2019 – What a year

Ivowen attended the Medicines for Europe conference in January (Regulatory and Pharmacovigilance), the annual EuDRAcon conference in May, exhibited at TOPRA in October and joined our clients from around the world at CPhI in November.

We all saw Brexit come and go, Twice !! We wait to see what lies in store for the next deadline in January 2020.

The FMD came into effect across Europe in February in most member states.

Bulgaria joined CESP, eCTD became mandatory for all human procedures, lots of new guidance was published (to keep us all on our toes) and Nitrosamines in medicinal products moved to the top of everyone’s agenda.

With the festive season now upon us and 2020 on the horizon, Ivowen are setting our sights on the year ahead.

We will be attending the Medicines for Europe conference in January 2020 (Regulatory and Pharmacovigilance) and we encourage you to contact us before mid-January with any specific questions you might like us to ‘ask the regulators’. This is a great opportunity to ask those difficult questions that you just could not get a straight answer to in 2019, on the ever present grey areas of Regulatory procedures.

To help you to plan ahead here are some helpful updates, in brief, as full articles will be posted in 2020:

Falsified Medicines Directive – Where we are now:

  • Implemented on 9th Feb 2019 in all MS except Greece, Italy and Belgium
  • The European Commission has produced a video to explain more about the safety features.
  • The HPRA have extended the use and learn period, initially to Sep 2019 and extended it again to end on a phased basis starting from 31st January 2020.
  • The MHRA is also taking a pragmatic, flexible approach to how they enforce the new legal requirements.



Ivowen are here to assist you in 2020 and will continue to provide the top quality service you have come to expect from us.

For more information on Ivowen’s services and how we can help you, contact us.

Written by Alice D’Alton.

HPRA update on Batch-specific requests for safety features

The recent medicinal products newsletter (issue 61) published by the HPRA includes an article about batch-specific requests (BSRs) and safety features.  This is an update on the Falsified Medicines Directive safety features information.
The Commission Delegated Regulation (EU) 2016/161 with detailed rules for the safety features appearing on the packaging of medicinal products for human use, came into force in Ireland on the 9th February 2019.

BSRs will be considered for medicines for the Irish market that come within the scope of the regulation but do not bear safety features (UI and ATD).

The article outlines the details the MAH must provide in the BSR application.
Furthermore, the MAH must confirm that safety features have already been registered with the HPRA and if not a simultaneous Article 61 (3) notification must be submitted with the BSR application. 

For full details on this issue the full article can be found here: https://www.hpra.ie/homepage/about-us/publications-forms/newsletters/item?id=55950b26-9782-6eee-9b55-ff00008c97d0&t=/docs/default-source/publications-forms/newsletters/hpra-medicinal-products-newsletter—issue-number-61

Written by:

Claire Brown

HPRA Safety Features Workshop – update

Ivowen recently attended the HPRA Safety Features Workshop Athlone (3rd 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 9th 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:





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

Laura Oakey