European Regulatory Affairs Limited

We have some exciting news to share – as many of you are aware the company’s name changed to ‘European Regulatory Affairs’ in 2020 and we have continued trading as ‘Ivowen’ to facilitate this transition.

After many years as ‘Ivowen’ we are thrilled to announce that we are shedding our old moniker and stepping into the future with our new name. So, say goodbye to ‘Ivowen’ and say hello to ‘European Regulatory Affairs’ (ERA). A new ‘ERA’ one could say.

You can be assured that our commitment to providing top-notch services will remain unchanged, we are still the same company with the same values, just a new and improved wardrobe.

So watch this space for our new website design and new signage – coming soon.

We look forward to the years ahead of continuing to be your go-to provider for regulatory services in Europe and beyond.

Alice D’Alton

Managing Director

Nitrosamines: Step 3 Deadline Extension

The deadline for Step 3 (updating the marketing authorisation) for chemical medicines has been extended from 26 September 2022 to 1 October 2023.

Step 2’s deadline (confirmatory testing) for chemical medicines remains as the 26th of September 2022 and MAHs should still submit their variations as soon as they conclude their investigations.

The extension of Step 3 deadline is to enable companies to perform a thorough investigation and to establish any required risk mitigating actions in light of new scientific developments since 2020.

What are the regulators doing as Covid restrictions are being lifted?

International Regulators COVID-19 Omicron variant workshop

International regulators participated in a ‘COVID-19 Omicron variant’ workshop. They discussed the effectiveness of current vaccines against the COVID-19 Omicron variant. They also considered regulatory requirements for possible future updates to vaccine compositions.

The workshop took place on 12th January 2022 and was coordinated by the International Coalition of Medicines Regulatory Authorities (ICMRA). A report from the workshop is published on the ICMRA website

A review of data from several countries was presented and discussed at the workshop. This included data resulting from Comirnaty vaccines (developed by BioNTech and Pfizer) and Janssen COVID-19 vaccines.

The data indicates that while a decrease in vaccine effectiveness against Omicron infection was generally observed, vaccination continues to provide significant protection from serious infection and hospitalisation by the Omicron variant. Furthermore, the importance of a booster dose is clearly evident from the data.

A review of the design of clinical studies to demonstrate the effectiveness of modified COVID-19 vaccines against variants was also discussed. Neutralising antibodies were deemed the most appropriate immune parameter to measure as primary outcome in clinical studies, as they have been shown to be correlated with protection.

In relation to updates to vaccine composition and manufacturing towards any specific single variant vaccine, e.g. a monovalent Omicron variant vaccine, it was considered too early at this point in time. More data is needed before such changes are deemed necessary. In this regard, the regulators suggest that bivalent or multivalent vaccines should be investigated as possible alternatives, as they could provide broader protection against variants.

The regulators advised that clinical studies would be needed to support new updated vaccines and that global coordination of changes in vaccine composition will be important as we move forward.

Written by

Claire Brown

Merry Christmas and a Happy New Year from Ivowen










Another year draws to a close………

With so many of us working from home again this winter, due to the pandemic, Ivowen has decided to give charitable donations in lieu of gifts and a party this Christmas.
As 2021 comes to a close we gives thanks for all that we do have. We are most grateful for
•Our valued clients
•Our dedicated colleagues
•Our trusted suppliers
•Our friends and families
•Our health and wellbeing
•and of course the Vaccines we received in 2021, which have kept us safe

Amongst the charities Ivowen have donated to this year we have chosen to support UNICEF’s ‘Get a Vaccine, Give a Vaccine’ campaign.

As most of us have been double vaccinated with a third on the horizon we acknowledge the many who have not yet received any vaccine at all. Ivowen is proud to support UNICEF’s efforts to deliver COVID-19 vaccines to low and middle-income countries. These vaccines protect frontline healthcare workers, social workers and the most vulnerable. And this means that UNICEF are protecting the most vulnerable children by helping ensure that the lifesaving health, nutrition and protection services children rely on can keep going despite the challenges of the pandemic (for more information e-mail

Stay safe, stay well and we look forward to seeing you again soon.

Written by

Alice D’Alton

Still finding your feet with Remote Audits?

Here are Ivowen’s Remote Auditing Tips to help you get ready for that next audit

Remote, off-site, paper-based, desk-top auditing call it what you want, what was once always put on the long finger is now becoming the norm for certain areas of auditing.

Here are a few of our tips to help you prepare to conduct a remote audit:

  • As with any audit, decide on the scope and purpose of the audit, identify the topics/areas which you wish to focus on
  • Establish the lead contacts (post, during and pre audit)
  • Decide on the best mode of communication for all and test it, do dry runs, establish what works best, let your IT department know of your audit date so they can be on hand to assist you with any IT issues
  • Establish the time table, give yourself and the auditee a realistic timeframe to compile and review the requested documentation, remember you may have a lot more distractions working remotely
  • Compile and request the list of documents (procedures, policies, training records, logs) you wish to review in advance, organise them per topic
  • Ensure you and the auditee have a secure method of data transfer
  • Have an internal pre-audit meeting to
    • discuss your findings
    • compile your questions, who will ask what, who will take the lead
    • test your communication systems (again)
    • establish the most relevant interviewee per topic/area
    • establish a rough time line for each topic/area
  • Accept that there will be glitches and issues on the day, keep calm and carry on, if they occur be prepared to take an unscheduled break and cycle back to the issue later
  • Make time for the chit-chat and small talk. Communication and good relations are vital for any partnership and this aspect may be lost without the face-to-face interactions
  • Discuss the inconvenience and hardship of the pandemic but also any positives that may have resulted from it
  • Prepare your audit report as you proceed.

Should you need any support in conducting your remote audit just contact us  and the Ivowen team will be here to help.

Written by

Fiona Downey.

To 2019 and beyond (Brexit)…

With the festive season upon us and 2019 on the horizon, Ivowen are setting our sights on the year ahead.  So what’s going on in 2019 and beyond, including and excluding Brexit…

What’s happening in early 2019?

We will be attending the Medicines for Europe Regulatory and Scientific Affairs and Pharmacovigilance conferences in January and we encourage you to contact us before mid-January with any specific questions you might like us to ‘ask the regulators’.

Brexit follows quickly on the tail of the new year, and we will all be hopefully ready and able for this new challenge.  Take our Brexit quiz here to see if you are Brexit ready and contact us to help.

What’s happening in later on in 2019?

We are also looking forward to attending the annual TOPRA symposium this year, hosted in Dublin, and we hope to see you at our stand to discuss how we can assist you with your regulatory needs in 2019 and beyond.

What about us?

Ivowen consists of an amazing team with extensive experience of the pharmaceutical industry. Our aim is to understand our customer’s needs and offer services that meet those needs in a timely and efficient way.
As part of EuDRAcon, a pan European network of regulatory consultants, we can provide expert advice on all matters regulatory for the EU and beyond, including Brexit

We hope that in 2019 Ivowen can help you with your specific and unique requests.

And for now…

The office will be closed from the afternoon of Friday 21st December 2018 until Wednesday 2nd January 2019. Merry Christmas and a Happy New Year for 2019!

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



Written by Mary Canning

Falsified Medical Directive (FMD) and updated QRD template released February 2016

Falsified medicines are fake medicines that are designed to mimic real medicines. Due to the increase of falsified medicines on the market the EU has a strong legal framework for licensing, manufacturing and distribution of medicines. In July 2011 DIRECTIVE 2011/62/EU ( ) came into force; this directive aims to prevent falsified medicines entering the legal supply chain and thus reaching patients. One of the Directive’s measures is the introduction of safety features on medicines.


Update on Safety Features on Medicines:

On February 9th 2016 the EC published an implementation plan for the introduction of the safety features on the packaging of nationally authorised medicinal products for human use:

In conjunction, a Regulation was also published laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use:


What do you need to do?:

The Delegated Regulation will apply in all European countries from the 9th February 2019 (3 years after its publication). Belgium, Greece and Italy have the option of deferring the application of the rules by an additional period of up to 6 years.

There are two safety features to be placed on the packaging of most prescription medicines and certain non-prescription medicines no later than 9 February 2019.

-1). a unique identifier (a 2-dimension barcode) and

-2). an anti-tampering device (ATD).


How does this affect your medicinal products and applications?

 New MAAs submitted from April 2016:

  • QRD:
    • Revised QRD template.
  • Revised dossier sections:
    • In the case of medicinal products where the ATD is placed on the immediate packaging because there is no outer packaging and the ATD affects the container and its closure system(s), applicants are required to include information on the ATD and how the ATD affects the container and its closure system(s) (sections 3.2.P.2.4 and/or 3.2.P.7 of the Notice to Applicants Volume 2B)

 Ongoing MAAs

  • QRD:
    • CHMP opinion in March 2016 advised to comply Revised QRD template
    • CHMP opinion from April 2016 onwards, applicants must comply with the revised QRD template
  • Revised dossier sections:
    • As per new MAAs

 Existing MAs

  • QRD:
    • Revised QRD template within 3 years – Can be implemented in Type IA, Type IB, Type II, Renewals, Line extension etc. where the submission affects the product information (PI). Approval of submissions must be no later than the 9th February 2019. If no regulatory procedure occurs within the required timeframe a notification is requested to be submitted pursuant to article 61(3).
  • Revised dossier sections:
    • If the ATD is placed on the immediate packaging and the ATD affects the container and its closure system(s), applicants are required to submit the appropriate variations to include the information on the ATD and how the ATD affects the container and its closure system(s) (see section B.II.e of the Variation Guidelines).
    • If the ATD does not affect the container and its closure system, or is placed on the outer packaging, no regulatory procedure is necessary. However, if the addition of the ATD has an impact on the readability of the packaging information, MAHs are requested to submit mock-ups as per

Medicinal product no longer needs to bear safety features

  • QRD:
    • Regulatory procedure to remove the standard statements regarding the unique identifier and ATD.
  • Revised dossier sections:
    • ATD on immediate packaging: Regulatory procedure to remove the statements regarding the ATD in the dossier. ATD on outer packaging – no regulatory procedure necessary.

Change of Legal Status

  • QRD:
    • Non-prescription to prescription following a MAH switch application: MAH should use the regulatory procedure to comply with the revised QRD and regulations. Non-prescription to prescription following a Commission referral or a PSUR assessment, the Commission Decision will cover, inter alia, the regulatory requirements to implement the safety features.
  • Revised dossier sections:
    • Non-prescription to prescription: MAH should use the regulatory procedure to include the information on the ATD and how the ATD affects the container and its closure system(s)


What does the new QRD template now include?

The new QRD template includes the following sections in: Particulars to appear on <the outer packaging> <and> <the Immediate packaging:


Updated QRD template in track changes is available here:


Are any medicinal products exempt from the above?

Yes, the medicinal products exempt from the above are listed in Annex I of the Regulation located here:


Are any medicinal products not subject to prescription but that should include the safety features above?

Yes, the medicinal products not subject to prescription that shall bear the safety features, referred to in Article 45(2) are listed in Annex II of the Regulation located here:

If you have any queries on the above, if you would like any help with complying with the new regulation or if you have any other queries please contact us .

Written by Emily Fletcher.

EF photo

Ivowen Launch New Website

Ivowen launched its new website in September 2014!