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1© 2016 McGee Pharma International
What You Need To Know
When Establishing
Operations In Europe

|We are passionate about putting safe and
effective products in the hands of patients.
We are an award winning pharmaceutical consultancy that
combines industry leading quality and technical insight with robust
product development and commercialisation expertise.
This enables you to maximise innovation and product quality by
implementing smarter, practical solutions that allow you to focus on
what matters – ensuring your patients receive safe and effective
treatment.

your partner in compliance
McGee Pharma International
Individual Contract
Scale Exceeds
€0.5M
In-house team at 11
people and
Associate
Consultancy panel
at 40+
Company
Rebranding as
McGee Pharma
International
MPI Win Enterprise
Ireland Award for
Female
Entrepreneur
Delivery Service
Development
Operations
Manager apponted
Delivery Team
Development
through In-House &
Associate
Consultant Panel
e-learning Centre
Developed - Online
Market
Associate
Consultant Panel
commences
Ann McGee
Consulting
Founded
Ann McGee MD
HPRA Senior
Inspector & CEO
of Pharmaceutical
Ireland
2004 2006 - 2008 2008 2012 2013 - 2014 2015 - 2016
Our in-house team is supported by a global network of over
50 expert Associate Consultants
Extension of
corporate services
Website
redeveloped and
focus now on US
market

McGee Pharma
International
MPI has grown to
over 40 Consultants
with expertise
across all GxPs.
The technical
delivery team is
supported by MPI’s
administrative team
which is based in
Dublin, Ireland.
Ann McGee
Managing Director | Principal Consultant,
Quality & Compliance
Consultant
Ann recognises the
need for an
experienced Irish-
based
pharmaceutical
consultant. Ann
McGee Consulting
is founded, later
becoming McGee
Pharma
International
Chief Executive of
the Pharmaceutical
Society of Ireland
(PSI)
Ann is appointed as
Registrar and CEO
of the PSI, the
Regulatory
Authority, the
Pharmacy regulator
in Ireland
Irish Medicines Board
Senior Inspector
Ann joins the Irish
Medicines Board (now
the HPRA) inspecting
across all GxPs. She is
elected Vice Chair of
PIC/S, takes an active
part in the
development of many
guidance documents,
some of which became
Annexes to the EU
GMP Guide
B.Sc. Pharmacy
M.Sc. Science
Ann receives a
B.Sc. Pharm from
University of
Dublin, Trinity
College where she
also obtained an
M.Sc, in science
1983 1993 1998 2004 2015

EU Regulatory Environment
Within the EU, to ensure that quality, safety and efficacy
of medicinal products many activities within the
pharmaceutical supply chain are considered ‘Regulated
Activities’
These ‘Regulated Activities’ may not always be obvious

EU Regulatory Environment
These ‘Regulated Activities’ are covered by Authorisations and
Registrations
• Manufacturing Importation Authorisation
• Wholesale Distribution Authorisation
• Active Substance Registration
• Broker Registration
These activities can sometimes be misunderstood or missed
completely leading to a company operating in non-compliance
with the regulations and possible risk to the quality, safety and
efficacy of medicinal products supplied & to business continuity

Wholesale Distribution Authorisation
This is not only linked to the physical holding of material
Needs to focus on financial movement in addition to physical
movement
Requires in-depth mapping and understanding of the supply chain
• Key to understanding the requirements is knowing the supply
chain and understanding the ‘Money Trail’ in addition to the
physical movement of product

Manufacturing Importation Authorisation
Product needs to be released to the market by a Qualified
Person (QP) - a position recognised under EU law
Includes product that is manufactured in the EU for export
Is your product manufactured outside the EU? Partly in the
EU? In a country with an MRA?
• Do you understand what has to happen to place your product on the market?
• Is your product manufactured by CMOs in the EU? Is your CMO QP willing to
complete Certification of the finished product batch or only provide
Confirmation that manufacturing or analytical testing have been conducted in
accordance with GMP
• Have you considered requirements for retesting your product on importation
to the EU?

Registrations
Broker Registration
• If you do not buy or sell the product but are involved in the
negotiation of the sale you may be considered a broker
• Within the EU brokers are required to be registered with the
national competent authority and a Quality Management System
should be in place to control the activities
• The use of brokers in the supply chain should be identified; the
need for registration and a QMS should be determined & acted
upon

Registrations
Active Substance Registration
• Manufacture, importation and distribution of API into the EU
requires registration
• These registrations may be required in addition to an MIA and/or
WDA depending on the specific activities
• Key to understanding the requirements is knowing the supply
chain and understanding the ‘Money Trail’ in addition to the
physical movement of product e.g. supply without sale is still
considered supply

Marketing Authorisation/ Holder
Within the EU a product must be issued with a
Marketing Authorisation (MA) prior to being placed on
the market
The legal entity (registered company) that holds the
Marketing Authorisation is known as the Marketing
Authorisation Holder (MAH)
The MAH has ultimate responsibility for the product in
the market

Marketing Authorisation/ Holder
The MAH has a number of Responsibilities that they must
ensure are appropriately controlled
Responsibilities cannot be delegated; Activities can be
outsourced under appropriate oversight by the MAH
Although the MAH does not require an authorisation, they
may be subject to inspection by the Competent Authority and
have responsibility to ensure that their obligations are met

How MPI can Help
Work with you to develop your Regulatory strategy for
distribution in the EU, including product reimbursement
Work with you to map your Supply Chain
• Material movement & paper trail
Work with you to identify licensing that applies to your
proposed EU operations

Design & develop a tailored QMS specific to your
EU business operations
Provide interim resources- QP, RP, QA support staff
Support importation, product testing & batch
release
Provide virtual QA services eg complaint/quality
defect/ recall management
How MPI can Help

MPI’s lifecycle services

What we do
MPI’s services cover all
product types across the
entire product lifecycle
• Large and small molecules/biotech
and non-biotech
• Steriles and non-steriles
• Active Pharmaceutical Ingredients
(API)
• All dosage forms
• Medical device and device
combinations
• Traditional Herbal Medicines
• Cosmetics

Winner - Enterprise of the Year 2009
Accolades

Our values
McGee Pharma International abides by a set of fundamental,
enduring values that guide how we operate with clients, colleagues
and stakeholders. These values act as our compass, determining
how we behave and make decisions, shaping the culture and spirit
of McGee Pharma International.
We firmly believe that by living our values every day we will always
act in the best interests of public health, and our success will always
follow.
“
”

McGee Pharma International achieves in one day what
it takes other consultancies three to complete
EMEA Quality Director
“ ”
We deliver value

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