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An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
Get help to classify articles of leather and other items in chapter 42 of the tariff for import and export.
Series of reports looking at farming practices and the impact on the environment.
This guidance explains what rules of origin (RoOs) are and the changes under the Developing Countries Trading Scheme (DCTS).
Find out about partial exemption special methods for government departments.
Show what impact an activity will have on European protected species and whether their favourable conservation status will be maintained.
From 13 May 2024 we are introducing a change to the procedure for new Marketing Authorisation (MA) applications, where a joint assessment of labels is requested.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
Helping public health practitioners conducting evaluations – using process evaluations to explain how complex interventions work.
A collection of resources, links and documents aimed to help students prepare for their exams and formal assessments.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Procedures rules and forms not replaced by the Criminal Procedure Rules or the Family Procedure Rules and statutory instruments.
Applications received to amend the specification of a patent under sections 27 and 75 before the court and the Office.
A capitated approach to payment for mental health services with outcomes and risk share.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
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