Tag: MHRA

Perrigo Recalled Ranitidine Products

perrigo
The UK Medicines and Healthcare Regulatory Agency (MHRA) has issued alerts to healthcare professionals and retailers that Perrigo Company is precautionarily recalling its ranitidine medicines. The ...

Britain Informs on Possible Drug Shortage Ahead of Brexit Deadline

Although the UK has prepared for drug supply issues ahead of a no-deal Brexit on 31 October, Matt Hancock, UK secretary of state for health and social care, explained recently what still needs to be d...

MHRA Issued Alert over GSK Recall of Zantac

The MHRA has issued an alert to heathcare professionals, as GlaxoSmithKline is recalling all unexpired stock of four types of Zantac, the medicine used to treat conditions such as heartburn and stomac...

Upperton to Bring New Manufacturing Capabilities

In recent weeks Upperton has been focussing heavily on enhancing formulation capabilities with a series of investments in new equipment for R&D and QC laboratories. This is now being followed by t...

MHRA Cleared API in AZ’s Calquence for Export to EU in No-Deal Brexit

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has added the active pharmaceutical ingredient (API) in AstraZeneca’s Calquence to the list of materials cleared for export to the E...

Bavencio, Inlyta Combo Granted Early Access to Medicines status by MHRA

Merck and Pfizer have announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued an Early Access to Medicines Scheme (EAMS) positive scientific opinion for Bavencio (a...

MHRA Recalled Medicines with Missing Safety Labels

In England, imported medicines have appeared which have apparently been removed or "stolen" from the legal supply chain in order to be reintroduced later into regular sales. With this, both correc...

Pharmaswiss Česka republika Informed MHRA of Emerade Product Failing Risk

Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage ...

MHRA Renewed EAMS Scientific Opinion for Santhera’s Idebenone

Santhera Pharmaceuticals announces that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has renewed for a further year the Early Access to Medicines Scheme (EAMS) scientific opinio...

Pfizer UK Recalled Docetaxel Injection 160mg and Docetaxel Injection 20mg

Pfizer
Pfizer UK Limited is recalling batches as routine stability testing has identified that levels of a known impurity, 10-oxo-docetaxel, may exceed the acceptable level at end of shelf-life. CLDA Number...

MHRA Published Serious Breaches of GCP in 2018

The MHRA recently published the 2018 metrics report for GCP serious breaches. Serious breaches of the clinical study protocol or Good Clinical Practice (GCP) have to be reported to the MHRA within ...

EMA to Launch Safety Review of Alemtuzumab

The European Medicines Agency (EMA) has launched a safety review of alemtuzumab following reports of two deaths and several other cases of people experiencing life-threatening reactions shortly after ...

GDP Inspector Explains Demand in Supplier Qualification

Peter Brown, GDP Inspector at the U.K. Medicines and Health Regulatory Agency MHRA, explains in a Blog what qualification of suppliers means. In the recent GDP inspection history, the MHRA noted se...

British Regulators Issued PIM Designation to MYR

MYR Pharma announced that the British Medicines and Healthcare products Regulatory Agency (MHRA) has issued the Promising Innovative Medicine (PIM) designation for MYR's lead compound Bulevirtide (Myr...

MHRA Recalls Drugs for Heart Diseases

The Medicines and Healthcare Products Regulatory Agency (MHRA) recalled 3 batches of Irbesartan.  The recall is taking place as part of the continued investigation into potential N nitrosodiethylam...

SID&GP about MoU and Relatioship with UK

On January 29, the UK and Russia have signed a memorandum of understanding enhancing cooperation in the field of regulation of medicines. Radio Sputnik discussed the development with Nikolay Tsatsy...