HPRA updates June 2021

Notification of a clinical investigation under Article 82 MDR

Clinical investigations of medical devices that are not performed for any of the purposes listed in Article 62 (1) or Article 74 of the MDR require notification to the HPRA under Part 3 of the Medical Devices Regulations 2021 (S.I. 261 of 2021).

Notifications will only be accepted via CESP, unless previously agreed with the HPRA.

You can download the notification form here.


Guide to Labels and Leaflets of Human Medicines

This guide has been updated from the version of 15 July 2020 to the version of 17 June 2021.

The only significant update appears to be to the section, 5.4 Labels of vaccine products and plasma-derived medicinal products.

Here you can view the track changed and clean versions of the document.


HPRA Medicinal Products Newsletter – Issue Number 68 published

As always, this newsletter is packed with very useful information. Some of the information is non-specific and is therefore applicable to to any EU member state.

In this edition, there is useful information on all of the following topics:

  • Approval dates for package leaflets – A reminder that the approval date for a package leaflet is the date that the case implementing or amending the leaflet is closed by the HPRA.
  • Nitrosamine impurities – Information is provided in some detail to help Marketing Authorisation (MA) holders with a clear understanding of the steps involved in the CHMP Article 5 (3) ‘call for review’ process. MA holders of human medicinal products are required to review their medicinal products to determine the risk for the presence of nitrosamines and to complete the required risk evaluation.
  • Article 31 referral for Sartan medicines – Reminder
  • Preparation of labelling for joint IE/UK (NI) packs – In response to MA holders asking about the approach to taken when preparing joint IE/UK (NI) packs, HPRA would like to highlight the flexibility available already in the HPRA guide to labels and leaflets. Additional guidance is also provided.
  • Audits of Type IA notifications: 2019/2020 review -The most common deficiencies identified during an HPRA audit were:
    • ‘EC Classification Guideline’ page not submitted
    • Missing or incomplete documentation
    • Conditions relevant to the chosen Type IA category not fulfilled
    • Type IAIN notifications not submitted immediately after the implementation of the change in the quality system of the marketing authorisation holder
    • Incorrect classification of Type IA notifications where the wrong Type IA notification subcategory was selected or where a change was incorrectly classified as a Type IA notification when a Type IB variation was required.
  • Reference medicinal product – Updated CMDh Brexit guidance – As the Brexit transition period has now ended, the CMDh has published updated guidance on Reference Medicinal Product (RefMP) in the latest version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP (Feb 2021). Particular attention is drawn to the responses to Q34 and Q39.
  • Clinical Trials regulation progress – On 24 April 2021, the EMA’s Management Board confirmed that the introduction of the Clinical Trial Regulation (Regulation (EU) No 536/2014) was on track to be introduced on 31 January 2022. The introduction of the new regulation will see a significant change in how trials are processed across Europe, with a more streamlined approach being adopted Further detail is provided here.