These Regulations make consequential amendments to the references in the Medicines Act 1968 and various statutory instruments relating to medicinal products and devices following the adoption of Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. That Codification Directive repealed and re-enacted Council Directive 65/65/EEC (and its successive amendments, namely Council Directives 66/454/EEC, 75/319/EEC, 83/570/EEC, 87/21/EEC, 89/341/EEC, 92/27/EEC and 93/39/EEC); Council Directive 75/318/EEC (and its successive amendments, namely Council Directives 83/570/EEC, 87/19/EEC, 89/341/EEC, 91/507/EEC and 93/39/EEC and Commission Directives 1999/82/EC and 1999/83/EC); Council Directive 75/319/EEC (and its successive amendments, namely Council Directives 78/420/EEC, 83/570/EEC, 89/341/EEC, 92/27/EEC and 93/39/EEC and Commission Directive 2000/38/EC); Council Directive 89/342/EEC; Council Directive 89/343/EEC; Council Directive 89/381/EEC; Council Directive 92/25/EEC; Council Directive 92/26/EEC; Council Directive 92/27/EEC; Council Directive 92/28/EEC and Council Directive 92/73/EEC. Where references to the repealed Directives appeared in the Medicines Act 1968 and statutory instruments numbered 1971/972, 1971/974, 1976/1726, 1992/3146, 1993/2538, 1994/105, 1994/1932, 1994/1933, 1994/2987, 1994/3017, 1994/3144, 1995/309, 1995/449, 1995/1116, 2000/123, 2000/1763, 2001/1422 and 2001/3798, they have been replaced with an appropriate reference to the 2001 Codification Directive and related legislation.

In addition, these Regulations implement Commission Directive 2000/38/EC of 5th June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products. That implementation is effected by adding a new sub-paragraph (d) to paragraph 10 of Schedule 3 to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 and importing the amendments made by Commission Directive 2000/38/EC into the amended definition of “the relevant Community provisions” which appears in those Regulations. For the purposes of the implementation, that definition is relevant in particular in regulation 7 of those Regulations (obligations of holders of marketing authorisations and offences).

A Regulatory Impact Assessment in relation to these Regulations, and a Transposition Note in relation to the implementation of Commission Directive 2000/38/EC, have been placed in the libraries of both Houses of Parliament and copies may be obtained from the Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.