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”.