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Approval of medicines
Approval and follow-up of marketing authorisation (MA)
Application for marketing authorisation
Announcement of needed products in Norway
Forms and guidance for MA-application
Guideline for the naming of medicinal products
Homeopathic medicinal products
Homeopathic medicinal products for human and veterinary use – Registration provisions in Norway
Homeopathic medicinal products for human use – simplified registration application
Homeopathic veterinary medicinal products – simplified registration application
Registration of homeopathic medicinal products for human and veterinary use – Variations, renewals, withdrawals and Sunset Clause
List of newly adopted marketing authorisations in Norway
List of pending marketing authorisation applications
Request for Norway to act as RMS in Decentralized Procedure
Sunset Clause
WHO-certificates
Renewal of MA
Variations regarding marketing authorisation
Transfer of MA/change in name and address of the MAH
Supplementary information regarding variation applications in NP
Batch-specific variation applications
Medicinal products to be distributed without medical prescription
OTC substance reports
Application for OTC legal status and change of OTC legal status
Harmonization of packaging leaflet and labelling for OTC-medicinal products with an OTC substance report
Parallel import: Application for MA and post-marketing obligations
Application for MA for parallel importet medicinal products
Post-marketing obligations for parallel imported medicinal product
Product information - templates and guidance
Warning triangle
Summary of product characteristics (SmPC) and Package leaflet (PIL)
Packaging
QRD templates
Readability testing and bridging
Implementation date and batch-specific variations
Notification of shortages or withdrawal of medicinal product in Norway
Other information regarding MA
Regulatory fees
Submission of applications
Whom to contact regarding regulatory questions?
Product information - recommended updates
Recommendations after referral adopted by the European Commission
Clinical trials
Clinical Trials Information System (CTIS)
Application for clinical trials
Transitional rules from Directive 2001/20/EC to Regulation (EU) No 536/2014
Fees for assessment of clinical trials and assessment of safety information
Ongoing studies subject to the old regulation
Notification of Amendments to a Clinical Trial
Compassionate Use Program
Adverse drug reactions and drug safety
Reporting of adverse reactions and The Norwegian Adverse Drug Reaction Registry
The Norwegian Adverse Drug Reaction Registry
How do I report suspected adverse reactions after taking medicines or vaccines?
What is pharmacovigilance
Pharmacovigilance information for the marketing authorisation holders
Educational material - guidance for submission and distribution
Frequently asked questions (FAQ) – Electronic transmission of individual case safety reports (ICSRs)
Guidance for submission of Norwegian translations of direct healthcare professional communication (DHPC)
No national requirements to the pharmacovigilance legislation
Procedure for follow-up information requests for adverse reaction reports
Procedure for notifying emerging safety issues
Compassionate use, named patient
General information about Compassionate use, named patient
Medicine shortage
Application for license to sell foreign packages
Medical devices
Guidance and regulations
The legislation for medical devices
Guidance from the EU Commission/MDCG
Transitional provisions for medical devices
Medical devices for animals
Development and manufacturing of medical devices
Qualification and classification
Qualification
Classification of medical devices
Documentation and quality management system
Technical documentation
Quality management system and risk management
Person responsible for regulatory compliance - PRRC
Standards and common specifications
Language requirements and information following the medical device
Unique Device Identification (UDI) System
Conformity assessment
Conformity assessment involving notified body
EU Declaration of Conformity
CE marking of conformity
Derogation from the conformity assessment procedure
Free Sales Certificate
Devices for special purposes
Custom-made devices
Systems and procedure packs of medical devices
Monitoring after device is placed on the market
Supply, import and distribution
The different roles of economic operators
General obligations for manufacturers of medical devices
General obligations for authorised representatives of medical devices
General obligations for importers and distributors of medical devices
General obligations for health institutions when using medical devices
Cases in which obligations of manufacturers apply to importers, distributors or other persons
Distance Sales/Online sales/E-commerce
Market surveillance and auditing of medical devices
Parts and components that change performance or intended purpose
Advertising for medical devices
Clinical investigation of medical devices
Introduction to clinical investigation of a medical device
Clinical investigations which require an application
Clinical investigations which require a notification
Other clinical investigations
Safety reporting in clinical investigations
Substantial modifications to a clinical investigation
End or temporary halt of a clinical investigation
Clinical investigations started prior to 26th May 2021
Performance studies of in vitro-diagnostic medical devices (IVDs)
Performance studies which require an application
Performance studies which require a notification
Post-market performance follow-up (PMPF) studies
Studies involving companion diagnostics (CDx)
Other performance studies
Safety reporting in performance studies
Substantial modifications to a performance study
End or temporary halt of a performance study
Serious Incidents and Field Safety Corrective Actions
Serious incidents with medical device
How to report a serious incident
Field Safety Corrective Action
How to report a Field Safety Corrective Action
Norwegian register for devices and EUDAMED
Registration of medical devices
Eudamed
For Healthcare Facilities
Reporting serious incidents from healthcare facilities
Field Safety Corrective Actions for healthcare facilities
Medical gas pipeline systems
Public funding and pricing of medicines
Horizon scanning or request for assessment
Pipeline meetings
Single technology assessments
Single technology assessments of pharmaceuticals - status and reports
Submission of documentation for single technology assessment of pharmaceuticals
Guidelines for the submission of documentation for single technology assessment (STA) of pharmaceuticals
Guidelines for pre-meetings in connection with single technology assessments (STAs)
Template for submission of documentation for the single technology assessment of pharmaceuticals
FINOSE
Waiver of confidentiality
Previous FINOSE-assessments
Working with confidential data in the FINOSE collaboration
Products prioritised in FINOSE
Assessment process
Pharmaceuticals granted exceptions from the documentation requirements for single technology assessments (STAs)
Access to pharmaceuticals for very small patient groups with extremely severe conditions
Unit cost database
Pricing of medicines
Maximum price
Manufacturing, import and retailing of medicines
Fees
Supplier tax
Importing medicines for personal use
Importing medicines for personal use in the form of consignments
Bringing medicines into Norway by travel
Taking medicines out of Norway
Import and wholesaling of medicines
Import of medicines
Import of medicinal products for clinical studies in Norway
Wholesaling in Norway based on a MIA or a WDA issued within the EU/EEA
Manufacturing of medicines
Guideline on use of bulk packages with automated dose dispensing
Dispensing and sale of medicines in pharmacies
Dispensing regulations
Veterinary medicine
Fish medicine
Approved medicines for use in fish
Import and sale of medicines for animals
Travelling abroad with pets and medicines
Reporting of Adverse Events for Veterinary Medicinal Products
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About us
Approval of medicines
Approval and follow-up of marketing authorisation (MA)
Clinical trials
Adverse drug reactions and drug safety
Reporting of adverse reactions and The Norwegian Adverse Drug Reaction Registry
What is pharmacovigilance
Pharmacovigilance information for the marketing authorisation holders
Compassionate use, named patient
General information about Compassionate use, named patient
Medicine shortage
Application for license to sell foreign packages
Medical devices
Guidance and regulations
Development and manufacturing of medical devices
Supply, import and distribution
Clinical investigation of medical devices
Performance studies of in vitro-diagnostic medical devices (IVDs)
Serious Incidents and Field Safety Corrective Actions
Norwegian register for devices and EUDAMED
For Healthcare Facilities
Public funding and pricing of medicines
Horizon scanning or request for assessment
Single technology assessments
Pricing of medicines
Manufacturing, import and retailing of medicines
Fees
Importing medicines for personal use
Import and wholesaling of medicines
Manufacturing of medicines
Dispensing and sale of medicines in pharmacies
Veterinary medicine
Fish medicine
Import and sale of medicines for animals
Reporting of Adverse Events for Veterinary Medicinal Products
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