Last week’s round-up;
27 -31 July 2020

published 3 Aug 2020

Country-specific requirements update for MRP/DCP variations and/or renewals

The CMDh has revised its “Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/ Recommendation papers” document. Croatia has now been removed from the list, which indicates that Croatia does not have any country-specific requirements for Variations and/or Renewal Applications related to the MRP/DCP.

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Revision of Ph.Eur.  Sieve Test

A revised Ph. Eur. Chapter 2.9.12 Sieve Test has been published in Pharmeuropa 32.4. The chapter was revised in response to comments received to a previous proposed revision of the chapter that was released in Pharmeuropa 20.4 and 22.4. The chapter was previously revised to adapt it to the newer harmonized general chapter 2.9.35 Powder fineness, which provides a classification of powders according to their degree of fineness.

EDQM Clarification on revision of CEP applications

The EDQM has issued some clarifications on the revised ‘Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia Monographs’, which was introduced in January 2019. In the announcement the EDQM provides clarifications on several situations involving the revision/renewals of CEPs, including:

· When a new substantially different route of synthesis is introduced.

· Where different grades of material with different specifications are involved.

· Misclassification of minor/major revisions by CEP holders.

EMA requirements for the qualification and validation of computerised systems for CT data.

EMA published a notice for clinical trial sponsors to highlight the requirements for the qualification and validation of computerised systems used for managing clinical trial data. This is based on inspection findings and based on the implications on the integrity, reliability, robustness and acceptability of data in future MAAs.

EMA has also updated associated questions 8 and 9 on their Q&A, which can be found here:

CMDh Q&A – QP Declaration Update

The CMDh has revised its QP Declaration Q&A guidance. The document includes an update to guidance on QP declaration requirements in situations where a CEP or ASMF has two manufacturing sites but the MAH just wishes to approve one of the sites.

The updated document with tracked changes may be viewed at the following link:


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