http://www.imb.ie/news.aspx The national regulations required to implement the Traditional Herbal Medicinal Products Directive [2004/24/EC] are now in place. The Medicinal Products (Control of Placing on the Market) Regulations 2007 [SI No. 540 of 2007] came into force on the 23rd July 2007. Following on from this the IMB is pleased to announce that the Traditional Herbal Medicinal Products Registration Scheme is now availab... EN/Medicines/Human-Medicines/Herbal-Medicines/Traditional-Herbal-Medicinal-Products-Registration-Scheme.aspx 2010-09-10T19:13:39.3095Z The IMB launched its new website on the 19th of October 2007.The new site is designed to provide up-to-date information on medicines safety and licensing matters in Ireland and Europe.We welcome feedback on the new site and your comments and suggestions are welcome and should be forwarded to imb@imb.ie .Visitors to the IMB website are encouraged to Register on the site to ensure they receive the l... EN/About-Us/New-IMB-Website-.aspx 2010-09-10T19:13:39.3095Z Increasing co-operation between international medicines regulatory agencies on monitoring licensed medicines and preventing illegal and counterfeit medicines will provide enhanced consumer protection going forward, the Chief Executive of the Irish Medicines Board (IMB), Pat O’Mahony stated today at a conference for the pharmaceutical industry. He stated that the abundance of and ceaseless attempts... EN/Medicines/GLOBAL-COOPERATION-NEEDED-TO-STEM-COUNTERFEIT-MEDICINES.aspx 2010-09-10T19:13:39.3095Z The Irish Medicines Board (IMB) today released details of its key activities and performance highlights for 2006. It was a successful year for the IMB across all departments and functions.   Highlights: Safety monitoring of medicines and medical devices continued as the core  priority Processed and evaluated over 1,900 nationally occurring suspected adverse reaction reports associated with use of ... EN/About-Us/YEAR-OF-GROWTH-.aspx 2010-09-10T19:13:39.325125Z The IMB Veterinary Medicines Department held its 2007 Info Day on 13 November 2007 at the Crowne Plaza Hotel, Santry.  Fifty-one delegates from the animal health industry and related organisations, including the Department of Agriculture, Fisheries & Food, joined 20 staff from the IMB for a successful day of interaction. In his welcoming address, Dr Gabriel Beechinor, Director of Veterinary Me... EN/Medicines/Veterinary-Medicines/IMB-Veterinary-Information-Day-2007--Report.aspx 2010-09-10T19:13:39.325125Z The Paediatric Regulation includes a provision that requires MA holders to submit to NCAs the line listings of paediatric studies (required under Article 45) and other information on all authorised products by 26 January 2008 ...Paediatric Regulation Requirements EN/Medicines/Human-Medicines/Paediatric-regulation-requirements-on-marketing-authorisation-holders-to-submit-paediatric-informat.aspx 2010-09-10T19:13:39.325125Z The IMB would like to take this opportunity to highlight an update in the accepted mechanism for reporting of adverse reactions occurring outside the European Economic area (EEA). Companies and sponsors are advised that with immediate effect there will no longer be a requirement to submit adverse reaction case reports occurring outside the EEA directly to the Irish Medicines Board (IMB) provided t... EN/Safety--Quality/Update-on-electronic-reporting-of-adverse-reactions-occurring-outside-the-European-Economic-Area.aspx 2010-09-10T19:13:39.325125Z The Medicinal Products Regulations 2007 (S.I. 538/2007, 539/2007, 540/2007) require the notification of receipt and importation of exempt (unauthorised) medicinal products by wholesalers and manufacturers, respectively, to the Irish Medicines Board (IMB). The IMB has set up a Notification System to meet this requirement, and the system will become operational from February 18th 2008. Essentially t... EN/Medicines/Human-Medicines/Notification-System-for-Exempt-Unauthorised-Products.aspx 2010-09-10T19:13:39.325125Z On the 20 December 2007 the IMB published a notice to marketing authorisation holders on how to submit information regarding existing paediatric studies and paediatric uses. Completed templates were required by the 26 January 2008 for all authorised medicinal products and not just those products with a paediatric indication. Marketing authorisation holders that have not yet responded are reminded ... EN/Medicines/Reminder-to-MAH-to-submit-paediatric-information-in-accordance-with-the-requirements-of-the-Paediatr.aspx 2010-09-10T19:13:39.325125Z The Irish Medicines Board (IMB) today states that cough and cold medicines for use in children under two have never been recommended in Ireland without appropriate advice from a doctor or pharmacist. It states that, whilst the UK had a range of cough and cold medicines available on open sale for under twos this is not the practice in Ireland. Dr Joan Gilvarry, Director of Human Medicines, IMB is a... EN/Medicines/Human-Medicines/IMB-advises-on-cough-medicines-for-children.aspx 2010-09-10T19:13:39.325125Z Following recent discussions at QWP and CMD(h), marketing authorisation holders of medicinal products containing active substances in the form of mesilates, (di)isetionates, tosilates or besilates are requested to undertake a risk assessment on the occurrence of mesilate esters and related compounds as impurities in their medicinal products. Preclinical studies with certain mesilate esters have re... EN/Medicines/Human-Medicines/Request-to-all-Marketing-Authorisation-Holders-of-medicinal-products-containing-active-substances-in.aspx 2010-09-10T19:13:39.325125Z The Irish Medicines Board (IMB) today released details of its key activities and performance highlights for 2007. As part of its function to protect and enhance public health, the IMB licenses and monitors the safety of all medicines on the Irish market. In 2007, the number of new medicines licensed by the IMB increased by 28% from 848 in 2006 to 1,082. The IMB’s Enforcement Section also saw the n... EN/About-Us/Irish-Medicines-Board-announces-2007-performance-outturn.aspx 2010-09-10T19:13:39.325125Z EudraGMP & Manufacturer’s / Importer’s Authorisation (MIA)In April 2007 the EMEA launched a database called EudraGMP, which contains information on manufacturing and importation authorisations issued by EEA competent authorities. It also contains information on GMP certificates, which Member State competent authorities issue following each satisfactory GMP inspection.As noted on the EMEA’s web... EN/Medicines/IMB-will-be-modifying-the-format-of-the-current-Manufacturers-Authorisation-so-that-the-information.aspx 2010-09-10T19:13:39.325125Z On June 26th 2008, the European Pharmacopoeia Commission, in accordance with the provisions of Article 6, paragraph c of the Convention on the Elaboration of the European Pharmacopoeia, adopted the revised version of the monographs Heparin sodium (333) and Heparin calcium (332), the texts of which are set out in the attachment to this announcement. Furthermore the Commission has decided to set 1st... EN/Safety--Quality/How-the-IMB-monitors-product-safety/Rapid-Revision-of-heparin-monographs-June-2008-.aspx 2010-09-10T19:13:39.325125Z Updated versions - Application forms for Marketing Authorisation of Medicinal Products and for Variations Notice to Applicants, Volume 2B, incorporating the Common Technical Document (CTD) (May 2008) Application form: Module 1.2 updated version, revised 9 May 2008Click here to read MAA and Variation application form EN/Medicines/Human-Medicines/Licensing/New-Product-/Updated-Application-Form.aspx 2010-09-10T19:13:39.325125Z For further information please click on the following link:http://www.emea.europa.eu/whatsnewp.htm EN/Medicines/Human-Medicines/Public-Statement-on-the-current-shortage-of-radiopharmaceuticals-in-the-European-Union.aspx 2010-09-10T19:13:39.325125Z Stakeholders are reminded of two ongoing consultations and invited to make their submissions before the relevant closing dates:- For further information see:-Public Consultation on Fees - 03/10/2008http://www.imb.ie/EN/Consultations/Medicines/Public-Consultation-on-Fees.aspx Consultation on Electronic and/or on-line submissions of licensing applicationshttp://www.imb.ie/EN/Consultations/Medicines/... EN/About-Us/consultation.aspx 2010-09-10T19:13:39.325125Z International Internet Day of ActionThe Irish Medicines Board (IMB) participated in Operation PANGEA on 12 November 2008 in conjunction with eight other countries. This is the first international Internet Day of Action, targeting the illegal online sale of medicines. It was co-ordinated by the Permanent Forum on International Pharmaceutical Crime, INTERPOL and the World Health Organisation’s (WHO)... EN/Medicines/Human-Medicines/IMB-takes-part-in-Operation-PANGEA.aspx 2010-09-10T19:13:39.34075Z The IMB has issued a new Guide to Fees (veterinary) to reflect revised fees which have been published in new Regulations made by the Department of Agriculture, Fisheries and Food. The revised fee application form has also been issued and must be used for all new applications made on or after 9 March 2010. Guide to fees (veterinary) 2010 Fee application from (veterinary) 2010 EN/News/Guide-to-Fees-and-fees-application-form-2009.aspx 2010-09-10T19:13:39.34075Z The Irish Medicines Board is aware that there is currently a global shortage in supply of acetonitrile, a solvent commonly used by the pharmaceutical industry in manufacture and analysis of drug substances and drug products. As a consequence of the restricted availability of this solvent, Marketing Authorisation holders may currently be evaluating alternative solvents for use in manufacture and/or... EN/News/Advice-on-the-global-shortage-of-acetonitrile.aspx 2010-09-10T19:13:39.34075Z ‘Tan jab’ may pose risk to health warns Irish Medicines Board The Irish Medicines Board (IMB) today issued a precautionary safety alert in relation to the unauthorised medicine Melanotan (I and II) which is illegal on the Irish market. This product is not available in pharmacies or authorised channels in Ireland and it is thought that it is being sourced by consumers on the internet. There is ... EN/News/IMB-issues-safety-alert-on-Melanotan.aspx 2010-09-10T19:13:39.34075Z NOTICE TO ALL MARKETING AUTHORISATION HOLDERS OF CURRENTLY AUTHORISED MEDICINAL PRODUCTS PRESENTED AS PRESSURISED METERED DOSE INHALERS. REQUEST TO REVIEW DOSSIERS TO ENSURE THAT STUDIES HAVE BEEN PERFORMED TO ESTABLISH WHETHER A STORAGE ORIENTATION EFFECT EXISTS, AND IF SO, TO ENSURE THAT AN APPROPRIATE RECOMMENDATION FOR STORAGE ORIENTATION AND/OR RE-PRIMING IS INCLUDED IN THE PRODUCT INFROM... EN/News/Pressurised-metered-dose-inhalers--Dossier-review.aspx 2010-09-10T19:13:39.34075Z The certification of Free Sale Certificates (FSC) for Medical Devices has been transferred from the Medical Devices Department to the Licensing Section of the Compliance Department as of 2nd June 2009. The current electronic submission and format of the FSC will remain the same and applications should now be submitted electronically in Word 2000 format to exportcerts@imb.ie. For further inform... EN/News/Free-Sale-Certificates-for-Medical-Devices.aspx 2010-09-10T19:13:39.34075Z The EMEA will host its 6th EudraVigilance Information Day on July 1, 2009. The EudraVigilance Information Day will provide a forum for marketing authorisation holders and sponsors of clinical trials to gain an update on the key activities of the EV-EWG in line with their work programme for 2009. Further information on this information day is available at the link below. 6th EudraVigilance I... EN/News/6th-EudraVigilance-Information-Day--EMEA.aspx 2010-09-10T19:13:39.34075Z   The European Medicines Agency (EMEA) has reviewed the use of Tamiflu (ostelamivir) and Relenza (zanamivir).  The Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that during the pandemic:- - Tamiflu can be used in children younger than one year of age - Tamiflu and Relenza can be used in women who are pregnant or breastfeeding Detailed information in relati... EN/News/Pandemic.aspx 2010-09-10T19:13:39.34075Z The Irish Medicines Board (IMB) today released details of its key activities and highlights for 2008. While maintaining its core focus of protecting public and animal health through the regulation of medicines and healthcare products, the IMB recorded a number of significant increases in outputs throughout the year. 2008 Annual Outturn EN/News/2008-Annual-outturn-release-.aspx 2010-09-10T19:13:39.34075Z The policy of the Irish Medicines Board (IMB) for the allocation of an appropriate method of supply for veterinary anthelmintics (wormers) and antiparasitic agents (flea treatments etc.) for dogs and cats pre-dates the 2007 change in national legislation relating to the supply of prescription medicines. Many such products originally restricted as prescription-only medicines have maintained this cl... EN/News/IMB-establishes-a-Working-Group-on-Classification-of-Method-of-Supply-of-Veterinary-Antiparasitic-Agents-for-Companion-Animals.aspx 2010-09-10T19:13:39.34075Z > Download IMB Guidance for patients and members of the public EN/News/How-to-report-a-sideeffect-to-a-medicine-used-to-treat-or-prevent-pandemic-H1N1-2009.aspx 2010-09-10T19:13:39.34075Z The European Medicines Agency (EMEA) has recommended to the European Commission that two vaccines against influenza A(H1N1), Focetria and Pandemrix, be granted a marketing authorisation. It is intended that one of these vaccines, Pandemrix, will be available for use in Ireland. Download EMEA Press Release EN/News/European-Medicines-Agency-recommends-authorisation-of-two-vaccines-for-influenza-pandemic-H1N1-2009.aspx 2010-09-10T19:13:39.34075Z The European Medicines Agency (EMEA) has recommended to the European Commission that a third influenza pandemic vaccine, Celvapan, be granted a marketing authorisation. This follows a decision by the Commission to grant authorisations for Focetria and Pandemrix. It is intended that both Celvapan and Pandemrix, will be available for use in Ireland. Download EMEA Press Release For more infor... EN/News/European-Medicines-Agency-recommends-authorisation-of-a-third-vaccine-for-influenza-pandemic-H1N1-2009.aspx 2010-09-10T19:13:39.356375Z The European Medicines Agency (EMEA) has concluded that its recommendations adopted in September, that the three licensed H1N1 vaccines be preferably used as two doses, at least three weeks apart, be maintained. This follows the recent meeting (19-22 October 2009) of the EMEA’s Committee for Medicinal Products for Human Use. The Committee will review further clinical trial data as they become ... EN/News/European-Medicines-Agency-maintains-dosage-recommendations-for-pandemic-H1N1-vaccines.aspx 2010-09-10T19:13:39.356375Z 42,000 tablets seized in a joint IMB, Customs and Garda operation during International Internet Week of Action. The Irish Medicines Board (IMB) participated in Operation PANGEA II in conjunction with 26 countries as part of on International Internet Week of Action which took place from the 16th – 20th November 2009. Operation PANGEA II targets the illegal online sale of counterfeit and illicit ... EN/News/Irish-Medicines-Board-take-part-in-Operation-PANGEA-II.aspx 2010-09-10T19:13:39.356375Z The Irish Medicines Board has issued the follow warning relating to the use of herbals products presented for the treatment of Erectile Dysfunction. Please click on the link below for further information: Herbal Products presented for the treatment of Erectile Dysfunction EN/News/Herbal-products-presented-for-the-treatment-of-Erectile-Dysfunction.aspx 2010-09-10T19:13:39.356375Z The Irish Medicines Board (IMB) has today announced, with immediate effect, the suspension of all authorisations in Ireland for medicines containing sibutramine. Currently marketed as Reductil in Ireland, sibutramine is a prescription medicine used to assist weight loss in the treatment of obesity in adult patients or overweight patients with other risk factors such as type-2 diabetes or dyslipida... EN/News/Suspension-of-Medicines-containing-Sibutramine.aspx 2010-09-10T19:13:39.356375Z Thousands of students from all over Ireland last week visited the Irish Medicines Board’s exhibition stand at the BT Young Scientist Exhibition 2010. The exhibition took place from Tuesday 12th to Saturday to 16th January in the RDS. The exhibition welcomed huge numbers of visiting students, teachers, parents and members of the general public. The IMB’s stand focused on building awareness of t... EN/News/Irish-Medicines-Board-at-the-Young-Scientists-Exhibition.aspx 2010-09-10T19:13:39.356375Z www.rarediseaseday.org EN/News/Friends-of-Rare-Disease-Day.aspx 2010-09-10T19:13:39.356375Z Following an analysis of new data concerning the possible interactions between clopidogrel and proton-pump inhibitors (PPIs), the European Medicines Agency has recommended an amendment to the existing warning over the concomitant use of clopidogrel-containing medicines and PPIs. The class warning for all PPIs has been replaced with a warning stating that only the concomitant use of clopidogrel... EN/News/Interaction-between-clopidogrel-and-protonpump-inhibitors--European-Medicines-Agency-updates-warning-for-clopidogrelcontaining-medicines.aspx 2010-09-10T19:13:39.356375Z 3 in 4 Irish adults read product information before taking new medicines - 1 in 4 source important health information online A key goal for the Irish Medicines Board (IMB) is to ensure that the benefit of medicines outweighs any risks. While all medicines have some risk associated with their use, these risks are greatly reduced when consumers take the right medicines, in the right way and at t... EN/News/IMB-publishes-consumer-research-findings-on-sources-of-medicines-information.aspx 2010-09-10T19:13:39.356375Z Leaflets designed to provide clear independent advice on how best to purchase, care for and safely use medicines The IMB has today (6 April 2010) published a series of information leaflets providing important advice on medicine safety. They will be of interest to a broad range of people and are freely available to download from the IMB website (see links below). Printed copies can be requested ... EN/News/IMB-publishes-consumer-information-leaflets-on-safe-use-of-medicines.aspx 2010-09-10T19:13:39.356375Z 8 out of 10 adults would use generic medicines. Research findings published today (4 May 2010) by the IMB measures the extent to which consumers are aware of generic medicines. The findings also outline the willingness of consumers to use generic medicines if offered to them by their doctor or pharmacist. The Behaviour & Attitudes commissioned research involved face to face interviews wi... EN/News/IMB-publishes-consumer-research-findings-on-generic-medicines.aspx 2010-09-10T19:13:39.356375Z Dangers of buying prescription medicines over the internet   Buying prescription medicines on the Internet may be easily done, but the Irish Medicines Board (IMB) advises there are serious concerns for the safety of persons who purchase prescription medicines in this manner.  Supply of prescription medicines via the Internet route is illegal and in contravention of Irish legislation.    It h... EN/Danger-of-Buying-Medicines-via-the-Internet.aspx 2010-09-10T19:13:39.356375Z   Buying prescription medicines on the Internet may be easily done, but the Irish Medicines Board (IMB) advises there are serious concerns for the safety of persons who purchase prescription medicines in this manner. Supply of prescription medicines via the Internet is illegal and in contravention of Irish legislation.  It has been found that unscrupulous suppliers, posing as respectable and ... EN/News/Medicines-via-the-Internet.aspx 2010-09-10T19:13:39.372Z A National Rules Scheme for Homeopathic Medicines was provided for by S.I. 540 of 2007. This scheme is designed to cover homeopathic medicinal products that do not qualify for the Simplified Registration Scheme (SRS) due to the presence of indications or because the products are outside the potency range of the SRS. In particular the scheme covers products with indications for mild self-li... EN/News/Guide-to-the-National-Rules-Scheme-for-Homeopathic-Medicinal-Products-for-Human-Use.aspx 2010-09-10T19:13:39.372Z The European Commission, acting on the advice of the Committee for Medicinal Products for Veterinary Use (CVMP), has instructed European Member States to suspend the marketing authorisations for PregSure BVD and to withdraw the product from the distribution chain at wholesaler level. The basis for the advice of the CVMP relates to a possible link between use of the vaccine in dams and the deve... EN/News/Pregsure BVD vaccine in cattle and BNP.aspx 2010-09-10T19:13:39.372Z The Irish Medicines Board (IMB) today (28 June 2010) released details of its key activities and highlights for 2009 which showed a significant increase across all its departments’ outputs. A core focus of the IMB’s work is to protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products. Its remit covers human medicines, medical devices, ... EN/News/Irish-Medicines-Board-Records-Year-of-Significant-Increase-in-Work-Outputs.aspx 2010-09-10T19:13:39.372Z Mr Pat O’Mahony, Chief Executive of the Irish Medicines Board (IMB), has been unanimously re-elected as Chairman of the European Medicines Agency (EMA) for a further three years with immediate effect. The EMA is the European Union body responsible for coordinating the scientific resources available in the Member States for the evaluation, supervision and pharmacovigilance of medicinal products... EN/News/Chief-Executive-of-the-Irish-Medicines-Board-Unanimously-Reelected-as-Chairman-of-the-European-Medicines-Agency-.aspx 2010-09-10T19:13:39.372Z ASR Hip Replacement System & ASR Hip Resurfacing System The Irish Medicines Board (IMB) is working with the HSE and Orthopaedic surgeons in relation to the worldwide recall announced yesterday by DePuy of their ASR Hip System. Most hip replacements involving the ASR hip system have been successful. However, data recently received by DePuy shows that after 5 years approximately 12 per cent... EN/News/Recall-of-DePuy-ASR-Hip-Systems.aspx 2010-09-10T19:13:39.372Z From 1 September to 30 September 2010 the Irish Medicines Board is accepting requests for Ireland to act as RMS in outgoing decentralised procedures for the period April 2011 - December 2011 inclusive.   For detailed information on the process for submitting requests please refer to the Guide to Submitting a Request for Ireland to act as RMS in a Decentralised Procedure for a Human Medicinal Pr... EN/News/Invitation-for-Requests-for-Ireland-to-act-as-Reference-Member-State-in-the-Decentralised-Procedure.aspx 2010-09-10T19:13:39.372Z The IMB has commenced a full investigation into a Phase 1 clinical trial conducted at Shandon Clinic today. The volunteers involved are continuing to be monitored in Shandon Clinic and Cork University Hospital. Shandon Clinic has informed the Clinical Research Ethics Committee of the Cork Teaching Hospitals. The trial in question was to determine the bioavailability of a drug for its potential ... EN/News/IMB-Statement-on-Shandon-Clinical-Trial.aspx 2010-09-10T19:13:39.372Z