A fairy tale introducing Tamper Evident and Child Resistant packaging, their goals and the issues that they can successfully address. FMD Falsified Medicine Directive 2011/62/EU.

1. A Tale of the Magic Boxes
Tamper Evident and Child Resistant
Folding Boxes 1
Germano Alberti, Marketing Manager

2.  Igb
 A tale of the Magic Boxes
 The reality: drug poisoning, counterfeit drugs, packaging
requirements
 Specialized folding boxes can increase safety:
 Tamper Evident
 Child Resistant
 Goals:
 Improved safety
 Lower impact on the pharmaceutical industry
 Added value
Contents 2

3. Once upon a time…
 There was a single mother with beloved young kids.
 The grandparents lived in a house in the forest and got ill.
 A Fairy gave them magic drugs in magic boxes:
“They will heal the grandparents but be careful: they can be
very poisonous to kids!”

4.  They walked through the forest to take the medicine to the
grandparents.
 They met a Prince on a white horse who fell in love with
the mother.
 Prince and mother spent some time picking flowers
together.
For a split second they lost
sight of the children…..

5.  640,000 children age 5 and younger were treated in
emergency rooms for ingesting drugs between 2004
and 2013.
 During the early 2000s, the number of children’s ER
visits increased, peaking at about 76,000 in 2010.
 Almost half involved prescription pills, tablets or
capsules.
That’s in the US alone.
The findings appear in pediatrics.aappublications.org
The real world: fairy tale or
horror story?

6. 6Back to the story..
The children tried to open the first box but could not do it
It was Child Resistant

7. Igb Child resistant folding box
Easy packaging
Igb Child resistant folding box
 Has been designed to be mass-packaged on standard packaging
lines
 Does not require machinery investments
 Does not require special components like shells or trays
 Is suitable for manual packaging
Certified
 EU: BS EN ISO 8317
 US: 16 CFR §1700.20
Social responsibility
 Helps prevent drug poisoning in children
 Can be certified as FSC and PEFC
7

8. The story goes on..
 The Prince did not like kids very much.
 He angrily asked: “Have you opened the other box?!”
 The children said: “No and we can prove it, it is a Tamper
Evident box!”
The prince turned happy.

9. World Health Organisation: SSFFC - Substandard,
spurious, falsely labelled, falsified and counterfeit drugs
 Availability of machines and ingredients: clandestine
manufacturing facilities are quick and easy to assemble.
 No countries remain untouched by this issue.
 Exponential increase in internet connectivity: the SSFFC
medical products business has gained access to a global
market place
9The real world: counterfeit drugs

10. 10Tampering
Pilfering
The US Drug Enforcement Administration says that
between 2010 and 2013, “employee pilferage” has
constituted the largest single percentage of
pharmacy thefts nationwide
Malicious tampering
Accidents in 1982 and 1991 resulted in a few deaths
and some people became severely ill

11. Igb Tamper evident folding box
Facts
 Directive 2011/62/EU: from 9 February 2019 pharma products in
Europe must have tamper evident packaging
 Glue is not accepted in the US and Australia
 Labels and glue add costs and complexity
A simple solution: Igb Tamper evident folding box
 No glue
 No labels
 No extra space in packaging department
 No slow downs
 No machinery investments
 No ancillaries
11

12.  Accidents can seriously damage companies’
reputation
 Accidents and regulations can lead to huge
costs to companies
12Costs to pharma companies
Costs
Reputation

13. Safety
 EU Directive 2011/62, FDA, TGA
13A simple solution:
Mechanical packaging
Low costs
 No gluing, no labels ALL
 Same packaging machines as standard boxes TE, CR
 Same packaging speed as standard boxes TE
 No extra space required in packaging department TE, CR
 Suitable for manual packaging ALL
High value
 Special packaging creates marketing opportunities
 FSC and PEFC certifiable ALL
 Blind friendly TE

14. 14
And they all lived happily
ever after...

15.  Igb srl
 www.igbressan.it
 Via Pontaccio, 14 – 20121 Milano, Italy
 germano.alberti@Igbressan.it
 Tel +39 0332 48 73 72
15Contacts