Agreement on the European Economic Area

XIII. MEDICINAL PRODUCTS

The EFTA Surveillance Authority may designate, according to its working procedures, two observers entitled to participate in the tasks of the Committee which are described in Article 2, first indent of the Council Decision 75/320/EEC of 20 May 1975 setting up a pharmaceutical committee.

Notwithstanding Article 101 of the Agreement, the EC Commission shall invite experts from the EFTA States according to Article 99 of the Agreement, to participate in the tasks which are described in Article 2, second indent of the Council Decision 75/320/EEC.

The EC Commission shall, in due time, inform the EFTA Surveillance Authority about the date of the meeting of the Committee and transmit the relevant documentation.

ACTS REFERRED TO

1. 365 L 0065: Council Directive 65/65/EEC of the 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ No 22, 9.2.1965, p. 369/65), as amended by:

• 375 L 0319: Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ No L 147, 9.6.1975, p. 13),

• 383 L 0570: Council Directive 83/570/EEC of 26 October 1983 (OJ No L 332, 28.11.1983, p. 1),

• 387 L 0021: Council Directive 87/21/EEC of 22 December 1986 (OJ No L 15, 17.1.1987, p. 36),

• 389 L 0341: Council Directive 89/341/EEC of 3 May 1989 (OJ No L 142, 25.5.1989, p. 11), as corrected by OJ No L 176, 23.6.1989, p. 55.

2. 375 L 0318: Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (OJ No L 147, 9.6.1975, p. 1), as amended by:

• 383 L 0570: Council Directive 83/570/EEC of 26 October 1983 (OJ No L 332, 28.11.1983, p. 1),

• 387 L 0019: Council Directive 87/19/EEC of 22 December 1986 (OJ No L 15, 17.1.1987, p. 31),

• 389 L 0341: Council Directive 89/341/EEC of 3 May 1989 (OJ No L 142, 25.5.1989, p. 11) as corrected by OJ No L 176, 23.6.1989, p. 55.

3. 375 L 0319: Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ No L 147, 9.6.1975, p. 13), as amended by:

• 378 L 0420: Council Directive 78/420/EEC of 2 May 1978 (OJ No L 123, 11.5.1978, p. 26),

• 383 L 0570: Council Directive 83/570/EEC of 26 October 1983 (OJ No L 332, 28.11.1983, p. 1),

• 389 L 0341: Council Directive 89/341/EEC of 3 May 1989 (OJ No L 142, 25.5.1989, p. 11), as corrected by OJ No L 176, 23.6.1989, p. 55.

4. 378 L 0025: Council Directive 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products (OJ No L 11, 14.1.1978, p. 18), as amended by:

• 172 B: Act concerning the Conditions of Accession and Adjustment to the Treaties - Accession to the European Communities of the Kingdom of Denmark, Ireland and the United Kingdom of Great Britain and Northern Ireland (OJ No L 73, 27.3.1972),

• 381 L 0464: Council Directive 81/464/EEC of 24 June 1981 (OJ No L 183, 4.7.1981, p. 33),

• 1 85 I Act concerning the Conditions of Accession and Adjustment to the Treaties - Accession to the European Communities of the Kingdom of Spain and the Portuguese Republic (OJ No L 302, 15.11.1985).

5. 381 L 0851: Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (OJ No L 317, 6.11.1981, p. 1), as amended by:

• 390 L 0676: Council Directive 90/676/EEC of 13 December 1990 (OJ No L 373, 31.12.1990, p. 15).

6. 381 L 0852: Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (OJ No L 317, 6.11.1981, p. 16), as amended by:

• 387 L 0020: Council Directive 87/20/EEC of 22 December 1986 (OJ No L 15, 17.1.1987, p. 34).

7. 386 L 0609: Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (OJ No L 358, 18.12.1986, p. 1).

8. 387 L 0022: Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology (OJ No L 15, 17.1.1987, p. 38).

9. 389 L 0105: Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ No L 40, 11.2.1989, p. 8).

10. 389 L 0342: Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens (OJ No L 142, 25.5.1989, p. 14).

11. 389 L 0343: Council Directive 89/343/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for radiopharmaceuticals (OJ No L 142, 25.5.1989, p. 14).

12. 389 L 0381: Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma (OJ No L 181, 28.6.1989, p. 44).

13. 390 L 0677: Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products (OJ No L 373, 31.12.1990. p. 26).

14. 390 R 2377: Council Regulation No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ No L 224, 18.8.1990, p. 1).

15. 391 L 0356: Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use (OJ No L 193, 17.7.1991, p. 30).

ACTS OF WHICH THE CONTRACTING PARTIES SHALL TAKE NOTE

The Contracting Parties take note of the content of the following acts:

16. C/310/86/p. 7: Commission Communication on the compatibility with Article 30 of the Treaty of Measures taken by Member States relating to price controls and reimbursement of medicinal products (OJ No C 310, 4.12.1986, p. 7).

17. C/115/82/p. 5: Commission Communication on parallel imports of proprietary medicinal products for which marketing authorization has already been granted (OJ No C 115, 6.5.1982, p. 5).