Displaying 41 - 50 of 51 results.
Annual Report 2018
for Brexit 11
Human Medicines 14
Interview with Dr. Joan Gilvarry 22
Medical Devices 25
Blood, Tissues and Organs 30
Veterinary Medicines 32
Scientific Animal Protection 36
Controlled Drugs and Precursor Chemicals 38
Cosmetic Products 39
Other Regulatory Programmes 40
Managing Medicines, in place
at year end – 127 for human
medicines and 23 for veterinary
medicines
1 50
International, for human and veterinary
medicines in advance of Brexit
502
Public sector organisation
to receive
Annual Report 2020
Preparing for Brexit 15
Human Medicines 18
Medical Devices 26
Blood, Tissues and Organs 31
Veterinary Medicines 33
Scientific Animal Protection 36
Controlled Drugs and Precursor Chemicals 38,
The number of EMA scientific
advice procedures for human
medicines co-ordinated by the
HPRA
medical,
1 83
MRP/DCP lead member state
roles for the assessment of
veterinary medicines
10
applications issued for clinical
trials of human medicines
73
new human medicines
authorised during
Annual Report 2019
units of fake
(falsified) and other illegal
medicines detained
1,654
1,01 8,678
medicine,
Human Medicines 16
Medical Devices 24
Blood, Tissues and Organs 29
Veterinary Medicines 31, in
place at year end – 135 for
human medicines and 24 for
veterinary medicines
1 59
delegates, transfers to Ireland for
human and veterinary medicines
in advance of Brexit
554
new human medicines
authorised during 2019
applications issued for clinical
trials of human medicines
433
88
Guide to Wholesaling and Brokering of Medicinal Products for Human Use in Ireland
by substandard
and falsified medicines and introduces requirements for
brokers.
Medicinal Products (Safety, , the supply of medicines from an
EU Member State to a contracting State of the European Economic, in relation to human
medicines is considered a broker and must comply with the requirements, of medicines and may
only relate to the financial transactions carried out at an office. This can, ) and/or supply (sell or physically supply) medicines but are
involved in facilitating such transactions
Guide to New Applications and Variations to Wholesale Distribution Authorisations
Authorisation (PPA)
Refer to the ‘Guide to Parallel Imports of Human Medicines’ available on the HPRA, Registration
(DPR)
Refer to the ‘Guide to Parallel Imports of Human Medicines’ available on the HPRA, , all the activities which could affect the quality of the medicines. It is desirable, of medicinal products uses the service of a broker, that broker is required by the
Falsified Medicines Directive to register with the HPRA. The name and address of any brokers
used must
IMB Newsletter-Issue No. 44-January-April 2013
activities (see categories below), as
required by Directive 2011/62/EU
(Falsified Medicines Directive, 2013 Issue No. 44
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
Human Medicines
Ongoing implementation of
the provisions of the
pharmacovigilance,
authorisation of a medicinal
product for human use
(April 2013)
2
Veterinary Medicines
Report, Medicines Directive
– Waiver to written con rmation
for an imported active substance
4
Falsi ed
Guide to Quality System for General Sale Wholesale Distributors
strategy against falsified medicines. In addition to establishing the authority of the
supplier, –MANAGEMENT OF FALSIFIED MEDICINAL PRODUCTS 80
24 SOP – WASTE MANAGEMENT OF MEDICINAL PRODUCTS 85, of returned, rejected, recalled or falsified medicinal products
The RP must also ensure that a record,
and that they have not been damaged or altered during transportation. See SOP 20
‘Management of Falsified, the product and batch number is listed on the Falsified Medicinal Product
Notification Log (Appendix
Guide to Registration Requirements for Active Substances Manufacturers Importers and Distributors in Ireland
for
registration as set out in Falsified Medicines Directive (FMD), Directive 2011/62/EU. It provides, of investigational medicinal products for human and veterinary use, medical
devices or to veterinary medicines.
2, register with the European Medicines Agency Organisation
Guide to Registration Requirements, or wholesale
authorisation for human medicines, please provide the authorisation number(s,
authorisation for human medicines, please provide the authorisation number(s): N/A
Name and address
Public consultation on medical device fees 2021
-level strategic goals under the current plan are as follows:
-
Access to medicines (enhancing regulatory support to patient access to medicines)
-
Better informed users (providing current, COVID-19 as it relates to medicines and
medical devices
-
Increasing collaboration, December 2020
-
Dedicated project and resources to manage medicines and medical device shortages, a number of falsified and counterfeit
devices as well as incorrectly CE marked devices. Examples
Guide to Parallel Imports - Human Medicines
in line with the Falsified Medicines Directive (Directive
HPRA Guide to Parallel Imports of Human, Guide to Parallel Imports - Human Medicines,
AUT-G0006-16
12 JULY 2023
This guide does, to
Parallel Imports of Human Medicines
HPRA Guide to Parallel Imports of Human Medicines, of Human Medicines
AUT-G0006-16 3/32
DEFINITIONS
Parallel importation
The importation from an EU, Medicines
AUT-G0006-16 4/32
ABBREVIATIONS
DPR Dual Pack import Registration
EEA European