“Harmonisation of Greek legislation with the equivalent community legislation in the fields of production and marketing of medicines for human use, in compliance with Directive 2001/1983/EC on “the Community Code relating to medicinal products for human use”, as amended by Directives 2004/27/EC, 2004/24/EC on traditional herbal medicinal products and Article 31 of Directive 2002/1998/EC on the adoption of standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components”

THE MINISTERS
FOR ECONOMY AND FINANCE – FOR HEALTH AND SOCIAL SOLIDARITY

Having regard to the following:

1. Provisions:

A)  Article 1, par. 1, 2 and 3 and Article 3 of law 1338/1983 “Application of community law” (GG Α 34), as amended by Article 6 of law 1440/1984 “Participation of Greece in equity, reserves and provisions of the European Coal and Steel Community and of the EURATOM Supply Agency (GG 70, A') and Article 65 of law 1982/1990 (GG Α 101);
B)  Articles 14, par.  4 and 2, par. 1 and 2 of law 1338/1983 (GG Α 34), as the latter was amended by provisions in Article 1 of law 1965/1991 (GG Α 146) “Amendment and supplement to the applicable provisions of the National Organization for Medicines (EOF)” and other provisions;
C) Article 10, par.  1 of law 1965/1991 (GG Α 146);
D) Articles 47 and 48 of law 3370/2005 1965/1991 (GG Α 176);
E)  Article 90 of presidential decree 63/2005 “Codification of legislation regarding government and government bodies” (GG Α 98).

2. EOF BoD proposal No. 0-613/15th/25.7.2005;

3. Joint decision of the Prime Minister and of the minister for health and social solidarity No. 27304/17.3.2004 on “Assignment of responsibilities to the under-Secretaries for health and social solidarity.”

4. Directive 2001/1983/EC on “the Community Code relating to medicinal products for human use”, as amended by Directives 2004/27/EC, 2004/24/EC.

5. The fact that provisions in this decision entail no expenditure under the national budget, we hereby decide:

Article 11

Paragraph 6

Performance of studies and tests required to implement paragraphs 1, 2, 3 and 4 and related practical requirements are not deemed contrary to the patent rights or supplementary protection certificates for medicinal products.