HELLENIC REPUBLIC
MINISTRY OF HEALTH
NATIONAL ORGANIZATION FOR MEDICINES
DIRECTORATE: PRODUCTION'S CONTROL AND PRODUCT'S MARKETING DEPARTMENT OF MARKETING CONTROL
SUBJECT: Granting of the license for the wholesale of pharmaceutical products to pharmaceutical warehouse: MEDICINES WAREHOUSE MARIO D. KATSIKAS S.A. - TRADING OF MEDICINES.
DECISION
Having taken into consideration:
1. The provisions of Law 1316/1983 (Government Gazette 3 A/11-1-1983) as applicable and especially in case z of paragraph 1, article 3 which was set by paragraph 1, article 17 of Law 4052/2012 (Government Gazette 41 A/1-3-2012)
2. The provisions of Legislative Decree 96/1973 (Government Gazette A 172) and especially of article 19 as applicable.
3. The provisions of the Mutual Ministerial Decision no DYG3a/G.P.32221/2013 (Government Gazette 1049 B/29-4-2013) on the "Harmonization of Greek Legislation with the corresponding legislation of EU in the sector of production and marketing of medicines for human use, in compliance with Directive No 2001/83/EU on the "communal code for medicines for human use" (L 311/28.11.2001) as applicable and as amended by the Directive 2011/62/EU regarding the prevention of the entry of falsified medicines in the legal supply chain (L 174/1.7.2011) as amended by Mutual Ministerial Decision DYG3a/G.P.oik. 90023/2013 (Government Gazette 2485 B/3-10-2013).
4. The hermeneutical Ordinance no 96870/8-11-14 on the Licenses for Wholesale issued by the National Organization for Medicines.
5. The application for renewal no 114722/24-12-15 and additionally the applications no 23752/2-4-2015 and 27098/17-4-2015 of the medicines warehouse MARIO D. KATSIKAS S.A.
6. The decision of the Board of Directors of the National Organization for Medicines no O-160/5th/24-6-2015 for the removal of license suspension granted to the medicines warehouse MARIO D. KATSIKAS S.A. and its reoperation.
7. The supervision of the National Organization for Medicines date 12/06/2015 according to the Directive 2013C 343/01
WE DECIDE
The grant the license for the wholesale of pharmaceutical products for human use to the medicines warehouse MARIO D. KATSIKAS S.A. - TRADING OF MEDICINES, head office at 6, Pararigopoulou Str., Peristeri, with responsible pharmacist Mr. Katsikas Mario, father's name: Dimitrios.
The present license will be valid for five years and the medicines warehouse is obliged to comply with the Directives of 5 November 2013 regarding the correct practice of distribution of medicines for human use (2013/C 343/01).
Chairman of the Board of Directors of the National Organization for Medicines
Aikaterini Antoniou