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Pozastavení registrace,
 stažení z trhu - Kexxtone

 

Stažení šarží M-1 AER
240 mg/ml

 

Stažení šarže VITAR Veterinae Artivit Sirup 

Nesprávné označení u VLP
Fungiconazol 200 mg tablety pro psy

 

SPC harmonizace -

Aktuální informace pro držitele

 rozhodnutí o registraci 

 

Hlášení nežádoucích

účinků VLP/VP/VTP 

 

Implementace nařízení 

2019/6 o veterinárních 

léčivých přípravcích

 

Aktuálně 

registrované 

VLP

 

Kódy balení VLP

("SÚKL kód") 

 

Pro veterinární lékaře
For vets
 
 
 Nesprávné označení u VLP Draxxin 100 mg/ml
 inj. rozt. pro skot, prasata a ovce

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Information on the project co-funded by EUROPEAN HEALTH AND DIGITAL EXECUTIVE AGENCY (HADEA)

Ústav pro státní kontrolu veterinárních biopreparátů a léčiv
Project name: Antimicrobials´ Sales and Use data collection and reporting CZ vet
Project acronym: ASU_Czvet data call
Project number: 101103146
The Grant Agreement “Antimicrobials´ Sales and Use data collection and reporting CZ vet” was signed between the ÚSKVBL and European Health and Digital Executive Agency (HADEA) under the powers delegated by the European Commission.
Legal background for this project: Article 57(1) and (2) of Regulation (EU) 2019/6 and related delegated and implementing legal acts - Commission Delegated Regulation (EU) 2021/5784 and Commission Implementing Regulation (EU) 2022/2095.

The main project aims are:
- setting the systems of AS (antimicrobials sale) and AU (antimicrobial use)
- systems validation and practical implementation of the data collection
- gaining valid datasets, where relevant trends in the volume of sales of VMPs can be monitored, what ensure having relevant data in MSs
- measure progress towards the achievement of the Farm-to-Fork (‘F2F’) strategy objective to reduce overall EU sales of antimicrobials´ sales for farmed animals and in aquaculture by 50% by 2030.
- having valid data on the use of antimicrobial medicinal products per animal species at national level plays an essential role in supporting the development of targeted tailored measures to use antimicrobials more rationally and fight antimicrobial resistance.

For further information, please contact:
Ústav pro státní kontrolu veterinárních biopreparátů a léčiv
Hudcova 232/56a
621 00 Brno

For assistance in reporting data on antimicrobials sales, please contact:
MVDr. Lenka Maxová (ESUAvet data manager)
Phone: (+420) 541 518 217, 777 361 392
E-mail: Tato emailová adresa je chráněna před spamboty, abyste ji viděli, povolte JavaScript ; Tato emailová adresa je chráněna před spamboty, abyste ji viděli, povolte JavaScript

For assistance in reporting data on antimicrobials use, please contact:
MVDr. Jaroslav Kratochvíl
Mgr. Jana Jandlová
Phone: (+ 420) 541 518 228, 724 263 468
E-mail: Tato emailová adresa je chráněna před spamboty, abyste ji viděli, povolte JavaScript ; Tato emailová adresa je chráněna před spamboty, abyste ji viděli, povolte JavaScript ; Tato emailová adresa je chráněna před spamboty, abyste ji viděli, povolte JavaScript

For information on antimicrobials´sales/use data analysis and interpretation, please contact:
Mgr. Lucie Pokludová Dr. (ESUAvet national contact point)
Phone: (+ 420) 541 518 208, 724 838 570

 


Ústav pro státní kontrolu biopreparátů a léčiv participates in EU4Health Joint Action EU4H 11.

EU4H 11 (Joint Action on quality of edicines and implementation of the pharmaceutical legislation/strategy) is part of the EU4Health programme funded by the uropean Commission. The total budget of this Joint Action amounts to more than 3 million EUR, 80% of the costs will be co-financed by the European Commission. The project aims at strengthening capacities of EU/EEA GMP/GDP inspectorates in the global vision of mutual reliance of inspection data to better ensure quality of medicinal products and protection of Public
Health.

39 EU/EEA Medicines Inspectorates from a total of 29 EU/EEA countries are participating in EU4H11: they are supervising the regulatory compliance of pharmaceutical manufacturers of human and veterinary medicines throughout EU/EEA. The Joint Action is steered by Austria (AGES/BASG) as Coordinator, together with the National Competent Authorities of France (ANSM), Croatia (HALMED) and Hungary (NCPHP) work package leaders.

The three main goals of EU4H 11 are:
• Strengthening the Joint Audit Programme (JAP) for EU/EEA GMP Inspectorates.
• Developing a proposal to include GDP to the existing Joint Audit Programme.
• Establishing harmonised training and qualification processes for GMP inspectors, in cooperation with the PIC/S Inspectorates’ Academy.

In addition, the co-financing of costs related to JAP activities supports member states’ participation in the JAP. The co-financing of costs related to training activities supports initial and continuous training of GMP inspectors, thus enhancing competences of GMP inspectors throughout EU/EEA.

For further information, please contact:

Ústav pro státní kontrolu biopreparátů a léčiv
Hudcova 232/56A
621 00 Brno
e-mail: Tato emailová adresa je chráněna před spamboty, abyste ji viděli, povolte JavaScript

Koordinátor projektu:
EU4H11 – Coordinator AGES/BASG: Tato emailová adresa je chráněna před spamboty, abyste ji viděli, povolte JavaScript
Website: https://www.ages.at/en/research/project-highlights/eu4h11

 
 


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