MHRA

Guidance on legislation

MHRA. All notifications should be submitted using the application process on the IRAS portal. If, within 60 days of formal acceptance of the Notice, the MHRA has not given written notice of objection, the clinical investigation may proceed. The MHRA may give such notice of objection on

  Harm

BSI guide to masks and face coverings for use in the UK ...

(MHRA) Regulator or enforcement authority The table below summarizes common types of face mask, other PPE designed to reduce the risk of transmission of the virus and other products such as face coverings. It includes intended users, the protection offered, the applicable regulations and the relevant UK regulator or enforcement authority.

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Overview of applications for Marketing Authorisations ...

Quality Assessor, MHRA, UK . 1 Outline Quality • Structure • Content (CTD) • Requirements Quality Requirements • Guidance Recent experience . 2 Quality – Content of a dossier • Legislation (EU Directives and Regulations) • European Commission – Notice to Applicants (2B) –

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MHRA Guideline for the Naming of Medicinal Products and ...

MHRA assesses each invented name individually and in conjunction with a specific medicinal product. Where the proposed invented name has been registered as a trademark in the UK for use with a medicinal product, an assessment by MHRA, including safety considerations,

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MHRA recommendations on simvastatin interactions: …

The MHRA . Drug Safety Update (August 2012) highlights changes to the simvastatin SmPC regarding interactions that can increase the risk of myopathy and/or rhabdomyolysis. When used with amlodipine, the maximum dose of simvastatin is now 20mg; higher doses are ‘off-label’. For . patients taking amlodipine and simvastatin 40mg consider: 1.

  Recommendations, Interactions, Harm, Simvastatin, Mhra recommendations on simvastatin interactions

Joint statement on seeking consent by electronic methods

Joint statement on seeking consent by electronic methods September 2018 The Health Research Authority is a Non-Departmental Public Body established to promote

Health Guidance: The Temperature Requirements for ...

Page 2 of 3 . Introduction and purpose of guidance . If medicines are not stored properly they may not work in the way they were intended, and so pose a …