AsphaNews 4: January 2014

January 16, 2014

With this AsphaNews, we want to wish everyone a happy and prosperous 2014 and want
to share our optimism and ambition to collaborate
this year!




New national
requirements implemented in Spain

1. The Spanish Agency
published a clarification on the payment requirements of the annual maintenance
MAHs must update the application “Notifications on drug marketing” in
the electronic portal of AEMPS (new option “maintenance authorized
medicinal products” has been recently included).

Information on the proof
of payment of the “fee 1.09 – annual maintenance fee of approved
drugs” has to be included
(number of form for telematic
payments or proof of payment if payment has been performed from out of Spain).
For more information, please visit this link


2. The Spanish Agency
has implemented a new obligation for new registered products to enter the SmPC
and PIL fragmented in the local (RAEFAR) portal

From 18 November the second phase of the project was implemented. It allows
management of the SmPC and PIL in affecting texts after variations.

At IL3 conference, the Spanish Agency strongly recommended MAH´s to start
uploading the SmPC and PIL of their products in this tool.

For more information, please refer to this link or contact us.


3. The AEMPS reports that the extended term of 10 days to 3 months is maintained between the payment of the fee and filing service for European procedures, mutual recognition and decentralized (DCP / MRP), according to information note of the Ref SG 3/2013 issued on November 14, 2013.


CESP acceptance in EU

The Common European Sumission Platform (CESP) provides a simple
and secure mechanism for exchange of information between applicants and
regulatory agencies.

The purpose of the system is

  • Provide a secure method of communicating with the Regulatory
    Agencies via one platform
  • Allow submission of an application once to reach all
    required Agencies
  • Reduce the burden for both Industry and Regulators of
    submitting/handling applications on CD-ROM and DVD

National submissions
outside of the scope of eCTD in MRP/DCP
: In CMDh’s latest Q&A
, a new clarification has been provided.


Question 1.6: Could national submissions for an MRP dossier in eCTD format
be submitted “outside? the eCTD (i.e. not as an eCTD sequence)?

Answer: In the current and previous versions of CMDh guidance on eCTD in
MRP and DCP, it is stated that submissions concerning just one or a few of the
CMS should only be submitted as a sequence to that particular CMS(s).

This way of working can, however, often lead to problems in the lifecycle
management for MRP products. Therefore, it has been agreed that, beside national
translations, purely national submissions for the following specified
regulatory activities can be handled outside the eCTD:

  • MAH transfer
  • Change of local
  • Sunset Clause
  • Dose dispensing (dose
  • Change in prescription
  • Change of mock-up design


This also includes national notification procedures, since they are not
regular variations, but only concern the national handling of the already
approved MRP dossier.

National notifications for a pack size in a CMS, which is already included
in the core SmPC of the MRP

National notifications to remove/add an already approved indication, due to
patent usage in a CMS.

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