Services specific to TMC EU
Acting as Sponsor for Orphan Drug Designation (ODD) Application in the European Union
The legislation on orphan medicinal products, Regulation (EC) 141/2000 states that the Sponsor must either be a company or an individual established within the European Economic Area (EEA).
TMC provide its ODD sponsor services through TMC (EU).
Legal Representative in the European Union for Clinical Trials
The EU Regulation specifies the requirements 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 as contact person, according to local requirements.
European Qualified Person for Pharmacovigilance (EU QPPV)
The Commission implementing Regulation (EU) 520/2012 and the Good Pharmacovigilance Practices (GVP) Module 1 states that the QPPV must reside and operate in the EU or EU associated countries.
TMC provide its EU QPPV services through TMC (EU).
Provision of a Qualified Person in the EU for Medicinal Product Batch Release
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 of EU countries and provides QP batch release services in the most appropriate countries for our clients.
Small/Medium Enterprise (SME) Status in the European Economic Area
In order to be eligible for significant financial and administrative assistance from the EMA, Sponsor companies must usually meet the definition of a Small/Medium Enterprise (SME) and be legally established in the European Economic Area (EEA).
However, SME incentives can be accessed through an EU/EEA-established SME regulatory consultancy. Both the regulatory consultancy and the non-EU/EEA-based company must be assigned SME status by the EMA SME office.
TMC (EU) has SME status and can provide access to clients who also meet SME criteria.
EMA User Guide for Micro, Small and Medium-Sized Enterprises
Acting as a Marketing Authorisation Holder (MAH) in the European Union
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 (MAH) must be established within the European Economic Area (EEA).”
TMC provide its EMA-approved MAH services through TMC (EU).