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Approval of medicines
Clinical trials of human medicines
Legislation and guidelines
Clinical Trials Information System (CTIS)
Application for clinical trials
Transitioning Clinical Trials from the Old to the New Regulatory Framework (Transition Applications)
Fees for assessment of clinical trials and assessment of safety information
Ongoing studies under the old directive
Clinical Trial Application for GMO Medicinal Products for Humans
Compassionate Use Program
Approval and maintenance of marketing authorisation (MA)
Application for marketing authorisation
Submission of applications
Request for Norway to act as RMS in Decentralized Procedure
List of newly adopted marketing authorisations in Norway
List of pending marketing authorisation applications
Announcement of needed products in Norway
Renewal of MA
Variations to marketing authorisations
Transfer of MA/change in name and address of the MAH
Batch-specific variation applications
Relevant information regarding approval and maintenance of the MA
Guideline for the naming of medicinal products
Regulatory fees
Withdrawal, temporary withdrawal and reactivation
Sunset Clause
Product information
Summary of product characteristics and Package leaflet
Digital package leaflet
Packaging
Implementation date and batch-specific variations
QRD templates
Recommended updates
Recommendations after referral adopted by the European Commission
The warning triangle
Readability testing and bridging
Medicinal products to be distributed without medical prescription
OTC substance reports
Harmonization of packaging leaflet and labelling for OTC-medicinal products with an OTC substance report
Application for OTC legal status and change of OTC legal status
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
Parallel import
Application for MA for parallel importet medicinal products
Post-marketing obligations for parallel imported medicinal product
Other information
Whom to contact regarding regulatory questions?
WHO-certificates
OCABR of human blood products and vaccines
Disinfectans - approval, manufacturing and import
Guidance on approval of disinfectants for technical use in health and nursing
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
Laboratory control of medicines
Pharmacovigilance information for the marketing authorisation holders
Pharmacovigilance legislation
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)
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
Security of supply and emergency preparedness
Medicine shortages
Information for marketing authorisation holders regarding medicine shortages
Application for license to sell foreign packages
Notification of medicine shortages
NOMA’s role in supply chain security and preparedness
Medical devices
Guidance and regulations
The legislation for medical devices
Guidance from the EU Commission/MDCG
Transitional provisions for medical devices
Devices for animals
Development and manufacturing of medical devices
Qualification and classification
Qualification of medical devices
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
Systems and procedure packs of medical devices
Custom-made devices
Monitoring after a device is placed on the market
Supply, import and distribution
Distance Sales/Online sales/E-commerce
Market surveillance and auditing of medical devices
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
Parts and components that change performance or intended purpose
Advertising for medical devices
Clinical investigation of medical devices
Introduction to clinical investigations of medical devices
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 (IVD) medical devices
Introduction to performance studies of IVD medical devices
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
Combined 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
Horizon scanning and assessment requests
Submission of documentation
Horizon scanning for new medical devices
Horizon scanning or request for assessment
Pipeline meetings
Health technology assessments
Single technology assessments of medicines
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
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
Health technology assessment of medical devices
Submission of documentation
International collaboration and activities
EU Regulation on Health Technology Assessment (HTAR)
Joint Nordic HTA-Bodies
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
Companies authorised to import medicines to Norway
Companies performing wholesaler activities based on authorisation issued within the EU/EEA
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
Handling quality defects of medicines
Electronic cigarettes (e-cigarettes)
Manufacturing of medicines
Guideline on use of bulk packages with automated dose dispensing
Dispensing and sale of medicines in pharmacies
Dispensing regulations
Veterinary medicine
Reporting of Adverse Events for Veterinary Medicinal Products
Fish medicine
Approved medicines for use in fish
Import and sale of medicines for animals
Travelling abroad with pets and medicines
Blood, cells and tissue
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Approval of medicines
Clinical trials of human medicines
Approval and maintenance of marketing authorisation (MA)
Disinfectans - approval, manufacturing and import
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
Security of supply and emergency preparedness
Medicine shortages
NOMA’s role in supply chain security and preparedness
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 (IVD) medical devices
Serious Incidents and Field Safety Corrective Actions
Norwegian register for devices and EUDAMED
For Healthcare Facilities
Public funding and pricing
Horizon scanning and assessment requests
Health 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
Reporting of Adverse Events for Veterinary Medicinal Products
Fish medicine
Import and sale of medicines for animals
Blood, cells and tissue
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