότητας για τη δραστική ουσία βαλσαρτάνη, που παράγεται από το εργοστάσιο Zheijiang Tianyu Pharmaceutical Co Ltd (Κίνα).

Η επανεξέταση από τον Ευρωπαϊκό Οργανισμό Φαρμάκων της βαλσαρτάνης σε σχέση με το NDMA συνεχίζεται και ο Οργανισμός συνεργάζεται στενά με την…

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[luigiderosa]

EDQM publishes the final report of its Pharmaceutical Care Quality Indicators Project

EDQM publishes the final report of its Pharmaceutical Care Quality Indicators Project

The EDQM has just published the final report of its Pharmaceutical Care Quality Indicators Project.

The report presents the results of the multinational validation study aimed at validating 4 basic sets of indicators to assess the quality of pharmaceutical care in Europe. It also contains the data collection forms that were developed and used in the above validation study. This report will…

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[luigiderosa]

You could finally use CEP in Brazil

You could finally use CEP in Brazil

The European Directorate for the Quality of Medicines & HealthCare (EDQM) and ANVISA, the Health Surveillance Agency of Brazil, have signed a Memorandum of Understanding which lays the foundation for ANVISA to consider the use of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) for their evaluation of marketing authorisation applications (MAAs) for medicinal…

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[amcrasto]

New EDQM's Public Document informs about the Details required in a New CEP Application for already Referenced Substances

New EDQM’s Public Document informs about the Details required in a New CEP Application for already Referenced Substances

    A Policy Document recently published by the EDQM describes regulations for referencing already existing CEPs in an application for a new CEP. Read more about how the certificates of an intermediate or starting material have to be used in new applications for a CEP.

http://www.gmp-compliance.org/enews_05624_New-EDQM-s-Public-Document-informs-about-the-Details-required-in-a-New-CEP-Application…

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[amcrasto]

New EDQM's Public Document informs about the Details required in a New CEP Application for already Referenced Substances

New EDQM’s Public Document informs about the Details required in a New CEP Application for already Referenced Substances

  A Policy Document recently published by the EDQM describes regulations for referencing already existing CEPs in an application for a new CEP. Read more about how the certificates of an intermediate or starting material have to be used in new applications for a CEP.

click

http://www.gmp-compliance.org/enews_05624_New-EDQM-s-Public-Document-informs-about-the-Details-required-in-a-New-CEP-Applicat…

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[amcrasto]

EDQM's new Guideline on Electronic Submissions for CEP Applications

EDQM’s new Guideline on Electronic Submissions for CEP Applications

EDQM’s new Guideline on Electronic Submissions for CEP Applications

As of today (June, 1st 2016), the EDQM doesn’t accept any CEP application in paper format. Read more here about the structure of the electronic submission of an application for a Certificate of Suitability and the errors to avoid.

SEE

http://www.gmp-compliance.org/enews_05380_EDQM-s-new-Guideline-on-Electronic-Submissions-for-CE…

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[amcrasto]

EDQM's new Guideline on Electronic Submissions for CEP Applications

EDQM’s new Guideline on Electronic Submissions for CEP Applications

  EDQM’s new Guideline on Electronic Submissions for CEP Applications

As of today (June, 1st 2016), the EDQM doesn’t accept any CEP application in paper format. Read more here about the structure of the electronic submission of an application for a Certificate of Suitability and the errors to avoid.

SEE

http://www.gmp-compliance.org/enews_05380_EDQM-s-new-Guideline-on-Electronic-Submissions-for-…

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[amcrasto]

EDQM adopts revised monograph for WFI allowing non-destillation techniques

  In a press release the EDQM has announced that the new monograph draft on Water for Injection (169) had been adopted. Read on to learn more about the production of WFI with membrane systems.

http://www.gmp-compliance.org/enews_05274_EDQM-adopts-revised-monograph-for-WFI-allowing-non-destillation-techniques_15254,15160,15090,15267,Z-PEM_n.html

  In a press release, the European Pharmacopeia…

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