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Mail order pharmacy: cross-border trade and internet sales Klaus Gritschneder Vice President EAMSP Agenda • • • • Who we are Short history of mail order pharmacies Legal basis of mail order pharmacies Challenges and solutions EDQM Zagreb 20.11.2014 Who we are? • Umbrella organisation for all European based mail order pharmacies • 12 members from 6 European countries (D, NL, UK, SK, CH, B) • Covering more then 90% of the European mail order market in sales for drugs (Rx and OTC) EDQM Zagreb 20.11.2014 History • 1999 first mail order pharmacy in UK: pharmacy2you • Since 2000 mail order pharmacies in the Netherlands for the German market • First One: DocMorris starting in 2000 • 2004 mail order pharmacies legal in Germany: more then 3000 mail order pharmacies, but max. 100 important one`s • Mail order in other countries: Switzerland, Sweden, Island, France, Austria EDQM Zagreb 20.11.2014 Actual status in Europe EDQM Zagreb 20.11.2014 OTC in or outside of pharmacies EDQM Zagreb 20.11.2014 Legal basis • • • • • DocMorris sentence ECJ (11.12.2003 - C-322/01) Cross-Border Directive (2011/24/EU) Falsified Medicine Directive (2011/62/EU) Legal frameworks in the memberstates Mail order pharmacies must hit the rules in their country of origin, but also the rules in the country of destination EDQM Zagreb 20.11.2014 Challenges • • • • • • • • • What`s different to high street pharmacies? No local business, but nationwide or even cross border Patient is not in front of the pharmacist Consulting of patients via phone and e-mail Special adherence programs Safety first: drug safety within the dispensing process Drug safety in the supply chain (cool chain) Fight against fakes Fight against illegal internet traders EDQM Zagreb 20.11.2014 Illegal and falsified drugs – only a problem in Afrika? EDQM Zagreb 20.11.2014 Some examples from the European market EDQM Zagreb 20.11.2014 easy-apotheke.com cialis20mgkaufen.net shopapothekeonline.de What we will do • Implementing the FMD • Implementing .pharmacy TLD • Supporting the activities of ASOP EDQM Zagreb 20.11.2014 EDQM Zagreb 20.11.2014 Internationale cooperations within ASOP EDQM Zagreb 20.11.2014 Thank you for your attention