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.
Nitrosamines
Step 1: MAHs should conduct a risk evaluation to identify products at risk of N-nitrosamine formation or (cross-)contamination and report the outcome by 26 March 2020 at the latest.
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.
https://eureg.ie/wp-content/uploads/2019/12/Hot_Air_Baloon.jpg356570ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2019-12-06 09:52:522023-11-06 11:08:332019 – What a year
In an ever changing and at times a fast paced environment the world of pharmaceuticals demands cohesion and understanding across the board, to allow growth and success in any business either directly or indirectly involved with it. With regulations and guidelines becoming more stringent and extensive along with constant revisions and updates of the same it can be hard to keep up. It is important that you and your colleagues have an understanding of these guidelines that relate to the work that you do to ensure safety of patients and company compliance.
In certain instances guidelines and recommendations are hundreds of pages long and differ between countries, this places huge time pressure on individuals and businesses to keep up to date and often a brief read over them leaves people feeling a little confused and sometimes without even a basic understanding as to what actually needs to be done.
IVOWEN are here to help you gain a better understanding of, and, confidence in, current guidelines and technical updates. Ivowen has always offered training in many areas of pharmaceuticals but are now looking at providing these training sessions online to help our clients to gain a higher level of expertise through easier access.
We would be very grateful if you could complete the online survey we have created to help us assess how the online training sector can benefit our clients.
It takes less than 3 minutes to complete and would help us immensely:
“No company can afford not to move forward. It may be at the top of the heap today but at the bottom of the heap tomorrow, if it doesn’t.”
— James Cash Penney, founder, JC Penney
Written by Emily Fletcher
https://eureg.ie/wp-content/uploads/2019/11/Help-Support-Advise-Guidance-21-11-19.jpg248372ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2019-11-21 14:01:232023-11-06 11:08:37Are you interested in online training??
This year’s TOPRA Annual Symposium was held in Dublin in October. The Annual Symposium is an essential meeting for regulatory professionals to gain both an understanding of current and evolving regulatory requirements, as well as insights into future plans for regulations in the Human medicines, Veterinary medicines and Medical Device sectors.
Three members of our Team attended the Symposium this year, Majella Ryan, Alice D’Alton and Nanda Naik. This year was particularly satisfying for Ivowen as we had an exhibition stand at the three day event.
As well as exhibiting, Ivowen attended the sessions including ‘Life after Brexit’. This session was a live discussion of predictions and concerns about the possible outcome of ongoing negotiations with the EU.
Now that an extension has been granted, which will delay the UK exit until January 2020, we are left wondering if we will finally know the UK position when Ivowen attend the Medicines for Europe regulatory conference being held in Amsterdam on 29th – 31st January.
In the meantime, we await instruction from the regulators on whether UK will still be available on the CESP portal later this week. Ivowen is registered on the new MHRA submissions portal so either way we have you covered.
Ivowen will keep you up to date in the coming days and weeks
Please contact us, Ivowen are dedicated to keeping you up to date with the latest regulatory updates and innovations. We remain at your disposal to assist in all of your regulatory endeavours today and into the future.
The European Union updated its eSubmission Roadmap in June 2019 to reflect changes in timelines.
What is it?
The eSubmission roadmap is a high level, strategic plan for business and technology changes within the EU. Its function is to align the plans and implementation timelines of target groups and stakeholders, including the EMA, National Competent Authorities (NCAs) and the pharmaceutical industry.
Full details on the eSubmission Roadmap are available on the EMA’s eSubmission website here.
What is happening?
Centralised Procedure(s) (CP)
It is mandatory since January 2010 that all submissions in the CP are made in the eCTD format
National Procedure(s) (MRP & DCP and national only procedures)
It is mandatory since July 2015 and January 2017 that all submissions for new MAAs using the DCP and MRP respectively are made in the eCTD format. For purely national procedures, eCTD has been mandatory for new MAA submissions since July 2018.
For all new submissions in MRP and DCP, the mandatory use of eCTD has been in force since January 2018, and for all new national submissions, since January 2019.
What does this mean?
This means that ALL submissions in the EU for human medicinal products now have to be made in eCTD format. Are you ready? If not, contact us to find out how we can help switch all your current MAs to eCTD and manage all your lifecycle needs. Ivowen has been eCTD compliant since 2009, and therefore has a wealth of experience to become your key partner in this vital step of your registration process.
If you need any clarification or support to manage the changeover to eCTD, Ivowen will gladly work with you to ensure a seamless and efficient transition to eCTD. Contact us for more information or to make an enquiry.
The HPRA are always striving to improve their processes and ways of working. The following updates in the Human Medicines Department should help us all in our dealings with each other.
New electronic workflow system
The human medicines department within the HPRA have transitioned to using a new (internal) electronic workflow system. Due to this the following changes are worth noting for MA (marketing authorisation) applications and the issuing of licences and summary of product characteristics (SmPCs) by the HPRA:
Product Specific Details (PSD)
The product specific information (which included the product composition and the manufacturers’ details) will no longer form part of the product licence document that is issued by the HPRA. Previously the product licence document consisted of the licence cover page, PSD and Summary of Product Characteristics (SmPC). In future, the product licence document will consist of the licence cover page and the SmPC only. The information previously detailed in the PSD will be logged on the HPRA database and remain a registered part of the product marketing authorisation.
Summary of Product Characteristics (SmPC)
Updated SmPCs and Package Leaflets will publish on the website 24 hours after case closure.
(For details relating to the font/format of SmPC documents, further details are found in HPRA newsletter number 62).
PA numbers
PA, or Product Authorisation numbers, are the Irish version of the MA number. Newly allocated PA numbers for new holders will now contain 5 digit prefix.
Case Reference Number (CRN)
Previously CRNs were displayed as seven digits. These will now be alpha numerical for any new cases e.g. CRN00011X. The HPRA will still be able to identify any closed or ongoing cases using the old CRN.
Digital communications
All cases on the new system will be assigned a dedicated e-mail address e.g. [CaseNumber]@case.hpra.ie. This will enable you to send the HPRA case specific communications directly to the case and the allocated team. E-mail correspondence sent to you from the HPRA that is relevant to the case will come from this dedicated e-mail address. The European e-mail boxes will still be used where applicable. You should consult with your IT department to ensure that e-mails of this nature are not blocked in your organisation.
National Scientific Advice Guide
The HPRA have recently updated their National Scientific Advice Guidance (which commenced in 2017) to include additional therapeutic areas for stakeholders. These areas include: anti-infective products, vaccines, disorders of haemostasis and thrombosis, cardiovascular diseases, common allergic conditions, advanced therapies in certain clinical indications and biostatistics. The updated guidance can be found at the following link:
https://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svg00ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2019-08-07 15:22:032023-11-06 10:26:30News from the HPRA
Brexit extension date is now 31 October 2019, but there’s not time to be complacent.
Are you planning to submit a Marketing Authorisation Application (MAA) for a Non-Prescription Medicine?
If you are preparing an MAA for a Non-Prescription Medicine for a Decentralised (DCP) or Mutual Recognition Procedure (MRP) you will need to prepare a ‘Justification for Non-Prescription Classification’ document in accordance to CMDh best practice guide issued in January 2019 (CMDh/250/2012, Rev 1).
Ideally this document should be submitted as part of the initial MAA. Otherwise, you will be requested to provide it at the validation stage.
This document should be titled, “Justification for Non-Prescription Classification” and should be provided in Module 1.2. It should contain all the supporting data and evidence required to justify classification of the medicinal product as not subject to medical prescription as set out in the Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/c/switchguide_160106_en.pdf].
If you need any clarification or advise to prepare a justification for Non-Prescription classification report to support a Marketing Authorisation Application, Ivowen will gladly assist you in a timely manner. Please contact us.
Related news in relation to Brexit
The current Brexit extension date is 31 October 2019. The UK remains an EU Member State for the duration of the extension, with all the rights and obligations set out in the treaties and under EU law.
Nevertheless, all pharmaceutical companies in the EU are reminded to continue their preparedness for the UK’s withdrawal.
Based on the European Council decision, the deadline of 29 March 2019 referred to in Brexit related guidance should be understood as referring to 31 October 2019.
The MHRA have updated guidance on Exporting active substance manufactured in the UK in a no deal scenario on 03/06/2019.
In the event of a no deal EU exit, the UK will be recognised as a Third Country for the export of active substances for human use to the EEA.
In the event of a no deal scenario, the UK will continue to accept importation of active substances into the UK without a Written Confirmation from the same list of countries as currently (namely the European Economic Area (EEA) countries, USA, Japan, Brazil, Australia, Israel and Switzerland).
A Written Confirmation will then be required for each shipment of active substances manufactured in the UK that is exported to the EEA.
Please contact us if you need any clarification or support to supply Written Confirmation(s) for the orderly import of Active Substances, Ivowen will gladly assist you in a timely manner.
The MHRA have issued a guidance on the Handling of Active Substance Master Files and Certificates of Suitability in the event of no deal published 18 March 2019.
After Brexit, the UK will no longer participate in ASMF work-sharing procedures with EU Member States or have access to the EU Communication and Tracking System (CTS) assessment report repository. Any reference in the above guideline to the CTS ASMF assessment repository or to EU/ASMF/XXXXX reference numbers will not be applicable to UK national applications after the UK leaves the EU.
Certificates of Suitability (CEPs) are not affected by the UK leaving the EU as they are issued by the European Directorate for the Quality of Medicines and Healthcare (EDQM), which is a Directorate of the Council of Europe and a body that is independent of the EU. On leaving the EU, the UK will remain a member of the Council of Europe and a signatory to the Convention on the Elaboration of a European Pharmacopoeia.
Please contact us if you need any additional information or if you need any clarification or advise on ASMFs or CEPs, Ivowen will gladly assist you in a timely manner.
An Environmental risk assessment (ERA) of medicines ensures that the potential effects of pharmaceuticals on the environment are studied and that adequate precautions are taken in case specific risks are identified.
An ERA is required for all new marketing authorisation applications for a medicinal product through centralised, mutual recognition, decentralised or national procedures.
In the case of medicinal products comprised of naturally occurring substances such as vitamins, electrolytes, amino acids, peptides, proteins, nucleotides, carbohydrates and lipids as active pharmaceutical ingredient(s) (API), the ERA may consist of a justification for not submitting ERA studies.
For type II variations and extension applications, the ERA dossier should be updated if there is an anticipated increase in the environmental exposure. The environmental data previously submitted in the original dossier of the same marketing authorisation holder (MAH) may serve as a basis for the revised ERA for the variation or extension application.
An ERA is not required for renewals of marketing authorisations or Type IA/IB variations.
Applicants are required to submit an ERA irrespective of the legal basis. Generic medicinal products are therefore not exempted from providing an ERA. However, cross reference to the ERA dossier of the originator is permitted with consent from the originator.
In order to avoid unnecessary repetition of studies, and in particular animal studies, applicants are encouraged to share their data. If the current applicant has access to an ERA that was performed earlier by another marketing authorisation holder, this ERA (including study reports) may be submitted, including a letter of access. If the reference ERA is not complete in accordance with the current guideline (e.g. studies are missing, or increased environmental exposure may be anticipated) the applicant should conduct the missing studies and/or update the ERA.
Public Assessment Reports (PARs and EPARs) and reviews or summary data from other regulatory frameworks cannot be used in the ERA dossier without the underlying study reports. All data submitted (whether study reports or peer reviewed literature) should contain enough information to permit assessment of the reliability of the study performed.
The applicant may request scientific advice on issues related to environmental risk assessment and on possible precautionary and safety measures to be taken with respect to the use and disposal of a medicinal product.
Structure of the ERA report
The ERA report should be presented in Module 1.6 of the eCTD dossier.
The ERA report should start with a clear identification of the active ingredient, including company name/code, IUPAC name, CAS number, empirical formula, structural formula, SMILES code, and molecular weight.
The full study reports and references should be provided in the annex of the ERA. There may be cases in which the absence of environmental studies could be justified. In these cases, the expert should provide a rationale for the absence of studies.
A dated signature of the author, information on the author’s educational, training and occupational experience, and a statement of the author’s relationship with the applicant, must be included.
Are you in search of advice and support on ERA?
Please contact us, Ivowen Regulatory are available to offer advice and support on Health Product Regulatory compliance.
Written by Nanda Naik
https://eureg.ie/wp-content/uploads/2019/05/Ecosystem.jpg506670ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2019-05-13 13:39:342023-11-06 11:08:40Environmental Risk Assessment (ERA) – revised guideline to assess risk of human medicines for the environment…….
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.
https://eureg.ie/wp-content/uploads/2019/03/FMD.jpg14411915ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2019-03-25 17:17:252023-11-06 11:15:38HPRA update on Batch-specific requests for safety features
The European Union is arguably the world’s most powerful bloc and very soon it’s about to lose the United Kingdom, one of its biggest members. How and when the UK leaves the EU will have further implications that ripple around the globe.
So if you’ve heard about Brexit but haven’t been keeping up with every twist and turn of the developments, no worries! Ivowen team will provide you with everything you need to know to have your products designed for UK and Brexit affected markets authorised successfully.
What is happening?
EMA
The European Medicines Agency (EMA) will physically relocate to the Netherlands in early March 2019.
EMA will leave its premises in London on 1 March 2019.
It was confirmed that from 4 to 8 March, the Agency will operate on the basis of extended teleworking. During the course of the following week EMA staff will gradually move into the Spark building.
From 4 March 2019 onwards the official address of EMA will be that of the permanent building, located in Amsterdam Zuidas:
European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
Meetings and visits will take place at the Spark building:
Orlyplein 24, 1043 DP Amsterdam, The Netherlands
UK guidance on Brexit
Following the outcome of the EU referendum, MHRA still feels responsible for playing a crucial role in medicines and devices regulations as well as vigilance and market surveillance.
As part of the MHRA response to exiting the EU the following Brexit guidance was issued:
If you need any clarification or support to complete variations to support changes needed as a result of Brexit, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.
MHRA guidance on Brexit
Bearing in mind the worst-case scenario if the UK leaves the EU with no deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks and consequently submissions related to human medicines would need to be submitted directly to the MHRA.
The webinar below is relevant for all pharmaceutical companies involved in making medicines regulatory submissions and vigilance activities. It also ensures that stakeholders can be informed of any IT plans and preparations. There is also a section on how all medicines related clinical trial sponsors will register and submit:
If you need any clarification or support to complete variations to support changes needed as a result of Brexit, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.
UK legislation on medicines and medical devices
Legislation has been published which, in the event of the UK leaving the EU with no agreement, will cover the regulation of medicines, medical devices and clinical trials and allow for the continued sale. The Brexit guidance is available here:
The 2012 Regulations (as amended by the 2019 Regulations) make reference to various pieces of EU guidance, as that stood immediately before the exit day (29 March 2019).
If you need any clarification or support to complete variations to support changes needed as a result of Brexit, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.
EU Commission and EMA Q&As
The EU Commission & EMA have published an updated list of questions and answers related to the UKs withdrawal from the EU on the 1st February:
This confirms that dual labelling between UK & Ireland is acceptable where the labels meet the requirements of the Directive and reflect the SPC in Ireland (see Q24).
The focus of this Q&A is on the regulation of medicinal products within the centralised procedure.
If you need any clarification or support to complete variations to support changes needed as a result of Brexit, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.
Brexit Stakeholder Event
Brexit Stakeholder Event – Ivowen was there
Following the UK’s departure from the European Union, the HPRA, together with medicines agencies in Europe, is making preparations to ensure continuity to deliver on patient and animal health remits even if the UK fully exits the current systems as scheduled. There are potential implications for the European network as a whole and particularly for Ireland with its shared marketplace, see meeting agenda below:
Contact us if you would like some more information on this event or Brexit in general
Written by Karolina Dobrychłop
https://eureg.ie/wp-content/uploads/2019/02/Brexit3.jpg437625ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2019-02-19 17:53:522023-11-06 11:15:36Brexit – because it affects you too…
Ivowen have provided some practical guidance and documents below, which may help you prepare for Brexit for products authorised by the DCP and MRP procedures.
Do you still need to change your MAH(s) in any of the EU Member States because of Brexit?
If so, refer to the following updated guidance issued in January 2019 which details the documentation and requirements to submit a Marketing Authorisation Holder transfer:
If you need any clarification or support to complete a Marketing Authorisation Holder transfer, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.
Is the UK your current RMS?
If so, you need to initiate an RMS switch as soon as possible. The guidance issued in July 2018 along with the template issued in June 2018 is required to complete this process. This template needs to be completed and sent to a specific e-mail address at the proposed new RMS. The list of contacts points to send the completed template is provided below:
If you need any clarification or support a RMS switch, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.
Do you need to change your UK batch release site, etc., if it currently within the UK?
If so, you can refer to the updated guidance document issued in December 2018, which provides information on the type of variation that is required to change functions such as batch release site(s), QC testing site(s), packaging site(s), deletion of site(s) for batch release and changes to the QP for Pharmacovigilance (QPPV) and PSMF where these functions still reside within the UK:
If you need any clarification or support to complete variations to support changes needed as a result of Brexit, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.
Do you supply product to Cyprus?
If so, the Cypriot Competent Authority has issued a newsletter to Stakeholders on the 14 January 2019 which lists 105 products authorised via an exceptional marketing authorisation affected by Brexit which are considered critical. The Drugs Council in Cyprus recommends that pharmaceutical companies register these products via an exceptional marketing authorisation using another reference state other that the UK.
If you need any clarification or support to complete an Exceptional Marketing Authorisation to avoid no supply of these critical products on the Cypriot market, Ivowen will gladly assist you in a timely manner. Contact us for more information or to make an enquiry.
