Tag Archive for: MAH

Brexit

Are you Brexit ready?

Brexit in:

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Test your knowledge, take our Brexit quiz here 

What do you want to do next?  Do you want to continue to market your product in the EU only, or are you interested in both the EU and UK markets?  Read on to find out what you need to do for both scenarios.

If you would like to continue to market your product in the EU there are a few things that need to be finalised before Brexit on the 29th March 2019:

 

Reference Member State (RMS transfer)

This should have been done yesterday(!) The time it takes depends on the requested RMS’s workload.

Since July 2018 the MHRA is no longer accepting new applications with UK as RMS. However there are some currently authorised products wherein the UK is still the RMS.

If you have products and the UK is currently the RMS then it is vital a RMS transfer is initiated immediately. If there is only one CMS then this CMS should become the RMS (submission required). If there is more than one CMS, the preferred CMS needs to be consulted and a request sent asking them to be RMS. It is the responsibility of the MAH to secure a new RMS. The timeline for such transfers are solely dependent on the workload of the requested RMS.

 

Marketing Authorisation Holder (MAH) transfer

Needs to be done immediately – the time it takes is dependent on where the application is submitted.

From the 29th March 2019 the MAH for a product licensed in an EU Member State (MS) other than the UK must be based in the EU. Therefore if the MAH is currently based in the UK there needs to be a MAH transfer to one based in the EU.

  • If this involves purely an address change (i.e. the marketing authorisation holder remains the same legal entity but they have an address in the EU) then this is a simple type IAin (A.1).
  • If the new MAH is a different legal entity then the MAH transfer must follow the guidelines of the currently registered RMS and CMS, at the very least documents such as transfer agreement, proof of establishment, , power of attorney(s), Pharmacovigilance (PV) update, etc., should be in place before submission of the request.

 

Batch release

Needs to be done within the next 4-8 weeks unless a product is a biological / immunological product in which case submission needs to be immediate.

Products that only have batch release and quality control testing sites for finished product in the UK will have to change the batch release and testing sites for their EU products. For products that have other batch release and testing sites the MAH may choose to delete the UK site(s) or may choose to replace them. For finished products manufactured in the UK an importation site (in EEA) will need to be introduced. In many cases, a single site can perform manufacturing, testing, importation and/or batch release activities.

The timelimes will follow the type IA/IB or type II (biological / immunological product) categories depending on what change is applied for. Please see https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/c_2013_2008/c_2013_2008_doc/c_2013_2804_en.doc

 

PV

Needs to be done asap and in association with any MAH transfers – usually a type IA or type IAin

 

The Qualified Person for Pharmacovigilance (QPPV) and Pharmacovigilance Site Master File (PSMF) must be based in the EU/EEA.

 

If you wish to continue to market the product in the UK in addition to the EU:

The MHRA have stated that after Brexit, all currently approved authorisations will be transferred into national procedures and will remain valid.

If an application is in-progress at the time of Brexit the application will need to be submitted to the MHRA again as a national application in the case of CP procedures and that for MR or DC procedures a transitional provision will be made.  HOWEVER, this is contingent on a Brexit deal that allows for a transition period.  This has not yet been agreed.

To ensure the product can remain on the market / licensed, the UK are proposing the following if there is a no-deal Brexit

  • a MAH should be established in the UK by the end of 2020. Until then, the MHRA will require a contact in the UK. A Change of Ownership will need to be submitted to MHRA to change from an EU MAH to a UK MAH for UK MAs
  • the Qualified Person for Pharmacovigilance (QPPV) should be established in the UK on day one, although those without a current UK presence will have until the end of 2020 at the latest to do so, but would nevertheless be required to make arrangements for providing the MHRA with access to the relevant safety data related to UK Marketing Authorisations (MAs) at any time. Companies may choose to have the EU QPPV take on responsibility for UK MAs until the UK QPPV can be established. A variation should be submitted to the MHRA to change QPPV. Exact details of this will be consulted upon
  • a Qualified Person (QP) for products manufactured in the UK or directly imported into the UK from outside a country on a designated country list (whitelist) must reside and operate in the UK. A QP for products manufactured in a country on a whitelist or manufactured in a third country and imported into the UK from a country on a whitelist can reside in a country on the whitelist.

(https://www.gov.uk/government/publications/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal)

 

Do you need help with any of the above or any other regulatory issue?

Contact us!  We’re here to help.

 

Written by Emily Fletcher

Emily Fletcher

Emily Fletcher

 

IE EU flag

HPRA’s support as you prepare for Brexit……

Brexit in:

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The Health Products Regulatory Authority (HPRA) of Ireland is geared up and ready to support MA holders as they prepare for Brexit.

 

What happens if UK leaves the EU with no deal?

The implications of Brexit with regard to the UK’s role in the licensing of medicines will be determined by the terms of the ongoing exit negotiations. However, in accordance with Directives 2001/82/EC and 2001/83/EC:

  • For marketing authorisations issued through the mutual recognition procedure (MRP) or decentralised procedure (DCP), the Reference Member State (RMS) must be based in the EU/EEA.
  • The marketing authorisation holder (MAH) must be located within the EU/EEA.
  • MAHs will need to ensure that their EU qualified person responsible for pharmacovigilance (QPPV) and their pharmacovigilance system master file (PSMF) are located within the EU/EEA.
  • The batch release/testing site must be located within the EU/EEA.

 

HPRA are working “extraordinarily” hard on preparing for all scenarios

HPRA are Brexit ready

– Willing to act as RMS for all products where Ireland (IE) is currently CMS and a change of RMS is required. No fees will apply to the process for changing RMS to IE. The HPRA commits to an efficient and simple process for handling these requests (for example allowing the inclusion of multiple products in one request where applicable).

– To encourage the use of multilingual labelling the HPRA will proactively work with other European regulators to help optimise opportunities for multilingual labelling. The HPRA ‘Guide to labels and leaflets of Human Medicines’ has been updated (Oct 2018) to give specific guidance on the development of multilingual labelling

– HPRA MAH transfer procedures have recently been changed to allow MAHs up to 6 months to implement packaging changes following issue of the transferred authorisation, for Brexit related transfers. In addition the HPRA no longer requires stock to be recalled from wholesaler level six months following the issue of the transferred authorisation/ licence/registration.

 

Timeline for changing RMS

Can be completed within a matter of days. The critical issue will be the timing of when the change in RMS should occur as it is required to occur when there are no open regulatory activities for a product.

 

Procedures for MAHs to transfer MAH to EU/EEA based MAH

The transfer procedure must be used where the legal entity of an authorisation/licence holder is changed as marketing authorisations are transferred to a new company number. It is possible to transfer the MAH while there are ongoing/open variations. If the transfer is processed/issued, the new MA holder details will transfer onto the open/ongoing variations

  • Bulk transfers are accepted by the HPRA for Brexit and reduced fees apply.
  • New PA number is provided in advance of application.
  • Word version of an updated package leaflet is acceptable.

If the only changes proposed relate to MAH details and a new PA number, an Article 61(3) application is not required. However, if there are additional changes to the labels and package leaflet an Article 61(3) application must be submitted. This can be submitted in parallel to the transfer.

 

Medical devices containing an ancillary medicinal substance

Transfers of medical devices containing a medicinal ancillary substance with a valid CE certificate are considered administrative only. Transfers typically take less than 30 days from validation of the submission to be completed. No fees will apply to this transfer process.

 

Parallel Product Authorisations

If the UK is listed as one of a number of source countries on a PPA, this will need to be removed by way of a type IA variation (category 4).

Where the holder of PPA is located within the UK, the authorisation will need to be transferred to holder located within the EEA.

Qualified person certification of repackaging activity must take place within the EEA. Variations to change the site of batch certification can be submitted using the PPA variation category No 9a and 9b.

 

Variations to Marketing Authorisations to change Qualified Person Responsible for Pharmacovigilance (QPPV), manufacturing site or/and batch release sites.

Any variations required for a marketing authorisation (MA), e.g change in location of QPPV or site of batch release, should be completed prior to the date of the UK’s departure from the EU (prior to the 29 March 2019).

Changes in the QPPV, including contact details (telephone, and fax numbers, postal address and email address) may, for medicinal products for human use, be updated through the Article 57 database only (without the need for a variation)

Changes to the location of the PSMF (street, city, postcode, country) may be updated through the Article 57 database only (without the need for a variation)

 

 

Are you in search of advice and support on Brexit?

Please contact us, Ivowen are available to offer advice and support on HPRA compliance.

 

Written by Nanda Naik

Nanda Naik

 

 

 

 

 

 

 

2017 11 EV News image

Launch of the new EudraVigilance System – National arrangements for Ireland and what this means for you

With the launch of the improved EudraVigilance (EV) System, and the move to the simplified reporting of adverse reaction reports (ADRs) on 22nd November 2017, Marketing Authorisation Holders and EV users in Ireland must familiarise themselves with the HPRA’s national arrangements that will be in place during the changeover period.

As of 4th November the HPRA closed its reporting gateway and MAH’s must not submit ICSRs/SUSARs to HPRA from this time, as all submissions will be lost upon go-live date (22nd November) in the system (EudraVigilance Go-Live Plan).

To facilitate EV users, there will be a 3-day ‘cutover legacy’ period from 22nd – 24th November when all ‘backlog’ ICSRs can be submitted to EudraVigilance with Compliance timelines adjusted to reflect the downtime during this period.

Any SUSARs sent to EVCTM from 4th to 7th November should be submitted to HPRA after 22nd November along with the other cutover legacy SUSARs. Sponsors and investigators are also obliged to notify the HPRA within 3 days of any action needed to protect the health and safety of clinical trial subjects, in accordance with the HPRA Guide to clinical trial applications

 

New Simplified reporting of Adverse Reaction Reports

From 22nd November all serious ICSRs that occur within or outside the EU will be reportable directly to EudraVigilance and no longer to individual National Competent Authorities (NCAs)/ Marketing Authorisation Holders (MAHs).

All non-serious cases occurring in the EU will also be reportable to EudraVigilance by NCAs and MAHs. These final reporting arrangements are further described in Revision 2 of Module VI of the Good Pharmacovigilance Practice guide.

All reporting shall be in line with the final reporting arrangements as described in Directive 2001/83/EC as amended. Therefore all serious and non-serious ICSRs that occur in Ireland will be reportable directly to EudraVigilance by the MAH and not to the HPRA.

A key aspect of the new EudraVigilance system is its compatibility with the E2B(R3) format. Stakeholders may submit and receive ICSRs and SUSARs in the E2B(R3) format from 22nd November 2017 onwards, if their internal systems have been updated to meet this requirement.

 

For MAH EVWEB users any reports will automatically be generated in the E2B(R3) format and so it is recommended that these MAHs undergo training on EVWEB and the new ICH E2B(R3) format to gain familiarity with new functionalities and changes as there will be a new interface and improved functionalities.

 

We can help

Ivowen are fully equipped to advise and assist during this changeover period and beyond.  Please see our Pharmacovigilance services page or contact us for more information.

 

Written by:

Edel Behan

 

Need help with all the regulatory jargon?

Check out our updated GLOSSARY OF ABBREVIATIONS AND ACRONYMS.

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