A fake medicine that passes itself off as a real, authorised medicine. (1)

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1 Falsified medicines Index 1 Intrductin 2 Types f falsified medicines 3 Eurpean regulatin n falsified medicines 4 Risks f falsified medicines 5 Buying medicine nline safely 6 References 7 Further resurces Intrductin Since 2011, the Eurpean Parliament has declared an alarming increase in medicinal prducts cntaining pr quality r falsified ingredients, n ingredients r in the wrng dse either t high r t lw that pse a majr threat t public health and patient safety. Accrding t the EMA definitin, a falsified medicine is: A fake medicine that passes itself ff as a real, authrised medicine. (1) The intrductin f a definitin fr falsified medicine was necessary t differentiate it frm ther illegal medicinal prducts knwn as cunterfeit medicines (thse that d nt cmply with intellectual-prperty rights r that infringe trademark law), and t facilitate the identificatin f strategies t address each issue. Falsified medicines have nt undergne the nrmal quality, safety and efficacy assessments by regulatry authrities that are required fr EU authrisatin prcedures. Because f this, the cnsequences f taking falsified medicines can be serius, and can include: Untreated diseases, r failure f medical treatments. Unexpected and dangerus interactins with the medicines that the patient is already taking regularly. Severe side effects.

2 Types f falsified medicines Falsified medicines are nt limited t a single type f medicines, targeted ppulatin r regin. Fr example: In develping cuntries, there is evidence f falsified vital (ptentially lifesaving r crucial t prviding basic health services) and first necessity medicines (thse that satisfy the pririty health care needs f the ppulatin) such as antibitics, tuberculsis, malarial and anti-retrviral medicines used against HIV. Other prducts like analgesics, antiinflammatry medicines, and bld prducts may als be falsified. In wealthy cuntries in Eurpe, as well as in the United States, the presence f falsified medicines has increased cnsiderably, especially nline. Prducts that are nt reimbursed by health systems are a prime targets fr falsificatin, such as medicinal prducts against sexual dysfunctin r thse that prmte weight lss. Eurpean regulatin n falsified medicines Several glbal rganisatins and assciatins are invlved in tackling the threat caused by falsified medicines. Sme f the key players are the Wrld Health Organisatin (WHO), Interpl, the Wrld Custms rganisatin and the Heads f Medicines Agencies Wrking Grup f Enfrcement Officers (HMA/WGEO). They all crdinate peratins and share infrmatin t stp the supply f falsified medicines. Directive 2011/62/EU (3) n falsified medicines fr human use s prvides a framewrk fr the distributin f medicines, s that they are ffered fr sale nly thrugh licensed pharmacies and apprved retailers, including apprved internet prviders. This directive intrduced safety features aiming t prevent falsified medicines entering the legal medicine supply chain (frm manufacturers t distributrs, pharmacies and hspitals) and reaching patients with fur main types f measures acrss Eurpe: 1. Safety features f medicines

3 Tw safety features are t be placed n the packaging f mst medicines: a 2- dimensin barcde r unique identifier and an anti-tampering device. This regulatin was published in February 2016 by the Eurpean Cmmissin (4) fr the Marketing Authrisatin (MA) hlder t place these features n the packaging f mst prescriptin medicines and certain nn-prescriptin medicines n later than February These safety features aim t guarantee the authenticity f medicines fr the benefitf patients and businesses, and strengthen the security f the medicine supply chain. 2. Supply chain and gd distributin practice The Directive intrduces new respnsibilities fr whlesalers that includes regulatins in quality system, persnnel training and hygiene, premises and equipment, dcumentatin, and thers. 3. Substances manufactured utside the EU Frm July 2013, all active substances manufactured utside the EU have t be accmpanied by a written cnfirmatin frm the regulatry authrity f the exprting cuntry when imprted int the EU, many cuntries have cmmitted t ding this. These statements are issued per manufacturing site and per active substance and ensure that Gd Manufacturing Practice (GMP) is bserved and is equivalent t that f the EU. 4. Internet sales The Directive has intrduced an bligatry lg that will appear n the websites f legally perating nline pharmacies and apprved retailers in the EU (5). Risks f falsified medicines The WHO estimates that ver half the medicines sld via the Internet are falsified. In Eurpe, 97% f nline pharmacies are illegal. Online purchasing f medicinal prducts has increased ver the years, since it may seem attractive t the cnsumer fr different reasns: Time saved in the purchase. Cheaper medicine. Aviding previus medical cnsultatin t btain prescriptin medicine. Risks f falsified medicines t patients are multiple:

4 Falsified medicines culd include fake r wrng ingredients, inactive pharmaceutical ingredients. Falsified medicines can even cntain dangerus substances. They may cntain ingredients in the wrng amunt, and the active cmpnents might be t weak r t strng, r might have expired. Falsified medicines fail t treat the patient s illness and can wrsen the cnditin, r cause disability r even death. They can als increase resistance t legitimate treatments (antibitics r anti-parasites) and pse an increased risk f adverse drug reactins/side effects. Falsified medicines might nt be safe when used with ther medicinal prducts. Falsified medicines might nt be labelled crrectly, and might have been stred r shipped at incrrect temperatures r humidity cnditins, causing the deteriratin f the cmpnents. It is imprtant t enable patients t recgnise trustwrthy surces and t be aware f the risk f illegal Internet sales. They shuld be aware f the risks frm falsified medicines thrugh infrmatin abut the cmmn lg, in websites and campaigns. Patient rganisatins can raise awareness by infrming patients and prmting safety f their medicine t supprt public awareness campaigns. A strng patient-health prfessinal relatinship shuld be established in rder t supprt the dctrs and ther medical persnnel in raising awareness abut the prblems and risks assciated with falsified medicines. Buying medicine nline safely In sme EU cuntries, it is pssible t buy medicines nline. Purchasing medicines ver the Internet can be easy and cnvenient. Hwever, it has t be safe. Patients shuld buy medicines nly frm nline vendrs that have registered with the natinal cmpetent authrities in the EU member states. Obligatry pharmacy lg

5 EU nline pharmacy lg (UK versin) that shuld appear n the websites f all nline medicine vendrs in the EU. Figure 1: Obligatry lg (UK versin) that shuld appear in the websites f all nline medicine vendrs in the EU (6). A lg is intended t allw patients and cnsumers t be able t identify nline pharmacies and retailers that have been apprved and that prvide authrised medicines. It is imprtant t check these nline pharmacies and retailers in the nline registries available fr each EU cuntry. A list f these registries can be fund n the Eurpean Medicines Agency website: /general_cntent_ jsp&mid=wc0b01ac05808fd210 The patient shuld nt cntinue with the purchase if the retailer is nt n the list. Patients as well as healthcare prfessinals have a very imprtant rle in detecting and reprting falsified medicines. Prviding patients with accessible and accurate infrmatin is crucial t avid cnfusin. References 1. /general_cntent_ jsp Directive 2011/62/EU n falsified medicines 1/dir_2011_62/dir_2011_62_en.pdf 3 4. Eurpean Cmmissin Delegated Regulatin 2016/ /reg_2016_161/reg_2016_161_en.pdf 4 5. Buying medicines nline 6. Technical guidance in using the bligatry lg

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