Post on 15-Jan-2016
transcript
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.