Download What public health benefits could be secured by using universal

What public health benefits could be
secured by using universal labelling &
packaging for influenza pandemic
vaccines?
Workshop on the joint procurement of medical countermeasures
29 April 2015, Luxembourg
Sophie Marszalek, Regulatory Affairs Director – Flu Franchise, Sanofi Pasteur
Agenda
1
Scope/definition
2
Challenges
Anticipated and simplified regulatory process
3
4
5
2
Public health impact of early vaccine availability
Vaccines Europe recommendations for the
packaging and labeling of pandemic vaccines
Scope/definition
•
A Packaged finished product is composed of
o Outer packaging
o Primary container (syringe, vial)
Outer
ƒ Containing the vaccine
packaging
ƒ A primary label is stuck
o Package Leaflet
Label
leaflet
•
These packaging elements are the physical support of vaccinerelated information
•
The labeling information is compliant with the terms of the marketing
authorization and ensure the safe and effective use of the vaccine
o Information are made available through the EU QRD template applicable
to any drug product in Europe
3
Challenges
• During the H1N1 influenza pandemic, companies had
difficulties in making available the most up to date
package leaflets (PILs) to the patients
• Introducing a change in the labeling requires a
minimum lead time of 4 weeks from design to actual
printing without taking into account the time necessary
to include these “new” materials into the production line
• Labelling (especially SPC and package leaflet) are
subject to changes on a monthly basis
4
Challenges
• The inclusion of separate sheets with peel-off stickers in
(or with) boxes of multi-dose vials is not considered an
ideal approach to minimise risks of misreporting safety
issues because:
ƒ It adds a level of complexity in the production/supply chain and
therefore may affect delivery timelines;
ƒ It may be an additional source of errors and confusion:
¾for example, mistakes/mix-ups are possible at the user-end after
vials/syringes are taken out of their original outer packs in preparation
for the vaccination (This is probably more likely to happen in large
vaccination centers where larger amount of doses are shipped and
where the probability of getting boxes from different batches is higher)
5
Anticipated and simplified packaging and labeling regulatory
process could save 6 to 8 weeks for dose availability
USUAL PROCESS
Vaccine
manufacturing
Vaccine filling
Packaging
operations
Artwork
activities
Mock up
creation
Release
- Update
- Printing
- Quality Check
Text approval
Translation
Text proposal
Registration procedure
License
6
6 to
to 8
8 weeks
weeks can
can be
be saved
saved
ANTICIPATED
ANTICIPATED PROCESS
PROCESS
Vaccine
manufacturing
Vaccine filling
Packaging
Packaging
operations
operations
Mock up
creation
Release
Release
Common ENGLISH text
approval (CORE)
License
Registration procedure
6
Shipping
Shipping
Dose
Dose
availab
availab
ility
ility
Dose
Dose
availab
availab
ility
ility
Why early dose availability is crucial
for public health in pandemic context?
•
In a pandemic context, the responsibility of the industry is to
develop, produce and deliver as many safe and effective vaccines
doses as possible in a timely manner to meet public health
expectations and to respond to government's requests
•
Early availability of the vaccine doses to vaccinate the target
population is crucial to:
o fight against the disease
o have better chances to smoothen/delay the pandemic peak
7
VE recommendations for packaging
and labeling of pandemic vaccines
• A universal packaging and labeling approach is
recommended to reduce the timelines and increase the
supply chain flexibility in and outside Europe:
ƒ “Specific QRD template for pandemic vaccines” with a simplified
labelling content for outer packaging, labels and the package leaflet
(shortened package leaflet)
ƒ Early approval with only the essential information in English to
ensure the patient safety and secure the instructions for HCPs
ƒ Up-to-date package leaflet made available on the internet in local
languages (e.g. EMA/NRA websites)
ƒ Vaccines Europe recommendation would be to consider other
more appropriate traceability systems (such as a bar code
system)
8
How could the universal labeling
and packaging look like?
•
The term of “generic packaging” has often been used
Æ “Universal labeling and packaging” would be more appropriate
•
It would be composed of all the usual packaging elements with
essential information in English: (1 set for each manufacturer)
Composition, Storage conditions
Vaccine (Invented) Name
Number of doses
Dosage
Administration route
Batch n°
Exp
Batch
n°
Exp.:
Vaccine (Invented) Name
International Non-Proprietary Name
Pharmaceutical form, Dosage
Number of doses
Administration route
Name and address of the Manufacturer
Label
leaflet
No local specificities:
-No local registration number
-No local bar code
9
Indication
Contra-indications
Warning and Precautions
Special population (e.g. pregnancy, children…)
Possible side effects
How to use the vaccine
A unique contact point for side effects reporting
Name and address of the manufacturer
Thank You
Vaccines Europe / EFPIA
Rue du Trône 108 – 1050 Brussels, Belgium
Tel +32 2 626 25 55 - www.vaccineseurope.eu