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Document 12003TN12/01

Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded - Annex XII: List referred to in Article 24 of the Act of Accession: Poland - 1. Free movement of goods

OJ L 236, 23.9.2003, p. 875–875 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

In force

12003TN12/01

Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded - Annex XII: List referred to in Article 24 of the Act of Accession: Poland - 1. Free movement of goods

Official Journal L 236 , 23/09/2003 P. 0875 - 0875


1. FREE MOVEMENT OF GOODS

1. 31990 L 0385: Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17), as last amended by:

- 31993 L 0068: Council Directive 93/68/EEC of 22.7.1993 (OJ L 220, 30.8.1993, p. 1).

Certificates issued by the Institute of Medicines (Instytut Leków) for those medical devices defined as "medical materials" under the law of 10 October 1991: Ustawa o środkach farmaceutycznych, materiałach medycznych, aptekach, hurtowniach i Inspekcji Farmaceutycznej (Dz. U. 1991 Nr 105, poz. 452 ze zm.), and its secondary legislation of 6 April 1993: Zarządzenie Ministra Zdrowia w sprawie wykazu jednostek upoważnionych do przeprowadzenia badań laboratoryjnych i klinicznych oraz warunków przeprowadzenia tych badań (M. P. 1993 Nr 20, poz. 196), prior to the entry into force of the laws of 27 July 2001: Ustawa o wyrobach medycznych (Dz. U. 2001 Nr 126, poz. 1380 ze zm.) and Ustawa o Urzędzie Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Dz. U. 2001 Nr 126, poz. 1379 ze zm.) which entered into force on 1 October 2002, shall remain valid until their expiry or until 31 December 2005, whichever is the earlier. By way of derogation from Article 5 of Directive 90/385/EEC, Member States shall not be obliged to recognise such certificates.

Member States may prevent the putting on their markets of Polish medical devices as long as they are not in conformity with the Directive as amended.

2. 31993 L 0042: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1), as last amended by:

- 32001 L 0104: Directive 2001/104/EC of the European Parliament and of the Council of 7.12.2001 (OJ L 6, 10.1.2002, p. 50).

Certificates issued by the Institute of Medicines (Instytut Leków) for those medical devices defined as "medical materials" under the law of 10 October 1991: Ustawa o środkach farmaceutycznych, materiałach medycznych, aptekach, hurtowniach i Inspekcji Farmaceutycznej (Dz. U. 1991 Nr 105, poz. 452 ze zm.), and its secondary legislation of 6 April 1993: Zarządzenie Ministra Zdrowia w sprawie wykazu jednostek upoważnionych do przeprowadzenia badań laboratoryjnych i klinicznych oraz warunków przeprowadzenia tych badań (M. P. 1993 Nr 20, poz. 196), prior to the entry into force of the laws of 27 July 2001: Ustawa o wyrobach medycznych (Dz. U. 2001 Nr 126, poz. 130 ze zm.) and Ustawa o Urzędzie Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Dz. U. 2001 Nr 126, poz. 1379 ze zm.) which entered into force on 1 October 2002, shall remain valid until their expiry or until 31 December 2005, whichever is the earlier. By way of derogation from Article 5(1) of Directive 93/42/EEC, Member States shall not be obliged to recognise such certificates.

Member States may prevent the putting on their markets of Polish medical devices as long as they are not in conformity with the Directive as amended.

3. 31998 L 0079: Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).

Certificates issued by the Institute of Medicines (Instytut Leków) for those medical devices defined as "medical materials" under the law of 10 October 1991: Ustawa o środkach farmaceutycznych, materiałach medycznych, aptekach, hurtowniach i Inspekcji Farmaceutycznej (Dz. U. 1991 Nr 105, poz. 452 ze zm.), and its secondary legislation of 6 April 1993: Zarządzenie Ministra Zdrowia w sprawie wykazu jednostek upoważnionych do przeprowadzenia badań laboratoryjnych i klinicznych oraz warunków przeprowadzenia tych badań (M. P. 1993 Nr 20, poz. 196), prior to the entry into force of the laws of 27 July 2001: Ustawa o wyrobach medycznych (Dz. U. 2001 Nr 126, poz. 1380 ze zm.) and Ustawa o Urzędzie Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Dz. U. 2001 Nr 126, poz. 1379 ze zm.) which entered into force on 1 October 2002, shall remain valid until their expiry or until 31 December 2005, whichever is the earlier. By way of derogation from Article 5(1) of Directive 98/79/EC, Member States shall not be obliged to recognise such certificates.

Member States may prevent the putting on their markets of Polish medical devices as long as they are not in conformity with the Directive as amended.

4. 32001 L 0082: Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).

By way of derogation from the requirements of quality, safety and efficacy laid down in Directive 2001/82/EC, marketing authorisations for the pharmaceutical products on the list (in Appendix A to this Annex as provided by Poland in one language) issued under Polish law prior to the date of accession, shall remain valid until they are renewed in compliance with the acquis and in accordance with the timeframe set out in the abovementioned list, or until 31 December 2008, whichever is the earlier. Notwithstanding the provisions of Title III, Chapter 4, of the Directive, marketing authorisations covered by this derogation shall not benefit from mutual recognition in the Member States.

5. 32001 L 0083: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

By way of derogation from the requirements of quality, safety and efficacy laid down in Directive 2001/83/EC, marketing authorisations for the pharmaceutical products on the list (in Appendix A to this Annex as provided by Poland in one language) issued under Polish law prior to the date of accession, shall remain valid until they are renewed in compliance with the acquis and in accordance with the timeframe set out in the abovementioned list, or until 31 December 2008, whichever is the earlier. Notwithstanding the provisions of Title III, Chapter 4, of the Directive, marketing authorisations covered by this derogation shall not benefit from mutual recognition in the Member States.

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