Table of Contents

4   EXECUTIVE SUMMARY
5   DRUG APPROVAL AND REGULATORY PROCESSES
5   The MHRA is the national body in charge of regulating medicines
8   The EU centralized procedure is convenient but expensive
8   Decentralized procedure introduced to address disputes in mutual recognition procedure
9   References
10 RECENT CHANGES IMPACTING DRUG LICENSING
10 BROMI: a UK initiative to reduce regulatory burdens on pharma
11 Improving communications between agency and industry
12 40 years of UK regulations consolidated by new law
12 Regulatory moves underway to allow earlier access to medicines
14 References
16 INTELLECTUAL PROPERTY ENVIRONMENT
16 UK court determines validity of patents
16 Data exclusivity issues in the UK: the 8+2+1 rule
18 References
19 DRUG IMPORTATION, PARALLEL TRADE, AND COUNTERFEITS
19 UK measures have driven down counterfeit medicines activity
21 Drug importation and wholesaling in the UK require special licenses
21 A rise in parallel exports has led to shortages of medicines
22 References
24 APPENDIX
24 About the author

LIST OF FIGURES

5 Figure 1: Four routes for obtaining market authorization in the UK
7 Figure 2: The UK’s MHRA application process
17 Figure 3: EU – the 8+2+1 market exclusivity rule

LIST OF TABLES

6 Table 1: MHRA applications and corresponding fees