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HPRA Medicinal Products Newsletter - Issue Number 61
Technical Document format
for herbal medicinal products
Human Medicines
Notifcation of marketing, Medicines)
• Potential withdrawals arising due to Brexit
• Packaging
• Request for PA/VPA numbers in advance
of an application
• Brexit and Clinical Trials for Human Medicines
• Type IA Annual,
• Safety features Update for manufacturers
and Marketing Authorisation Holders
Human Medicines
• Notifcation of marketing status for traditional
herbal medicinal products (THMPs)
• Appropriate use
How to take medicines safely
. Tell your doctor and pharmacist about any other medicines that you are taking including herbal, How to take medicines safely,
HPRA Website, HPRA Logout How to take medicines safely Medicines can make the quality of our, some conditions from developing in the first place. In this way, medicines can help us live longer and healthier lives. Nearly all of us will need to take medicines at some point in our lives
Homeopathic Medicines
indications and a National Rules Scheme for homeopathics with indications. Homeopathic Medicines are distinct from other types of medicines, such as Herbal Medicines or Pharmaceutical Drugs, although, Homeopathic Medicines,
HPRA Website, Logout Homeopathic Medicines Homeopathic medicines must be licensed by the HPRA, in their preparation as well as the principles on which they are prescribed. Preparation of Homeopathic Medicines
Guide to Withdrawal of Authorisations or Certificates for Human Medicines
Guide to Withdrawal of Authorisations or Certificates for Human Medicines,
AUT-G0020-4 1/2
Guide to
Withdrawal of Authorisations or Certificates
for Human Medicines
1
SCOPE
This guide,
registration for a herbal medicinal product. For the withdrawal of a product from the market,
please see the ‘Guide to Notification of Marketing Status of Human Medicines’.
2
INTRODUCTION
Withdrawal, for Human Medicines
AUT-G0020-4 2/2
When the PA is withdrawn for commercial reasons, no further batches
IMB Newsletter-Issue No. 42-May-August 2012
General
Update on herbal medicines 1
Human Medicines
Implementation of the new EU
pharmacovigilance legislation:
changes to reporting
requirements
2
Veterinary Medicines
Staff changes 3, or to be registered under the
Traditional Herbal Medicines (THM)
scheme provided for by the Directive.
From 30, . Those herbal medicines
which were subject of applications for
THM registration as of the time, No. 42
M E D I C I N A L P R O D U C T S
IRISH MEDICINES BOARD, KEVIN O’MALLEY HOUSE, EARLSFORT
HPRA Medicinal Products Newsletter - Issue Number 55
Human Medicines
• Contamination of herbal products
with pyrrolizidine alkaloids
• Improved Access, on
the draft Commission acts on GMP
In this Issue
Human Medicines
Contamination of herbal, the presence of
these alkaloids in herbal products,
although they do not contain plants
that produce, with weeds during
harvesting.
A public statement on the contamination
of herbal medicinal product with
pyrrolizidine alkaloids was published by
the EMA’s herbal medicinal products
committee (HMPC
HPRA - Press Release - Operation Pangea 2015
used to bulk up the medicines are harmful. People also need to be cautious about
buying herbal, OPERATION TARGETING
ONLINE FALSIFIED MEDICINES
Over 142,000 units of illegal prescription medicines, sale of
falsified (counterfeit and illegal) medicines where the HPRA, Revenue’s Customs Service,
networks behind the sale of counterfeit and illegal medicines via illicit online sales.
Locally, (analgesics), weight loss products as well as anabolic steroids and medicines indicated
for erectile
Electronic submissions
to electronic submissions - human medicines either in eCTD format / non -eCTD (Nees) format or through, Herbal MP Application Homeopathic MP Application Homeopathic National Rules, , Regulatory, Authority, HPRA, Ireland, Eire, European Union, Safety & Quality, Medicines, Medical Devices, , the quality, safety and efficacy of medicines available in Ireland and to participate in systems
Medsafe New Zealand - 2010 MoU with MedSafe (NZ)
Medsafe New Zealand - 2010 MoU with MedSafe (NZ),
NEW ZEALAND MEDICINES
AND MEDICAL DEVICES
SAFETY
AUTHORITY
A BUSINESS UNIT OF
THE' MIN IS
my
OF HEAL TH IRISH MEDICINES BOARD
m,
and
the Irish Medicines Board of Ireland
CONCERNING C O O P E R A T I O N IN T H E REGULATION O F, for and on behalf of the New Zealand
Medicines and Medical Device Safety Authority (Medsafe) of New Zealand and The Irish
Medicines
Board (1MB) of Ireland (hereinafter referred as the "Participants