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Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
A form of IP that extends the protection of patented active ingredients present in pharmaceutical or plant protection products.
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
Apply to become or identify an approved manufacturer authorised to carry out conformity assessment.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Information about the EU Regulations and their implementation in Northern Ireland
What you need to do to comply with regulations on manufactured goods you place on the Northern Ireland market.
What you need to do to comply with regulations on manufactured products you place on the market in Great Britain.
Find out which gas appliances must comply with the Gas Appliances (Safety) Regulations 1995, exemption and penalties for non-compliance
Guidance providing practical information for placing construction products on the GB market.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Legal terms for veterinary medicines, marketing of non-medicinal products including medicinal words and phrases, how to complain.
ISSUES UNDER THE EUROPEAN PUBLIC LIMITED-LIABILITY COMPANY (EMPLOYEE INVOLVEMENT) REGULATIONS ON WHICH APPLICATIONS OR COMPLAINTS CAN BE MADE TO THE CAC
MHRA scientific and regulatory advice for COVID-19 vaccine developers
Things to consider when buying and using products.
How to identify and report harmful trade practices that affect your business when exporting, importing or operating domestically.
Find out about the Industry Security Assurance Centre (ISAC) and its associated responsibilities.
How to place CE marking on your product, how to identify UK requirements relating to construction products, and how to apply to be a UK Notified Body or Technical Assessment Body.
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