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Guidance on infant and follow-on formula, the application form for infant and follow-on formula made from protein hydrolysates, and forms to notify the authority.
A list of herbal ingredients that are banned or restricted for unlicensed medicines.
E-learning modules for healthcare professionals on minimising the risks of using medicines and information on how to access medical device modules.
How to use PharmaQC to access pharmaceutical suppliers, Quality Control (QC) pharmacists and Commercial Medicines Unit (CMU) buyers.
How manufacturers in Northern Ireland should undertake a clinical investigation for medical devices to ensure they comply with EU medical device regulations.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
Guidelines to provide developers of biosimilar products with a clear outline of the requirements in Great Britain.
Approved countries for batch testing and importation of medicines
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
How the MHRA treats traditional herbal medicines and homeopathic medicines.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
Outlining the principles for the management and oversight of the import of investigational medicinal products (IMPs) to Great Britain from listed countries.
This publication clarifies which regulatory guidelines should be followed, and which apply, in the development of phage therapeutic products.
A proposed format to help prepare responses to good distribution practice (GDP)/good manufacturing practice (GMP) post inspection letters.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Guiding principles for the use of predetermined change control plans (PCCPs) for managing rapid product changes in medical devices.
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
Helping interpret the Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025 regulations.
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