The Medicines (Codification Amendments Etc.) Regulations 2002

Explanatory Note

(This note is not part of the Regulations)

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 That Codification Directive repealed and re-enacted Council Directive 65/65/EEC (and its successive amendments, namely Council Directives 66/454/EEC, 75/319/EEC, 83/570/EEC, 87/21/EEC, 89/341/EEC,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 Where references to the repealed Directives appeared in the Medicines Act 1968 and statutory instruments numbered 1971/972, 1971/974, 1976/1726, 1992/3146, 1993/2538, 1994/105, 1994/1932,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.