The guideline MDCG 2022-5 has been published on 26th April 2022. The proper implementation of legislation on medical devices (pursuant to...

Cannabidiol is a substance that can be obtained from Cannabis sativa L. plants and be synthesised chemically as well. However pure CBD or...

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...

For some manufacturers, it may still be a question of when their product can still be considered a dietary supplement and when it is...

Like other sectors, the food industry is indirectly affected by the war in Ukraine, which is affecting the availability of certain raw...

Based on the studies, that were conducted and in view of the serious risks that certain patient populations are still exposed to, EMA’s...

On 31 January 2022, the Clinical Trials Regulation (CTR) will come into application harmonising the submission, assessment and...

The European Commission has adopted a ban on the use of Titanium Dioxide as a food additive (E171). The Commission Regulation (EU)...

The State Institute for Drug Control notifies importers and domestic producers of food for special medical purposes (PZLÚ) about the new...

The European Commission has launched two more modules of the EUDAMED database for voluntary use. One of them is device identification...

The Ministry of Agriculture announces on its website, that new Food notification system (SOP) will be launched, which and it will serve...

In the context of the forthcoming effectiveness of EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR, Regulation), the...

The Clinical Trials Regulation (Regulation (EU) No 536/2014) becomes applicable on 31 January 2022 and the Clinical Trials Information...

SÚKL has added a new folder in the clinical trial section called „REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE...

EMVO informs MAHs and OBPs about the national fees for year 2022. Therefore the NMVO Fee Models Overview has been published on the EMVO...

All SMEs and Stakeholders are invited to provide their comments to this guideline on texts for advanced therapy medicinals products...

EMA and SÚKL has informed on their website that the entry into application of the Clinical Trials Regulation and hence the go-live date...

Court of Justice of the European Union ruled in 19 November 2020 that cannabidiol (CBD) ‘does not appear to have any psychotropic effect...

Due to some uncertainties concerning the provision of implant information card to the patient pursuant to Article 18 (1) of regulation...

Within the unification of the practice of the State Institute for Drug Control (SÚKL), there is a change in the requirements for the...