Global logistics company, JAS has received the Wholesale Distribution Authorisation (WDA(H)) license from the UK's Medicine and Healthcare Products
Regulatory Agency (MHRA) for its Pharma and Healthcare Division.
In a press release issued on Thursday (22 February), the company said that securing the license empowers its UK healthcare division to "seamlessly connect" with
its more than 40 GDP (Good Distribution Practice) certified overseas stations, strengthening its capabilities for handling pharmaceutical shipments.
Headquartered in Atlanta, Georgia, USA, the company boasts a team of over 7,000 professionals, with operations spanning over 100 countries.
Adrian Frodsham, Regional Director for JAS, said that they were granted the WDA(H) license after a "stringent audit process."
"JAS UK's pharma and healthcare division prides itself of offering innovative solutions for the international delivery of pharmaceutical products, further
enhancing the growth of our pre-established healthcare division," he added.
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The Medicines and Healthcare products Regulatory Agency (MHRA) has been accepted as a full member of three international work-sharing partnerships.
Through these partnerships the agency said it will play vital international role in making sure medicines and medical devices are regulated safely and efficiently
worldwide,
Two of these, the International Medical Device Regulatory Forum (IMDRF) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH) are focused on improving the harmonisation and convergence of medicines and medical devices regulation globally.
The partnerships will also help the MHRA to share expertise with other leading organisations, support the development of regulatory guidelines and drive greater
harmonisation of regulation around the world. This will help deliver timely access to innovative medical products not just in the UK but globally.
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on the reclassification of codeine linctus to a prescription-only
medicine after considering multiple Yellow Card reports for its opioid effects, rather than for its intended use as a cough suppressant.
This medication is currently licensed as a pharmacy medicine, which means that it is available to purchase over the counter in pharmacies. If reclassified as a
prescription-only medicine, all strengths of codeine linctus will only be available upon presentation of a prescription.
Dr Alison Cave, MHRA Chief Safety Officer, said: "Codeine linctus is an effective medicine, but as it is an opioid, its misuse and abuse can have major health
consequences.
Every response received will help us to develop a broader view on whether codeine linctus should be restricted to prescription-only status.
We want to hear from members of the public, health professionals and others who would be affected by this potential change so we can make a properly considered
decision for the benefit of patients, carers, and healthcare professionals across the UK.
The Medicines and Healthcare products Regulatory Agency (MHRA) and the Committees of Advertising Practice (CAP) have issued a joint enforcement notice about
the 'illegal' advertising of Kenalog injections on digital platforms.
The notice warns all organisations offering Kenalog as a 'hay fever treatment' to stop advertising it in any of their social media or website advertising.
"Kenalog is a prescription-only medicine (POM), which must not be directly or indirectly advertised to the public. Kenalog is not licensed for the treatment of hay
fever in the UK, although it is offered by some beauty and aesthetics clinics, under the personal responsibility of an individual prescriber, and advertised widely
on social media," said MHRA.
"Now, advertisers must ensure that all references to Kenalog in the text, images or emojis on social media are removed, as well as commonly-used descriptive phrases
for the jab such as 'hay fever injection' or hay fever jab' or any account names, testimonials or memes by 29 August 2022."
After this date, the CAP's compliance team will remove non-compliant ads using targeted software and those who continue to promote it may be referred to the MHRA for
further enforcement action.
The Medicines and Healthcare Products Regulatory Agency (MHRA) confirmed that Ozempic has been found at two UK wholesalers on 18 October.
The pre-filled falsely labelled pens have been purchased from legitimate suppliers in Austria and Germany.
However, there has been no evidence that fake Ozempic has been supplied to UK patients.
Dr Alison Cave, MHRA Chief Safety Officer spoke about closely with regulatory partners to ensure patients' safety.
He said: "Buying semaglutide from illegally trading online suppliers significantly increases the risk of getting a product either falsified or not licensed for
use in the UK.
"Products purchased in this way will not meet our strict quality and safety standards, and taking such medicines may put your health at risk," he added.
The Medicines and Healthcare products Regulatory Agency (MHRA) has warned the public to avoid buying pre-filled weight loss pens without a prescription.
The warning came after 369 fake Ozempic injections have been seized since January 2023.
However, Saxenda pens were obtained by members of the public in the UK through "non-legitimate routes".
The health regulator has urged the public to buy the pens after consulting a healthcare professional and with a prescription.
Dr Alison Cave, MHRA Chief Safety Officer shared her opinion on the matter, she said: "Buying products such as Ozempic or Saxenda without a prescription,
from illegally trading suppliers, significantly increases the risk of receiving something which is either fake or not licensed for use in the UK.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised an innovative and first-of-its-kind gene-editing treatment for sickle-cell
disease and transfusion-dependent β-thalassemia.
Known as Casgevy (exagamglogene autotemcel), the treatment is based on the innovative gene-editing tool CRISPR, for which its inventors were awarded the Nobel
Prize in 2020.
Casgevy is the first medicine to be licensed that uses CRISPR, and it is to be used for treating patients aged 12 and over.
To date, a bone marrow transplant has been the only permanent treatment option for these life-long conditions, which in some cases can be fatal.
The MHRA's authorisation came after a rigorous assessment of its safety, quality and effectiveness.
In the pharmaceutical industry, maintaining high standards for water quality is crucial for ensuring product safety, efficacy, and compliance with
regulatory standards.
Water is a fundamental ingredient in drug manufacturing, and its quality directly impacts the production process and the end products. This makes adherence
to water service compliance a legal obligation and a critical aspect of operational integrity.
THE LEGAL COMPLICATIONS OF POOR WATER QUALITY
Compliance with water quality standards in the pharmaceutical industry is mandated by regulatory agencies such as the MHRA, several regulations that set
strict criteria for the types of water used, including purified water, water for injection, and sterile water.
Failure to meet these standards can result in severe penalties, including product recalls, fines, and loss of manufacturing licenses. Regulatory compliance
ensures the pharmaceutical companies adhere to legislations and avoid legal repercussions that can damage their reputation and financial standing