Update on Continued Supply of Medical Devices and Clinical Consumables
- A letter on “EU Exit actions for medical devices and clinical consumables” which contains “Guidance for Heads of Procurement on the Implementation of EU Exit actions” was published by the Keith Willett (EU Exit Strategic Commander, Medical Director for Acute Care & Emergency Preparedness) on 11 February 2019 (copy of the letter attached to email and guidance available here).
MHRA Guidance and Publications on a Possible No Deal Scenario
- As you may already be aware, the MHRA is publishing a series of guidance documents for industry and other stakeholders covering their proposed arrangements for the regulation of medicines, medical devices and clinical trials if we leave the EU with no deal. We expect these to be published shortly.
- New publication since 24 January 2019: Legislation concerning a no deal scenario “Contingency legislation covering regulation of medicines and medical devices in a no deal scenario” on 24 January 2019.
- The MHRA’s collection of guidance and publications on a possible no deal scenario is available here.
MHRA CAPs (Centrally Authorised Product) Grandfathering Process
- In their letter of 2 January 2019 on grandfathering of centrally authorised products (Community Marketing Authorisations), the MHRA encouraged marketing authorisation holders to respond by the end of January 2019 if they intended to opt-out of the grandfathering process to transfer products to national marketing authorisations.
- Please do respond as soon as possible to email@example.com even if you are not in a position to respond in full to the other actions set out in that letter. To help with their contingency planning, MHRA would particularly welcome responses which confirm which authorisations you intend to transfer.
MHRA Webinar Friday 15 February 2019
- MHRA hosted a live webinar on Friday 15 February 2019 at 11am. The content covered 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.
- A recorded copy of the webinar as well as additional guidance will be published shortly.
- There will be future sessions focusing on vigilance solutions and how to make specific submissions.
HMRC Partnership Pack
- HMRC published an updated Partnership Packon 6 February 2019 (the fourth edition). It contains specific advice to businesses on action that is required to continue importing and exporting in the event of a no deal.
HMRC Guidance on Trading with the EU in a Possible No Deal Scenario
- HMRC have been publishing a set of guides informing businesses of what they need to do in the event of a no deal scenario.
- New publications since 24 January 2019:
- HMRC also sent out a letter to VAT registered business who trade with the EU on 4 February 2019, setting out actions that are important to take now and changes to be prepared for in the event of a no deal scenario. The letter is available here.
EORI (Economic Operators Registration and Identification System)
- In order to continue trading with the EU after 29 March 2019, businesses will need a UK EORI number and a European EORI from the customs authority of the EU Member State they are moving goods to/from (it is then good for use anywhere in the EU).
- A link to the GOV.UK site to apply for an EORI is available here, and a link to HMRC guidance provided in December 2018 is available here.
Transitional Simplified Procedures (TSPs)
- HMRC has put in place TSPs to make it easier for UK businesses (who meet the criteria) to import goods from the EU using roll on roll off locationslike Dover or the Channel Tunnel.
- A link to HMRC Guidance is available here (as well as in the HMRC guidance point above)
- The link to register is available here.
Mutual Recognition Agreement Update
- The UK and USA signed a Mutual Recognition Agreement on Conformity Assessment on 14 February 2019. The agreement continues existing arrangements between the two nations.
Trade Continuity Agreement Updates
- Trade Continuity Agreements signed since 24 January 2019 include: