2001 Marketing Packaging Treatment 
Agency IQ
NOVEMBER 3, 2023
Currently, only Article 23a and Article 81 of Directive 2001/83/EC address medicines supply across the E.U. The provision aims to ensure patient access to medicines where they have been marketed. no available alternative treatments, 2. healthcare systems for years. level coordination to address critical shortages.
Agency IQ
JULY 12, 2024
In October 2024, the European Commission published a communication putting forth a package of reforms to address medicines shortages. Next, the European Commission collected data from marketing authorization holders, suppliers and national competent authorities for the selected medicines. Read AgencyIQ’s analysis of the non-paper.]
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Drug Discovery World
AUGUST 24, 2023
This looks to be a significant milestone which will ideally propel other regulatory agencies forward in this field. For instance, though psilocybin remains illegal in Maryland, The Johns Hopkins Center for Psychedelic and Consciousness Research continues to explore innovative treatments using psilocybin and its potential for mental illnesses 3.
Agency IQ
MARCH 29, 2024
Specifically, the NPRM proposed changes to manifest regulations for shipments of hazardous waste that are exported for treatment, storage, and disposal. Additional revisions that would impact permitting, for example, changes to definitions or references, may also be proposed for other RCRA regulatory sections.
Agency IQ
APRIL 12, 2024
Directive 2001/83/EC and Regulation (EC) No 726/2004. Additionally, reform package included revisions of the regulations for pediatric medicines and orphan drugs. For the regulation , this centered on market exclusivity for orphan drugs and whether there should be a separate category for medicinal products addressing unmet need.
Agency IQ
DECEMBER 15, 2023
The allowance or “variance” to the prohibition on the open burning of hazardous waste was established at a time when there were no alternatives to the safe treatment of waste explosives. This routine Methods Update Rule (rMUR) was proposed in February 2023. EPA is not considering methods for new analytes in this routine MUR.
Agency IQ
JUNE 16, 2023
For increased flexibility in bringing PIPs to market, a developer can also submit both. Amendments to TSCA in 2016 included several new provisions concerning the assertion and Agency review and treatment of CBI claims. EPA is reviewing the comments received and is planning to issue a final rule.
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