EXPECTED EFFECTS OF SERIALIZATION SYSTEM IMPLEMENTING FROM THE STANDPOINT OF REGULATORY AUTHORITY 3-4 DECEMBER 2014 SHAKARYAN MKRTICH

COMBATING AGAINST COUNTERFEITING - MEDICRIME CONVENTION DIRECTIVE ON FALSIFIED MEDICINES SERIALISATION - eTACT

MEDICRIME RATIFIED COUNTRIES 1. УКРАИНА 2. ИСПАНИЯ 3. МОЛДОВА 4. ВЕНГРИЯ 5. РОССИЙСКАЯ ФЕДЕРАЦИЯ

Chapter II – Substantive criminal law MEDICRIME CONVENTION Chapter II – Substantive criminal law Article 5 – Manufacturing of counterfeits 1   Each Party shall take the necessary legislative and other measures to establish as offences under its domestic law, the intentional manufacturing of counterfeit medical products, active substances, excipients, parts, materials and accessories. 2   As regards medicinal products and, as appropriate, medical devices, active substances and excipients, paragraph 1 shall also apply to any adulteration thereof. 3   Each State or the European Union may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, by a declaration addressed to the Secretary General of the Council of Europe, declare that it reserves the right not to apply, or to apply only in specific cases or conditions, paragraph 1, as regards excipients, parts and materials, and paragraph 2, as regards excipients.

MEDICRIME CONVENTION Article 6 – Supplying, offering to supply, and trafficking in counterfeits 1.   Each Party shall take the necessary legislative and other measures to establish as offences under its domestic law, when committed intentionally, the supplying or the offering to supply, including brokering, the trafficking, including keeping in stock, importing and exporting of counterfeit medical products, active substances, excipients, parts, materials and accessories. 2 .  Each State or the European Union may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, by a declaration addressed to the Secretary General of the Council of Europe, declare that it reserves the right not to apply, or to apply only in specific cases or conditions, paragraph 1, as regards excipients, parts and materials.

MEDICRIME CONVENTION Article 7 – Falsification of documents 1.   Each Party shall take the necessary legislative and other measures to establish as offences under its domestic law the making of false documents or the act of tampering with documents, when committed intentionally. 2.   Each State or the European Union may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, by a declaration addressed to the Secretary General of the Council of Europe, declare that it reserves the right not to apply, or to apply only in specific cases or conditions, paragraph 1, as regards documents related to excipients, parts and materials.

MEDICRIME CONVENTION CHAPTER V –MEASURES FOR PREVENTION Article 18 - Preventive measures 1. Each Party shall take the necessary legislative and other measures to establish the quality and safety requirements of medical products. 2. Each Party shall take the necessary legislative and other measures to ensure the safe distribution of medical products.  3. With the aim of preventing counterfeiting of medical products, active substances, excipients, parts, materials and accessories, each Party shall take the necessary measures to provide, inter alia, for: a.   training of healthcare professionals, providers, police and customs authorities, as well as relevant regulatory authorities; b.   the promotion of awareness-raising campaigns addressed to the general public providing information about counterfeit medical products;

General public; Health professionals MEDICRIME CONVENTION, PRINCIPLES MEDICRIME CONVENTION, PRINCIPLES National SPOC Role in international/national co- operation; Central Reporting Point International Co-operation SPOC for Customs SPOC for Police Other as needed SPOC for Judiciary Industry Investigation SPOC e.g. Qualified/ Responsible Person) Medicines Regulatory Authority (DRA) incl. Official Medicines Control Laboratories Competent Authorities for Medical Devices Signals General public; Health professionals

MEDICRIME CONVENTION, PRINCIPLES the term “document” shall mean any document related to a medical product, an active substance, an excipient, a part, a material or an accessory, including the packaging, labeling, instructions for use, certificate of origin or any other certificate accompanying it, or otherwise directly associated with the manufacturing and/or distribution thereof;

FALSIFIED MEDICINES DIRECTIVE DIRECTIVE 2011/62/EU introduces measures designed to strengthen the medicines supply chain from the threat of counterfeit medicines.

COMBATING AGAINST COUNTERFEITING The Directive extends regulation to BROKERS From 02/01/2013 brokers will have to register - requirement to have established premises and a permanent address for their business which must be registered, with their corporate name.

COMBATING AGAINST COUNTERFEITING 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.

COMBATING AGAINST COUNTERFEITING Active Pharmaceutical Ingredients (APIS) 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. 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.

COMBATING AGAINST COUNTERFEITING 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.

COMBATING AGAINST COUNTERFEITING 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.

COMBATING AGAINST COUNTERFEITING 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 2014. 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.

Falsified Medicines Directive COMBATING AGAINST COUNTERFEITING Falsified Medicines Directive A common EU logo to be used, and the means by which its authenticity is protected will be determined by the European Commission and specified in separate legislation (an implementing act). General Pharmaceutical Council Logo (UK)

MULTI-LEVEL, ANTI-COUNTERFEITING STRATEGY АНТИКОНТРАФАКТНАЯ СТРАТЕГИЯ MULTI-LEVEL, ANTI-COUNTERFEITING STRATEGY

Unique Medicine Identifier (UMI) It is based on the principle of generating a Unique Medicine Identifier (UMI) at the manufacturing stage. This UMI can be traced and verified by the different stakeholders in the legal supply chain. Verification must be performed at the dispensing stage. Patients are also allowed to verify the authenticity of their medication: it is a unique feature of the EDQM project that will significantly contribute to strengthening the public’s confidence in the legal supply chain.   

As a public, intergovernmental organisation, the EDQM promotes a public governance for the eTACT system to ensure the confidentiality of the data handled by the system.   The project is currently restricted to the traceability of secondary packaging. It is designed for any medicinal product and is opened to any registered business stakeholders willing to join the project. All 37 member states of the European Pharmacopoeia are eligible to use eTACT.

COMBATING AGAINST COUNTERFEITING - Linear barcode (today usually used on majority of products)                                                                                                         - 2D-barcode (can store more information that linear barcode) -  Radio-frequency identification (RFID-more expensive compared to the above mentioned carriers)                                                                                                  

COMBATING AGAINST COUNTERFEITING

COMBATING AGAINST COUNTERFEITING Действующие системы ЕвроСоюз 2011/62/EU с 1 января 2016 США Закон 113-54 2013г. Аргентина Регуляция N 3683 GS1 стандарт Бразилия Федеральный закон 11.903 – 2D матрикс Южная Кореа Уведомление 2011-58, 2012 и 2013 Индия 1 Июля 2014, 2D матрикс для экспорта Китай С 2008 обьязательно для некоторых лек. Турция С 2010г. Компенсация для лек. с 2D бар кодом

Страны намеревающие внедрить системы COMBATING AGAINST COUNTERFEITING Страны намеревающие внедрить системы Саудовская Арабия 2016 Иорданий 2017 Украина Мексика В ближайщем будущем Колумбия

Основные цели проекта eTACT -  First, it uses a harmonised approach to ensure inter-operability with existing national systems. This is important, as counterfeiting of medical products is a global phenomenon which cannot be solved by a single country.   - Second, it is flexible, allowing better control of the supply-chain and providing patient access. - Third, it will be under public governance, ensuring protection of sensitive commercial data. As a trusted public body, the EDQM is ideally placed to deliver public governance of the system in co-ordination with regulatory authorities

Основные цели проекта eTACT Национальный уровень Национальный уровень Национальный уровень Национальный уровень Национальный уровень Пациенты, интернет аптеки, дистрибьюторы, переупаковщики и остальные участники цепи дисртибьюции лекарств

Основные цели проекта eTACT

Основные цели проекта eTACT

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