Paragraph 2 List of countries where a sponsor of a clinical trial, or their legal representative, may be established on IP completion day (regulation 3(11A))F1

For the purpose of regulation 3, the licensing authority must include each EEA State in the list referred to in paragraph (11A) of that regulation.

Notwithstanding regulation 3(11C), the licensing authority must not, before the end of the transitional period, remove an EEA State from the list referred to in regulation 3(11A).

In this paragraph, “transitional period” is the period of two years beginning with IP completion day.