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International regulators stress value of safe and effective vaccines

22 Jun 2020
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EMA has endorsed two statements about the importance, safety and effectiveness of vaccines published today by the International Coalition of Medicines Regulatory Authorities (ICMRA).
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Covid-19
confidence in vaccine safety and effectiveness.

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 June 2020

22 Jun 2020
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CVMP adopts a draft strategy on antimicrobials 2021-2025 CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a grouped type II variation application for Bluevac BTV8 to add the strains BTV1 and BTV4 into the vaccine. The Committee adopted by consensus a positive opinion for a type IB variation application for Stronghold Plus and Felisecto Plus (selamectin/sarolaner) to correct the translations of product information. More information about the above-mentioned medicines, including their full indication, will be published on the Agency’s w
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medicines
indication
quality
safety and efficacy

SURGE IN COUNTERFEIT GOODS DURING CORONAVIRUS OUTBREAK SPARKS HIKE IN DEMAND FOR AUTHENTICATION PROTECTION

21 Jun 2020
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Speciality security printer Eltronis has reported a 20 per cent increase in enquiries for its brand protection and track and trace solutions since the outbreak of Coronavirus. The majority of these new enquiries have come from the pharmaceutical sector, reflecting the rise in public demand for immunity and health protection against the virus. Eltronis, which recently opened its European head office in the UK in Oxfordshire, delivers security and authentication solutions to leading global brands in the pharmaceutical, automotive, security, brand protection and industrial sectors.
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pharmaceutical
automotive
security
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Laser marking on biodegradable capsules

20 Jun 2020
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One of these innovative applications is biodegradable single-dose capsules. Manufactured with a plastic substance, it allows different products to be encapsulated by vacuum to maintain all their characteristics while offering a better experience to the end-user. Marking these types of capsules is done with CO2 laser marking system (with a 10.6 wavelength μm) that leaves a high contrast whitish mark without damaging the package and no risk of altering the characteristics of the product or breaking it.

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Abrasion-Resistant and Award-Winning: TEVA Relies on Schreiner MediPharm for Novel Adrenaline Injector Label

16 Jun 2020
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Patients suffering from life-threatening allergies always carry a life-saving companion with them: an adrenaline autoinjector in order to immediately inject themselves in the event of an anaphylactic shock and to thus counter an allergic reaction. For the emergency drug epinephrine from TEVA, Schreiner MediPharm developed an Autoinjector-Label with special protection against abrasion. Thus, the vital user and product information remains perfectly legible over an extended period of time.
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drugs and specialty medicines
patient safety

Luminer Introduces Dedicated Inspection Suite at NJ Labels Manufacturing Facility

16 Jun 2020
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Company inaugurates segregated 7,000-sq-ft space with a new back-number system and its third 100% inspection platform. Lakewood, NJ – Luminer, a labeling solutions provider specializing in extended content labels (ECLs) for pharmaceutical ethical and OTC packaging, clinical trials and various other narrow web applications for the cosmetics, F&B and chemicals sectors, has streamlined its precision product inspection capabilities by introducing a dedicated 7,000-square-foot inspection suite at its primary manufacturing facility in Lakewood, NJ.
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Cosmetics
F&B and chemicals sectors
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Honeywell: Aclar Edge Polymer Bottles and Vials

15 Jun 2020
Yukta Arora
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Honeywell announced Aclar Edge, a pharmaceutical packaging system for oral liquids for human health and sterile injectables for animal health applications. Designed with Honeywell’s proprietary multi-layer extrusion blow molding technology, Aclar Edge bottles and vials preserve shelf-life and efficacy for a wide variety of challenging liquid dosage forms while improving user safety during the handling and administration. Aclar Edge bottles and vials provide a moisture barrier performance that is comparable with glass and an enhanced oxygen barrier compared to other polymeric containers.

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2020

13 Jun 2020
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Glossary: Safety signal assessments. A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under Signal management. Periodic safety update reports, abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation.

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Highlights of Management Board: June 2020 meeting

13 Jun 2020
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At its virtual meeting on 11 June, the Management Board was updated on how EMA is prioritising the response to the COVID-19 pandemic and what measures the Agency has put in place to tackle the crisis. The Agency and the European medicines regulatory network are currently operating under a network COVID-19 business continuity plan to ensure that core public and animal health regulatory activities, such as the authorisation, maintenance and supervision of medicines continue to be carried out during the pandemic and do not incur any possible delays.
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Covid-19
digitalisation
new scientific methods and technologies
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CURRENT SITUATION "CORONA COVID 19"

13 Jun 2020
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The production of packaging for disinfectants and liquid soaps is given priority in production planning. We ask for your understanding if we cannot immediately confirm an order or cannot deliver on time. Our team tries to process all inquiries, orders and deliveries promptly. Thank you for your comprehension.

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