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Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.
Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.
The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.
Lack of clarity on indications and uninformed usage of drugs and biological products may lead to unforeseen adversities, which might in turn affect manufacturers / sponsors through financial penalties and legal actions.
The United States Food and Drug Administration’s (USFDA’s) Pregnancy, Lactation and Labeling Rule (PLLR), which came into effect in June 2015, establishes a labeling standard for prescription drug products which can be used during maternity and lactation.
Effective communication can bridge information gaps between two different ends of a process. With so many processes involved and with a need to communicate accurate safety information to the end user, the Pharmaceutical industry must employ utmost caution when taking its products to market.
Therapeutic Goods Administration (TGA), the Australian regulatory authority has approved a new product information (PI) form on 8th November 2017. The commencement date of the new PI form was 1st January 2018, with a transition period of three years ending 31st December 2020.
As it has been known, for medicines, EMEA require certain documents (including the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and labels) which should be submitted in English as a first draft for necessary approvals. If there are any changes required in the draft version, they should be executed and resubmitted in the English draft.
Do you know? Excipients which are used in drugs, thought to be inactive, but in some circumstances, they may lead to severe reactions. To safeguard patients from such adversities, the European Medicines Agency (EMA) has updated its annex to the European Commission’s guideline on the labeling of five new excipients.
Since 31st August 2016, the Therapeutic Goods Administration (TGA) is continuously working to update its guidelines for labeling of medicines supplied in Australia to ensure companies be aligned with international labeling best practices and reduce medication errors.
It’s been almost a year since we’ve reported that Therapeutic Goods Administration (TGA) is on its way to impose new labeling requirements.
Codeine medicines seems to have attracted all the attention right now. Not for the ways they are to be used, but for the ways they need to be labelled and advertised. To protect children from serious risks, two top most health authorities, the US Food and Drug Administration (USFDA) and the Therapeutics Good Administration (TGA) have rolled out label and advertisement changes.
It is drug manufacturers’ responsibility to ensure the drug/device is developed in accordance with compliance and is also used in safe and secured way. When it comes to hazardous drugs (HD), they are obliged to inform the healthcare facilities about the ways to handle them.
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