News

Media And Political Bulletin – 04 April 2019

Media and Political Bulletin

04 April 2019

Media Summary

Brexit: Some drugs ‘cannot be stockpiled’ for no-deal

BBC Newsnight, 03 April 2019

BBC Newsnight reports on confidential NHS England files, viewed by the BBC, which suggest that supply chain issues mean that some drugs used to treat conditions like epilepsy and bipolar disorder ‘cannot be stockpiled.’

The documents state that potential shortages would have a ‘significant impact,’ but that the Department of Health said that supplies ‘should be uninterrupted.’

Watch the full clip here.

Webinars related to making submissions to the MHRA if the UK leaves the EU with no deal

MHRA, 03 April 2019

The MHRA has updated its guidance webinars related to making submissions to the MHRA if the UK leaves the EU with no deal.

See the updated guidance here.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Webinars related to making submissions to the MHRA if the UK leaves the EU with no deal

MHRA, 03 April 2019

Leaving the EU with a deal remains the Government’s top priority. This has not changed.

However a responsible government must plan for every eventuality, including a no deal scenario. We are continuing with our no deal planning to ensure we are fully prepared.

The Agency is making preparations to ensure that in the event we leave the EU with no deal, you can continue to submit regulatory and notification information to the UK.

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. Submissions related to human medicines would need to be submitted directly to the MHRA.

We have a contingency programme in place to deliver new systems and processes should we lose access to the current EU IT systems. Where feasible, we are trying to minimise additional administrative burdens and are trying to make any changes as simple to use as possible.

See our detailed guidance on Making submissions to the MHRA in a no deal scenario.

Making submissions via MHRA Submissions – webinar

View our webinar on how to make submissions via MHRA submissions.

This webinar replaces the earlier ‘Making submissions’ webinar and is relevant for:

* all pharmaceutical companies involved in making medicines regulatory submissions

* all medicines clinical trial sponsors wishing to submit clinical trial applications to the Agency

* e-cigarette producers

* brokers of medicinal products

The content covers how to navigate around MHRA Submissions and outlines the steps involved in submitting regulatory notifications via MHRA Submissions.

The content is designed to help with preparedness and addresses queries raised during the session. The processes and screenshots provided in this webinar are subject to minor changes prior to Day One. From Day One, please refer to the detailed and finalised guidance materials found in Making submissions to the MHRA in a no deal scenario.

Vigilance: MHRA Gateway and ICSR Submissions – webinar

View our webinar on how to register for the MHRA Gateway or ICSR Submissions

This webinar is relevant for:

* all pharmaceutical companies responsible for submitting Individual Case Study Reports (ICSRs)

* all medicines clinical trial sponsors responsible for submitting Suspected Unexpected Serious Adverse Reactions (SUSARs)

The webinar content covers the steps involved in registering and setting up access to the MHRA Gateway. It also covers how to register for the ICSR Submissions solution for companies who will not be using the MHRA Gateway option.

How to gain access to the MHRA submissions portal – webinar

View our webinar on how to gain access to the MHRA submissions portal.

This webinar is relevant for:

* all pharmaceutical companies involved in making medicines regulatory submissions and vigilance activities

* all clinical trial sponsors wishing to submit clinical trial applications to the Agency

* e-cigarette producers

* brokers of medicinal products

The content will cover the steps involved in gaining access to the MHRA submissions portal, the critical role of the initial company administrator and guidance on how to manage access to third party consultants/consultancies who submit on your behalf.

Please note that the systems and processes outlined are subject to change.

Media And Political Bulletin – 04 April 2019

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

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