Marketing authorisation holders

Overview of MA holder obligations regarding safety features 

Marketing authorisation holders (MAHs) 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:

  1. 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).
  2. Changing packaging to include safety features and having it approved by the regulatory authority.
  3. Upgrading production lines to apply the unique identifiers and anti-tamper device.
  4. 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.
  5. 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.
  6. 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 MAHs

  1. Complete a registration form so we have all your details, including invoicing requirements. One form will be required per MAH, but this may be completed by the local affiliate - click on the icon shown to download the registration form
2.  Sign the ‘IMVO MAH Agreement’. Each MAH is required to sign a separate agreement -  click on the icon shown to download the agreement

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

What fees are payable to IMVO by MAHs?

1. Registration fee

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

Early bird discounts are available if the fee is paid before the end of 2018 - see table below for details.

Surcharges will be levied on existing MAHs who delay paying the registration fee until after 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

All MAHs will be required to pay an annual user fee to IMVO from 2019 onwards when the system goes live to cover the costs of running the Irish Medicines Verification System and IMVO’s contribution to EMVO. This fee will be reviewed each year as part of IMVO’s annual budgeting process. The amount of the annual MAH user fee will be notified by IMVO to MAHs in writing no later than 30th September in the previous calendar year. 

The annual user fee for 2019 will be €12,000 (+VAT) per MAH. It is payable on 9th February 2019 and invoices will be issued to registered MAHs in early January with a 30 day payment term as per the IMVO MAH Agreement.

Are there any variations to the above fee structure?

1. Rebates for MAHs with low turnover 

Like most other national medicines verification organisations, IMVO has based its financial projections on a flat fee per MAH model. In recognition of the challenges that this may pose for MAHs with a low turnover, a rebate of 60% will be provided on the annual MAH fee and the one-off registration fee for MAHs with a turnover of less than €100,000 in Ireland (based on previous year’s data), The turnover figure will be self-certified, but IMVO reserves the right to request supporting evidence and/or audit the declared turnover. Fee rebate decisions will be valid for one financial year only. Separate application must be made in subsequent year(s) if a MAH considers that it continues to be eligible for a rebate and such application(s) will be considered by IMVO independently of previous decision(s). 

If you are a MAH that might be eligible for this rebate, please email us at mah@imvo.ie and we will provide details of how to apply.

2. Annual ‘holding’ fee 

MAHs who won’t any have pack data in the Irish repository before 2020/2021, but wish to register in 2018 to avail of the discounted registration fee, may do so, subject to payment of an annual holding fee of €500 in the years when they have no data in the Irish repository. The standard annual MAH user fee will become payable from the year in which the MAH’s first pack is uploaded to the Irish repository.  If you are interested in availing of this option, please email us at mah@imvo.ie. 

3. Transfer of MAs

If all the MAs belonging to one MAH are transferred to another MAH within a pharmaceutical co-operation prior to 9th February 2019, an early bird registration fee paid by the original MAH may be allocated to the second MAH. The second MAH will be required to complete a new registration form and IMVO MAH Agreement. If you are in this position, please send details to mah@imvo.ie. 

4. Brexit-related MA transfers

Where MAs are being transferred from a UK-based MAH to an EU-based MAH within the same pharmaceutical corporation because of Brexit and the relevant MA transfers have not been completed by 9th February 2019, IMVO will not require two sets of MAH fees to be paid, even though both MAHs will have data in the Irish repository on that date. Both MAHs will be required to complete a registration form and sign the IMVO MAH Agreement. If you are in this category, please email us at mah@imvo.ie with details.

IMVO webinars for MAHs

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. Further webinars covering the same material as the earlier series will take place in December 2018 (see our Events page for dates and details of how to book).

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.

Regulatory guidance for MAHs

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 is available 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

European Commission