Ivowen recently attended the HPRA Safety Features Workshop Athlone (3^rd May 2016).  The following is a summary of the key take-home points from this workshop.

Introduction of a Unique Identifier (UI) and Anti-tampering Device (ATD) on Packaging of POM and Certain OTC Medicines

Certain aspects of the implementation of the Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on safety features (Commission Delegated Regulation (EU) 2016/161) may impact the product information of MAs.  The Delegated Regulation applies to medicinal products for human use and specifically prescription only medicines (POM) and certain non-prescription/over-the-counter/general-sale-list medicines (OTC/GSL).

• All POMs are required to carry safety features, with the exception of radiopharmaceuticals and those products listed in Annex I of the Regulation (EU) No 2016/161 (“white list”)
• Categories not subject to prescription; OTC/GSL medicines are not required to carry a safety feature unless they are listed in Annex II of the Regulation (EU) 2016/161 (“black list”). The black list includes documented evidence of falsification of medicines other than POMs e.g. omeprazole
• The purpose of the safety features is to allow for the identification and authentication of human medicinal products
• The safety feature including ATD must be placed on the outer packaging or in the case of no outer packaging on the immediate packaging (if the ATD affects the container closure system, then information on how the ATD affects the container closure system is required in section 3.2.P.2.4 and/or 3.2.P.7 of the MA dossier)

Products outside the scope of the Delegated Regulation include veterinary, investigational, and exempt medicinal products.  Additionally medicinal products manufactured in the EU and destined for export only are also exempt.

Composition of the Unique Identifier (UI)

Manufacturers will be required to encode the unique identifier in a 2-D barcode and to print data elements in human-readable format.

2-D Barcode

The 2-D barcode will consist of a sequence of numeric or alphanumeric characters.

• Product Code: allowing identification of at least the Tradename, common name, the pharmaceutical form, the strength, the pack size and the pack type
• Serial Number: a numeric or alphanumeric sequence of maximum 20 characters
• Reimbursement Number: if required by the Member State
• Batch Number
• Expiry Date

Human-readable Format

In addition to the 2-D barcode manufactures will also be required to print the data elements in human-readable format so as to allow the verification of the authenticity of the unique identifier and its decommissioning in case the two-dimensional barcode is unreadable.

Anti-tampering Device (ATD)

Manufacturers Choice of tamper evident seal.

The Regulation shall apply from 9^th February 2019 where all relevant medicinal products placed on the market or QP certified will need to have the new safety features in place.  The safety features may be implemented in advance of this date provided the functioning repository is in place and the MA dossier has been updated to include reference to the safety feature.  MA holders are advised to update product information during the 3-year transition period and this can be done during any ongoing regulatory procedure (e.g. Renewal, Variation IA, IB, II, new or existing MAA application) – no additional fees; or alternatively submit an Article 61(3) Notification – usual fee will apply.

Further detailed guidance can be found under the following links:

http://ec.europa.eu/health/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf

http://ec.europa.eu/health/files/falsified_medicines/qa_safetyfeature.pdf

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/02/WC500201413.pdf

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Falsified_Medicines/CMDh_345_2016_Rev0_February_2016.pdf

Ivowen can assist you in notifying competent authorities of the safety features and updating your MA dossier for new, on-going and existing MAAs.  Ivowen are also fully eCTD-ready and compliant. Please contact us for more information and for support of your application.

Written by Laura Oakey