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 2013-05-23T09:02:30.734375Z 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 2013-05-23T09:02:30.734375Z 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 2013-05-23T09:02:30.734375Z 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 2013-05-23T09:02:30.734375Z 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 &amp; 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 2013-05-23T09:02:30.734375Z 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 2013-05-23T09:02:30.734375Z 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 2013-05-23T09:02:30.734375Z 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 2013-05-23T09:02:30.734375Z 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 2013-05-23T09:02:30.734375Z 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 2013-05-23T09:02:30.734375Z 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 2013-05-23T09:02:30.734375Z EudraGMP &amp; 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 2013-05-23T09:02:30.734375Z 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 2013-05-23T09:02:30.734375Z 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 2013-05-23T09:02:30.734375Z 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 2013-05-23T09:02:30.75Z 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 2013-05-23T09:02:30.75Z 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 2013-05-23T09:02:30.75Z 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 2013-05-23T09:02:30.75Z ‘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 2013-05-23T09:02:30.75Z 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 2013-05-23T09:02:30.75Z The certification of Free Sale Certificates (FSC) for Medical Devices has been transferred from the Medical Devices Department of the IMB to 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 information, plea... EN/News/Free-Sale-Certificates-for-Medical-Devices.aspx 2013-05-23T09:02:30.75Z 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 2013-05-23T09:02:30.75Z   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 2013-05-23T09:02:30.765625Z 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 2013-05-23T09:02:30.765625Z 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 2013-05-23T09:02:30.78125Z &gt; 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 2013-05-23T09:02:30.78125Z 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 2013-05-23T09:02:30.78125Z 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 2013-05-23T09:02:30.78125Z 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 2013-05-23T09:02:30.78125Z 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 2013-05-23T09:02:30.78125Z 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 2013-05-23T09:02:30.78125Z 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 2013-05-23T09:02:30.78125Z 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 2013-05-23T09:02:30.78125Z www.rarediseaseday.org EN/News/Friends-of-Rare-Disease-Day.aspx 2013-05-23T09:02:30.78125Z 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 2013-05-23T09:02:30.78125Z 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 2013-05-23T09:02:30.78125Z 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 2013-05-23T09:02:30.78125Z 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 &amp; Attitudes commissioned research involved face to face interviews wi... EN/News/IMB-publishes-consumer-research-findings-on-generic-medicines.aspx 2013-05-23T09:02:30.78125Z   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 2013-05-23T09:02:30.78125Z 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 2013-05-23T09:02:30.78125Z 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 2013-05-23T09:02:30.78125Z 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 2013-05-23T09:02:30.78125Z 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 2013-05-23T09:02:30.796875Z ASR Hip Replacement System &amp; 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 2013-05-23T09:02:30.796875Z 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 2013-05-23T09:02:30.796875Z The Irish Medicines Board (IMB) today confirms that in line with the European Medicines Agency (EMA) recommendation, rosiglitazone-containing anti-diabetes medicines (Avandia, Avandamet and Avaglim) will no longer be available for clinical use in Ireland due to concerns regarding cardiovascular safety. Patients who are currently taking these medicines should make an appointment with their doct... EN/News/Suspension-Rosiglitazone.aspx 2013-05-23T09:02:30.796875Z The Veterinary Medicines Department of the IMB is pleased to announce the launch of a new online reporting form for reporting suspected adverse events to veterinary medicinal products. The form is similar to that which has been in place for reporting adverse events to human medicinal products for some time and can be accessed from the homepage of the IMB website by clicking on the ‘Online Repor... EN/News/IMB-launches-new-online-reporting-form-for-veterinary-medicines~.aspx 2013-05-23T09:02:30.796875Z The invitation to submit requests for Ireland to act as RMS in outgoing decentralised procedures for the period of April 2011 – December 2011 is now closed.   Requests received during September will now be reviewed and the IMB will revert to applicants in accordance with our guidance. Following review further invitations may be invited via our website.   It is envisaged that the window will ... EN/News/Closing-Window-for-Invitation-for-Requests-for-Ireland-to-act-as-Reference-Member-State-in-the-Decentralised-Procedure.aspx 2013-05-23T09:02:30.796875Z The Veterinary Medicines Department of the IMB wishes to clarify that it continues to invite applications for Ireland to act as Reference Member State (RMS) in the Decentralised Procedure and Mutual Recognition Procedure in respect of 2011 and future years. The department has a long track record in acting as RMS for veterinary medicinal products, being amongst the top performers in Europe in this ... EN/News/Invitation-for-Requests-for-Ireland-to-act-as-Reference-Member-State-in-the-Decentralised-Procedure-and-Mutual-Recognition-Procedure-Veterinary-Medicines.aspx 2013-05-23T09:02:30.796875Z Quarter of a million counterfeit and illegal tablets &amp; capsules detained in Ireland The Irish Medicines Board (IMB) participated in Operation PANGEA III in conjunction with 45 countries as part of an international internet week of action which took place from 5th to 12th of October. The operation targeted the illegal online sale of counterfeit and illegal medicines to raise awareness of the... EN/News/Irish-Medicines-Board-takes-part-in-Operation-PANGEA-III.aspx 2013-05-23T09:02:30.796875Z The Irish Medicines Board has announced the signing of three separate co-operation arrangements with counterpart regulatory bodies in Canada, New Zealand and Singapore. The arrangements, which will facilitate enhanced regulatory performance and public safety, are designed to broaden existing contacts and to establish a co-operative framework of mutual support and information exchange. Down... EN/News/Irish-Medicines-Board-signs-cooperation-arrangements-with-regulatory-counterparts-in-Canada-New-Zealand-and-Singapore.aspx 2013-05-23T09:02:30.796875Z The Irish Medicines Board participated in a coordinated Post Market Surveillance Operation with the French and UK Competent Authorities (Afssaps and the MHRA respectively) during 2009-2010. The three member states, under the authority of the Compliance and Enforcement group (COEN) and within the scope of the <em>In vitro</em> diagnostic medical devices Directive 98/79/EC, undertook a coordinate... EN/News/Irish-Medicines-Board-participates-in-coordinated-Post-Market-Surveillance-Operation-with-French-and-UK-Competent-Authorities.aspx 2013-05-23T09:02:30.796875Z The Irish Medicines Board in collaboration with the European Medicines Agency recommends an action plan to deal with the possible presence of endotoxins in Baxter peritoneal dialysis solutions. Further information is available at the links below. Press release on European Medicines Agency website Q &amp; A document on European Medicines Agency website EN/News/Irish-Medicines-Board-in-collaboration-with-the-European-Medicines-Agency-recommends-an-action-plan-to-deal-with-the-possible-presence-of-endotoxins-in-Baxter-peritoneal-dialysis-solutions.aspx 2013-05-23T09:02:30.796875Z The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Avastin, when used to treat metastatic breast cancer, should only be used in combination with the taxane paclitaxel. This follows a review of Avastin in combination with taxanes, where the Committee concluded that Avastin should no longer be used in combination with another taxane, docetaxel. The Committee also ad... EN/News/European-Medicines-Agency-EMA-completes-its-review-of-Avastin-bevacizumab-used-in-breast-cancer-treatment.aspx 2013-05-23T09:02:30.796875Z The Irish Medicines Board and the HSE’s Environmental Health Service are warning Irish consumers about the use of a number of hair straightening products, a number of which are marketed as providing a “12 week blow-dry” effect. Please click on the link below for further information:  Concerns relating to the use of certain Hair Straightening Products EN/News/Concerns-relating-to-the-use-of-certain-Hair-Straightening-Products-.aspx 2013-05-23T09:02:30.796875Z The IMB has issued a new Guide to Fees for Human Products to reflect revised fees which have been approved by the Department of Health and Children. The fee application form has also been revised and must be used for all new applications made on or after 1 January 2011. Guide to fees (human) 2011 EN/News/Guide-to-Fees-for-Human-Products-.aspx 2013-05-23T09:02:30.796875Z Thousands of students from all over Ireland last week visited the Irish Medicines Board’s exhibition stand at the BT Young Scientist &amp; Technology Exhibition 2011. The exhibition, which took place from Tuesday 11th to Saturday 15th of January in the RDS, welcomed huge numbers of visiting students, teachers, parents and members of the general public. The IMB stand focused on building awa... EN/News/Irish-Medicines-Board-at-the-BT-Young-Scientist-Exhibition.aspx 2013-05-23T09:02:30.796875Z Link to press release on European Medicines Agency website Link to original news item on this issue on Irish Medicines Board website EN/News/Review-of-the-manufacture-of-Baxters-peritoneal-dialysis-solutions-initiated-over-potential-presence-of-endotoxins-in-some-batches.aspx 2013-05-23T09:02:30.796875Z The Irish Medicines Board (IMB) today (9 February 2011) published its annual report for 2009 which details key activities and performance highlights from the year. While maintaining its core focus of protecting public and animal health through the regulation of medicines, medical devices and healthcare products, the IMB recorded significant increases across all its departments’ outputs. Downloa... EN/News/Irish-Medicines-Board-Publishes-2009-Annual-Report.aspx 2013-05-23T09:02:30.796875Z The inaugural meeting of the Irish Medicines Board’s newly appointed Board took place today (23 February 2011). The new Board comprises: Mr. Michael D. Hayes (Chair) Mr. Pat Brangan Prof. Brendan Buckley Mr. Wilfred Higgins Ms. Ann Horan Mr. Brendan McLoughlin Mr. Noel O’Donoghue Prof. Caitriona O’Driscoll Ms. Maureen Windle EN/News/Inaugural-Meeting-of-Newly-Appointed-Board.aspx 2013-05-23T09:02:30.796875Z The invitation to submit requests for Ireland to act as RMS in outgoing decentralised procedures for the period of January 2012 - December 2012 is now closed. Requests received during the period the window was open (15th March 2011 - 15th April 2011) will now be reviewed and the IMB will revert to applicants in accordance with our guidance. Following review, further invitations may be invited v... EN/News/Invitation-for-requests-for-Ireland-to-act-as-Reference-Member-State-in-the-Decentralised-Procedure.aspx 2013-05-23T09:02:30.796875Z The Irish Medicines Board (IMB) today reiterated its warning against the dangers of purchasing medicines online, as it released details of a 66% rise in the quantity of illegal medicinal products detained during 2010. 822,484 dosage units of counterfeit and illegal medicines were detained by its enforcement section to the year end (494,502 units in 2009). It stated, it is particularly concerned ... EN/News/Irish-Medicines-Board-reports-66-rise-in-illegal-medicines-detained-in-2010.aspx 2013-05-23T09:02:30.796875Z EU Traditional Herbal Medicines Registration Scheme comes into effect Research carried out by the Irish Medicines Board reveals that some 77 per cent (8 out of 10) consumers think it is important that traditional herbal medicines should be regulated and that 80% of people believe it is necessary to inform their doctor when taking a herbal medicine. The survey findings were released today i... EN/News/8-out-of-10-consumers-support-regulation-of-traditional-herbal-medicines.aspx 2013-05-23T09:02:30.8125Z The Irish Medicines Board and the Medical Council have today signed a Memorandum of Understanding (MoU) which will strengthen the cooperation between the two bodies, further promoting the highest standards of practise in medicine. Download:  Press Release Media Queries: Siobhan Molloy / Orla Molloy (Weber Shandwick) Tel: (01) 676 0168 Mobiles: 086 817 5066 or 087 770 5108 EN/News/Irish-Medicines-Board-and-Medical-Council-agree-to-strengthen-cooperation.aspx 2013-05-23T09:02:30.8125Z The European Medicines Agency (EMA) has today published an update regarding the ongoing benefit/risk review of pioglitazone-containing medicines. Data from pharmacoepidemiological studies, non-clinical and clinical data and post-marketing reports on pioglitazone-containing medicines and the occurrence of bladder cancer are currently being evaluated to assess their impact on the balance of benefits... EN/News/European-Medicines-Agency-publishes-update-on-pioglitazonecontaining-medicines-review.aspx 2013-05-23T09:02:30.8125Z The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has finalised its review of Pandemrix which was initiated to investigate a possible link between Pandemrix vaccination and narcolepsy. This followed an increased number of reported cases of narcolepsy among children and adolescents in Finland and Sweden. While stressing that further research is necessary, the... EN/News/European-Medicines-Agency-recommends-restricting-use-of-Pandemrix-vaccine.aspx 2013-05-23T09:02:30.8125Z The Irish Medicines Board (IMB) has been closely monitoring the discovery, on the UK market, of packs of Nurofen Plus Tablets containing rogue blister strips of either Seroquel XL 50mg Tablets or Neurontin 100mg Capsules. Whilst the UK implicated pack size of Nurofen Plus of 32 tablets is not available for sale on the Irish market and there is no evidence at this time that packs of Nurofen Plus ... EN/News/IMB-INITIATES-PRECAUTIONARY-RECALL-OF-NUROFEN-PLUS-TABLETS.aspx 2013-05-23T09:02:30.8125Z The Irish Medicines Board’s (IMB) founding legislation and Corporate Governance policies have specific provisions which require annual disclosure of interests by all staff and by Board and expert advisory committee members. These provisions are administered by the IMB in line with best Irish and International practice. Our policies are also consistent with those of the European Medicines Agency. T... EN/News/Declarations-of-Interests.aspx 2013-05-23T09:02:30.8125Z The Irish Medicines Board (IMB) is today recommending a number of new measures in relation to the use of over the counter cough and cold medicines for children. Following a review by the IMB of the safety and effectiveness of these medicines, it is advising that over the counter cough and cold medicines are no longer used in children under the age of six years.  The product information for ... EN/News/IMB-gives-new-advice-for-use-of-cough-and-cold-medicines-in-children.aspx 2013-05-23T09:02:30.8125Z The European Medicines Agency (EMA) has responded to concerns expressed by Sane Vax Inc. and confirmed that the benefit-risk profile of Gardasil remains positive. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has written to Sane Vax addressing the issues it raised.  Download EMA Letter EN/News/European-Medicines-Agency-reaffirms-safety-and-effectiveness-of-Gardasil-HPV-vaccine-.aspx 2013-05-23T09:02:30.8125Z Over 50,000 counterfeit and illegal tablets &amp; capsules detained in Ireland The Irish Medicines Board (IMB), Revenue’s Customs Service and An Garda Síochána have announced details of their role in Operation Pangea IV which is an international week of action targeting the online sale of counterfeit and illegal medicines in the interests of protecting public health. They were among authoritie... EN/News/IMB-Customs-and-Gardai-in-Global-Interpol-Operation.aspx 2013-05-23T09:02:30.8125Z Parents urged to review ingredients of face paints prior to purchase The Irish Medicines Board (IMB), in conjunction with the Health Service Executive (HSE), is calling on parents to be aware of the dangers posed by the contents of some children’s face paints when purchasing this Halloween. High levels of lead have been found in some brands of children’s cosmetics in the last number of year... EN/News/IMB-recommends-vigilance-of-childrens-cosmetics-ahead-of-Halloween.aspx 2013-05-23T09:02:30.8125Z The Irish Medicines Board has issued a safety notice on Chelford childrens ‘5 Face Paints’ set with stencil (product code TA2212, barcode 5015931122122, batch number 101210), due to safety concerns. The face paint set contains five paints (black, white, blue, yellow and red), a stencil and two applicators. Tests have found excessive levels of lead in the yellow paint. If you have this produc... EN/News/Chelford-childrens-5-Face-Paint-set--Safety-information-for-consumers.aspx 2013-05-23T09:02:30.8125Z Consistent with the IMB's commitment to publish a report on the usage of veterinary antimicrobial agents sold in Ireland each year, a Report on the 2010 situation may be obtained in the following link Veterinary News Update on Antimicrobial Surveillance.  This exercise of annual reporting and uploading national data to a pan-European database held by the European Medicines Agency (EMA) is part of ... EN/News/Veterinary-News-Update-on-Antimicrobial-Surveillance~.aspx 2013-05-23T09:02:30.8125Z Leaflet advises best care to maximise AED performance The Irish Medicines Board (IMB) today published a leaflet providing advice to people on how to correctly maintain an automated external defibrillator (AED) so that it works effectively in the event it is needed in an emergency. AEDs can improve a person’s survival chances following sudden cardiac arrest when used in an emergency situati... EN/News/IMB-publishes-new-information-leaflet-that-provides-advice-on-how-to-correctly-maintain-an-automated-external-defibrillator-AED.aspx 2013-05-23T09:02:30.8125Z The IMB notes the update published today by the Therapeutic Goods Administration (TGA) in Australia concerning testing of PIP breast implants. The update contains the latest information about reports of rupture as well as test results obtained to date on new and explanted implants. According to the update, 'testing undertaken by the TGA has not found evidence that the risks involved with the u... EN/News/Poly-Implant-Prosthese-PIP-breast-implant-update.aspx 2013-05-23T09:02:30.8125Z The Irish Medicines Board (IMB) today issued a strong precautionary message for consumers on the health dangers of taking any Sibutramine containing slimming products. The IMB stated that Sibutramine was withdrawn from use as a medicine in Ireland and across the entire EU in early 2010 due to the increased risk of heart attacks and strokes. Specifically, the IMB is warning consumers not to pur... EN/News/IMB-cautions-consumers-against-purchase-of-illegal-online-medicines.aspx 2013-05-23T09:02:30.8125Z Thousands of students from all over Ireland visited the Irish Medicines Board’s exhibition stand at this week's BT Young Scientist &amp; Technology Exhibition 2012. The exhibition, which was open to the public from Thursday 12 to Saturday 14 January in the RDS, welcomed huge numbers of visiting students, teachers, parents and members of the general public. The IMB stand focused on building... EN/News/Irish-Medicines-Board-at-the-BT-Young-Scientist-Exhibition~.aspx 2013-05-23T09:02:30.8125Z The Irish Medicines Board (IMB) and the Parenteral Drug Association (PDA) Ireland Chapter today announced a major two day scientific meeting for Dublin on 10 and 11 July 2012. The meeting will be on the theme of Making Gene and Cell Therapy Medicines a Reality. This scientific gathering will be a satellite event to the EuroScience Open Forum or, ESOF2012, the major European scientific event to... EN/News/Irish-Medicines-Board-and-Parenteral-Drug-Association-Ireland-Announce-Major-Scientific-Meeting-on-Gene-Cell-and-Tissue-Therapies.aspx 2013-05-23T09:02:30.8125Z Both men found guilty in separate but connected cases taken by the Irish Medicines Board The Irish Medicines Board (IMB) today noted that two men received nine (9) month suspended sentences at Dublin District Court (20 February, 2012) for their respective roles in the illegal importation, supply and sale of counterfeit medicines. The men were charged in two separate cases following an investig... EN/News/Suspended-sentences-for-two-men-charged-in-counterfeit-and-illegal-medicine-cases.aspx 2013-05-23T09:02:30.8125Z The Irish Medicines Board (IMB) today hosted a visiting delegation from Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS). The visit followed the recent signing of a co-operation arrangement between the IMB and COFEPRIS at the 2011 International Summit of Heads of Medicines Agencies. Download:  IMB Press Release Media Queries: Weber Shandwick PR - (01) 676 0... EN/News/Irish-Medicines-Board-welcomes-delegation-from-Mexican-regulatory-agency.aspx 2013-05-23T09:02:30.8125Z The Irish Medicines Board (IMB) announced today that new dosage instructions for children’s liquid paracetamol medicines will appear on product information (package leaflets and labels) within the coming weeks. The updated information will include more precise age and dosage bands to ensure that children get the most effective amount of medicine for their needs whilst making it easier for pare... EN/News/Irish-Medicines-Board-announces-new-dosage-instructions-for-childrens-liquid-paracetamol-medicines.aspx 2013-05-23T09:02:30.8125Z The Irish Medicines Board (IMB) and The Organisation for Professionals in Regulatory Affairs (TOPRA) have announced that they will co-host an Annual Symposium in Dublin, from Monday 1 to Wednesday 3 October 2012. This is the key annual European regulatory forum for all those involved in the pharmaceutical sector and aims to provide all the latest information and, importantly, what is coming over t... EN/News/Irish-Medicines-Board-and-TOPRA-to-CoHost-Annual-Symposium-2012-.aspx 2013-05-23T09:02:30.8125Z The Irish Medicines Board (IMB) today noted the Dublin District Court’s ruling (03 April, 2012) in a case involving the supply of unauthorised and prescription only medicines. Gary Murphy pleaded guilty to two charges of keeping unauthorised prescription only medicines for supply at the retail outlet Cosmic Closet Ltd., at Bolton Street, Dublin. The charges arose following an investigation by ... EN/News/Retailer-pleads-guilty-to-supply-of-unauthorised-medicines.aspx 2013-05-23T09:02:30.828125Z The Irish Medicines Board (IMB) notes that James Bellamy, Director of Harmony Products Ltd, yesterday received a three year prison sentence and a fine of €100,000 at the Dublin Circuit Criminal Court. This followed his conviction for the illegal importation and wholesale of unauthorised prescription only medicinal products which were later sold as ‘herbal viagra’ for erectile dysfunction. Harm... EN/News/Fine-and-prison-sentence-for-James-Bellamy-in-illegal-medicines-case.aspx 2013-05-23T09:02:30.828125Z Agreement is part of enhanced use of intelligence in the fight against doping in sport The Irish Medicines Board (IMB) and the Irish Sports Council have signed a Memorandum of Understanding that will formalise the sharing of information and intelligence in an effort to protect Irish athletes and to combat the illegal use of medicinal products. In recent years the two state agencies have co... EN/News/Irish-Medicines-Board-and-Irish-Sports-Council-formalise-their-collaboration-through-a-Memorandum-of-Understanding.aspx 2013-05-23T09:02:30.828125Z The Irish Medicines Board (IMB) has noted the Dublin Circuit Criminal Court’s ruling yesterday in a case involving the unauthorised manufacture of a medicinal product. Darren Pidgeon pleaded guilty to charges of manufacturing medicinal products containing the active substance Zopiclone. Mr Pidgeon was sentenced to four years in prison to be suspended pending good behaviour. The case was br... EN/News/Fouryear-sentence-for-unauthorised-medicine-manufacture-.aspx 2013-05-23T09:02:30.828125Z The Irish Medicines Board website is being upgraded today and you may experience some interruptions in service throughout the day. We apologise for any inconvenience caused. EN/News/Irish-Medicines-Board--Website-Update.aspx 2013-05-23T09:02:30.828125Z The recent public consultation on the draft guide to cosmetic-biocide borderline products resulted in a significant level of feedback and comment from industry and other stakeholders. The Irish Medicines Board (IMB) and the Pesticide Registration and Control Division (PRCD) of the Department of Agriculture, Food and the Marine would like to thank all participants for their contribution to this pro... EN/News/Update-on-the-Draft-Guidance-on-CosmeticBiocide-Borderline-Products.aspx 2013-05-23T09:02:30.828125Z The Minister for Health, Dr James Reilly TD, is inviting expressions of interest from suitably qualified and experienced persons interested in being appointed to fill a vacancy that has arisen on the Board of the Irish Medicines Board. Further information, including application details, is available from the Public Appointments Service website www.publicjobs.ie. The closing date for receip... EN/News/Expressions-of-interest-sought-for-Board-vacancy-at-the-Irish-Medicines-Board.aspx 2013-05-23T09:02:30.828125Z This document clarifies, in a question and answer format, some practical considerations that pharmaceutical companies will need to take into account before and after the legislation starts to apply in July this year. The document applies to all medicinal products for human use regardless of the route of authorisation. The information provided represents the view of the European Medicines A... EN/News/Questions-and-answers-document-published-clarifying-procedural-elements-in-relation-to-the-implementation-of-new-EU-pharmacovigilance-legislation-.aspx 2013-05-23T09:02:30.828125Z The Minister for Health, Dr James Reilly TD, is inviting expressions of interest from suitability qualified and experienced persons interested in being appointed to fill vacancies that have arisen on the Advisory Committee for Human Medicines of the Irish Medicines Board. Further information, including application details, is available from the Public Appointments Service website. Applicat... EN/News/Expressions-of-interest-sought-to-fill-vacancies-on-the-Advisory-Committee-for-Human-Medicines-of-the-Irish-Medicines-Board.aspx 2013-05-23T09:02:30.828125Z The IMB has recently provided updates on the publication of the Implementing Regulation (EU) No 520/2012 by the European Commission, the first set of finalised modules of the guidelines on good pharmacovigilance practices (GVP) by the EMA, the Department of Health public consultation on the national transposition of the EU Pharmacovigilance Legislation, and the IMB national ICSR reporting requirem... EN/News/New-EU-Pharmacovigilance-Legilsation--Latest-News.aspx 2013-05-23T09:02:30.828125Z The Irish Medicines Board and the Food Safety Authority of Ireland today issued a strong precautionary message for consumers on the health dangers of taking food supplements or products containing the substance DMAA (1,3 -dimethylamylamine). The warning comes after a number of adverse reactions internationally related to products containing DMAA. Further Information: Download Press Release ... EN/News/Irish-Medicines-Board-and-Food-Safety-Authority-of-Ireland-issue-consumer-warning-on-health-dangers-of-illegal-stimulant-DMAA.aspx 2013-05-23T09:02:30.828125Z The invitation for submission of requests for Ireland to act as RMS in outgoing decentralised procedures for human medicinal products for 2013 has now closed. Requests received during 2012 will now be reviewed and the IMB will revert to applicants in accordance with our guidance. Following review further invitations may be invited via our website. It is envisaged that the window will reopen ... EN/News/Closing-window-for-invitation-for-requests-for-Ireland-to-act-as-Reference-Member-State-in-the-Decntralised-Procedure.aspx 2013-05-23T09:02:30.828125Z The Irish Medicines Board (IMB) today noted that Balbriggan District Court’s ruling by Judge Dermot Dempsey in a case involving the unauthorised supply of medicinal products.  David Power and Green Ecotech Ltd pleaded guilty to breaches involving supplying medicinal products without a prescription and not having a marketing authorisation.  The products, found at the premises in Express Grow i... EN/News/Retailer-pleads-guilty-to-supply-of-medicines-without-prescription.aspx 2013-05-23T09:02:30.828125Z The Irish Medicines Board (IMB) and the Parenteral Drug Association (PDA) Ireland Chapter hosted a major two day scientific gathering (10 and 11 July 2012) entitled “Making Gene and Cell Therapy Medicines a Reality”; a satellite event to the EuroScience Open Forum (ESOF2012). The two day IMB/PDA event focussed on the regulatory framework and challenges of translating the basic scientific disco... EN/News/Irish-Medicines-Board-and-Parenteral-Drug-Association-Ireland-Host-Major-Scientific-Meeting-on-Gene-Cell-and-Tissue-Therapies.aspx 2013-05-23T09:02:30.828125Z The survey is now closed. We are grateful to all those who responded for their time and support. We will use the feedback we have received to guide the future development of our online presence. EN/News/Irish-Medicines-Board-website--Participate-in-our-user-satisfaction-survey.aspx 2013-05-23T09:02:30.828125Z The Irish Medicines Board (IMB) today advises that children's herbal products containing echinacea will no longer be recommended based on the lack of scientific data to support their use. This new advice follows a review by the IMB of available data on the safety and effectiveness of echinacea and it is now advising that such products should not be used for children under 12 years of age. The IMB ... EN/News/Irish-Medicines-Board-Advises-Against-Use-of-Echinacea-in-Children-Under-12-Years.aspx 2013-05-23T09:02:30.828125Z The national legislation transposing the EU pharmacovigilance legislation was signed by the Minister of Health Dr. James Reilly on 25/07/2012. This legislation has now been officially published in the Irish Statute Book, and is available via the below links: SI 272 of 2012 (Medicinal Products (Control of Placing on the Market)(Amendment) Regulations2012) SI 273 of 2012 (Medicinal Products (Co... EN/News/National-Legislation-transposing-201084EU-now-published.aspx 2013-05-23T09:02:30.828125Z ‘Tan jab’ continues to pose a risk to health, warns IMB The Irish Medicines Board (IMB) today reiterated a precautionary safety alert in relation to the unauthorised tanning medicine Melanotan (I and II) which is illegal on the Irish market. This product is not available in pharmacies or authorised distribution channels in Ireland and it is thought that it is being sourced by consumers on the i... EN/News/Irish-Medicines-Board-updates-safety-alert-on-Melanotan.aspx 2013-05-23T09:02:30.828125Z The Directive on standards of quality and safety of human organs intended for transplantation (Directive 2010/53/EC) was adopted by the European Parliament and the Council on 7 July 2010. (See also Corrigendum to the Directive). This Directive was transposed into Irish legislation by Statutory Instrument (S.I. No. 325 of 2012) and was signed by the Minister for Health on 27 August 2012. Un... EN/News/EU-organs-transplantation-Directive-transposed-into-Irish-legislation.aspx 2013-05-23T09:02:30.84375Z Over 120,000 tablets and capsules with an estimated value of €375,000 detained in Ireland The IMB, Revenue’s Customs Service and An Garda Síochána have announced details of their role in Operation Pangea V which is an international week of action targeting the online sale of counterfeit and illegal medicines. They were among authorities from more than 100 countries who participated in this ... EN/News/Irish-Medicines-Board-Customs-and-Gardai-In-global-Interpol-operation-targeting-counterfeit-and-illegal-medicines.aspx 2013-05-23T09:02:30.84375Z The Irish Medicines Board (IMB) today noted Judge Brian Sheridan’s ruling at Midleton District Court in a case involving the unauthorised supply of medicinal products. Brian Buckley pleaded guilty to breaches involving the supply of medicinal products without a prescription and advertising such products to the general public. Mr Buckley was fined €6,000, with additional expenses relating to an... EN/News/6000-fine-for-online-supply-of-medicines-without-prescription.aspx 2013-05-23T09:02:30.84375Z The IMB warns parents to be aware of the dangers posed by the contents of some children's face paints when purchasing this Halloween. Download: IMB press release Further information: Orla Molloy/Siobhan Molloy - 087 7705108 / 086 8175066 Weber Shandwick PR - 01 6760168 EN/News/IMB-Recommends-Continued-Vigilance-of-Childrens-Cosmetics-ahead-of-Halloween-.aspx 2013-05-23T09:02:30.84375Z The IMB today published its annual report for 2011, a year which marked the 15th anniversary of its establishment as a national regulatory authority. The key activities and achievements for 2011 highlight the significant programme of work delivered across the organisation. Of particular note were a 10 per cent increase in the number of new product applications approved in respect of human medi... EN/News/Irish-Medicines-Board-publishes-2011-annual-report.aspx 2013-05-23T09:02:30.84375Z The IMB recently celebrated a landmark 50th edition of its Drug Safety Newsletter. Seventeen years after it was first published in 1995, intended as an occasional publication, the Drug Safety Newsletter remains an important source of information on medicines cited by healthcare professionals in a recent survey. Download - Press Release - Drug Safety Newsletter 50th Edition   <!--[if gte... EN/News/Irish-Medicines-Boards-Drug-Safety-Newsletter-celebrates-50th-edition.aspx 2013-05-23T09:02:30.84375Z The Minister for Health, Dr James Reilly TD, is inviting expressions of interest from suitably qualified and experienced persons interested in being appointed to fill a vacancy that has arisen on the Advisory Committee for Medical Devices of the Irish Medicines Board. Further information, including application details, is available from the Public Appointments Service website. Applications ... EN/News/Expressions-of-interest-sought-to-fill-vacancies-on-the-Advisory-Committee-for-Medical-Devices-of-the-Irish-Medicines-Board.aspx 2013-05-23T09:02:30.84375Z Visit the IMB stand at this year’s BT Young Scientist &amp; Technology Exhibition in the RDS, Dublin from Thursday 10 to Saturday 12 of January We invite everyone attending the exhibition to come along and meet our staff members and to hear a little about the IMB and the functions we carry out. In particular, our stand will highlight the important issue of medicines and medical devices safety. ... EN/News/Irish-Medicines-Board-at-the-BT-Young-Scientist--Technology-Exhibition-2013.aspx 2013-05-23T09:02:30.84375Z The IMB hosted the 31st meeting of Competent Authorities for Medical Devices (CAMD) on 30 to 31 January 2013. Delegates from over 42 regulatory authorities across 31 different European countries were in attendance at the meeting which was organised as part of the Irish Presidency of the Council of the European Union. The press release issued following the meeting is now available to download f... EN/News/IMB-hosts-31st-meeting-of-Competent-Authorities-for-Medical-Devices-CAMD-.aspx 2013-05-23T09:02:30.84375Z The Irish Medicines Board (IMB) today noted Judge Brigid Reilly's ruling at Dun Laoghaire District Court in a case involving the supply of unauthorised medicines. Kevin Doogan and Manor Trading Novelty Goods Ltd. pleaded guilty to breaches involving the supply of pharmacy confined medicines and their supply without a marketing authorisation. Mr Doogan pleaded guilty to two counts of supply ... EN/News/6000-in-fines-for-retail-supply-of-unauthorised-medicines.aspx 2013-05-23T09:02:30.84375Z The results of a survey released today by the Irish Medicines Board (IMB) which examined how consumers source and use information in relation to medicines, reveals that close to nine out of 10 people (87%) confirm they understand the product information (i.e. leaflets and packs) accompanying their medicines. Some two thirds of people (63%) state that they always read the product information when t... EN/News/3-out-of-5-People-Read-Product-Information-for-Prescription-Medicines.aspx 2013-05-23T09:02:30.84375Z The Irish Medicines Board is accepting requests for Ireland to act as RMS in decentralised procedures for human medicines. &nbsp; 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 Product. Requests should be submitted to rmsrequests@imb.ie using the CMDh ... EN/News/Invitation-for-requests-for-Ireland-to-act-as-Reference-Member-State-in-the-decentralised-procedure-for-a-human-medicine.aspx 2013-05-23T09:02:30.84375Z