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Requirements of EU
pharmacovigilance
legislation for
distributors
Version 03
Julia Sipos
Quality Management Director
Pharmacovigilance coordinator
Pharmacovigilance
Science and activities relating to the detection,
assessment, understanding and prevention of
adverse effects or any other medicine-related
problem
(Guideline on good pharmacovigilance practices –GVP - Annex I –
Definitions)
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Objectives
Today’s work supports tomorrow’s safety
 Pharmacovigilance activities provide
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more information on the pharmaceuticals as
• during clinical investigations limited information can be gained
• some impacts may become known in long term only
• real environment of use may be different from that of the
clinical investigation
free flow of and access to information on pharmaceutical safety
room for necessary measures to be taken by MAH
useful information to required risk assessment
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Tools and scope
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Tools to achieve the objectives
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continuous collection all available information
share the information gained: report adverse events to the EU
database (according to law)
Scope
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Distributed pharmaceuticals where Institute of Isotopes is the
MAH
(however other MAHs can have similar requirements)
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Definitions

Signal
Science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other
medicine-related problem

Adverse event (AE)
Any untoward medical occurrence in a patient or clinical trial subject
administered a medicinal product and which does not necessarily
have a causal relationship with this treatment
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Definitions
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Adverse (drug) reaction (ADR)
A response to a medicinal product which is noxious and unintended
Response in this context means that a causal relationship between a
medicinal product and an adverse event is at least a reasonable
possibility
Adverse reactions may arise from use of the product within or outside
the terms of the marketing authorisation or from occupational
exposure. Conditions of use outside the marketing authorisation
include off-label use, overdose, misuse, abuse and medication errors.
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Definitions
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Serious adverse event (SAE)
An adverse reaction which results in death, is life-threatening,
requires in-patient hospitalisation or prolongation of existing
hospitalisation, results in persistent or significant disability or
incapacity, or is a congenital anomaly/birth defect.
Life-threatening in this context refers to a reaction in which the
patient was at risk of death at the time of the reaction; it does not
refer to a reaction that hypothetically might have caused death if
more severe.
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Abbreviations
MAH: Marketing Authorization Holder – in this case:
Institute of Isotopes
 QPPV: Qualified person for pharmacovigilance
 SDEA: Safety Data Exchange Agreement
 CIOMS (form): Council for International Organizations of
Medical Sciences - form for Suspect adverse event report
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Types of adverse events
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Diagram shows the relationships of adverse events, serious
adverse events that can be unexpected and drug related
 Yellow part shows cases to be reported to the EU database
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The legal framework of pharmacovigilance for
medicines marketed within the EU/1.
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Basic
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Regulation (EC) No 726/2004 with respect to centrally authorised
medicinal products
(laying down own Community procedures for the authorisation
and supervision of medicinal products for human and veterinary
use and establishing a European Medicines Agency)
Directive 2001/83/EC with respect to nationally authorised
medicinal products (including those authorised through the mutual
recognition and decentralised systems)
(on the Community code relating to medicinal products for human
use)
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The legal framework of pharmacovigilance for
medicines marketed within the EU/2.
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Additional
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Commission Implementing Regulation (EU) No
520/2012 includes details in relation to certain aspects of
pharmacovigilance to be respected by marketing authorisation
holders, national competent authorities and EMA
(on the performance of pharmacovigilance activities provided for
in Regulation (EC) No 726/2004 of the European Parliament and
of the Council and Directive 2001/83/EC of the European
Parliament and of the Council)
Good pharmacovigilance practice guidelines(GVP) released by
EMA in order to facilitate the performance of pharmacovigilance
activities. (These GVP modules replace Volume 9A)
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The legal framework of pharmacovigilance for
medicines marketed in 3rd country.
-2001/83 The MAH shall strive to collect any safety information from 3rd
countires (out of EU Community Territory and inform the relevant
Agencies, stakeholders accordingly.
Legal background:
EC. (Art 104, paragraph 1 and 4)
- (EC) No 726/2004
– Good pharmacovigilance practice guidelines(GVP) released by EMA in
order to facilitate the performance of pharmacovigilance activities.
(These GVP modules replace Volume 9A)
– If regional or local regulations conflict with international guidelines, the
stakeholders should follow a conservative approach (i.e., the aim is to be
able to comply with the strictest regulation).
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Requirements for distributors/1.

To be familiar with relevant requirements of EU legislation
on pharmacovigilance
 To be familiar with their national legislation on
pharmacovigilance
 Share with MAHs the following information as a
minimum:
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national requirements for pharmacovigilance
– access data of person responsible for receiving all incoming
information on drug safety (adverse reactions): name, e-mail,
phone number, address.
Any changes in these data shall be reported immediately to the
MAH’s QPPV.
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Requirements for distributors/2
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Conclude a SDEA with the MAHs – covering in detail all
co-operation
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activities
– tasks and
– responsibilities
of the parties in terms of pharmacovigilance
 Continuous screening of domestic professional literature for
any safety issues of the distributed pharmaceuticals – report
any signals to MAHs
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Requirements for distributors/3
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Encourage their partners (health institutions and/or health
care professionals and/or patients as applicable) to report all
information on drug safety
For this purpose:
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share contact data with their partners
provide information on the 4 necessary (minimum) data to
MAH – see next slide
forward all information arriving from the MAH to their
partners in this issue in due time
inform their partners on further fate of their reported signals or
adverse/pregnancy events
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Requirements for distributors/4
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Information may arrive from
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patients/their relatives or
healthcare professionals
Collect and provide all follow-up information if required by
MAH
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additional data related to the reported case
answer on authorities’ requests
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Meet time frames required by MAH for
 Pharmacovigilance information must not be made public
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Reporting to MAH
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Report
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signals, adverse or pregnancy event information to the MAH’s
QPPV
immediately
via e-mail or fax using free text or phone or using CIOMS form
(Can be downloaded from: http://www.cioms.ch/)
At least four basic data shall be included
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data of the reporter (name, address, access data, e.g. e-mail
address or phone number)
patient data (monogram or identification code, date of birth or
age, sex)
at least one suspected pharmaceutical
at least one suspected adverse event
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Special cases
Institute of Isotopes (IoI) is distributor of a product of another
MAH
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In case of incoming event report
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the same information should be sent to that MAH as in case of
IoI’s product and
please send to IoI as well for information
if no contact is available to the MAH, send the information to IoI
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Contacts at IoI
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Pharmacovigilance Coordinator (connection to QPPV)
Sipos, Julia
e-mail: [email protected]
phone: +36-1- 391-0900
mobile: +36-30-991-0468 (available 24 hours/day)
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Contact us in case of any questions!
THANK YOU FOR YOUR ATTENTION!
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