The Impacts of Pharmaceutical & Retail Legislation Melvin 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

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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 2 nd 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 st January 2014 Specific requirements regarding minced meat composition and labelling 13 th December 2014 Mandatory allergen information and general labelling rules Nutritional declaration provided on a voluntary basis must comply with new regulations 13 th December 2016 Mandatory nutrition declaration needed for most Pre-packed food New nutrition declaration applies for all other foods 2017

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Verification of Pharmaceutical Products at the point of dispense The EFPIA Project European Federation of Pharmaceutical Industries and Associations

Who is EFPIA The 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 manufactures 4 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% online Wholesalers labelled products

Response from pharmacists Positive 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 ProjectEFPIA Project Read more about healthcare GTIN allocation rulesGTIN allocation rules Download the EU1169/2011 pdf overviewpdf overview GS1 UK Brandbank EFPIA 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.