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Information for manufacturers.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Information on good laboratory, manufacturing and distribution practice, good pharmacovigilance practice (GPvP), out-of-specification investigations, inspection metrics and fees.
Information on cleaning an oil spill including your options, how to get a product approved and how long it will take.
Why it's important to evaluate digital health products that have been developed rapidly and how to choose evaluation methods in these circumstances.
How you import from and export to Jordan.
Use the case studies to help you decide when your goods may (or may not) go beyond insufficient production.
What animal by-products (ABPs) are, how to set up a site that uses them safely, the paperwork you need, and how to dispose of them.
How to import animals and animal products to Great Britain (England, Scotland and Wales), the Channel Islands and the Isle of Man from non-EU countries.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
Guidance for manufacturers, importers and distributors on the Product Security and Telecommunications Infrastructure Act 2022 and Regulations 2023.
Labelling rules for businesses in Great Britain (England, Scotland and Wales) and retailers in Northern Ireland, for certain agri-food products moved under the Northern Ireland Retail Movement Scheme.
How to use a quasi-experimental study to evaluate your digital health product.
The guide, toolkit and further information for GB authorities with responsibility for consumer product safety.
These published standards relate to a number of KPIs in the VMD Deliverables and KPI document.
Comply with good pharmacovigilance practice and prepare for an inspection.
Find out if you need to use the UKCA (UK Conformity Assessed) marking on products you manufacture or handle.
Don’t include personal or financial information like your National Insurance number or credit card details.
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