HPRA to host workshops on safety features on outer packaging of specified medicines for human use

Event Date: 03/05/2016 - 05/05/2016

The EU Falsified Medicines Directive (FMD) 2011/62/EU, introduces the requirement for manufacturers / Marketing Authorisation Holders (MAHs) to add safety features (that include an unique identifier) to the outer packaging of specified medicines for human use and to fund an Europe- wide verification system which will enable the authentication of medicines before the unique identifier is decommissioned and the pack is dispensed to a patient.

The Commission Delegated Regulation (EU) 2016/161, that sets out the details of how the Directive is to  be implemented, has now been adopted by the European Commission, the EU Parliament and Council of Ministers and was published in the official journal on the 9th February 2016.


The mandatory implementation of the regulation must be completed no later than 3 years from its publication, i.e. by the 9th February 2019.

Aims of the workshop

Now that the Delegated Regulation has been published, the Health Products Regulatory Authority (HPRA) would like to provide the industry and healthcare sectors with specific opportunities to engage with us in relation to the implementation of these systems. This will include workshop sessions in Athlone on the 3rd May and Cork on the 4th May. Details of both workshops are below: 

Who Should Attend

Stakeholders such as MAH, manufacturer or wholesaler

Fee & Venue Details

These workshops are free events. 
Venue: Sheraton Hotel, Athlone
Date: 3 May 2016
1.30pm - 2.00pm - Registration

2.00pm - 4.00pm Workshop

Venue: Clarion Hotel, Cork City
Date: 4 May 2016
Time: 1.30pm - 2.00pm - Registration
2.00pm - 4.00pm - Workshop

Venue: HPRA Offices
Date: 5 & 6 May 2016
Time: 2.45pm - 3.00pm - Registration
3.00pm - 5.00pm - Workshop 

Registration closed

If you have any queries on the above events please contact safetyfeatures@hpra.ie

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