The Transposition of the Falsified Medicines Directive – the UK story Lynda Scammell / Enforcement Group / MHRA

The Falsified Medicines Directive Houston Brussels– we have a problem!

The Falsified Medicines Directive Medicines are making us sick!

The Falsified Medicines Directive The Falsified Medicines Directive (2011/63/EU) was introduced to combat counterfeit medicines infiltrating supply chains across the EU and introduces measures designed to strengthen these supply chains.

Falsified Medicines Directive The resulting Regulation [SI 2013/1855] was laid before Parliament in July and came into force on 20/08/13. The Regulations amended the Human Medicines Regulation 2012 [SI 2012/1916]

The Falsified Medicines Directive Falsified Medicinal Product – Definition Any medicinal product with a false representation of: its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or its history, including the records and documents relating to the distribution channels used.

The Falsified Medicines Directive Key objective is to address problem of increase in falsified medicines found in EU by: Improving controls on quality of active substances and excipients Requiring safety features for medicines at risk of counterfeiting Regulating medicines imported for re-export (new term -“introduced”) and rules governing access to medicines held in free trade zones & warehouses Strengthened obligations on wholesale dealers and extending regulation to brokers of medicines Addressing electronic supply of medicine Strengthening inspection and ensuring appropriate penalties for counterfeiting are in place in Member States

Falsified Medicines Directive Wholesale Dealers additional obligations to - Verify that wholesalers, manufacturers and importers of medicines from whom they obtain supplies hold the appropriate licence and comply with Good Distribution or Good Manufacturing Practices. Confirm that brokers from whom they obtain medicines fulfil the requirements for registration with the national authorities and other obligations.

Falsified Medicines Directive Verify that medicines they receive that are subject to the new safety feature provision are not falsified, by checking the safety features on the outer packaging. Record the batch numbers of medicines they receive that are subject to the safety features, including for medicines that are to be exported to third countries (together with manufacturing authorisation holders). They must report to the national competent authority and the marketing authorisation holder if they suspect that medicines they receive may be falsified.

Falsified Medicines Directive Maintain a quality system that sets out responsibilities, processes and risk management measures in relation to their activities. Competent authorities are required to enter details of holders of wholesale distribution licence holders on a public EU database (EUDRA GDP) The Directive clarifies the regulatory regime already in place in the UK for Wholesale Dealers who engage in “parallel trade”.

Falsified Medicines Directive The Directive extended regulation to BROKERS of medicinal products From 02/01/2013 brokers are required to register with MHRA - requirement to have established premises and a permanent address for their business which must be registered, with their corporate name.

Falsified Medicines Directive Brokers may only deal in medicines that have a marketing authorisation (licence), unless they are brokering medicines from outside the European Economic Area (EEA) for direct export from the UK to a third country. Brokers must: Keep records of all transactions for 5 years; Maintain a quality system; Check that those from whom they purchase and to whom they sell hold the appropriate licence; Report to the MHRA offers of medicines they believe to be or suspect to be counterfeit.

Falsified Medicines Directive To extend the existing licensing requirements to exporters of medicines exporting to non EEA countries (including importers that import medicinal products for that purpose)

Falsified Medicines Directive A new definition of “introducing” medicines is established for medicines that are imported into a Member State of the EU solely for the purpose of export to a 3rd country, with no intention that the medicine will be placed on the market in the EU. Under the new legislation anyone importing a medicine from outside the EEA for export to a 3rd country must hold a Wholesale Dealer’s licence. This has the effect of extending the existing licensing regime to exporters of medicines. Commission granted powers to bring forward legislation (delegated act) setting out the checks to be made to ensure that falsified medicines imported for export do not enter into free circulation in the EU.

Falsified Medicines Directive Manufacturers, importers and distributors of active substances (ASs) imported into the European Economic Area (EEA) for use in the manufacture of authorised medicinal products.

Active Substances Direct obligations for manufacturers, importers and distributors of API – Manufacturers of active substances in the EU, importers and distributors of active substances must, under the new legislation, notify the national competent authority of their activities, including the active substances concerned and provide annual updates – Details will be included in a community database Activities cannot commence until notified by authorities Changes in registration to be communicated to authorities annually and immediately where they impact the quality or safety of the API

Active Substances Only import active substances when accompanied by written confirmation that equivalent GMP standards and supervision apply in the exporting country, unless API sourced from a listed country (or EU GMP certificate is available) Manufacturers of medicines will be required to conduct the necessary audits to enable a written confirmation of the compliance of the API manufacturer with GMP standards to be provided Member States to ensure API manufacturers on their territory comply with GMP for API and API importers and distributors with API GDP.

Active Substances The Commission together with the EMA shall assess third countries regulatory framework for APIs and if assessment is positive include country in list. They shall verify regularly whether the conditions are fulfilled. May inspect API distributors in 3rd countries and manufacturers and importers of excipients where suspected non-compliance exists or at request of Commission or EMA. Frequency of inspection to be based on risk

Falsified Medicines Directive Excipients The holder of a manufacturing authorisation is required to verify the authenticity of excipients used and to undertake formal risk assessments to ascertain their suitability. The risk assessment must consider the source and intended use of the excipients, as well as any previous incidents of quality defects, and take account of relevant quality systems. They must use these assessments to determine the appropriate GMP standards that must be used in their manufacture. A record of the measures undertaken must be kept by the manufacturer.

Falsified Medicines Directive Supplying Medicines from a Distance

FMD Requirements re Distance Supply The Directive requires Member States to introduce national arrangements to register suppliers of medicines “at a distance”. This will involve the establishment of a national website and the adoption of the common EU logo. All websites supplying medicines at a distance will be required to display the EU logo and provide a hyperlink to the national website of the Member State in which the person offering to sell medicines at a distance is established.

FMD Requirements re Distance Supply The EU logo has been agreed and implementing legislation was published on 24/6/14 MS have until 1/7/15 to implement national systems

Falsified Medicines Directive Safety Features The Directive provides for safety features comprising a seal on the outer packaging (to indicate whether the pack has been tampered with) and a unique identifier to be applied to certain categories of medicines. It requires these features to be applied – in principle – to all medicines subject to medical prescription and to non-prescription medicines if they are at risk of counterfeiting. The unique identifier will allow operators (including wholesale dealers and pharmacists) in the medicines supply chain to verify the authenticity of the medicine and to identify individual packs.

Falsified Medicines Directive The characteristics and technical specifications of the unique identifier will be determined by the European Commission in separate legislation (a delegated act) which they currently expect to be in place by mid 2015. Member States will have three further years after adoption of the delegated act to ensure the requirements are put in place. Those Member States with pre-existing national systems will have a further three years in which to comply.

The Impact - Industry Marketing Authorisation Holders Manufacturing Authorisation Holders API Manufacturers / Importers / Distributors Wholesale Distribution Authorisation Holders Brokers Pharmacies + others who supply to the public Manufacturers in Third Countries

Thank you for listening хвала Hvala Lynda Scammell Senior Policy Adviser Enforcement Group MHRA