Explanatory Memorandum to COM(2002)529 - Inspection and verification of good laboratory practice (GLP) (codified version)

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dossier	COM(2002)529 - Inspection and verification of good laboratory practice (GLP) (codified version).
source	COM(2002)529
date	26-09-2002

1. In the context of a people's Europe, the Commission attaches great importance to simplifying and clarifying Community law so as to make it clearer and more accessible to the ordinary citizen, thus giving him new opportunities and the chance to make use of the specific rights it gives him.

This aim cannot be achieved so long as numerous provisions that have been amended several times, often quite substantially, remain scattered, so that they must be sought partly in the original instrument and partly in later amending ones. Considerable research work, comparing many different instruments, is thus needed to identify the current rules.

For this reason a codification of rules that have frequently been amended is also essential if Community law is to be clear and transparent.

2. On 1 April 1987 the Commission therefore decided ¹ to instruct its staff that all legislative measures should be codified after no more than ten amendments, stressing that this was a minimum requirement and that departments should endeavour to codify at even shorter intervals the texts for which they are responsible, to ensure that the Community rules were clear and readily understandable.

3. The Conclusions of the Presidency of the Edinburgh European Council (December 1992) confirmed this ², stressing the importance of codification as it offers certainty as to the law applicable to a given matter at a given time.

Codification must be undertaken in full compliance with the normal Community legislative procedure.

Given that no changes of substance may be made to the instruments affected by codification, the European Parliament, the Council and the Commission have agreed, by an interinstitutional agreement dated 20 December 1994, that an accelerated procedure may be used for the fast-track adoption of codification instruments.

4. The purpose of this proposal ³ is to undertake the codification of Council Directive 88/320/EEC of 7 June 1988 on the inspection and verification of good laboratory practice (GLP). The new Directive will supersede the various Directives incorporated in it ⁴; their content is fully preserved, and they are brought together with only such formal amendments as are required by the codification exercise itself.

5. The codification proposal was drawn up on the basis of a preliminary consolidation, in all official languages, of Directive 88/320/EEC and the instruments amending it, carried out by the Office of Official Publications of the European Communities, by means of a data-processing system. Insofar as the Articles have been given new numbers, the correlation between the old and the new numbers is shown in a table contained in Annex III to the codified Directive.

88/320/EEC

1.
COM(1987) 868 PV.
2.
See Annex 3 to Part A of such Conclusions.
3.
Carried out pursuant to the Communication from the Commission to the European Parliament and the Council - Codification of the Acquis communautaire, COM(2001) 645 final.
4.
Annex II, Part A of this proposal.
5.
OJ C , , p. .
6.
OJ C , , p. .
7.
OJ L 145, 11.6.1988, p.35. Directive as last amended by Commission Directive 1999/12/EC (OJ L 77, 23.3.1999, p.22).
8.
See Annex II, Part A.
9.
See Annex 3 to Part A of such Conclusions.
10.
OJ L , , p. .
11.
OJ L 358, 18. 12. 1986, p. 1.
12.
OJ C , , p. .
13.
OJ C , , p. .
14.
OJ 196, 16. 8. 1967, p. 1. Directive as last amended by Commission Directive 2001/59/EC (OJ L 225, 21.8.2001, p. 1).
15.
OJ L 184, 17.7.1999, p. 23.
16.
COM(1987) 868 PV.
17.
COM(1987) 868 PV.
18.
See Annex 3 to Part A of such Conclusions.
19.
See Annex 3 to Part A of such Conclusions.
20.
OJ C , , p. .
21.
COM(1987) 868 PV.
22.
See Annex 3 to Part A of such Conclusions.
23.
See Annex 3 to Part A of such Conclusions.