Update the means of requesting GMP Inspection and AIM from Italy
Companies request that paper measures be sent by registered mail to the GMP Inspections and Authorizations Office.
AEMPS publishes resolution on Allergenic Medicines
AEMPS sets specific deadlines and publishes a list of allergenic medicines for authorization and marketing.
EU publishes ‘Consensus Statement’ on Medical Devices
The consensus statement on the EU medical devices regulation receives approval from the National Competent Authorities, including INFARMED.
Infarmed approves two new ACMs for cannabis formulas
Infarmed approves Satalliv and Tilray and increases the number of medicinal cannabis preparations available in Portugal to six.
First nasal medication to treat anaphylactic reactions
The EMA approves Eurneffy, the first nasal medicine for anaphylactic emergencies, through the Committee for Medicinal Products for Human Use.
EMA proposes approval of 10 new drugs
The EMA recommends the approval of 10 new drugs, highlighting Balversa and Eurneffy for emerging therapeutic innovations.
The list of medicines whose export is suspended has been updated
The list of medicines with suspended export guarantees a continuous and safe supply without interruptions over time.
Anvisa publishes a new procedure for medicines
Anvisa has announced new procedures for classifying medicines as over-the-counter or subject to prescription, with a view to regulation.
Anvisa bans phenol in medical and aesthetic treatments
Anvisa bans phenol in health and aesthetics to guarantee the safety and well-being of the Brazilian population.
Framing and reframing the regulation of medicines
New criteria and procedures have been defined for classifying medicines as non-prescription or on prescription.