Tag Archive for: EMA

Brexit3

Brexit – because it affects you too…

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.

https://www.ema.europa.eu/documents/press-release/ema-relocation-updates_en.pdf

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:

Technical information on what the implementation period means for the life science sector

Update on negotiations and further guidance for pharmaceutical companies planning in advance of the final negotiated settlement

Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal

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:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/772918/Making_submissions_to_the_MHRA.pdf

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:

  1. Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc) (EU Exit) Regulations 2019
  2. The Medical Devices (amendment) (EU exit) Regulations 2019
  3. The Medicines for Human Use (Clinical Trials) (amendment) (EU exit) Regulations 2019

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:

https://ec.europa.eu/info/sites/info/files/medicinal_products_for_human_and_veterinary_use-qa_en.pdf

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:

Agenda for Brexit Stakeholder event 1 Feb 2019

Contact us if you would like some more information on this event or Brexit in general

 

KD

Written by Karolina Dobrychłop

EMA introduces changes to the QRD templates

The EMA has introduced changes to the QRD templates of the product information that accompany all medicines authorised for use in the EU including package leaflet (PL) and the summary of product characteristics (SmPC). Full details are available here:

Summary of Main Changes:

The changes to Quality Review of Documents (QRD)  templates are detailed in the updated guidance for the pharmaceutical industry. The main modifications are:

  1. the acceptance of combined SmPCs for different strengths of the same pharmaceutical form whereas until now a separate SmPC was required for each strength of the same pharmaceutical form
  2. the dates to be recorded in section 9 of the SmPC (i.e. date of first authorisation and date of latest renewal)
  3. the text to be included in Annex II (for centrally approved products (CAPs) only)
  4. the list of local representatives in the PL may only contain the address of the local representative of the marketing-authorisation holder (MAH) in the Member State where this particular medicine is sold, instead of the contact details of all local representatives in all EU Member States (for CAPs only)

What does this mean for you?

  1. This means that updates to common sections can be managed in one document, instead of multiple documents making life-cycle management much easier and reducing variation preparation time, etc.
  2. These dates only need to go in once, and the only one that will require updating is the renewal date. Since most products ordinarily undergo only one renewal, this date will also only have to be inserted once.
  3. The standard text to be included pertaining to the submission of PSURs has changed. This needs to be updated at the next variation to the your approved QRD text.
  4. This is really good news for all holders of Community Authorisations! (products approved through the Centralised Procedure). Instead of having to list up to 31 local contacts on the printed PIL, it is now permissible to list only the local contacts associated with that particular PIL. For example, for Ireland and UK dual packs, only the Irish and UK local contact need be listed. This will result in serious space savings on individual PILs, and time and efficiency improvements for regulatory affairs departments who need to keep the document life-cycles up to date.

What’s next?

Ivowen have extensive experience with the Centralised Procedure and QRD template changes and maintenance. Please contact us if you would like to discuss any of the above changes or any issues that you might have with your centrally approved products.

Ivowen would also advise that you take this opportunity to check over older approved QRD Annexes and correct any legacy typos, font issues, etc.

Written by Majella Ryan

MMR photo

Ecosystem

Environmental Risk Assessment (ERA) – revised guideline to assess risk of human medicines for the environment…….

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.

The EMA has published a revision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation. Stakeholders are invited to send their comments by 30 June 2019 to era_dg@ema.europa.eu using the template provided.

 

Dossier Expectations due to ERA revised guidance

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

Nanda Naik

Corona virus image 11 05 20 1

European Procedural Guidance during COVID-19 Pandemic

In response to the significant impact the COVID-19 pandemic is having on European regulatory activity, the European Commission, the European Medicines Agency and the Heads of Medicines Agencies network (EC, EMA and HMA, respectively) have approved a number of measures to help the management of marketing authorisations for human medicinal products considered crucial during the pandemic period.

The objective of these measures agreed at European level is to promote regulatory flexibility, facilitate, simplify and accelerate the administrative procedures, as far as possible, in order to respond more efficiently to emerging needs during this period.

As a result, the EC recently published questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic:

Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use during the COVID-19 Pandemic

This Q & A document which provides guidance to marketing authorisation holders (MAH) includes the following topics:

  • renewal applications
  • sunset clause
  • an exceptional change management process (ECMP) for crucial medicines for use in COVID-19 patients
  • circumstances under which the validity GMP certificates and authorisations to manufacture/import can be extended
  • circumstances under which the validity GDP certificates and wholesale authorisations can be extended
  • adaptions to the work of a Qualified Person (QP)
  • the possibility of adapting quality requirements for medicines intended to be used for the treatment of COVID-19 patients
  • the impact on reporting into EudraVigilance of Individual Case Safety Reports (ICSRs)
  • flexibility in the labelling and packaging requirements to facilitate the movement of medicinal products within the EU

Further to the European Commission’s Q&A document, the CMDh has agreed additional questions and answers that provide practical information on how to specifically address and apply the provisions determined by the European Commission for MR/DC procedures:

Practical Guidance of the CMDh for facilitating the Handling of Processes during the COVID-19 Crisis

The CMDh document addresses issues such as the impact of COVID-19 on assessment timelines, how to use the ECMP procedure (which is only applicable for products that are crucial for the treatment of COVID-19 patients) and QP declarations based on a desktop audits. It also includes a useful annex that details Member States’ email addresses and links to relevant published guidance on MS websites.

Both documents will be updated and supplemented with additional information, as appropriate during the pandemic.

Everyone at Ivowen is working tirelessly to keep our clients applications on track. We are liaising with the National Competent Authorities all the time to ensure we avoid delays and get the best results possible in these unprecedented times.

If you need any assistance in this regard please don’t hesitate to contact us.

ClaireBrown

 

 

 

 

 

 

Written by Claire Brown.

ICH Elemental impurities

New ICH guideline Q3D on elemental impurities (EMA/CHMP/ICH/353369/2013)

Elemental impurities guideline

What is it…

The ICH has introduced this new guideline to control the elemental impurities that may be present in drug products. It replaces EMEA guidance on Specification limits for residues of metal catalysts or metal reagents (EMEA/CHMP/SWP/4446/2000).

This guideline applies to new drug products (with a new drug substance) and to drug products containing existing drug substances. There are some exemptions, which you can find in the guideline.
It does not apply to drug products used during clinical research stages of development.

CHMP implementation dates for this guideline are
•    New MA application for new products (new drug substance) – June 2016
•    New MA application for products with existing drug substance – June 2016
•    Marketed products including new MR applications of already approved products – Dec. 2017

What does this mean for you?

Elemental Impurities (EIs) in Drug Product (DP) may arise from several sources. They may be residual catalysts that were added intentionally or may be present as impurities (e.g., through interactions with processing equipment, container/closure systems or by being present in components of the drug product, i.e. drug substance, excipients or water).

Because EIs do not provide any therapeutic benefit to the patient, their levels in the drug product should be controlled within acceptable limits. These limits are outlined in the new guideline.

This guideline presents a process by which to assess and control EIs in the drug product using the principle of Risk Management as described in ICH Q9. This process provides a platform for developing a risk based control strategy to limit EIs in the DP.

The Risk Assessment (RA) should be based on scientific knowledge and principles. It should link to safety considerations for patients with an understanding of the product and its manufacturing process, and it should be focused on assessing the level of EIs in a DP in relation to the Permitted Daily Exposure (PDE) presented in the guidance.

The summary of RA and any measures taken, to ascertain compliance and the overall control strategy for EIs, including any specification as needed, should be provided in the Regulatory dossier.
The documentation of RA should be maintained in company’s quality system and should be kept for inspection (at the time of GMP inspection of the site by the competent authority).

If RA fails to demonstrate that an EI level is consistently less than the Control Threshold, then additional controls should be established to ensure that the EI levels does not exceed the PDE in the drug product. Approaches that an applicant can pursue include but are not limited to:
•    Modification of the manufacturing steps that result in reduction of EIs,
•    Implementation of in-process controls,
•    Establishment of specification limits for excipients or drug substance or drug product,
•    Selection of appropriate container closure systems.

For marketed products, if the RA concludes that additional controls are to be established then the regulatory impact of these additional controls should be evaluated to see whether it triggers a variation(s) to the existing MA.

Where can I find the relevant information…

The new guideline is available on the EMA website. You can find it by following this link.

We can help…

Ivowen are fully equipped to apply for any such variations on your behalf. Please contact us for more information and for support of your dossier compilation or updates.

Written by Nanda Naik

Nanda Naik

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Pharmacovigilance most of all

The European Medicines Agency (EMA) has recently published an overview of pharmacovigilance activities that outlines just how strong and reliable a system we have in the EU. The report was prepared by EMA in collaboration with the National Competent Authorities (NCA).  The report includes quantitative data covering the period between 2015 and 2018 and shows that the European regulatory network for medicines is held accountable for the implementation of the pharmacovigilance legislation.

The measurement of impact is based on a strategy and action plan for measuring the impact of pharmacovigilance activities, adopted by EMA’s safety committee (PRAC) in 2017.

It shows that the EU pharmacovigilance system is strong and protects public health.

 Some key outcomes 2015-2018

  • More than 500 new or updated risk management plans were assessed by the PRAC each year, ensuring the safety monitoring and risk minimisation is proportionate and planned. In addition, nearly 7,000 risk management plans were assessed by the Member States for nationally authorised medicines during the reporting period.
  • Enhanced EudraVigilance database of suspected side effects, resulting in improved reporting and greater analytical power;
  • Evaluation of nearly 9,000 potential signals (information about new or changing safety issues potentially caused by a medicine) by EMA’s signal management team over the period covered by the report, and a similar number of potential signals assessed by Member States;
  • Radical simplification and improvement of the way periodic safety update reports are handled, by establishing a common repository with a single portal for access;
  • Development of criteria to determine when a public hearing on issues of medicines’ safety would be of value, and the successful holding of the first such hearings, for valproate-containing medicines in 2017 and for quinolone and fluoroquinolone antibiotics in 2018;
  • Continued development of the ‘Article 57 database’, which now contains information on more than 800,000 medicinal products authorised through central, decentralised, mutual recognition and national procedures across the European Economic Area.

For more details on the report please refer to EMA web page where you can access the press release issued.

The pharmacovigilance legislation established now reinforces the need for and format of various reports, including:

  • Risk Management Plans (RMP);
  • Periodic Safety Update Reports (PSUR);
  • Post-Authorisation Safety and efficacy Studies (PASS);
  • Pharmacovigilance System Master Files (PSMF).

Should you require assistance with respect to setting up a pharmacovigilance system, or the preparation and submission of pharmacovigilance related data we encourage you to contact us.

Written by Alice D’Alton.

eSub roadmap eAF 02 2016 1

Points to note on the eAF

General

The eAF is mandatory for all procedures from 01/01/2016 (CP, MR, DC, National in eCTD/NeeS/Paper). However, Presubmission Meeting Requests, Article 61(3) & MAT forms remain the outside scope and can be submitted as paper or PDFs.

Please contact us if you require any assistance with any of the forms or any advice on any of the above procedures. For your convenience, the following is a summary of the important aspects of using the eAF.

  • Always check the e-submission website for the latest version of the eAF (http://esubmission.ema.europa.eu/eaf/)
    • Word versions will be removed from Notice to Applicants in January 2016
    • After 11/01/2016 only version 1.19 will be acceptable for new procedures
    • eAF should be printed for Paper submissions
    • Version 1.20 is planned for April 2016 (unless hotfixes are required before then)
    • It is important to note, and welcome news, that there is no need to update to a newer version of the eAF in the middle of a procedure
    • See the guidelines (update planned in January 2016) and release notes (lists the changes made to newer versions) for further information
    • In line with the proposed move towards a Single Submission Portal (SSP) in place of CESP and the EMA Gateway, there are plans to reformat the eAF into a data capture system that can be submitted directly through CESP. This is in a very preliminary stage.
  • Technical queries should be sent to EMA Service Desk via IT service portal (login)
    • Q&A documents should be consulted first
    • Fast web view warning in the dossier validation report for the eAF can be ignored
  • Procedural queries should be directed to the National Competent Authority (NCA) (and response sent to EMA Service Desk). Complicated queries should be sent to both parties.
  • Webinars are available for the NCAs (to try to reduce the requests for MS specific national requirements)

 

Using the eAF

  • Technical Validation of the form (internal):
    • Once signature is added and form validated, it is now locked. Locked forms cannot be amended. Therefore, the signature should be the last thing added to the form.
    • Always keep a copy of the unlocked form so that amendments can be made (e.g. during preparation or for requests from NCA for updated forms during a procedure)
    • Do not use bookmarks as these may cause invalidation issues
  • Annexes to the form should be filed separately in module 1.2 (do not use the PDF function to insert them into the eAF)
    • Form should be named; cc-form-eaf-var
    • Annex should be named; cc-form-annex-var (e.g. cc-form-5-19 or cc-form-proofpayment)
  • Electronic signature can be an image of a real signature (e.g. jpeg file – a scanned copy of wet signature. This however is not an electronic signature and is only used to close/lock the form) or can also be a line of text which states that signature is on file internally (e.g. “This form was authorised following company policies by Majella Ryan, Regulatory Affairs Manager of Ivowen with authorisation to sign. The signature is on file”)
    • The eAF does not accommodate multiple signatures at present. A separate annex should be provided if multiple signatures are mandatory for a particular NCA. Multiple name sections will be incorporated into version 2.0 but no mention of whether multiple signatures will also be accommodated.
    • The signature should be provided by the responsible MAH or can be provided by any authorised deputy
    • Please also check national requirements for signatures.
    • See Q&A guidance for further information
  • Workaround solutions (e.g. Annex B for multiple MAH or Product names) should always be mentioned in your cover letter
    • Some unforeseen variations (category z) are not adequately accounted for yet. Details of such changes should be outlined in the scope section of form and in the cover letter.
    • Duplicate sections only if products differ with regard to API or Pharmaceutical Form
    • Annex A or Annex B can be used for multiple MAH or Product names. Click on Annex A/B button in form and add the annex as a separate file in Module 1.2
    • Detailed instructions on how to use workaround solutions is available in the eAF Q&A document and the eAF Technical Guidance documents – both are published on the eAF webpage – if you need more advice contact EMA Service Desk.
  • No translations of the eAF are available, nor should they be requested.
  • Drug substances can be entered from controlled vocabulary lists or free text, and these each have different EV codes.
    • The focus should be on using substance, product, organisation and referential (SPOR)
  • Request for New Terms:
  • Strikethrough text function is not available in eAF but text can be copied and pasted (with text struck through) from Word or Outlook
  • In MRP/DCP one common application form is highly recommended, one per pharmaceutical form or strength for all member states in case of new MAA and one eAF for all involved products for all member states in case of variations and renewals.

 

Written by Majella Ryan

MMR photo

Brexit

Preparing for Brexit

As the date for the withdrawal of the UK (also known as Brexit) from the EU approached closer, it pays to hope for the best and prepare for the worst.  With this in mind, the EMA have issued a guidance document on “Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure, EMA, 19 June 2018” to prepare for the UK’s exit from the EU by the 30 March 2019.  

 http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/11/WC500239369.pdf

 

What does it mean?

For marketing authorisation applications (MAAs) that are expected to receive a Commission Decision (i.e. be approved) after 29 March 2019, the QPPV, PSMF (for medicines for human use), batch release sites, batch control sites, intended OMCL (if applicable) and nominated local representatives for Member States other than UK must be located in in the Union (EEA).

As published on the EMA website on the 10 July, a recent European Medicines Agency (EMA) survey shows that marketing authorisation holders for more than half (58%) of the 694 centrally authorised products (CAPs) with an important step in their regulatory processes in the United Kingdom (UK), are on track with their regulatory planning to ensure that their marketing authorisation remains valid once the UK leaves the European Union (EU).

This also means that 42% are NOT ready… Are you one of the 42%

The EMA urges those companies who have not yet informed EMA of their Brexit preparedness plans to do so as soon as possible to mitigate any risks to the continuous supply of medicines for human and veterinary use within the EU.

 

We can help…

Ivowen can help Clients prepare to implement the required changes by providing the following services:

  • Provide practical guidance on what needs to be in place by the above date to address situations where the UK is the current MAH, batch release site, batch control sites, location of QPPV& PSMF, transfer of orphan designation, etc.
  • Act as a MAH in the EU
  • Provide Pharmacovigilance (QPPV) services in the EU
  • Provide Pharmacovigilance System Master File and backup services located in the EU
  • Assist Clients in selecting and transferring RMS to another EU member state where the UK is current MAH
  • Preparation of Brexit related variations to be ready for above timelines
  • Assistance in changes needed to Product Information to reflect changes such as new MAH, batch release site(s), amend names of local representatives

Please contact us for further information at any time.

 

 

PSUR repository

PSUR repository updated

On the 26th of January 2015, the EMA introduced the pilot phase on the use of the XML delivery file for submissions of PSURs via the eSubmission Gateway/Web Client.

This introduction,

1) Simplified package file names for PSURs and

2) Introduced the requirement of an XML delivery file.

The XML delivery file is created in the PSUR Repository user interface

The PSUR Repository user interface is basically broken down into 4 sections:

  • Section 1: Regulatory Activity

This is a simple drop down list and is currently only available for PSUR submissions and Supplementary information which is related to a PSUR submissions.

  • Section 2: Details of assessment procedure

This section requires you to enter the Procedure Number as per the EURD list, all other information (Submission deadline, DLP, Active name, Rapporteur name and Rapporteur country) will prepopulate based on this Procedure Number. Carefully check if all information is correct, if prepopulated information is wrong contact the EMA.

  • Section 3: Product Selection
  1. Select your Submission Format (eCTD or NeeS)
  2. Enter the product name(s) in the section products to which the submission relates for all your products to which the submission relates. This is a drop down menu based on the Art 57 database. Therefore you must first ensure that all your product information entered in the Art 57 database is up to date and correct.
  3. Select your products, enter your procedure number (where relevant) and the sequence number of your submission.
  •  Section 4 Routing information
  1. Enter EMA routing ID (e.g. ESUBPROD) and  your Routing ID (e.g. ESUBPTESTPROD123)
  2. The XML delivery file will always be called xml, this should not be renamed/edited
  3. Save the XML delivery file inside the PSUR submission folder (zipped).
  4. Your PSUR folder should have a meaningful file name and examples of these can be found in Annex 3.
  5. Your Submission file can be send in the normal manner via the eSubmission Gateway/Web Client.

From September 2015, it will be mandatory to use the XML delivery file for all PSUR submission to the EMA via the eSubmission/Web Client.

Please contact us if you require any further information or help with this process.

Written by Fiona Downey.

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CHMP referral

Referrals to the EMA and CHMP? Keep calm and carry on.

What is a Referral all about?

A Referral to the EMA and CHMP is a procedure used to resolve issues such as concerns over the safety or the benefit-risk balance of a medicine or a class of medicines. The matter is ‘referred’ to the European Medicines Agency, so that its expert committees can make a recommendation for a harmonised position across the European Union.
There are a number of reasons why a Referral may be started, ranging from concerns over the safety of a class of medicine to disagreements among Member States on the use of the medicine.
Whatever the reason, your product going to a Referral is a challenging and most probably an unknown (and unwanted) procedure and unfortunately it would seem in recent years Referral procedures have increased, especially Article 29 and Article 30 Referrals.

Recent success with a complicated fixed combination referral

Ivowen recently guided a company through a successful Article 29(4) Referral. This type of Referral is triggered when there is a disagreement between Member States regarding a medicine being evaluated during a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.
With all the “big players” involved in the concerned decentralised procedure; United Kingdom, Germany, France, Spain, Portugal, Austria, Belgium, Croatia, Ireland, Luxembourg, the Netherlands, this Referral was challenging in more ways than one.

However, on 18 May 2017, the EMA completed the arbitration procedure. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of the product outweigh its risks, and the marketing authorisation can be granted. Information regarding this Referral procedure can be found on the EMA website.

Need help with a Referral?

If your products are heading into any Referral, be it an Article 29, 30, 31, 35 or 36, and you need support; from talking you through the complicated timetable, supplying quality and clinical support to the provision of translations why not contact Ivowen to help you through this daunting task?

Need help with all the regulatory jargon?

Check out our updated GLOSSARY OF ABBREVIATIONS AND ACRONYMS.

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