Brexit

How will Brexit affect TMC?
Frequently asked questions

TMC is a global company headquartered in the UK.

Following the UK’s decision to leave the EU, TMC has opened an office in Ireland to maintain an EU presence. This EU entity will enable TMC to continue to provide services that require presence in the EU.

Specific information is provided in the ‘Frequently asked Questions’ below:

Legal Representative in the European Union for Clinical Trials

Question:

When Great Britain leaves the European Community ("Brexit") will TMC still be able to act as the legal representative in the EU for Clinical Trial Applications (CTAs)?

Answer:

Yes


At present, the Clinical Trials Directive 2001/20/EC states in Article 19 (General provisions) that “…the sponsor or a legal representative of the sponsor must be established in the Community.”

Britain remains part of the Community until at least March 2019.

After this time, TMC will provide its legal representative service for CTAs through our Irish entity TMC Pharma (EU) Ltd. This is already being done for all new studies.

The MHRA, EMA and Member State Competent Authorities will collaborate on CTA arrangements as part of Brexit negotiations.

However, a new Clinical Trial Regulation (EU) No 536/2014 comes into operation in 2018 which will supersede the current Clinical Trial Directive. The new Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via an EU portal and database.

Section 60 of the new Regulation changes the requirements as to legal representation in the EU: “…it is appropriate to leave to each Member State concerned, as regards its territory, the choice as to whether or not to require such a legal representative, provided that at least a contact person is established in the Union.”

Whatever the outcome in any EU country, TMC will be prepared to act as legal representative or contact person, according to local requirements.

Acting as Sponsor for Orphan Drug Designation Application in the European Union

Question:

When Great Britain leaves the European Community ("Brexit") will TMC still be able to act as the Sponsor in the EU for Orphan Drug Designation Applications (ODDAs)?

Answer:

Yes


The legislation on orphan medicinal products, Regulation (EC) 141/2000 states that the Sponsor can be either a company or an individual established within the European Economic Area (EEA).

At present, Norway, Iceland and Liechtenstein form the EEA with the 28 Member States of the European Union. Britain remains part of the European Union until at least March 2019.

After this time, either:

  • Britain may benefit from an agreement similar to that obtained by Norway, Iceland and Liechtenstein, in which case TMC can continue to provide its ODDA Sponsor services in the UK, i.e. with no change

Or:

  • TMC will provide its ODDA sponsor services through our Irish entity TMC Pharma (EU) Ltd.

Acting as Marketing Authorisation Holder in the European Union

Question:

When Great Britain leaves the European Community ("Brexit") will TMC still be able to act as Marketing Authorisation Holder (MAH) in the EU?

Answer:

Yes


According to The Rules governing Medicinal Products in the European Union, The Notice to Applicants, Volume 2A Procedures for marketing authorisation:
“…The marketing authorisation holder must be established within the European Economic Area (EEA).”

At present, Norway, Iceland and Liechtenstein form the EEA with the 28 Member States of the European Union. Britain remains part of the European Union until at least March 2019.

After this time, either:

  • Britain may benefit from an agreement similar to that obtained by Norway, Iceland and Liechtenstein, in which case TMC can continue to provide its MAH services through our UK office, i.e. with no change

Or:

  • TMC will provide its MAH services through our Irish entity TMC Pharma (EU) Ltd.

For companies wishing to submit MAAs prior to the finalisation of Brexit negotiations, we currently have the flexibility to provide these services via either our UK or our Irish entity. We’d be happy to discuss the best option on a case-by-case basis.

European Qualified Person for Pharmacovigilance (EU QPPV)

Question:

When Great Britain leaves the European Union ("Brexit") will TMC still be able to provide the services of a European Qualified Person for Pharmacovigilance (QPPV)?

Answer:

Yes


At present, the Commission Implementing Regulation (EU) 520/2012 and Good Pharmacovigilance practice (GVP) Module I states that the QPPV must reside and operate in the EU, except that, following European Economic Area (EEA) agreements, the QPPV may also reside and operate in Norway, Iceland or Liechtenstein. Britain remains part of Europe until at least March 2019.

After this time, either:

  • Britain may benefit from an agreement similar to that obtained by Norway, Iceland and Liechtenstein, in which case TMC can continue to provide its QPPV services in the UK, i.e. with no change

Or:

  • TMC will provide its QPPV services through our Irish entity TMC Pharma (EU) Ltd.

The MHRA, EMA, and Member State Competent Authorities will collaborate on QPPV arrangements as part of the Brexit negotiations.

Provision of a Qualified Person in the EU for Medicinal Product Batch Release

Question:

When Great Britain leaves the European Community ("Brexit") will TMC still be able to provide a Qualified Person (QP) for release of clinical trial medicinal product in the EU?

Answer:

Yes


EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use state at Annex 16:

“Each batch of finished product must be certified by a Qualified Person (QP) within the EU before being released for sale or supply in the EU or for export.”

TMC works with QPs in a number EU countries and will continue to be able to provide QP batch release services after Brexit.