Evropský antibiotický den (EAAD)
Minulý týden proběhl tzv. evropský antibiotický den. Ten si klade za cíl jednak zvýšit povědomí o uvážlivém používání antibiotik a s ním...
Regulatory House
- 27. 10.
- 1 min
Návrh stanoviska: veřejná konzultace o nitrosaminech v potravinách
Veřejná konzultace k návrhu vědeckého stanoviska EFSA k rizikům pro lidské zdraví v souvislosti s přítomností nitrosaminů v potravinách...
12 zobrazení0 komentářů
Regulatory House
- 18. 10.
- 1 min
Avoid promoting vitamin C infusion to the general public
Through suggestions, but also through its own official activities, SÚKL has found that many health care facilities, especially through...
4 zobrazení0 komentářů
Regulatory House
- 23. 8.
- 1 min
MDCG 2022-11: Ensure timely compliance with MDR requirements!
Medical Device Coordination Group has published a MDCG Possition Paper- MDCG 2022-11 recommending manufacturers to submit their...
5 zobrazení0 komentářů
Regulatory House
- 2. 8.
- 1 min
Boric acid and borates used as excipients – does your PIL need a revision?
Boric acid is used as an antimicrobial preservative and is used as a buffering agent to control the pH. It can be found in products like...
7 zobrazení0 komentářů
Regulatory House
- 19. 7.
- 1 min
Reporting drug shortages - new version of the electronic form available
State Institute for Drug Control (SÚKL) informs all MAHS about the transition to the new version of the electronig form of the mandatory...
4 zobrazení0 komentářů
Regulatory House
- 28. 6.
- 1 min
Guidance on borderline products under MDR: MDCG 2022 - 5 published
The guideline MDCG 2022-5 has been published on 26th April 2022. The proper implementation of legislation on medical devices (pursuant to...
5 zobrazení0 komentářů
Regulatory House
- 20. 6.
- 1 min
The safety of Cannabidiol as a novel food – regulatory update
Cannabidiol is a substance that can be obtained from Cannabis sativa L. plants and be synthesised chemically as well. However pure CBD or...
4 zobrazení0 komentářů
Regulatory House
- 10. 5.
- 1 min
Important information for MAHs of the medicinal products
An amendment to the registration Decree no. 27/2022 Coll. came into force on 8. March 2022. What does it mean for all current and future...
5 zobrazení0 komentářů
Regulatory House
- 4. 5.
- 1 min
Vitamin D products - is it a medicine or dietary supplement?
For some manufacturers, it may still be a question of when their product can still be considered a dietary supplement and when it is...
12 zobrazení0 komentářů
Regulatory House
- 13. 4.
- 1 min
Food production is also affected by the conflict in Ukraine
Like other sectors, the food industry is indirectly affected by the war in Ukraine, which is affecting the availability of certain raw...
6 zobrazení0 komentářů
Regulatory House
- 21. 2.
- 1 min
PRAC recommends the suspension of the MA for HES solutions for infusion in the EU
Based on the studies, that were conducted and in view of the serious risks that certain patient populations are still exposed to, EMA’s...
9 zobrazení0 komentářů
Regulatory House
- 14. 2.
- 1 min
Clinical Trials Regulation to enter into application and new CT Information System to be launched
On 31 January 2022, the Clinical Trials Regulation (CTR) will come into application harmonising the submission, assessment and...
8 zobrazení0 komentářů
Regulatory House
- 10. 2.
- 1 min
Food additive Titanium Dioxide (TiO2)banned as of this summer
The European Commission has adopted a ban on the use of Titanium Dioxide as a food additive (E171). The Commission Regulation (EU)...
7 zobrazení0 komentářů
Regulatory House
- 17. 1.
- 1 min
Obligation to report food supplies for special medical purposes since January 1, 2022
The State Institute for Drug Control notifies importers and domestic producers of food for special medical purposes (PZLÚ) about the new...
4 zobrazení0 komentářů
Regulatory House
- 26. 11. 2021
- 1 min
Module UDI/Devices registration and Notified Bodies and Certificates were launched
The European Commission has launched two more modules of the EUDAMED database for voluntary use. One of them is device identification...
5 zobrazení0 komentářů
Regulatory House
- 23. 11. 2021
- 1 min
News in the notification of food supplements in Czech
The Ministry of Agriculture announces on its website, that new Food notification system (SOP) will be launched, which and it will serve...
4 zobrazení0 komentářů
Regulatory House
- 12. 11. 2021
- 1 min
IVDR - Commission proposal
In the context of the forthcoming effectiveness of EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR, Regulation), the...
3 zobrazení0 komentářů
Regulatory House
- 7. 10. 2021
- 1 min
EMA is organising online webinar for SMEs and academic sponsor of clinical trial
The Clinical Trials Regulation (Regulation (EU) No 536/2014) becomes applicable on 31 January 2022 and the Clinical Trials Information...
0 zobrazení0 komentářů
Regulatory House
- 30. 9. 2021
- 1 min
News from the field of clinical evaluation
SÚKL has added a new folder in the clinical trial section called „REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE...
0 zobrazení0 komentářů
