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Information on distribution of medicines to pharmacies, other healthcare facilities and sellers of restricted medicinal products - 34%

12.06.2012 10:10:39 PharmDr. Kamil Kalousek
The subject of reports by distributors includes supplies of medicines to pharmacies, other healthcare facilities, and also to sellers of restricted drugs with regard to restricted medicinal products, also supplies of medicinal products for human use to veterinarians authorised to perform specialised activity, which SUKL also monitors based on the instruction DIS-13, the current version, within monitoring of supplies of medicines. The reports include supplies of medicinal products outside ČR, including mutual trading with foreign distributors. The data also includes information on specific treatment programs.  

Information acquired from the reports by pharmacies on dispensed medicines - 32%

12.06.2012 10:09:35 PharmDr. Kamil Kalousek
Information acquired from the reports on dispensed medicines from operators authorised to supply medicines in 1 st quarter of 2012.

Supplies of medicines – with focus on active substances - 32%

31.05.2012 10:42:10 Jitka Židlická
Summary information on prices and quantities of distributed and supplied medicines with breakdown by the contained active substances.    

Supplies of medicines – with focus on medicinal products - 31%

1.06.2012 14:02:57 Jitka Židlická
Summary information on prices and quantities of distributed medicines according to the code of SUKL according to the reports by distributors.

Human medicines - Czech Republic/EU - 25%

13.12.2007 12:25:45
Competences of the Institute in the area of human medicines - appropriate standards of quality, safety and efficacy. 

Distribution of medicines - 20%

12.06.2012 12:14:13 PharmDr. Kamil Kalousek

Dispensing of medicines - 20%

12.06.2012 12:25:13 PharmDr. Kamil Kalousek

2014 - 18%

21.02.2014 10:51:17 Jitka Židlická
Summary information on supplies of medicines to distributors and operators authorised to supply medicines in ČR and abroad.

2013 - 18%

22.11.2013 10:18:08 Jitka Židlická
Summary information on supplies of medicines to distributors and operators authorised to supply medicines in ČR and abroad.

2012 - 18%

1.06.2012 13:54:34 Jitka Židlická
Summary information on supplies of medicines to distributors and operators authorised to supply medicines in ČR and abroad.

2011 - 18%

4.06.2012 11:08:00 Jitka Židlická
Summary information on supplies of medicines to distributors and operators authorised to supply medicines in ČR and abroad.

May medicines of SpTP be sold via mail order? - 18%

4.06.2010 08:03:30 Veronika Petláková

Foreign Medicines Agencies - 18%

19.11.2007 12:23:03 vrana

Amendment to the reimbursement decree – payments for marketing authorisation variations - 17%

11.10.2013 10:57:00 Petra Špimrová
On 15 October 2013, the amendment to decree no. 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the Institute for State Control of Veterinary Biologicals and Medicines (the “reimbursement decree”),  has come into effect.

Centralised Procedure Documentation – change in submission to Czech NCA - 15%

11.08.2014 14:43:03 Ing. Irena Lukáčová
The introduction of the Common Repository in February 2014 by European Medicines Agency has enabled Czech NCA to use the system as the only source of Centralised Procedure submissions, therefore there is no longer required to submit additional copies of submissions in form of CDs/DVDs by mail. This applies to all types of Centralised Procedure related to centrally authorised products submitted in eCTD format apart of listed exceptions.  

International Activities - 13%

16.11.2007 12:36:55
International activities of the State Institute for Drug Control consist in co-operation with EU institutions, EU Member states and international organizations active in the field of pharmaceuticals. The employees of the State Institute for Drug Control actively participate in the work of more than 40 committees and working groups of the European Medicines Agency (EMEA), European Commission (EC), European Directorate for the Quality of Medicines and Healthcare), Council of Europe, World Health Organization (WHO), Organization for Economic Co-operation and Development (OECD) and working initiatives of the network of EU medicines regulatory authorities. Given the regular attendance of experts the State Institute for Drug Control co-operates actively on the processes within EU and EEA and simultaneously joins many projects within the centralized network.

Who is responsible for labelling of medicines in SpTP? - 13%

4.06.2010 07:59:11 Veronika Petláková

Medicines - 13%

2.12.2010 17:35:31
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