Databases of authorised medicines for use by humans

Listing of all medicines registered either by national either by EU authorities

Data and Resources

Databases of authorised medicines for use by humansjson Download

Field	Value
Modified	2020-06-22
Release Date	2018-05-09
Identifier	af42cb82-544e-43a8-83b0-89a5de538282
License	Creative Commons Attribution
Public Access Level	Public

Protocol

Protocol
Full title of the project	Databases of authorised medicines for use by humans
Name or abbreviated title of the project where available	No abbreviation available
Source type	Administrative sources

Sponsor(s)

Primary organization that oversees implementation of study and is responsible for data analysis.
Name of organisation	Federal Agency for Medicines and Health Products [DG Inspectie - afdeling Vergunningen]

Commissioner(s)

Organisation that commissioned this project
Name of organisation	Federal Agency for Medicines and Health Products
Website(s) of organisation	Website

Governance

Governance
Is there a Steering / Accompanying committee?	No information available

General information

General information
Project description	Listing of all medicines registered either by national either by EU authorities

Therapeutic area
Disease	Infectious Diseases Bacterial Infections and Mycoses Virus Diseases Parasitic Diseases Cancer Musculoskeletal Diseases Digestive System Diseases Mouth and tooth diseases Respiratory Tract Diseases Ear, nose and throat diseases Nervous System Diseases Eye Diseases Male diseases of the urinary and reproductive systems Female diseases of the urinary and reproductive systems and pregancy complications Cardiovascular Diseases Blood and lymphatic diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Skin and Connective Tissue Diseases Nutritional and Metabolic Diseases Hormonal diseases Immune System Diseases Injuries, poisonings, and occupational diseases Symptoms and general pathology

Objective of the project
Additional information	Reference table

Scope
Scope	Public Administration

Legal basis

Type of legal basis
Type of legal basis	National Law

Legal documents
Full reference of legal document	20 juli 2006. - Wet betreffende de oprichting en de werking van het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten.
URL to legal document	http://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?language=nl&la=N&cn=2006072078&table_name=wet

Design of the project

Data transfer frequency
Data transfer frequency	Daily Weekly

Method of data transfer
Data transfer method(s)	Unknown

Sites involved in the project

Type of site(s)
Care Provider	Unknown

Health professionals involved (encoding) in the project

Health professionals involved (encoding) in the project
Care Giver	Unknown
Specialty of physicians involved (encoding) in the project	Unknown
Type of paramedical professionals involved (encoding) in the project	Unknown

Informed consent

Informed consent
Are subjects informed?	No information available
How are subjects informed?	No information available
Do subjects have to give their consent?	No information available
How do subjects give their consent?	No information available
Is there a procedure to provide subjects the ability to consult their registered information?	No information available
Is there a procedure to provide subjects the ability to correct their registered information?	No information available
Additional information	No additional information available

Review

Ethics Committee
Authorization by an Ethics Committee?	No information available

Sectoral Committee National Registry (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	No information available

Sectoral Committee Health / Social affairs (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	No information available

Sectoral Committee Crossroads Bank of Enterprises (Privacy Commission)
Authorization by the sectorial committee Crossroads Bank of Enterprises of the Privacy Commission (Y/N)	No information available

Data dictionary

Classifications and Terminology
Name	Unknown

Data quality

Data quality
First year for which data is available	1961
Procedures for checking and validating the source data	No information available
Data compilation process	No information available
Punctuality for the most recent completed data collection: the data collection was completed	No information available
Participation rate of the health institutions	No information available
Participation rate of the health professionals	No information available
Extent of unit non-response	No information available
Extent of the item non-response	The rate of item non-response is not known or unacceptably high (>50%)
Extend to which the collected data are comparable across the Belgian regions	Comparability across the Belgian areas is unknown
Comparable or reconcilable over time	Comparability over time is unknown
Additional information	No additional information available
Extent of problems with the misclassification of statistical units for their key variables	No information available
Can records belonging to same entity be matched?	No information available
Additional information	Données principales: 1. médicaments qui ont fait l'objet d'une autorisation de mise sur le marché, d'un enregistrement ou d'une autorisation d'importation parallèle accordé(e) par le ministre ayant la santé publique dans ses attributions, après avis de la Commission pour les médicaments à usage humain, instituée auprès de l'Agence Fédérale des Médicaments et des Produits de Santé (procédure nationale, procédure de reconnaissance mutuelle, procédure décentralisée).2. médicaments qui ont fait l'objet d'une autorisation de mise sur le marché accordée par la commission européenne après avis du Comité des médicaments à usage humain (CHMP), institué auprès de l’Agence européenne des médicaments (EMEA).

Data storage

Data storage
The organisation in charge of storage of the collected data, is certified as being compliant with the international standards on information security management system (eg. ISO27001)?	No information available
Additional information	No additional information available

Data access

Data access
Written Data sharing policy?	No information available

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Databases of authorised medicines for use by humans

Data and Resources

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Databases of authorised medicines for use by humans

Data and Resources