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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 kingdomNorthern irelandGreat britainCommission regulationEuropean commissionEuropean medicines agencyNational united kingdomCentrally authorised productMarketing authorisationProduct characteristicsBlue boxNorthern ireland protocolVeterinary medicinesUnited kingdom regulationsAuthorised productsDecentralised procedure

Parallel submission of generic applications

Parallel submission of generic applications
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United kingdomNorthern irelandVeterinary medicines regulationsNorthern ireland protocolDecentralised procedureConcerned member stateMarketing authorisationMarketing authorisation holderஒன்றுபட்டது கிஂக்டம்வடக்கு ஐயர்ல்யாஂட்கால்நடை மருந்துகள் ஒழுங்குமுறைகள்வடக்கு ஐயர்ல்யாஂட் ப்ரோடொகால்சம்பந்தப்பட்ட உறுப்பினர் நிலை

Беларусбанк, Белинвестбанк и Белагропромбанк попали под санкции: что с ними будет?

Беларусбанк, Белинвестбанк и Белагропромбанк попали под санкции: что с ними будет?
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Belinvestbanki belagroprombankRespublika belaruBelarusbank belinvestbankEuropean unionBank reconstructioni developmenti europeanBank reconstructioni developmentMember statesi commissionMember statesGovernment belarusConcerned member stateArticle member statesInternational the bank reconstructionEuropean the bank reconstructionThey areஐரோப்பிய தொழிற்சங்கம்உறுப்பினர் மாநிலங்களில்

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. From: Contents Print this page 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 kingdomMarketing authorisationsVeterinary homeopathic remediesProduct literature standardParallel importsProduct literatureConcerned member stateBest practiceQualified personஒன்றுபட்டது கிஂக்டம்கால்நடை ஹோமியோபதி வைத்தியம்ப்ராடக்ட் இலக்கியம் தரநிலைஇணையாக இறக்குமதிப்ராடக்ட் இலக்கியம்சம்பந்தப்பட்ட உறுப்பினர் நிலைசிறந்தது ப்ர்யாக்டீஸ்

Apply for a licence to market a medicine in the UK

Apply for a licence to market a medicine in the UK How to license a medicine for sale in the UK, including applications through national and international routes. From: Contents Print this page This guidance also covers licensing a medicine in Northern Ireland through the centralised, decentralised and mutual recognition European procedures. Which procedure to follow There are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) or Northern Ireland. The options available will be determined by the intended market and the type of application. The markets in which each route is applicable are indicated in the following guidance:

United kingdomNorthern irelandGreat britainCanada healthCommittee for medicinal productsNational health serviceRegulatory authorityNational rules schemeDepartment of healthEuropean unionSwiss agency for therapeutic products of switzerlandScottish medicines consortiumFood branchEuropean commissionDrug administrationNational institute of heath research