Beruflich Dokumente
Kultur Dokumente
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consultation before the end of the year. While the public consultation for
Module XVI has completed.
Be aware that GVP Module XIII incident management (unlucky for
some?) is now to be incorporated into GVP Module XII. The modular
format should make it easier to amend the documents on an on-going
basis as necessary. Indeed at least 2 modules have already been
amended, while revisions to several others are expected.
GVP Module I covers quality systems and includes, though is certainly
not limited to, the roles and responsibilities of the all-important EU
Qualified Person for Pharmacovigilance (QPPV). One thing worthy of note
is that he or she must now both live and work in the EU (or Norway,
Iceland or Liechtenstein), so working in Switzerland while living in France
or Germany is now no longer an option.
GVP Module II which has already been revised once, lays out the
concept of the Pharmacovigilance Systems Master File (PSMF). This
replaces the oft maligned Detailed Description of Pharmacovigilance
Systems. Only a summary of the PSMF is required to accompany
Marketing Authorisations (MA), though the PSMF must be available to the
competent authorities on request. Unlike its predecessor, changes to its
content are not automatically notifiable to the competent authorities. Be
aware however that the PSMF must be available to the competent
authorities on request (the default time period is within 7 days, but
immediate access may also be required!), so complacency is not
advisable. Indeed in large and/ or complex organisations keeping the
PSMF up to date is likely to require an entire team in itself.
GVP Modules III and IV (which were part of the second wave of
released modules), cover inspections and audits from the EU perspective.
For the uninitiated these are useful reference documents, covering pretty
much all one needs to know about these somewhat daunting activities.
GVP Module V covers Risk Management Planning (RMPs). Whats new
here? An RMP describing the risk-minimisation strategy has been
required for all new MA applications from July 2012. However, in certain
circumstances some modules may be omitted unless specifically requested
by the competent authority. In other words the RMPs should be
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