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document on SPC, labelling and package leaflet veterinary medicinal products
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Topic
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Advertising
Animal feed additives
Animal feed claims
Animal testing
Application procedure advisory meetings
Application procedures
Authorisation Contact Committee (CCR)
Biosimilar medicinal product
Cascade
Centralised procedure
Certificates
Clinical trial with a veterinary medicinal product
Column by the chairman: 'On medicines'
Committee for the Authorisation of Veterinary Medicines (Ctd)
Committee on the authorisation of veterinary medicinal products
Compassionate use programme
Consultation procedure for medical devices
Cooperation in Europe
Cooperation in the Netherlands
Correspondence during procedure
Cover letter
Database for manufacturing and wholesale distribution (EudraGMDP)
Decentralised procedure
Decision-making process at the European level
Definition of novel foods
Determination of novel food status
Dietetic feeds
Direct Healthcare Professional Communication (DHPC)
Dossier modules
Duplex marketing authorisation
EudraVigilance signal management pilot
European authorisation procedure
Export of veterinary medicinal products
Falsified Medicines Directive
Feed materials
Fees and product types
Fees and product types Veterinary Medicinal Products Unit
GMP and quality defects
Generic medicinal product
Good distribution practice (GDP)
Homeopathic medicinal product
Homeopathic veterinary medicinal product
Implementation of agreed wording
Informed consent
Inspection
Integrity, openness and finances
Internet trade in veterinary medicinal products
Labelling
Legal status of supply
Legal status of supply
Legislation on veterinary medicinal products
Licence requirements for retail (D)
Licence requirements for wholesale (G)
Licence types
Line extension
MEB Advisory Board
MEB policy documents
Manufacturing (F) (GMP)
Marketing authorisation exemption
Marketing authorisation for reasons of public health
Marketing authorisations without Dutch translations of the product information and/or mock-ups
Marketing discontinuation, suspension and shortages
Medicinal gas marketing authorisation
Mutual recognition procedure
National contact person for pharmacovigilance
National procedure
New active substance
Nomenclature, excipients, abbreviated indications
Opium Act and veterinary medicinal products
Organisation Management Service (OMS)
Our story: Good medicines used better
Our tasks
PSMF
Package leaflet
Paediatric medicinal product
Parallel distribution
Parallel import
Parallel procedures: faster assessment of medicines
Parallel trade in veterinary medicinal products
Patented indication
Periodic safety update reports (PSUR)
Permission to carry out tests with additives for animal feed
Pharmacovigilance communication plan
Pipeline meetings
Planning tool for application procedures
Production and/or distribution licence application, change or withdrawal
Proposed withdrawals and patients' interest
QR code
QRD templates
Recall of veterinary medicinal product
Register of animal feed additives
Register of licences
Registration procedure for specific pets
Relevant legislation
Renewal
Reporting a product defect
Reporting adverse events
Reporting adverse events during clinical trials
Reporting an adverse event
Requirements for importation (I)
Responsibilities following marketing authorisation
Risk management plan
SPC, labelling and package leaflet veterinary medicinal products
Science
Scientific and regulatory advice
Signal management
Site clearance
Starting materials
Storage, transport and delivery of veterinary medicinal products
Submission of a dossier
Submission via CESP
Summary of product characteristics (SmPC)
TSE requirements
Technical validation
Temporarily supply of a medicinal product in a different packaging
The Agency
The Board
Traditional herbal medicinal product
Types of marketing authorisation
Union Product Database
Use of herbs in animals
Variation
Veterinary prescription
Well established use
Withdrawal of a marketing authorisation
Working at the MEB
Young MEB
Element
All elements
Veterinary medicines
Marketing authorisation – medicines for human use
About MEB
Type
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Annual report
Audio clip
Convenant
Form
Leaflet
Newsletter
Parliamentary document
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Question and answer
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Questions and answers SPC
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