This new
version is related with the Falsified Medicines Directive from the European
Commission – Directive 2011/62/EU which introduces obligatory “safety
features? to allow the verification of the authenticity of medicinal products
subject to prescription. The ultimate goal is to protect patients and business
alike from the risks of falsified medicines.
The new
safety features introduced by the Directive are a unique identifier (a
2-dimension barcode) and an anti-tampering device, to be placed on the
packaging of most medicines for human use.
As a
consequence, the new QRD template impacts the outer packaging, where two new
sections were added, to include the new unique identifier information:
“Unique Identifier ? 2D Barcode? and “Unique Identifier ? human readable data?.
The
implementation of the anti-tampering device is not expected to impact
the product information. However, if this device is placed on the immediate
packaging (because there is no outer packaging) and affects the container and
its closure system, this should be taken into consideration in Module 3,
particularly in sections 3.2.P.2.4 and/or 3.2.P.7 of the Notice to Applicants
Volume 2B.
Which
medicines should
comply with these new safety features?
1- Medicinal products subject to prescription,
with exception of the ones included in Annex I of Comission Delegated Regulation
2-Medicinal products not
subject to prescription included in Annex II – omeprazole – gastro-resistant
capsule, hard – 20 mg and 40 mg
Furthermore,
the following deadlines apply for implementation, both for Centralised
and non-Centralised applications:
–New MA applications -> from April 2016
–Ongoing MA applications ->
i) if CHMP opinion is expected for March 16 then the revision of texts
according to new QRD template is recommended; ii) if CHMP opinion is
expected from April 16 then the new QRD template should be used. Additionally,
the revision of Module 3, when necessary, can be submitted until day 180 of the
procedure.
–Authorised medicines -> no later than 3 years from
publication of the QRD template (9 February 2019). An exception is Belgium,
Greece and Italy, since these Member States already operate a national system
for identification of medicinal products. These three Member States have the
option of deferring the application of the rules by an additional period of up
to 6 years (9 February 2025)
For more information please contact us on info@asphalion.com
