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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.
Plastics are the products of human innovation, and they are stable, durable, lightweight, and most importantly, inexpensive. They are a type of polymer, composed of a chain of polymers. The life we currently live is not possible without these amazing polymers. Unfortunately, our appetite for plastic shows no sign of back-pedal.
The Food Safety and Standards Authority of India (FSSAI) has divided the ‘Food Safety and Standards (Packaging and Labeling) Regulations, 2011’ into two (02) separate regulations: Food Safety and Standards (Packaging) Regulations, 2018 and Food Safety and Standards (Labeling and Display) Regulations.
Effective communication has always ensured the safety and quality of care for patients. Over the years, there remains an unmet requirement of providing label translations to individuals who are not fluent in English.
The European Medicines Regulatory Network (EMRN) has adopted a common electronic Product Information (ePI) standard for human medicines. The common ePI standard was one of the major projects undertaken by the European Medicines Agency (EMA), the National Competent Authorities (NCA), and the European Commission (EC).
As you may know, every country has its own set of regulations when it comes to labeling food products. Food labeling is a legal requirement and provides a wide range of information to help consumers make informed food choices. It protects public health and safety by displaying ingredients, use-by dates, allergens, advisory/warning statements, instructions for storage and preparation, etc.
A pharmaceutical label is a monologue between the drug manufacturer and the patients. Miscommunication of any kind can affect the end-user. To protect the interest of the patient population, global Health Authorities (HAs) closely monitor pharmaceutical labels and indications of pre-approval.
Drug labeling and package leaflets play an important role for both patients and healthcare professionals in the safe and efficient use of the medication. Hence, the approval of the labeling content, Patient Information Leaflet (PIL), and Summary of Product Characteristics (SPC) are integral components of the marketing authorization process.
Any food product or ingredient, such as nuts, seafood, peanuts, gluten-containing cereal, latex, penicillin, etc., can pose allergies when ingested into a human body. According to research, generally, food allergies affect 2.5% of the general population.
Recently, Per the revised Manual of Policies and Procedures (MAPP) of the United States Food and Drug Administration (USFDA) has proposed new labeling rules under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act (FD & C Act).
While creating compliant packaging, controlling the labeling flow and its implementation through artwork, supply chain and printing involves several internal and external stakeholders. Following up with all the teams to meet the time-critical mandates and deadlines can be challenging.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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