To register for NDSWeb, controlleddrugs@hpra.ie must receive the following information: It is important to note that drugs (prescription and supply control) require by law that only one package of a listed paracetamol-containing product can be sold per retail transaction. This part of our website contains information for marketing authorisation holders and other industry stakeholders. Products for which medical claims are made or which contain substances which may have effects on the body are considered medicinal products and therefore require marketing authorisation by the HPRA. The market authorization is issued with a Product Authorization (PA) number included on the drug box/container. Individuals or companies seeking further information on the procedures for placing medicinal products for human use on the market in Ireland should consult the relevant documents, including guides and formularies, as well as explanatory information. You can also contact us at info@hpra.ie. Note: When contacting HPSA regarding an application, please provide the File Reference Number (SON) and/or MA number, procedure number and CESP, if applicable. Classification queries Phone: +353 (0) 1 676 4971 E: classification@hpra.ie Additional guidance explaining the requirements for the sale of acetaminophen-containing products by non-pharmacy retailers can be found in the PA`s Guide to the Sale of Paracetamol-Containing Drugs by Non-Drug Retailers. The reasons for the legal restrictions governing the sale of acetaminophen products are explained in the article Suicide Prevention Awareness – The Health Products Regulatory Authority (HPA) reminds retailers of the legal requirements for the sale of acetaminophen. The Privacy Act provides a service to stakeholders to help clarify which products should be classified as pharmaceuticals, medical devices or other regulated products. These products may or may not fall within the competence of the HPRA from a regulatory point of view.
However, our classification department will try to provide you with the appropriate regulatory framework to the extent possible. A classification service is operated for products that lie at the boundary between medicinal products for human use, medical devices and other products such as food supplements and cosmetics. Such applications may be submitted to an internal multidisciplinary committee on frontier products, which meets once a month. The outcome of the decision is communicated to applicants in a timely manner and is in turn accompanied by a recommendation for appropriate action. In the event of an appeal against the decision of the Committee for Marginal Products, the matter is normally referred to the Advisory Committee on Medicinal Products for Human Use for mediation. Detailed information on the procedure can be found in our guide to defining a medicinal product for human use. These guidelines should be used in conjunction with our application for classification of a device for human health and, where applicable, HPSA recommendations for the classification of medical devices. Our Limit Products Committee is comprised of HPRA staff with relevant scientific and regulatory expertise and experience and is led by the Manager of Scientific Affairs. Questions regarding changes to the classification of prescription drugs (“change requests”) should be directed to moss@hpra.ie. For more information, please see our Legal Status and Reclassification of Medicines page. In 2011, the Irish Medicines Board (IMB), now the Health Products Regulatory Authority (HPRA), established an advisory body for the legal classification of medicines.
The group was independently led and comprised of external representatives from a wide range of interested stakeholders, including patients, health professionals, the Ministry of Health and relevant government agencies. The Panel focused on examining strategies for the legal classification of medicinal products for human use and developing recommendations to address the current unmet need for non-prescription medicines. The Health Products Regulatory Authority (HPRA) is Ireland`s regulatory authority for pharmaceuticals, medical devices and other health products, including cosmetics. The HPRA protects and enhances human and animal health by approving medicines in Ireland that meet scientific requirements for quality, safety and efficacy. Only medicines authorised or registered with the HPRA can be sold by retailers in Ireland. Drugs from other countries cannot be legally sold by retailers other than pharmacies. It is emphasized that controlled drug licenses are issued under drug abuse laws and are a legal requirement in addition to other licensing requirements that may apply to commercial operations, such as a manufacturer/importer license, wholesale distribution license, etc. under drug law (human or veterinary).
HPSA promotes communication with the medical device industry. If you have any specific questions, please contact the Human Products Authorization and Registration Department of the ARPH, who will do their best to assist you. Please contact us at devices@hpra.ie. To obtain a LONO for Schedule 5 controlled drugs, an application form must be requested from controlleddrugs@hpra.ie (see below for more information). The HPRA invites MA holders to submit expressions of interest for their intention to request the conversion of the MoSS of their medicines. Expressions of interest must be made before 31.8.2014 by e-mail to moss@hpra.ie, indicating the PA number and the name of the medicinal product. For further information and requests for scientific or procedural opinions on changing the legal classification of a particular medicinal product, please contact moss@hpra.ie. Supply, import, export or possession of a controlled medicinal product included in the list of active substances eligible for reclassification in lists 1 and 2 Information on notified bodies for medical devices is also included. General sale medicinal products authorised/registered for sale in Ireland are included in the `latest list of general information on sales products` and only medicinal products on this list may be sold at non-pharmaceutical retailers in Ireland. And it is important to note that only drugs with the indicated name and marketing authorization or associated registration number can be sold. This requirement applies to both non-pharmaceutical and pharmaceutical retailers. Manufacture of listed controlled drugs The product range is very wide and includes several thousand items used daily by healthcare providers and patients.
To obtain an import/export license, the company responsible for the physical import/export must apply for an import/export license from NDSWeb. To obtain a LONO for Part 2 of Schedule 4, the responsible entity must also submit an application through NDSWeb (see below for more information on NDSWeb). Medical devices are divided into risk-based classes, which can represent low, medium and high risk. The text provided on this website is based on existing guidelines. European legislation on medical devices has been fundamentally revised by two new European regulations that will enter into force in the coming years. More details on these new regulations can be found on our page New Medical Devices Regulations Foreign Import Permit (required per export permit application). Further information on the background to HPRA`s development of this proactive approach and future developments in this area is listed below. Contact name and email address (it is recommended that this email address be a group email address accessible to all employees involved in the controlled drug licence application) It is not possible to apply for an import or export permit or LONO without an annual licence or registration.