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Medicines Healthcare Products Regulatory Agency


Press release: UK medicines and medical devices regulator investigating 14 cases of fake or unlicensed COVID 19 medical products

Press release: UK medicines and medical devices regulator investigating 14 cases of fake or unlicensed COVID 19 medical products

An increasing number of bogus medical products being sold through unauthorised websites claiming to treat or prevent COVID-19 are being investigated by the Medicines and Healthcare products Regulatory Agency (MHRA).

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Detailed guide: Medicines: get scientific advice from MHRA

Detailed guide: Medicines: get scientific advice from MHRA

How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.

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Detailed guide: Blood: authorisations and safety reporting

Detailed guide: Blood: authorisations and safety reporting

Licences and regulations for organisations that handle human blood or blood products and reporting adverse incidents with blood through SABRE.

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Detailed guide: Information for hospital blood banks during the coronavirus (COVID 19) outbreak

Detailed guide: Information for hospital blood banks during the coronavirus (COVID 19) outbreak

Guidance to hospital blood banks (HBBs) on flexible approaches to requirements

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Applications invited for the role of Chair of the MHRA

Applications invited for the role of Chair of the MHRA

Ministers are seeking to appoint a Chair of the Medicines and Healthcare products Regulatory Agency (MHRA).

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Detailed guide: Guidance on coronavirus (COVID 19) tests and testing kits

Detailed guide: Guidance on coronavirus (COVID 19) tests and testing kits

Advice on the use of testing kits and applications to place them on the market.

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Detailed guide: E cigarettes: regulations for consumer products

Detailed guide: E cigarettes: regulations for consumer products

Guidance on how to get an e-cigarette on the market in the UK, including the notification scheme and reporting problems with e-cigarettes.

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Detailed guide: MHRA regulatory flexibilities resulting from coronavirus (COVID 19)

Detailed guide: MHRA regulatory flexibilities resulting from coronavirus (COVID 19)

Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.

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Detailed guide: Register as a manufacturer to sell medical devices

Detailed guide: Register as a manufacturer to sell medical devices

Register a manufacturer or authorised representative (agent) for a manufacturer, to sell medical devices, including in vitro diagnostic (IVD) medical devices.

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Spinal implant: All MAGEC Systems – supply suspended to the (UK MDA/2020/011)

Spinal implant: All MAGEC Systems – supply suspended to the (UK MDA/2020/011)

Manufactured by NuVasive Specialized Orthopedics – supply of all MAGEC rods suspended to the UK market during a review by MHRA.

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Detailed guide: Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID 19) outbreak

Detailed guide: Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID 19) outbreak

Guidance for industry on flexible approaches we are taking on good distribution practices.

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Detailed guide: Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID 19) outbreak

Detailed guide: Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID 19) outbreak

Guidance for industry on flexible approaches we are taking on good distribution practices.

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Detailed guide: MHRA regulatory flexibilities resulting from coronavirus (COVID 19)

Detailed guide: MHRA regulatory flexibilities resulting from coronavirus (COVID 19)

Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.

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Detailed guide: MHRA regulatory flexibilities resulting from coronavirus (COVID 19)

Detailed guide: MHRA regulatory flexibilities resulting from coronavirus (COVID 19)

Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.

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Guidance: Medicines that cannot be parallel exported from the UK

Guidance: Medicines that cannot be parallel exported from the UK

Sets out medicines that cannot be parallel exported from the UK because they are needed for UK patients.

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Press release: MHRA approves new life saving breathing aid to help keep coronavirus (COVID 19) patients out of intensive care

Press release: MHRA approves new life saving breathing aid to help keep coronavirus (COVID 19) patients out of intensive care

Adapted breathing aid developed by UCL, UCLH and Mercedes Formula One provides vital technology to NHS.

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Detailed guide: Exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID 19) outbreak

Detailed guide: Exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID 19) outbreak

Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.

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Detailed guide: Exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID 19) outbreak

Detailed guide: Exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID 19) outbreak

Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.

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Corporate report: MHRA: policy for handling conflicts of interest

Corporate report: MHRA: policy for handling conflicts of interest

Information about how we handle potential conflicts of interest (COI) between MHRA, NIBSC and CPRD.

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Status of Phase 1 clinical trials in response to coronavirus (COVID 19)

Status of Phase 1 clinical trials in response to coronavirus (COVID 19)

We have written to all Phase I accredited units conducting early phase clinical trials to seek confirmation that all trials have undergone a risk assessment in relation to coronavirus (COVID-19) and the current government advice.

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Statutory guidance: MHRA fees

Statutory guidance: MHRA fees

Fees payable to MHRA for 2020 to 2021

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Detailed guide: Medical devices clinical investigations during the coronavirus (COVID 19) outbreak

Detailed guide: Medical devices clinical investigations during the coronavirus (COVID 19) outbreak

Advice for investigators and sponsors of ongoing clinical investigations and new applications.

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Field Safety Notices 23 to 27 March 2020

Field Safety Notices   23 to 27 March 2020

Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 March 2020

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Detailed guide: Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID 19)

Detailed guide: Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID 19)

The UK Good Laboratory Practice Monitoring Authority (UK GLPMA) recognises that there are potential challenges COVID-19 will present to members of the GLP monitoring programme.

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Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Ltd, Paracetamol 250mg/5ml Oral Suspension (500ml) PL 00427/0078 EL (20)A/19

Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Ltd, Paracetamol 250mg/5ml Oral Suspension (500ml) PL 00427/0078 EL (20)A/19

Rosemont Pharmaceuticals Ltd has informed us of an error in the barcode and GTIN number of the label on the bottle of the below batches.

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Guidance: Specification for Rapidly Manufactured CPAP System to be used during the coronavirus (COVID 19) outbreak

Guidance: Specification for Rapidly Manufactured CPAP System to be used during the coronavirus (COVID 19) outbreak

This is a specification of the minimally clinically acceptable Continuous Positive Airway Pressure (CPAP) system to be used in UK hospitals.

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Government response: Coronavirus (COVID 19) and high blood pressure medication

Government response: Coronavirus (COVID 19) and high blood pressure medication

There is no evidence from clinical or epidemiological studies that treatment with ACE-I or ARBs might worsen COVID-19 infection.

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Detailed guide: Regulatory status of equipment being used to help prevent coronavirus (COVID 19)

Detailed guide: Regulatory status of equipment being used to help prevent coronavirus (COVID 19)

There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)

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Detailed guide: Exemptions from Devices regulations during the coronavirus (COVID 19) outbreak

Detailed guide: Exemptions from Devices regulations during the coronavirus (COVID 19) outbreak

Fast-track approval of medical devices during COVID-19 outbreak

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MHRA services during the Coronavirus (COVID 19) response

MHRA services during the Coronavirus (COVID 19) response

How to get in touch with the MHRA during this period.

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Detailed guide: Good laboratory practice (GLP) for safety tests on chemicals

Detailed guide: Good laboratory practice (GLP) for safety tests on chemicals

Keep up to date with the latest information from the UK GLP monitoring authority.

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Guidance: Specification for ventilators to be used in UK hospitals during the coronavirus (COVID 19) outbreak

Guidance: Specification for ventilators to be used in UK hospitals during the coronavirus (COVID 19) outbreak

This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators.

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Detailed guide: Regulatory status of equipment being used to help prevent coronavirus (COVID 19)

Detailed guide: Regulatory status of equipment being used to help prevent coronavirus (COVID 19)

There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)

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Detailed guide: The Yellow Card scheme: guidance for healthcare professionals, patients and the public

Detailed guide: The Yellow Card scheme: guidance for healthcare professionals, patients and the public

Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.

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Detailed guide: Medicines: marketing authorisation holders submission of Nitrosamine risk evaluation

Detailed guide: Medicines: marketing authorisation holders submission of Nitrosamine risk evaluation

MAHs should review their manufacturing processes to identify and, if found, to mitigate risk of presence of nitrosamine impurities.

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Chloroquine and Hydroxychloroquine not licensed for coronavirus (COVID 19) treatment

Chloroquine and Hydroxychloroquine not licensed for coronavirus (COVID 19) treatment

Recent media reports have suggested that chloroquine can protect patients from coronavirus or treat COVID-19, the illness caused by a coronavirus.

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Detailed guide: Exemptions from Devices regulations during the coronavirus (COVID 19) outbreak

Detailed guide: Exemptions from Devices regulations during the coronavirus (COVID 19) outbreak

Fast-track approval of medical devices during COVID-19 outbreak

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Form: How to place a Coronavirus (COVID 19) test kit on the market

Form: How to place a Coronavirus (COVID 19) test kit on the market

What manufacturers need to do

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Class 4 Medicines Defect Information: Zamadol SR 50 mg prolonged release hard capsules, PL 46302/0149 (EL (20)A/18)

Class 4 Medicines Defect Information: Zamadol SR 50 mg prolonged release hard capsules, PL 46302/0149 (EL (20)A/18)

Mylan UK Healthcare Ltd has informed us that the GTIN barcode applied on the below batches is incorrect.

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Detailed guide: Guidance for Manufacturers Specials licence holders on ‘packing down’ medicines during the coronavirus (COVID 19) outbreak

Detailed guide: Guidance for Manufacturers Specials licence holders on ‘packing down’ medicines during the coronavirus (COVID 19) outbreak

If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions

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Detailed guide: Managing clinical trials during Coronavirus (COVID 19)

Detailed guide: Managing clinical trials during Coronavirus (COVID 19)

How investigators and sponsors should manage clinical trials during COVID-19

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Detailed guide: Medicines: marketing authorisation holders submission of Nitrosamine risk evaluation

Detailed guide: Medicines: marketing authorisation holders submission of Nitrosamine risk evaluation

MAHs should review their manufacturing processes to identify and, if found, to mitigate risk of presence of nitrosamine impurities.

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Detailed guide: Notify MHRA about a clinical investigation for a medical device

Detailed guide: Notify MHRA about a clinical investigation for a medical device

How to notify MHRA of your intention to carry out a clinical investigation for CE marking.

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Field Safety Notices 16 to 20 March 2020

Field Safety Notices   16 to 20 March 2020

Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 March 2020

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Notice: Register of brokers authorised to deal in human medicines

Notice: Register of brokers authorised to deal in human medicines

Current listing of UK brokers authorised to broker human medicines, including company name, registration and address.

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