Displaying 31 - 40 of 51 results.
Guide to Reporting and Investigation of Quality Defects in Medicinal Products for Human and Veterinary Use
.
Alert Management Guidance pertaining to Safety Features relating to the Falsified
Medicines, of
defects is not exhaustive and is intended as a guide only.
Falsified medicines and safety features
A falsified medicine is one with a false representation of:
-
its identity, including its, threatening or could pose a serious risk.
Examples include:
-
falsified product
-
wrong product, .
Marketing authorisation holders and medicines manufacturers are encouraged to review
these documents
Strategic Plan 2011-2015 English
.
Counterfeit medicines
Counterfeit or ‘falsified’ medicines pose a significant threat to public, HEALTH
The Irish Medicines Board’s
role is to protect and enhance
public and animal health
through the regulation
of medicines, medical devices
and healthcare products
Irish Medicines,
Irish Medicines Board | Strategic Plan 2011 - 2015
Page 4
Mr. Pat O’Mahony
Chief Executive, .
Protecting public and animal health
The Irish Medicines Board (IMB) is the independent regulator
IMB Newsletter-Issue No. 43-September-December 2012
of
Þnished medicinal products
Note: the Falsified Medicines Directive
does not
apply to the manufacture, (Falsified
Medicines Directive). These
amendments include measures
intended to prevent the entry, 2012 Issue No. 43
M E D I C I N A L P R O D U C T S
IRISH MEDICINES BOARD, KEVIN O’MALLEY HOUSE, of
applications
1
Human Medicines
Clinical trials – Noti cation of
adverse reactions
1,
authorisation holders relating to
the new EU pharmacovigilance
legislation
2
Veterinary Medicines
Inspections relating to Good Distribution Practice (GDP)
the risk of falsified medicines reaching the patients. A combination of a number of major deficiencies, Distribution Practice (GDP) Distributors of human medicines and active substances are regularly inspected, , Ireland, Eire, European Union, Safety & Quality, Medicines, Medical Devices, Blood, Tissues & Cells, and efficacy of medicines available in Ireland and to participate in systems designed to do that throughout
Guide to Managing Changes to Registration for Active Substance Manufacturers, Importers and Distributors
Guide to Managing Changes to Registration for Active Substance Manufacturers, Importers and Distributors,
AUT-G0130-2 1/4
Guide to
Managing Changes to Registrations of Active
Substance Manufacturers, Importers and
Distributors
1
INTRODUCTION
The Falsified Medicines Directive (FMD) (2011/62/EU), which amends Directive 2001/83/EC, is
the key legal instrument governing medicinal, and veterinary use, to medical devices or to
veterinary medicines.
2
GENERAL GUIDANCE
Active substance
Authority Report for the meeting of 29 April 2021
previously, the European Commission provided temporary exemptions for medicines in
relation to UK batch release, batch testing and decommissioning/reaffixing the unique identifier
under the Falsified Medicines Directive (FMD) for countries with small markets including Ireland,
Northern Ireland, ), the future of these is uncertain. Overall, the supply
of medicines to the Irish market remains, following vaccination with viral vector
vaccines were also discussed. The EMA’s human medicines
In-Vitro Diagnostic Tests for COVID-19
, Authority, HPRA, Ireland, Eire, European Union, Safety & Quality, Medicines, Medical Devices, Blood, , commercial test, antibodies, antibody, lateral flow, falsified test The objective of the Health Products, knowledge, the quality, safety and efficacy of medicines available in Ireland and to participate
IMB Newsletter-Issue No. 47 January-April 2014
2014 Issue No. 47
M E D I C I N A L P R O D U C T S
IRISH MEDICINES BOARD, KEVIN O’MALLEY HOUSE,
CONTENTS
New Name for the IMB
Irish Medicines Board (IMB) to
become The Health Products
Regulatory, November 2014
2
Pharmacovigilance Information
Day – 21 November 2014
2
Human Medicines
Electronic Reporting of ICSRs
to Marketing Authorisation
Holders
3
Veterinary Medicines
Report, as well as a number
of health related functions. In
addition to medicines, we now have
a role
HPRA Annual Report 2016
Members 6
Management Committee 7
Chief Executive’s Report 8
Human Medicines 11
Veterinary Medicines 30, FOR MEDICINES
AND 2,122 FREE SALE CERTIFICATES
FOR MEDICAL DEVICES
3,551
CLINICAL TRIALS OF HUMAN
MEDICINES WERE APPROVED TO
COMMENCE IN IRELAND
108
VARIATIONS TO MARKETING
AUTHORISATIONS ISSUED – 14,207
FOR HUMAN MEDICINES AND 1,341
FOR VETERINARY MEDICINES
1 5,54 8
THE TOTAL NUMBER OF NEW HUMAN
MEDICINES AUTHORISED
637
APPLICATIONS FOR CLINICAL
INVESTIGATIONS OF MEDICAL