Brexit implementation period

The MHRA has recently updated its information on the implications of Brexit, in particular on the terms that will be agreed for the implementation period:

 

Market Access for Medicinal Products

Manufacturing and distribution licences will continue to be recognised by the EU and companies can continue UK batch release testing of authorised medicinal products and investigational medicinal products for clinical trials.

Market Access for Medical Devices

CE marking will continue to be used and recognised for both the UK and EU markets, and UK-based manufacturers will not require an authorised representative established in the EU.

EU Mutual Recognition Agreements

In March 2018, the EU agreed that the UK would continue to be treated as an MS for the purposes of International Agreements.

Licensing & Packaging

Common rules will remain in place so that businesses will continue to trade on the same terms as at present until the end of 2020.

New Marketing Authorisation Applications (MAA)

The UK will be able to take part in the Assessment Procedure, but not as (Co)-Rapporteur for the CAP; they can be the RMS for a DCP/MRP, but applicants must be aware that transfer of an RMS will not be possible after the end of the implementation period, so should aim to ensure such procedures are completed by 29 March 2019.

Multi-country packs

These will be valid in the EU, including the UK throughout the implementation period.

Pharmacovigilance

The QPPV and PSMF will be able to be located in the UK throughout the implementation period

New Regulations & Directives:

Clinical Trial Regulation EU No. 536/2014

This is expected to be completed in 2020; the UK law will remain aligned with the parts of this legislation that are within UK control. The UK would not be able to use the shared central IT portal or participate in the single assessment model without a specific agreement with the EU.

Medical Devices Regulations

The EU Regulation on Medical Devices 2017/745 will be applied from May 2020; the EU Regulation on IVD 2017/746 does not apply until May 2022; however, both devices regulations have applied in UK law since May 2017.

Falsified Medicines Directive 2011/62

The requirements of this directive have to be implemented in February 2019 when the UK will still be a Member State; this will continue to be applied in the UK.

 

Full details of this guidance can be found at the following link https://www.gov.uk/guidance/technical-information-on-what-the-implementation-period-means-for-the-life-science-sector