Amendment of the Health Service Medicines (Control of Prices of Branded Medicines) Regulations 2000 and the Health Service Medicines (Control of Prices of Generic Medicines) Regulations 2000U.K.
17. In both the Health Service Medicines (Control of Prices of Branded Medicines) Regulations 2000 M1 and the Health Service Medicines (Control of Prices of Specified Generic Medicines) Regulations 2000 M2, in regulation 2(1) (interpretation) for paragraph (a) of the definition of “marketing authorisation”, in each of those instruments, there is substituted—
“(a)by the competent authorities of the United Kingdom in accordance with the Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use;”.