News | Regulatory House

Czech State authority provides info regarding Implant Card for medical devices

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

Submission of documents verified abroad for the purpose of reporting reimbursements for med. devices

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

EMA has recommended first COVID-19 vaccine for childrem aged 12 to 15 in EU!

The European Medicines Agency (EMA) has recommended extending use of Comirnaty to adolescents aged 12 to 15 years. Currently, the use of...

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 12-15 years of age

U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the...

Information sheet on medical devices and in vitro diagnostic medical devices

Slovak Authority has published on its website information about EUROPEAN COMMISSION communication campaing to a new regulatory Framework...

SÚKL has published a Notice of rapid binding of the text of the European Pharmacopoeia

Czech State Institute for Drug Control has informed about rapid binding of the text for Candesartanum cilexetilum (2573), Irbesartanum...

Call for data on ingredients with potential endocrine-disrupting properties used in cosmetic product

Cosmetics section of European Commision has published on the website a call for data on the ingredients Butylparaben, Methylparaben,...