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The rules that manufacturers and importers of fertilisers need to follow when trading in the UK.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
The way you apply to licence biological products has changed
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
What you need to do to comply with regulations on manufactured products you place on the market in Great Britain.
Guidance for manufacturers, importers and distributors.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
How to make sure that your products are properly checked for conformity and your technical documents are managed correctly.
You may be able to pay no Customs Duty or a reduced amount of duty for goods you bring or receive into the UK, depending on what they are and what you do with them.
Guidance for the pharmaceutical industry on who can be a Marketing Authorisation Holder, named distributor or local representative and how to make changes to these.
Use this form to notify the IPO of marketing authorisation for a medicinal or plant protection product, granted after your application for an SPC for that product.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to ensure the products you make or import comply with the law and are safe for consumers to use.
Marking, labelling and marketing standards you must follow to import and export plant seeds, food and manufactured goods.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
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