Regulatory Requirements for Medicinal Products

To protect public health, and on behalf of the UK Licensing Authority, the ........................... (MHRA) regulates medicinal products for human use in accordance with the ................... as amended, "the Directive") and UK law namely the Human Medicines Regulations 2012 1.Medicines and healthcare products regulatory agency 2. European Community's medicinal products directive (Directive 2001/83/EC, medicinal product Any substance or combination of substances presented for treating or preventing disease in human beings or animals under part 5 of the human medicines regulations 2012 how long after applying for a UK marketing authorisation does a decision need to be made? 210 days >in writing >signed by applicant How to apply for a UK marketing autho- >in english > statement showing if the medcicne that riation the application is stated for can be made available- POM, P, GSL? marketing authorization medical device a licence to place a medicinal product on the market to be used by patients means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings eg: dental and surgical instruments • bandages and splints •treatment chairs and hospital beds UKCA mark 1/7 What are medical devces marked by in england scotland and wales but not norther ireland? CE or UKNI mark What are medical devises in NI marked by? It shows that the device is fit for its intendwhat does medical device marks show? ed purpose stated and meets legislation relating to safety. To place a CE marking on your device for you must use an EU-recognised Noticirculation in both Northern Ireland and fied Body to undertake any mandatory the EU third-party conformity assessment. section 4 what section of the medicines act were advisory bodies are a group of indepenadvisory bodies for the MHRA appointed dent experts who are appointed by minby? isters no staff of MHRA Who approve covid 19 vaccines? MHRA Look at safety,quality and effectiveness lab studies and clinical trials What is the role of the HPRA - Health products regulatory agency? to protect and enhance public and animal health by regulating medicines, medical devices and other health products. It is also their role to monitor the safety of cosmetics. what was the HPRA formally known as ? Irish Medicined Board- IMB Human medicines Veterinary medicines Clinical trials Medical devices Controlled drugs 2/7 What does the HPRA include? What is the role of the EMA- European Medicines Agency? Blood and blood components Tissues and cells Cosmetic products The protection of animals used for scientific purposes Organs intended for transplantation protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use responsible for making a single marketing auhoriisation that is valid in all EU countries, iceland, liechtenstein and norway- -takes up to 210 days a Reference Member state and tells other member states that then become "concerned member states" that will hold when a member state decides to evalu- their own evaluations and wait on the ate a medicinal product it becomes reference member states decision on the product-- take up to 210 days and is referred as the "mutual recognition procedure." What is an unliscensed medicine? A medicine without a current UK Marketing Authorisation (MA) Examples of unlicensed medicines eg medicines undergoing clinical trials, medicines awaiting MA, medicines withdrawn from the UK market or medicines manufactured for export. What are "specials" medicines "Specials are unlicensed medicinal products manufactured in the UK for human use which have been specially prepared to meet a prescription ordered for individual patients without the need for the manufacturer to hold a marketing authorisation for the medicinal product concerned." 3/7 not assessed by MHRA therefore have no summary of product characteristics (SPC)outlining dose, contra-indications, storage and patient information leaflets are not routinely available Melatonin oral liquids - propylene, glycol what are some exapmples of "specials etc medicines? omeprazole oral liquids coal tar ointments How much can one bottle of omeprazole 10mg/5ml cost? £30-£610 When supplying a special the pharma- takes FULL responsablily in law for any cist adverse side effects. Where can you get specials? 'special-order' manufactures( NHS and non-NHS)- attached to hospital oharmacies >check for a liscenced alternative >call prescriber for dose, indicationa and other info >ensure prescriber knows > Prepare and supply to patient as per the pharmacies SOP's >obtain agreement on the specification for the product with the manufacturer what is the guidance for pharmacists if >make sure product has an appropriate they receive a prescription for an unli- shelf life censed medicine? >do a risk assessment in collaboration with the prescriber. >Keep records- PMR and. NPA specials procedure record book >The Human Medicines Regulations 2012 >patient must be informed that the mediicne is unliscensed 4/7 What is an off-label medicine? >Medicine which has a MA but which is prescribed outside the terms of the MA eg. For reason of dose, age, route of administration or contraindications. When can you prescribe unliscenced medicines? >would better serve the patient's needs than an appropriately licensed alternative What is onus of liability? policies that: >pharmacists are informed of potential concequences >doctors notify pharmacists if they prescribe off-label or unliscensed medicines Using off-label or unlicensed mediciens shifts the onus of liability for adverse events from the MA holder to the prescriber and the pharmacist What do SOPS and records have in them? approval to purchase an unliscenced medicine >aggreement of product specification >reciept and storage of unliscenced formulations low risk medications >from trusted manufacturer >comonnoly prepared extemporaneous or topical dermatological preperation Medium risk medicines >licensed preparations used outside liscenced indicatoins >products with limited stability info High risk medicines >Withdrawn from UK >Made outside of the EU >Pose a risk to staff >Imported and are unlicensed or ectemporaneousley made in their country of origin 5/7 >Do one for ALL unlicesned medicines >Keep records >Report suspected adverse drug reactions to the MHRA >Report defective named patient medihow to carry out risk assessments cor- cines to the MHRA rectly. >Ensure the patient receives a PIL or adequate written information in English >Ensure SOPS for handling unlicensed medicines are in place >Audit use of unlicensed medicine use or procedure >only give when al alternative licensed is not possible >You as a prescriber are completly accountable >Make pt informed on the medicine, risks responsibilitues of the prescriber when and adverse effects prescribing an unlicesned medicine >Need written consent >report suspected adverse reactions to MHRA >If unlicensed drug needs to continue, talk to their GP to obtain agreement to continue to supply what do you need to think about when dispensing unlicensed medicines? >Source of named -patient medicine are they reputable, reliable supplier >Supply chain - is it robust >Does supplier have an appropriate license >Where is medicine manufactured >Mediicne potential for adverse -drug reactions Contra-indications, >Written information supplied with medicine >Record of receipt and supply - continuity of supply 6/7 Product name and specification Manufacturer and supplier if different Date quantity ordered Batch number received What do you need to include in records? Source Person to whom product was supplied Date/quantity of supply Batch number supplied Prescribers name 7/7