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Application and authorisation information hub explainer

Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines. ....

United Kingdom , Northern Ireland , Great Britain , Commission Regulation , European Commission , European Medicines Agency , National United Kingdom , Centrally Authorised Product , Marketing Authorisation , Product Characteristics , Blue Box , Northern Ireland Protocol , Veterinary Medicines , United Kingdom Regulations , Authorised Products , Decentralised Procedure , Concerned Member State , Veterinary Medicines Regulations , Product Literature Standard , Centralised Procedure , Residue Limits , Maximum Residue Limits , Official Journal , ஒன்றுபட்டது கிஂக்டம் , வடக்கு ஐயர்ல்யாஂட் , நன்று பிரிட்டன் ,

Product Literature Standard (PLS) for veterinary medicines

Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment. ....

United Kingdom , Northern Ireland , Marketing Authorisations , National Competent Authorities , Marketing Authorisation , National Applications , Product Literature Standard , Product Characteristics , Best Practice , Times New , Marketing Authorisations Granted , Centralised Procedure , Veterinary Medicines Regulations , Blue Box , National Competent , Limited Marketing , Outer Packaging , Immediate Packaging , Small Immediate Packaging , Outer Packaging Immediate , Veterinary Homeopathic Registered , Drugs Regulations , Product Information , Import Marketing Authorisations , Material Safety Data Sheets , ஒன்றுபட்டது கிஂக்டம் ,

Summary of Product Characteristics and product literature for veterinary medicines

Summary of Product Characteristics and product literature for veterinary medicines
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
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This guidance applies to applications for national and mutually recognised Marketing Authorisations (MAs) and Veterinary Homeopathic Remedies (VHRs). It does not apply to Centralised applications. VHRs do not have SPCs.
Product Literature Standard
Joint labelling with Ireland
Joint labelling is the term used for a single label/leaflet that has been agreed by the UK and Ireland for use on veterinary medicines marketed in their countries. ....

United Kingdom , Marketing Authorisations , Veterinary Homeopathic Remedies , Product Literature Standard , Parallel Imports , Product Literature , Concerned Member State , Best Practice , Qualified Person , ஒன்றுபட்டது கிஂக்டம் , கால்நடை ஹோமியோபதி வைத்தியம் , ப்ராடக்ட் இலக்கியம் தரநிலை , இணையாக இறக்குமதி , ப்ராடக்ட் இலக்கியம் , சம்பந்தப்பட்ட உறுப்பினர் நிலை , சிறந்தது ப்ர்யாக்டீஸ் , தகுதி நபர் ,