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AsphaNews 3: October 2013

We are excited to present the new issue of our newsletter: ASPHAnews

We are excited to present the new issue of our newsletter: ASPHAnews
November 4, 2013

Asphalion Munich Office

Asphalion has taken a big step in order to be closer to their customers in Central Europe, by opening ASPHALION MUNICH OFFICE.

Since its establishment in 2000, many companies throughout
Europe have chosen Asphalion as a reliable partner for a wide range of
regulatory affairs services.

Now in 2013, Asphalion has taken a big step in order to be
closer to their customers in Central Europe, by opening Asphalion Munich

This branch office will accelerate Asphalion’s
internationalization, both in terms of services and clientele, and
provide additional physical and creative space for Asphalion’s steadily
growing team of experts.

Munich is located in the very heart of Europe and is the ideal
base to support companies with the whole variety of Asphalion’s
services. Some of the specific strengths of the combination Asphalion
Barcelona – Asphalion Munich are:

  • Competitive pricing for on-going collaborations in product maintenance
  • Local support in Spain
  • Regulatory procedures in South America through Asphalion’s established network AsphaLatam
  • Expert-support for all FDA procedures (facilitated in corporation with Asphalion’s US Agent)
  • High-quality eSubmission services
  • Specific expertise in advanced therapies and biologicals

…all in combination with local support and project management in Germany.

For more information, please contact:
Michael Schaub
– Director Munich Office
T +49 (0)89 921 314 230
M +49 (0)151 727 023 83

Asphalion Munich Office
Destouchesstrasse 68, of. 166
D-80796 München, Germany

FDA finalizes new system to identify medical devices

The U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.

The UDI system has the potential to improve the quality of
information in medical device adverse events reports, which will help
the FDA identify product problems more quickly, better target recalls,
and improve patient safety. The FDA has worked closely with industry,
the clinical community and patient and consumer groups in the
development of this rule.

The UDI system consists of two core items. The first is a unique
number assigned by the device manufacturer to the version or model of a
device, called a unique device identifier. This identifier will also
include production-specific information such as the product?s lot or
batch number, expiration date, and manufacturing date when that
information appears on the label.

The second component is a publicly searchable database
administered by the FDA, called the Global Unique Device Identification
Database (GUDID) that will serve as a reference catalogue for every
device with an identifier. No identifying patient information will be
stored in this device information center.

The FDA plans to phase in the UDI system, focusing first on
high-risk medical devices. Many low-risk devices will be exempt from
some or all of the requirements in the final rule.

This topic is also being evaluated within the European Union to be incorporated in the new legislation of medical devices

Portugal introduces mandatory use of national portal

From August, 5th 2013 all types of national and MR/DC
variation applications (Type IA, IAIN, IB, II, grouped applications and
worksharing procedures) should be submitted only via Infarmed’s electronic portal for management of medicinal products for human use (SMUH) in
particular, SMUH-ALTER for submission of variations to existing
marketing authorisations.

Applications delivered to Infarmed in paper/CD format will only be considered after online submission.
Applications for Transfer of MAH and Notifications in accordance
with article 61(3) of Directive 2003/81/EC as amended (corresponding to
No. 4 of article 31st of Decree Law No. 176/2006, from August 30th,
republished by the Decree Law No. 20/2013, from February 14th), are
outside of the scope of this portal and should continue to be submitted
in accordance with the current requirements.

If you have any question about the registration process, or need
support for submitting your applications through the portal, please
contact us at

Highlights of the New Real Decreto RD 577/2013 on Pharmacovigilance

The New Real Decreto RD 577/2013 on Pharmacovigilance was published on 27th July 2013.

This legal text contains specific measures on Local contact in
Spain, PSURs handling, Risk Management Plans, Suspected Adverse
Reactions and PAS.

Local contact: The MAH must have permanently and continuously available in Spain a contact person for pharmacovigilance Maintained,
and must communicate to AEMPS the contact details through an electronic
system provided for this purpose. MAH must communicate this information
the CA of the Autonomous Communities.

Periodic safety update reports (PSURs): The Submission of PSURs should be electronically using the enabled application for the time being New (

Risk Management Plans (RMPs):

The RMP should be presented to AEMPS together with a summary in Spanish, according to the established format. New

Suspected adverse reactions: Until
functionality of Eudravigilance (EV), the MAH will send information
electronically to Fedra (Spanish database) and AEMPS will forward it to


  • Suspected serious adverse reactions which are known to
    the MAH, which occurred outside the EU should be sent electronically to
    EV by the MAH. New
  • Include the autonomous community information when reporting suspected adverse reactions. Maintained
  • Report suspected adverse drug reactions for medicines in clinical research obtained through compassionate use. New
  • Include in the notification of suspected
    adverse reactions the exposure as a descriptive and integrated Spanish
    text exactly as it was notified, and a summary in English. Maintained

Post-authorisation studies: In some circumstances, the autonomous communities will evaluate
those applications of prospective post-authorization studies. A system
of mutual recognition between the regions will be established. New

Please contact us in case any question arises at

Survey to stakeholders by Heads of Medicines Agencies for the e-Submission roadmap

An e-Submission roadmap is currently being drafted by the
Heads of Medicines Agencies to progress the use of electronic
submissions for both Human and Veterinary Medicinal product submission
across Europe.

The industry survey consists of three topic areas:

1. eSubmissions
2. Electronic Application Forms
3. Single Submission Platform.

To gather as much feedback from stakeholders to draft a
roadmap that meets both industry and agency needs over the next few
years, the HMA is trying to contact as many stakeholders and request
them to complete the questionnaire.

The survey will close on the 31st October 2013.

Link to the questionnaire

For more information, please contact our expert Remco Munnik, Regulatory Information Director

Last June, the team held its annual outing and visited Tarragona.

Upcoming Events

16 – 18 October
TOPRA Symposium
Lisbon, Portugal

22 – 24 October
Frankfurt, Germany

4 – 6 November
Vienna, Austria

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