establishing eu operations

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 McGeeManaging 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-compliancewith 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.

“

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McGee Pharma International achieves in one day what

it takes other consultancies three to complete

EMEA Quality Director

“”

We deliver value

establishing eu operations

Health & Medicine