Eunaris

Regulatory Support

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We provide regulatory support services for your EU/UK Market authorisations in accordance to Title III of Directive 2001/83/EC and Annex 1 to Directive 2001/83/EC and Article 16 of Regulation (EC) No 726/2004.

 

The services include, but not limited to the following:

• New product development and preparation of eCTD dossiers for the UK & EU.

  • Providing assistance in manufacturing Bio-study batches.

  • Compiling data from bio-study reports and stability study reports.

  • Preparation of SmPC, PIL & other artworks.

  • Applying for Market Authorisations, follow-up until grant.

• Life-cycle management of all Market Authorisations, including Pharmacovigilance.

• Filing "Change of Ownership" or "Piggy" for MAs.

• Filing all types of Variations for your existing MAs, MIA, WDA.

• Maintaining & updating the eCTD baseline documents for all your licenses.

• Updating PSURs.

• Artwork preparations.

• User testing for Product Information Leaflet (PIL).

• Renewal applications.

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MAH responsibility 

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eCTD baseline preparation

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From January 2019 the EU eSubmissions Roadmap will mandate the use of eCTD format for National Procedures (NP) meaning that all submissions (human) in Centralised Procedures (CP), Decentralised Procedures (DCP), Mutual Recognition Procedures (MRP) and now also National Procedures must be submitted in eCTD format and any submissions in NeeS format will be rejected. A baseline submission is often used to effect this conversion.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

What a baseline is?

A baseline submission is a compiled submission of the current status of the dossier, i.e., a resubmission of currently valid documents (latest approved versions) that have already been provided to the agency but in another format.

 

Pharmacovigilance support

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We also provide PV support services in accordance to Regulation (EC) No 726/2004 and Directive 2001/83/EC.

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For medicines which are authorised nationally in the UK, you as a Marketing Authorisation Holder (MAH), will be required to submit pharmacovigilance data to the MHRA, according to UK requirements, including:

• UK and non-UK Individual Case Safety Reports (ICSRs)

• Periodic Safety Update Reports (PSURs)

• Risk Management Plans (RMPs)

• Post-Authorisation Safety Studies (PASS) protocols and final study reports

These will be assessed taking into account all relevant information and decisions will be made reflecting UK clinical practice to best support patient safety in the UK.

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New Applications

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If you are looking for obtaining Market Authorisation (MA), Manufacturing & Importation Authorisation (MIA) or Wholesale Distributor Authorisation (WDA) in the UK or the wider EEA, we can help you in that.

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We can provide comprehensive support services ranging from New Product Development, Bio-equivalence studies, Stability testing, preparation of eCTD dossiers (as per Annex 1 to Directive 2001/83/EC), and apply for new Market Authorisation, through various procedures like,

• Centralised Procedure (CP)

• Decentralised Procedure (DCP)

• Mutual Recognition Procedure (MRP)

• National Procedure 

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Site audits

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If your company is holding MA, MIA, WDA or PI license, we can conduct second-party audits at your site and third-party audits on behalf of your company inside the UK and the wider European member states and submit an audit report. We can also conduct third-party site audits in India, through our parent company ProLife Pharma Consultants.

 

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