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Media And Political Bulletin – 08 July 2019

Media and Political Bulletin

08 July 2019

Media Summary

How the implementation of Safety Features progresses 5 months in

MHRA, Tracy Moore, 5 July 2019

Tracy Moore, Senior GMDP Inspector and GMFP Operations Manager at the MHRA, has published a blog post which suggests that the performance of FMS safety feature systems is very mixed.

Moore argues that, based on inspections in the first five months since the safety features requirement came into force in February, the MHRA has seen “some excellent examples of robust systems” but also “some systems that required improvement and examples of systems that failed to identify falsified stock.”

The MHRA have also recently published specific guidance from Italian and Greek regulatory agencies on how to check incoming stock from these countries is compliant – read more here.

UK plans £3m no-deal medicine transport

BBC News, Howard Mustoe, 7 July 2019

BBC News reports that, as part of plans to spend £3m on no-deal Brexit measures to transport medication, the Department of Health and Social Care wants to hire an “express freight service” to transport medicines, blood and transplant tissue.

But the report states that experts have warned that the deadline of 1 September set for the deal is a “tight” timeframe.

The government’s current plan is to leave the EU on 31 October, with or without a trade deal.

It has smartened up its act on procurement after running up a bill of £80m trying to arrange ferry contracts in the event of a no-deal exit.

Seaborne Freight had been awarded a £13.8m deal last year, which the BBC found had never run a ferry service.

Gus Tugendhat, founder of Tussell, a data provider on UK government contracts, which uncovered the latest move said timelines were “still tight”.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

How the implementation of Safety Features progresses 5 months in

MHRA, Tracy Moore, 5 July 2019

I will be issuing a series of blog posts regarding the implementation of FMD: Safety Features and how it is progressing over the next few months. This is the first and looks at robustness of incoming checks.

The safety features element of the Falsified Medicines Directive (FMD) [EU Directive 2011/62/EU transposed into the Human Medicines Regulations (as amended) and Delegated Regulation 2016/161] came into force across the EU on 9 February 2019.

Since implementation, MHRA has been inspecting for the required new elements and we have seen some excellent examples of robust systems that have been brought in line with the FMD safety features requirements.  We have also seen some systems that required improvement and examples of systems that failed to identify falsified stock as part of the pharmaceutical quality system requirements.

The definition of a falsified medicine is as follows:

[The Human Medicines Regulations (as amended by SI 2013;1855 Regulation 8 (a)(vi))]

“Falsified medicinal product” means any medicinal product with a false representation of:

(a) its identity, including its packaging and labelling, its name or its composition (other than any unintentional quality defect) as regards any of its ingredients including excipients and the strength of those ingredients;

(b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or

(c) its history, including the records and documents relating to the distribution channels used.

Checking your systems comply

As part of the new measures your systems should be able to identify decommissioned, stolen or recalled stock.   This should include not just using the new FMD 2D barcode unique identifier (UI) scanning systems but also identifying stock from the two countries (Greece and Italy) that are yet to implement the 2D barcode UI system.

Where the 2D barcode UI is not yet in use, the MHRA are clear that it is still your responsibility to identify falsified, stolen or recalled stock received into your systems, including those that have already been decommissioned. Inspectors will be looking for this step as part of your incoming goods checks.

We have published specific guidance from Italian and Greek regulatory agencies on how to check incoming stock from these countries is compliant on our GOV.UK guidance page.   Please visit this page to find out more about Safety Features.

UK plans £3m no-deal medicine transport

BBC News, Howard Mustoe, 7 July 2019

The Department of Health and Social Care plans to spend £3m on no-deal Brexit measures to transport medication.

It wants to hire an “express freight service” to transport medicines, blood and transplant tissue.

But experts have warned that the deadline of 1 September set for the deal is a “tight” timeframe.

The government’s current plan is to leave the EU on 31 October, with or without a trade deal.

It has smartened up its act on procurement after running up a bill of £80m trying to arrange ferry contracts in the event of a no-deal exit.

Seaborne Freight had been awarded a £13.8m deal last year, which the BBC found had never run a ferry service.

Gus Tugendhat, founder of Tussell, a data provider on UK government contracts, which uncovered the latest move said timelines were “still tight”.

Andrew Dean, director of public law at Clifford Chance, a former government adviser and procurement law expert said there was sufficient time to run a compliant and robust procurement process, but it would be tricky, given the relatively short timeframe.

Last weekend, it emerged that the Department for Transport was asking logistics companies to bid to provide extra freight capacity to be used in the event of a no-deal Brexit.

‘Within the guidelines’

The plan is to set up “an express freight contingency arrangement to support continuity of supply of medicines and medical products,” Cabinet Office Minister David Lidington told Parliament.

“This will be an urgent contingency measure for products requiring urgent delivery, within a 24-48 hour timeframe, if the UK leaves the EU without a deal.”

Together with stockpiling and helping companies with paperwork at the border, the department hopes this will allow patients to receive the medicines they need, especially rarer ones with short shelf-lives, which may require specialist transport conditions such as refrigeration.

“Government will only pay for capacity as and when it is needed and used,” Mr Lidington insisted.

It is understood that while larger pharmaceutical companies would have their own plans, smaller ones were likely to need help.

A Department of Health and Social Care spokeswoman confirmed that the contract was new, but said that the speed of the contract was “within the usual guidelines”.

Media And Political Bulletin – 08 July 2019

From Factory to Pharmacy

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