The Impacts of Pharmaceutical

& Retail LegislationMelvin Fletcher

Datalinx Computer Systems

Introduction

• Datalinx Computer Systems

Our business today

• Changes to Food Labelling

EU 1169/2011

• Verification of Pharmaceutical Products at the

point of dispense

The EFPIA Project

European Federation of Pharmaceutical Industries and Associations

Sage ERP X3 (Product launched in August 2013)

“Centre of Excellence for Warehouse Management”

Sage approved:

Sage 200 Functionality and Sites

• Deeply embedded into Sage 200

• Inbound

• Outbound – Sales order picking and packing

• Stock taking

• Manufacturing

• Movements

• GS1 compliance

• Smallest site 1 hand held scanner – largest 52

Sage 500/1000 Functionality Sites

• Deeply embedded into Sage 500/1000

• In bound

• Outbound – Sales order picking and packing

• Stock taking

• Manufacturing

• Movements

• GS1 compliance

• Smallest site 1 hand held scanner – largest 98

• 4 new sites in 2013

Datalinx

If you want to know more about our applications –

Come and talk to us

Changes to food labelling

EU 1169/2011

Ref: GS1 UK and “Brandbank”

Ready for change

• Background to the new regulation

• Who will be effected

• Key changes you need to be aware of

• How this will impact your business

• Key deadlines

• More information

Goal of the Legislation

• Ensure that consumers can make informed

decisions about food they purchase

• Increase the amount of mandatory information

• New rules about how information is displayed on

products

• The requirement for information to be accessible

prior to purchase if the product can be bought

online

Who will be affected

The legislation applies to Food Business Operators (FBOs)

at all stages of the food chain, where their activities

concern the provision of food information to consumers

including;

• Food Manufacturers

• Food Retailers

• Online Retailers

• Catering Organisations

• Food Services

• Food Distributors

• Upstream Suppliers

Who’s responsible

• There is joint responsibility between the supplier

and the retailer.

• It is the responsibility of the supplier to provide

the data and the responsibility of the retailer to

display it correctly.

• Blame would be apportioned accordingly upon an

instance of non-compliance.

Key information

• Date Marks

• Product Name

• Storage Conditions

• Quantity of

Ingredients

• Origins

• Name of Business

• Instructions for

use

• Name and

Address

• Nutrition

Declaration

2nd Nov 2013

• Net Quantity

• Allergens

Key Information

This information has to be available any time and

any where:

• Online

• Delicatessen

• Retail outlet

• Restaurant

•Available to back office systems

Centralised data

• GS1 managed product identification numbers

• Working with Brandbank to provide a single

trusted source of product information and digital

assets based on global standards

Key Dates

Foods placed on sale or labelled prior to the above dates that do not meet the requirements of the new regulations (but are compliant with existing rules) may be marketed until stocks are exhausted.

2014 2015 2016

1st January 2014Specific requirements regarding minced meat composition and labelling

13th December 2014Mandatory allergen information and general labelling rulesNutritional declaration provided on a voluntary basis must comply with new regulations

13th December 2016Mandatory nutrition declaration needed for most Pre-packed foodNew nutrition declaration applies for all other foods

2017

For more information visit

www.datalinx.co.uk/gs1

Verification of Pharmaceutical Products at

the point of dispense

The EFPIA Project

European Federation of Pharmaceutical Industries and

Associations

Who is EFPIAThe European Federation of Pharmaceutical Industries

and Associations (EFPIA)

– Represents the R&D based pharmaceutical industry

operating in Europe

– Direct membership of 31 national associations and 44

leading pharmaceutical companies

– EFPIA is the voice of 2,200 companies committed to

researching, developing and bringing new medicines to

patients that will improve health and the quality of life

around the world

Objectives of verification

Improving patient safety

• Reduce the risk of counterfeit products being

dispensed

• Detect expired products automatically

• Perform product recalls more effectively and efficiently

• Deliver the right product to the right patient

These systems will also have other benefits such as

supporting governments with their reimbursement processes

EFPIA Product Coding Recommendations in Europe

Secondary Pack

• Guarantee the integrity of the original manufacturer’s pack

throughout the entire supply chain

• Use of overt and covert features to authenticate products

• Use of harmonised coding and identification systems for

secondary packs of pharmaceuticals

Specifications provided in EFPIA’s“European Pack Coding Guidelines”

Pilot Project Overview

25 Products (SKUs) with total of 100,000

packs

14 manufactures4 months duration

of operational phase

95,000 packs verified

25 pharmacies in the greater Stockholm area

with a total of 180 dispensing points

Response times: •99.9% of transactions completed in <2.0 sec•System 99.9% onlineWholesalers labelled products

Response from pharmacistsPositive Feedback

• Ease of use of the

system (94% of pharmacists

found the system easy or very

easy to use)

• Little additional effort

to verify (96% of pharmacists

found the level of effort

acceptable or better)

• Good experience with

the scanning equipment

85% found the system fast

Issues identified

• Additional effort when

scanning – scanners read

linear bar code instead of

the 2D

• Some process variation

resulted in some packs on

the shelf showing as being

dispensed

Key Conclusions from Pilot• The presence of more than one code on the pack causes confusion for the user and will jeopardise user

acceptance

• The practicalities of code location and application need to be considered

• Understanding the processes is critical to ensure the system works

• Support and buy in from the people scanning is important -involve in design

• System availability and performance allow pharmacists to work at normal pace and without

significant additional effort

• System is easy to use when fully integrated into pharmacy workflow and existing IT system

• System should be customised to existing pharmacy workflow, processes, local conditions and

regulatory requirement. It is therefore recommended to run a pilot phase for each deployment (region) so

that defects can be eliminated before roll-out

• The model EFPIA supports works in practice and allows for effective identification of fake packs

• System must provide correct answer to all transaction requests to achieve sustained credibility

• Pharmacists are highly interested to get expiry date and batch number in machine readable form through

the 2D data matrix

• Necessary data segregation and security can be technically ensured

Credits and more information

Reference has been made to the EFPIA Project Read more about healthcare GTIN allocation rules

Download the EU1169/2011 pdf overview

GS1 UK BrandbankEFPIA

Thank you to GS1 UK and EFPIA for their assistance with this presentation. If you would like more information on any of the points covered please contact Datalinx, GS1 UK or click on any of the links below.