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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.
In the European Union (EU), the promotion of medicinal products is governed by advertising laws and regulations.
Brexit has brought about significant changes in the EU and the UK in terms of regulations affiliated with cosmetics, pharmaceuticals, personal care products and medical devices. The UK decided to leave the EU in 2016 and officially left the trading bloc on Jan 31, 2020. Both countries decided to keep a few things unaltered until Dec 31, 2020.
The withdrawal of the United Kingdom from the European Union had many concerns. One of them being Regulatory Submissions. To smoothen the submissions process, the EU and the UK have set up a clear set of rules. Many of them are related to the existing and new marketing authorisation applications (MAAs) for CAPs, DCP and MRP, Batch testing, QP Certification, etc.
It is well known that from January 1, 2021, medical devices to be placed on the UK market are obliged to follow a new Regulatory regime. Currently, the UK market is a witness to many Regulatory changes, with the impact of Brexit.
On January 31, 2020, the United Kingdom (UK) officially left the European Union (EU) making the Brexit come alive. In the light of Brexit, the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have released certain Regulatory guidelines to ensure both pharmaceutical and medical device manufacturers are ready for the transition period.
Brexit is just around the corner and the United Kingdom (UK) is all set to leave the European Union (EU). The implementation date of Brexit was yet again postponed to January 31, 2020, after the UK requested more time for preparations.
Though scheduled to take place from March 29, 2019, the Brexit has now postponed to October 31, 2019. The decision is assumed to give more time to the United Kingdom (UK) and the European Union (EU) to agree upon the terms of the UK leaving the EU.
The impact of Brexit is evident in almost every industry based in the European Union (EU) and the United Kingdom (UK). Pharmaceutical industry too not to be spared.
The impact of Brexit has been a major topic for debates amongst the industry experts for the past two years. It has left companies on both the sides, the United Kingdom (UK) and Europe, hanging on a loose thread. As the date of Brexit is drawing closer, industries are aggressively looking for contingency plans for sustaining their business, if the UK leaves with a ‘no-deal’.
With each year, Life Sciences industry is transforming in unpredictable ways, of course it is to better the end-user’s safety. The industry is progressing with technological advancements and the health authorities are equally striving to upgrade the existing Regulatory frameworks to align with market requirements.
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