REGULATIONS | ENFORCEMENT | GLOBALIZATION | SECURITY & INTEGRITY

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PART I Regulations: USA Europe Asia International

PART II Enforcement Globalization Supply chain security Case studies Summary

Global standards

IMPACT taskforce

WHO Guideline on GDP

Other WHO guidelines

Medicrime Convention

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WHO guideline on Good distribution practice sets out appropriate steps to assist in meeting

the responsibilities involved in the different aspects of the distribution process.

WHO GDP Guideline

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Other WHO Guidelines

• WHO Guide to Good Storage Practices for Pharmaceuticals

• WHO Good Manufacturing Practices: Main Principles

• WHO Pharmaceutical Starting Materials Certification scheme

• WHO Guidelines on Import Procedures

• WHO Guidance on Good Trade and Distribution Practices for Pharmaceutical Starting Materials

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Applicability

All persons and companies involved in any aspect of the distribution of pharmaceutical products from the premises of manufacture to

the point of supply to health establishments, e.g. private pharmacies, hospitals, clinics, etc. for supply to the patient.

• Manufacturers (bulk & finished products) • Brokers, Traders

• Suppliers • Distributors wholesalers

• Transport companies • Forwarding agents

• Manufacturers (bulk & finished products) • Brokers, Traders

• Suppliers • Distributors wholesalers

• Transport companies • Forwarding agents ARETE-ZOE, LLC

WHO Good Distribution Practice Standards

Legally binding only if implemented locally ARETE-ZOE, LLC

А counterfeit medicine is one, which is deliberately and fraudulently mislabeled with

respect to identity or source.

• Counterfeiting affects both branded and generic products

• Counterfeit products and may include products with

the correct ingredients in wrong amounts

or with the wrong ingredients,

without active ingredients,

with insufficient active ingredients

or with fake packaging.

WHO GDP Guideline

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WHO Good Distribution Practices Guideline

are that part of quality assurance that ensure that the quality of a pharmaceutical product is maintained through adequate control throughout the

numerous activities which occur during the distribution process.

Distribution is the division and movement of pharmaceutical products

• from the premises of the manufacturer of such products, or another central point,

• to the end user, or to an intermediate point

• by means of various transport methods,

• via various storage or health establishments.

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Good manufacturing practices (GMP ) are that part of quality assurance which

ensures that products are consistently produced and controlled to the quality

standards appropriate to their intended use and as required by the marketing

authorization. ARETE-ZOE, LLC

Good Storage Practices

are that part of quality assurance that ensure that the quality of a pharmaceutical

products is maintained through

adequate control throughout the storage.

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Good Trade and Distribution Practices

are that part of quality assurance that ensure that the quality of a pharmaceutical

product is maintained through adequate control throughout the numerous activities

which occur during the trade and the distribution process.

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Labelling is the process of identifying a product

including the following information, as appropriate:

• name, active ingredient(s): type and amount, • batch number, • expiry date, • special storage conditions, • handling precautions, • directions for use, • warnings and precautions, • names and addresses of the manufacturer or the supplier. ARETE-ZOE, LLC

WHO Good Distribution Practice Standards

Implemented by most major economies ARETE-ZOE, LLC

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Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health

Sanctions shall have deterrent effect

Formally adopted on January 1, 2016

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Counterfeiting of medical products seriously endanger public health

• The Action Plan adopted at the Third Summit of Heads of State and Government of the CoE (2005) recommends strengthening of the security of European citizens

• Universal Declaration of Human Rights (1948)

• Convention for the Protection of Human Rights and Fundamental Freedoms (1950)

• Convention on the Elaboration of a European Pharmacopoeia (1964, Protocol 1989)

• Convention on Human Rights and Biomedicine (1997)

• Convention on Cybercrime (2001)

• Resolution concerning the pharmacist's role in the framework of health security

• Work of the WHO taskforce IMPACT, EU and the G8 forum

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Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health

Common Goal • Combating counterfeiting of medicinal products

• Threats to public health

• New offences and penal sanctions

Scope • Products irrespective IPR

• Medicinal products, accessories, excipients, parts, materials and medical devices ARETE-ZOE, LLC

Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health

“each Party shall take the necessary legislative and other measures to establish as offence

under domestic law the supplying, brokering, trafficking, keeping in stock, importing and

exporting of counterfeit medicinal products, active substances, excipients, parts, materials

and accessories.” ARETE-ZOE, LLC

Where more than one Party claims jurisdiction over an alleged offence, the Parties shall determine the most appropriate jurisdiction for prosecution.

• Specialized trained professionals • Adequate resources

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