Annexes to COM(2008)1 - Colouring matters which may be added to medicinal products (Recast) - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2008)1 - Colouring matters which may be added to medicinal products (Recast). |
|---|---|
| document | COM(2008)1  |
| date | April 23, 2009 |
(5) OJ L 237, 10.9.1994, p. 13. Directive repealed prospectively by Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16.).
(6) OJ L 226, 22.9.1995, p. 1. Directive repealed prospectively by Regulation (EC) No 1333/2008.
(7) OJ L 184, 17.7.1999, p. 23.
(8) OJ L 311, 28.11.2001, p. 1.
(9) OJ L 311, 28.11.2001, p. 67.
(10) OJ L 257, 10.9.1981, p. 1. Directive repealed prospectively by Regulation (EC) No 1333/2008.
ANNEX I
PART A
Repealed Directive with list of its successive amendments
(referred to in Article 7)
| Council Directive 78/25/EEC (OJ L 11, 14.1.1978, p. 18) | |
| 1979 Act of Accession, Annex I, Section X, point D (OJ L 291, 19.11.1979, p. 108) | |
| Council Directive 81/464/EEC (OJ L 183, 4.7.1981, p. 33) | |
| 1985 Act of Accession, Annex I, Section IX, point C (OJ L 302, 15.11.1985, p. 217) | |
| Council Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36) | Annex III, point 25 only |
PART B
List of time-limits for transposition into national law
(referred to in Article 7)
| Directive | Time-limit for transposition |
| 78/25/EEC | 15 June 1979 (1) |
| 81/464/EEC | 30 September 1981 |
(1) Pursuant to Article 7(2) of Directive 78/25/EEC: ‘2. However, any Member State may permit, on its own territory, until the end of a period of four years from the notification of this Directive, the marketing of medicinal products containing colouring matters which do not comply with the requirements of this Directive so long as these colouring matters were authorised in that Member State before the adoption of the Directive.’
ANNEX II
Correlation table
| Directive 78/25/EEC | This Directive |
| Article 1, first paragraph | Article 1 |
| Article 1, second paragraph | — |
| Articles 2 and 3 | Articles 2 and 3 |
| Article 4, first sentence | Article 4, first paragraph |
| Article 4, second sentence, first part | Article 4, second paragraph |
| Article 4, second sentence, second part | Article 4, third paragraph |
| Articles 5(1) and 6(1) and (2) | Article 5 |
| Article 6(3) | — |
| Article 7(1), (2) and (3) | — |
| Article 7(4) | Article 6 |
| — | Article 7 |
| — | Article 8 |
| Article 8 | Article 9 |
| — | Annex I |
| — | Annex II |