Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 199515
In the Medical Devices (Consultation Requirements) (Fees) Regulations 199527, regulation 1(2) (interpretation) is amended as follows—
a
in the definition of “competent body” for “Council Directive 65/65/EEC” there is substituted “Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use”; and
b
in the definition of “manufacturing authorisation” for “Article 16 of Council Directive 75/319/EEC” there is substituted “Article 40 of Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use”; and
c
in the definition of “medicinal substance” for “Article 1 of Council Directive 65/65/EEC” there is substituted “Article 1 of Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use”.