MA holders

Overview of MA holder obligations regarding safety features

Marketing authorisation (MA) holders who market in-scope products in Ireland must ensure that all packs released for the Irish market from 9th February 2019 carry safety features (unique identifiers and anti-tamper devices). In practice, many companies will start updating their packaging and releasing serialised packs to the market well ahead of that date.  

The key steps to be undertaken to comply with the new requirements include:

  •  Identifying what products are in scope of the new requirements and require safety features (as defined in Article 2 of the Commission Delegated Regulation (EU) 2016/161).
  • Changing packaging to include safety features and having it approved by the regulatory authority.
  • Upgrading production lines to apply the unique identifiers and anti-tamper device.
  • Onboarding to the EU Hub which is managed by EMVO – see EMVO website for details of onboarding process which has both contractual and technical elements.
  • Uploading unique identifier data that has been placed on packs to the EU Hub. The data will then transfer from the EU Hub to the national repository for the market where the packs are intended to be sold.
  • Registering with IMVO and paying the relevant fees.

How do we register with IMVO?

There are three steps in IMVO’s registration/onboarding process for MA holders:

 1.  

 Complete a registration form so we have all your details, including invoicing requirements. One form will be required per MA holder, but this may be completed by the local affiliate. Click on the icon shown to download the Agreement.

2.  

Sign the ‘IMVO MAH Agreement’. Each MA holder will be required to sign a separate agreement. Click on the icon shown to download the Agreement.

3.

Pay the IMVO MA holder registration fee (this may be paid before the Agreement is signed and IMVO will be flexible in terms of how invoices are issued).

What is the model for fees to be paid by MA holders to IMVO?

IMVO is applying a flat fee per MA holder model where each MA holder whose product data is held in the Irish system pays the same fees to IMVO. If there is more than one MA holder for the company’s products in Ireland, separate fees are payable by each of the MA holders.

The flat fee per MA holder model was developed by the stakeholders in European Medicines Verification Organisation including EFPIA (representing the research-based industry), Medicines for Europe (representing the generic / biosimilars industry) and EAEPC (representing parallel distributors) and is being rolled out across Europe. Information on how this model was selected is available on the EMVO website.


What fees are payable to IMVO by MA holders?

1.       Registration fee

A one-off registration fee of €16,000 (+VAT) is payable by all MA holders who will have in-scope products on Irish market on 9th Feb 2019 (‘existing MA holders’) and by all new MA holders joining the Irish Medicines Verification System after that date.

Early bird discounts are available if the fee is paid in 2017 or 2018 - see table below for details.

Surcharges will be levied on existing MA holders if the registration fee is not paid by 30th April 2019 (see table for details). IMVO is dependent on budgeted income from registration fees to cover many of its financial commitments in 2019 and the surcharge will be used to defray additional costs to IMVO associated with late payment of the fee. 

2.       Annual user fees

An annual user fee will be payable by MA holders from 2019 onwards when the system goes live. This fee will cover the ongoing costs of the Irish Medicines Verification System. The annual user fee is expected to be in the region of €12-€15,000 +VAT per annum and will be payable by each MA holder. The precise amount for 2019 will be confirmed and notified to MA holders in Q2 2018 when the level of update of the early bird registration fee offer is known. This fee will be reviewed each year as part of IMVO’s annual budgeting process.


IMVO webinars for MA holders

IMVO ran a series of webinars for MA holders from October 2017 to January 2018. Click on the icon shown to download the webinar slides or contact mah@imvo.ie  to request a copy.

Click on the icon shown to download the latest version of the webinar slides.

Regulatory guidance for MA holders

Guidance on the regulatory aspects of implementing the new requirements has been published by the HPRA, Head of Medicines Agencies Co-ordination Group for Mutual Recognition & Centralised Procedures – Human (CMDh), European Medicines Agency (EMA) and the European Commission and may be accessed via the following links: 

HPRA

CMDh  

  •  ‘CMDh Implementation plan for the introduction of the safety features on the packaging of nationally authorised medicinal                   products for human use’

  •   ‘CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive’

  •  'Guidance published by Member States on the implementation of the Falsified Medicines Directive’

EMA

•     ‘Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for         human use’ – latest version is available on the EMA Falsified Medicines webpage

•     ‘Quality Review of Documents (QRD) human product-information annotated template’ – latest version is available on the                        EMA product information templates webpage

European Commission


Coding / serialisation requirements

There are no Ireland-specific coding or serialisation requirements. GTINs from GS1 are used in the pharmaceutical sector in Ireland.  Reimbursement codes do not have to be included in unique identifiers on packs placed on the Irish market.

 

EMVO has published an ‘EMVO Master Data Guide’ to clarify what data is expected to be used by manufacturers for the European Medicines Verification System. This guidance is available on the EMVO website.