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  • Brazilian Regulatory Authorities to Expedite Minor Labeling Changes

    Brazil's national regulatory authority, Anvisa, has announced that its Board has approved an amendment that will permit its regulators to immediately approve minor labeling changes upon notice by a pharmaceutical company. The new rule, approved 12 December 2012, covers changes that pose no risk to the consumer such as safety information and packaging color, size, and layout of patient leaflets and package labeling. According to the CEO of Anvisa, Dirceu Barbano, the ne...
  • MHRA Releases New Guidance for Impending Changes to Labeling Regulations

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is announcing the launch of new guidance to assist sponsors looking to comply with the terms of new regulations set to change how sponsors can label their products. Under the terms of the Better Regulation of Medicines Initiative ( BROMI ), MHRA is taking a more targeted approach to how it regulates medicines by re-focusing its resources on higher-risk activities. One of the numerous changes to be imple...
  • Brazil: New Format Package Inserts for 135 Drugs Online

    Brazil's national health agency, ANVISA, has posted online  new package insert leaflets with revised content, large print, and more patient friendly text for 135 drug products. The site provides access to all versions of the package insert, from the most recent back to the oldest, and permits checking the date of approval by ANVISA, which items have been updated and whether changes should be considered in the inserts of follow-on drugs. Read more: ANVISA - Bu...
  • MHRA Announces 'Procedural Changes' for Submission of Labels, Patient Leaflets

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced last week (29 March) it would be making "procedural changes" to the process by which sponsors of marketing authorization applications (MAAs) submit full-color mock-ups of labels and patient leaflets. In its new guidance, Labels & Patient Leaflets in the Initial & Final Submission Documents for New MA and Type 1B or Type II Variation Applications , MHRA notes several changes, including:...