GovWire

Medicines Healthcare Products Regulatory Agency


Decision: Regulatory approval of Pfizer / BioNTech vaccine for COVID 19

Decision: Regulatory approval of Pfizer / BioNTech vaccine for COVID 19

Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine.

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Press release: UK medicines regulator gives approval for first UK COVID 19 vaccine

Press release: UK medicines regulator gives approval for first UK COVID 19 vaccine

The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).

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Decision: Regulatory approval of Pfizer / BioNTech vaccine for COVID 19

Decision: Regulatory approval of Pfizer / BioNTech vaccine for COVID 19

Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine.

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Press release: UK medicines regulator gives approval for first UK COVID 19 vaccine

Press release: UK medicines regulator gives approval for first UK COVID 19 vaccine

The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).

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Decision: Human and veterinary medicines: register of licensed manufacturing sites

Decision: Human and veterinary medicines: register of licensed manufacturing sites

Department of Health and MHRA register of licensed manufacturing sites - manufacturer specials (human) (MS) and manufacturer specials authorisation (veterinary) (MANSA) only.

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Decision: Human and veterinary medicines: register of licensed wholesale distribution sites

Decision: Human and veterinary medicines: register of licensed wholesale distribution sites

Department of Health and Social Care and MHRA register of licensed wholesale distribution sites (human and veterinary).

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Decision: Medicines: new manufacturing and wholesale dealer licences

Decision: Medicines: new manufacturing and wholesale dealer licences

List of sites granted a manufacturer or wholesale dealer licence

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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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Notice: Medicines: terminated and cancelled manufacturing and wholesale dealer licences

Notice: Medicines: terminated and cancelled manufacturing and wholesale dealer licences

List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled.

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Decision: Medical devices given exceptional use authorisations during the COVID 19 pandemic

Decision: Medical devices given exceptional use authorisations during the COVID 19 pandemic

List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.

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Guidance: Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021

Guidance: Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021

How the ‘Written Confirmation’ process for active substances manufactured in Great Britain (England, Wales and Scotland) will be handled from 1 January 2021.

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Detailed guide: Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, 'grandfathering' and managing lifecycle changes

Detailed guide: Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, 'grandfathering' and managing lifecycle changes

This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.

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Field Safety Notices: 23 to 27 November 2020

Field Safety Notices: 23 to 27 November 2020

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

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Guidance: Guidance on pharmacovigilance procedures from 1 January 2021

Guidance: Guidance on pharmacovigilance procedures from 1 January 2021

This guidance summarises our approach to pharmacovigilance from 1 January 2021.

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Research and analysis: MHRA: Business Impact Target

Research and analysis: MHRA: Business Impact Target

The Medicines and Healthcare products Regulatory Agency (MHRA) assesses its regulatory impact on businesses.

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Decision: Early access to medicines scheme: expired scientific opinions

Decision: Early access to medicines scheme: expired scientific opinions

Medicines that were granted a positive opinion under the early access to medicines scheme (EAMS) which has now expired.

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Oxford/AstraZeneca COVID 19 vaccine: MHRA statement confirming letter received

Oxford/AstraZeneca COVID 19 vaccine: MHRA statement confirming letter received

The safety of the public will always come first.

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Oxford/AstraZeneca COVID 19 vaccine: MHRA statement confirming letter received

Oxford/AstraZeneca COVID 19 vaccine: MHRA statement confirming letter received

The safety of the public will always come first.

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Detailed guide: On site access to Electronic Health Records by Sponsor representatives in clinical trials

Detailed guide: On site access to Electronic Health Records by Sponsor representatives in clinical trials

The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.

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Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Largactil 50mg/2ml Solution for Injection, EL (20)A/56

Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Largactil 50mg/2ml Solution for Injection, EL (20)A/56

Sanofi is recalling specific batches of Largactil 50mg/2ml Solution for Injection as a precautionary measure due to out of specification results obtained for the impurity chlorpromazine sulphoxide

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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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Class 2 Medicines Recall: Kent Pharmaceuticals Ltd, Betahistine dihydrochloride 8mg and 16mg Tablets, EL (20)A/55

Class 2 Medicines Recall: Kent Pharmaceuticals Ltd, Betahistine dihydrochloride 8mg and 16mg Tablets, EL (20)A/55

Kent Pharmaceuticals Ltd has informed us that several batches of finished product were contaminated with theophylline due to a cross-contamination issue identified with an excipient that was used in the manufacture of the finished product.

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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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Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A/54

Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A/54

Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of double tablets in a single blister pocket.

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Guidance: Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021

Guidance: Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021

How the ‘Written Confirmation’ process for active substances manufactured in Great Britain (England, Wales and Scotland) will be handled from 1 January 2021.

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Detailed guide: Placing an e cigarette on the market from 1 January 2021

Detailed guide: Placing an e cigarette on the market from 1 January 2021

From 1 January 2021, new rules mean notifications from Great Britain and Northern Ireland will need to be sent to different routes

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Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients

Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients

Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.

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Detailed guide: Advice for developers of COVID 19 vaccines

Detailed guide: Advice for developers of COVID 19 vaccines

MHRA scientific and regulatory advice for COVID-19 vaccine developers

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Field Safety Notice: 16 to 20 November 2020

Field Safety Notice: 16 to 20 November 2020

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

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Detailed guide: Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021

Detailed guide: Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021

Pharmacovigilance system requirements from 1 January 2021

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Pfizer/BioNTech COVID 19 vaccine: MHRA statement confirming data received

Pfizer/BioNTech COVID 19 vaccine: MHRA statement confirming data received

Safety is our watch word.

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Pfizer/BioNTech COVID 19 vaccine: MHRA statement confirming data received

Pfizer/BioNTech COVID 19 vaccine: MHRA statement confirming data received

Safety is our watch word.

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Pfizer/BioNTech COVID 19 vaccine: MHRA statement

Pfizer/BioNTech COVID 19 vaccine: MHRA statement

The safety of the public will always come first.

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Guidance: How tests and testing kits for coronavirus (COVID 19) work

Guidance: How tests and testing kits for coronavirus (COVID 19) work

The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.

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Detailed guide: Apply for a traditional herbal registration (THR)

Detailed guide: Apply for a traditional herbal registration (THR)

How to apply for a traditional herbal registration (THR) to market a herbal medicine (remedy) in the UK.

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Pfizer / BioNTech COVID 19 vaccine: MHRA statement

Pfizer / BioNTech COVID 19 vaccine: MHRA statement

The safety of the public will always come first.

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Pfizer / BioNTech COVID 19 vaccine: MHRA statement

Pfizer / BioNTech COVID 19 vaccine: MHRA statement

The safety of the public will always come first.

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Detailed guide: Medicines: reclassify your product

Detailed guide: Medicines: reclassify your product

Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.

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Decision: Medical devices given exceptional use authorisations during the COVID 19 pandemic

Decision: Medical devices given exceptional use authorisations during the COVID 19 pandemic

List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.

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Detailed guide: Medicines: reclassify your product

Detailed guide: Medicines: reclassify your product

Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.

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Research and analysis: Public Assessment Report of the Reclassification of Benacort Hayfever Relief for Adults 64 micrograms, nasal spray from POM to GSL

Research and analysis: Public Assessment Report of the Reclassification of Benacort Hayfever Relief for Adults 64 micrograms, nasal spray from POM to GSL

This PAR covers the assessment of an application to reclassify Benacort Hayfever Relief for Adults 64 micrograms, nasal spray from Prescription Only Medicine (POM) to General Sales (GSL).

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Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy

Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy

Modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment and for 2 months after stopping modafinil.

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Pirfenidone (Esbriet): risk of serious liver injury; updated advice on liver function testing

Pirfenidone (Esbriet): risk of serious liver injury; updated advice on liver function testing

Serious liver injury has been reported during treatment with pirfenidone in the first year after initiation, including 2 cases with a fatal outcome. Measure alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels before starting pirfenidone treatment, monthly for the first 6 months of treatment, and then every 3 months thereafter. Follow new guidance on testing liver function promptly in patients who report symptoms or have clinical signs that might indicate they have liver injury and adjust the dose or discontinue treatment according to new recommendations.

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Ferric carboxymaltose (Ferinject?): risk of symptomatic hypophosphataemia leading to osteomalacia and fractures

Ferric carboxymaltose (Ferinject?): risk of symptomatic hypophosphataemia leading to osteomalacia and fractures

Monitor serum phosphate levels in patients treated with multiple high-dose administrations, or those on long-term treatment, and in those with pre-existing risk factors for hypophosphataemia. Re-evaluate ferric carboxymaltose treatment in patients with persistent hypophosphataemia.

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Bupropion (Zyban): risk of serotonin syndrome with use with other serotonergic drugs

Bupropion (Zyban): risk of serotonin syndrome with use with other serotonergic drugs

Cases of serotonin syndrome have been identified in associated with bupropion, especially in overdose or when bupropion is administered with other drugs with a serotonergic effect.

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