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How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
The review of the safety of isotretinoin has concluded.
Canada and UK Trade Continuity Agreement enters into force
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
Guidance for Marketing Authorisation (MA) applicants on providing consent to share operational information during the MA application process.
Information to raise awareness with commissioners and providers of the community pharmacy offer for sexual health, reproductive health and HIV services.
What 'single-use' means and what symbol is used by manufacturers to show this.
Guidance for industry on flexible approaches we are taking on good distribution practices.
Guidance for specialists for initiation of valproate in female patients and for annual review and pregnancy testing to support adherence to pregnancy prevention requirements during the pandemic.
Information for patients who have been prescribed Paxlovid (nirmatrelvir 150mg and ritonavir 100mg) film-coated tablets COVID-19 antiviral medication.
Guidance for manufacturers who source their own-branded products from another company.
Guidance on how Pharmacy First will help pharmacies support their communities, with information on the new clinical pathways and fee structure.
What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland.
Information for patients, healthcare professionals and the wider public to help better understand the importance of AAIs as a potential life-saving medicine.
Guidance for manufacturers on reporting adverse incidents involving breast implants under the vigilance system.
Types of ingredients permitted in nicotine-containing liquids in electronic cigarettes and refill containers.
A document for patients explaining how the highest risk patient groups eligible for new coronavirus treatments will be identified.
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
This is a work sharing model for the co-ordinated assessment of a generic application that has been filed with multiple Access Consortium agencies.
The VDEC clinical evaluation team works to support vaccine and therapeutic development by providing expertise in immunological and functional assays used to support clinical trials (Phase I to IV)
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