COVID-19 Medicines (UK)

1st April, the UK medicines regulator has issued guidance for industry on regulatory flexibilities that apply to the production of medicines in the UK.

The Link is here (this link also links to other relevant guidance)

The regulatory flexibilities are too lengthy and complex to summarise here in this Blog. The reader is asked to use the Link and read the relevant sections.

The Chancellor has also waived import duties and VAT on medical imports – here.

COVID-19 Waste Shipment (EU)

On 16 March 2020, the Commission adopted Guidelines for border management measures to protect health and ensure the availability of goods and essential services.

On this basis, on 23 March 2020, the Commission adopted a Communication on the implementation of the Green Lanes under the Guidelines with specific recommendations designed to preserve the EU-wide operation of supply chains and ensure the functioning of the Single Market for goods, wherever internal border controls exist or have been introduced.

I blog posted about this at the time.

The European Commission issued (30th March) a Communication explicitly clarifying that the principles relating to transport of goods apply mutatis mutandis to shipments of waste.

This document is here.

COVID-19 PPE specification (UK)

The government (DHSC) has today (31st March) published its PPE specification – here.

This covers –

(1) gowns,

(2) masks, including respirator masks and hoods

(3) eye protection

General requirements

(1) All products must have their CE marking clearly evident on the product and/or packaging and must conform to the relevant directive:

Medical Devices Regulation 2017/745

(2) Any product that contains phthalates must be indicated on the packaging in accordance with:

Medical Devices Regulation 2017/745.
Personal Protective Equipment Directive 89/686/EEC

(3) In accordance with the Control of Substances Hazardous to Health Regulations 2002 (as amended) (COSHH) safety data sheets for all products that fall under this Regulation must be provided to NHS Supply Chain.

(4) All products and packaging should be latex free where possible. Any products or packaging containing latex must be clearly labelled as such to inform the user.

(5) All products must be supplied with a minimum 3 years shelf life from the date of manufacture.

(6) Where applicable all products must be supplied with instructions for use and disposal/recycling instructions or symbols printed in English.

Please read the attached link – here – for the detailed requirements applicable to each product group.

COVID-19 Factory & Transport Guidance (UK)

Manufacturing, factories and transport operations are not listed as restricted operations and are expected to stay open, with the workplace adjusted to ensure social distancing, and symptomatic workers sent home to recover. Some operations will also be able to be carried out via home working.

Transport workers are classed as essential workers with respect to their children attending school.

Guidance (rules) issued so far –

(1) food businesses – here

(2) Northern Ireland food and drink industry guidance – here

(3) transport – here

(4) freight transport – here

(5) marine settings of shipping and ports – here

Guidance (rules) for all employers, employees and businesses is here.

Guidance (rules) on cleaning is here.

The Health and Safety Executive also has guidance (rules) – here. (I blog posted about this yesterday)

Health and Safety Executive Northern Ireland guidance (rules) – here

COVID-19 New HSE Guidance (UK)

The UK Health and Safety Executive (HSE) has new COVID-19 guidance – here.

Covering –

(1) face masks

(2) hand sanitisers

(3) diver’s medical certificate

(4) driver welfare and hours (I blog posted before about this)

(5) health/medical surveillance

(6) protecting home workers

Plus links to key gov.uk issued guidance – note the employees, employers and businesses one was updated yesterday.

NOTE Subscribers will see a new COVID-19 compiled list of law and guidance loaded into their Occupational Health and Safety Registers from Tuesday. Find this near the Brexit lists.

STAY SAFE

Brexit and COVID-19 measures (EU)

The UK left the EU at end of January 2020, and will leave the transition period at end of December 2020.

The World Health Organisation (WHO) declared COVID-19 a pandemic on 11th March 2020.

These two events are prompting substantive changes in many occupational, health and safety, and environment related measures in EU member states and at EU level.

The EU’s Brexit measures are found here.

[the first round of negotiations on a trade deal with the UK to operate from 1st January 2021 was held 2-5 March, the second round is not scheduled]

[the EU published a new draft legal text on 18 March here, new UK legal texts submitted to the EU in March are not published]

The EU’s COVID-19 measures are found here.

[note the measures announced to keep air cargo moving – here]

The EU’s Brexit and the COVID-19 measures are rooted in law. Cardinal Environment Limited advises on occupational health and safety law and environmental law via Email Alert to subscribers to Cardinal Environment EHS Legislation Registers & Checklists. The next Email Alert on EU-26 Registers & Checklists will be at the next 6-month interval (as usual). Ireland receives monthly Email Alerts due to its connectivity with the UK (its next Email Alert is end of March unless otherwise a different interval is operated).

Subscribers are reminded that they can request Annual Review (a teleconference) on renewal of annual subscriptions, and this is recommended.

Of particular note are –

(1) changes around borders, goods transport and people mobility to keep the Single Market open during the COVID-19 pandemic

(2) measures that may result from the EU-UK trade deal negotiations

Individual member states will be operating internal COVID-19 emergency –

(1) changes around workplace organisation, particularly additional requirements to keep the workplace safe and provide for home working

(2) temporary bans on the opening of some business premises on health grounds

(3) changes around worker employment (this Blog does not address detailed matters of Employment Law)

COVID-19 EU Single Market Green Lanes (EU)

The World Health Organisation (WHO) declared COVID-19 a pandemic on 11th March.

On 16th March, the European Commission adopted Guidelines for border management measures to protect health and ensure the availability of goods and essential services.

These Guidelines stress the principle that all EU internal borders should stay open to freight and that the supply chains for essential products must be guaranteed. The free flow of goods, especially in times of emergency and in the interest of all, requires that Member States respect and fully implement the Guidelines at all border-crossings at internal borders.

A separate European Commission Communication – here – is designed to help Member States implement the Guidelines as regards the green lanes.

As the document states, it is intended to engender a cooperative process across the EU to ensure all freight, including but not limited to essential goods such as food and medical supplies, gets quickly to its destination without any delays.

Per the Communication summary –

In order to preserve the EU-wide operation of supply chains and ensure the functioning of the Single Market for goods, wherever internal border controls exist or have been introduced Member States are requested to designate immediately all the relevant internal border-crossing points of the trans-European transport network (TEN-T) and additional ones to the extent deemed necessary, as “green lane” border crossings – for land (road and rail), sea and air transport.

Going through these “green lane” border crossings, including any checks and health screening of transport workers, should not exceed 15 minutes on internal land borders. The “green lane” border crossings should be open to all freight vehicles carrying any type of goods.

Member States should act immediately to temporarily suspend all types of road access restrictions in place in their territory (week-end bans, night bans, sectoral bans, etc.) for road freight transport and for the necessary free movement of transport workers.

Transport workers, irrespective of their nationality and place of residence, should be allowed to cross internal borders. Restrictions such as travel restrictions and mandatory quarantine of transport workers, should be waived, without prejudice for competent authorities to take proportionate and specifically adapted measures to minimise the risk of contagion.