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Using an ecological momentary assessment to evaluate your digital health product.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
The MHRA is continuing to accept Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs)
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines.
Submission dates and how the submissions using the EC decision reliance procedure work.
Apply for an authorisation to manufacture authorised veterinary medicines and medicines marketed under the Exemptions for Small Pet Animals.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
Advice and guidance on the health needs of migrant patients for healthcare practitioners.
Legal terms for veterinary medicines, marketing of non-medicinal products including medicinal words and phrases, how to complain.
Apply to manufacture Extemporaneous preparations, Autogenous vaccines, authorisations for Equine Stem Cell Centre (ESCCA) or Non-Food Animal Blood Bank (NFABBA).
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Check the tariff classification for vitamin gummies.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to use a before-and-after study to evaluate your digital health product.
The agreement for a first-of-a-kind test rig will provide critical data for the design and development of Spherical Tokamak for Energy Production (STEP).
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.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
FCDO travel advice for Colombia. Includes safety and security, insurance, entry requirements and legal differences.
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