Services specific to TMC EU


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

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

TMC will provide its ODDA sponsor services through our TMC Pharma (EU).

2. Legal Representative in the European Union for Clinical Trials

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."

Section 60 of a draft new EU Regulation changes the requirements as to legal representation in the EU: " 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.

3. European Qualified Person for Pharmacovigilance (EU QPPV)

The EU Commission Implementing Regulation (EU) 520/2012 and Good Pharmacovigilance Practice (GVP) Module I states that the QPPV must reside and operate in the EU or EU associated countries.

TMC companies provide their EU QPPV services through TMC EU which is located in Ireland.

4. 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.

5. Small / Medium Enterprise 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.

Click here to see EMA’s brochure on SME (PDF).

6. Acting as Marketing Authorisation Holder 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 must be established within the European Economic Area (EEA)."

TMC will provide its EMA-approved MAH services through TMC Pharma (EU).