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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.
According to the CMDh practical guidance for Marketing Authorization Holders (MAHs) of nationally authorized products, the evaluation of nitrosamine impurity or cross-contamination in a marketed product is a critical criterion. Nitrosamines are proven to be carcinogenic and can affect the overall output of the formulated product.
Globally, the Health Agencies require foreign medical devices and IVD manufacturers to appoint a local representative. In Japan, under the revised Pharmaceuticals and Medical Device (PMD) Act, the In-Country Caretaker (ICC) system was replaced with Marketing Authorization Holder (MAH) system.
Over the decades, advancements in treatment procedures have brought about necessary amendments to the Regulatory framework.
The Health Authorities of all countries, with Canada being an exception, require all foreign medical device manufacturers to appoint a local, in-country or Authorized representative. The duty of a legal representative is to represent the manufacturer and the device in the targeted country and to liaison between Health Authorities and the foreign manufacturers.
Following the Brexit on 31 December 2020, Great Britain is no longer part of the EU scheme for regulating biocidal products. The existing EU Biocidal Products Regulation (EU BPR) has been transformed to Great Britain Biocidal Product Regulation (GB BPR). However, most aspects of the EU BPR will continue in the same way under the GB BPR.
Here are a few updates on the GB BPR:
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.
During unexpected emergencies, like COVID-19, conducting on-site pharmacovigilance (PV) inspections are not feasible due to travelling difficulties, orders from local authorities, and restrictions to accessing facilities justified by health hazards. Under such conditions, remote inspections would become the most preferable, replacing on-site inspections.
Health Products Regulatory Authority (HPRA) of Ireland has released a temporary measure to extend the permitted implementation time for labeling and/or package leaflet updates from six to nine months. It is a temporary decision, implemented to ensure the availability of medicines in Ireland during pandemic.
Being a Member State of the European Union (EU), the Republic of Cyprus through the Department of Pharmaceutical Services has mandated the submission of the medicinal products for human use through the Common European Submission Platform (CESP).
Why a Company Core Data Sheet (CCDS) is required and what is its significance for the marketing authorization holders (MAH).
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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