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2019 Medicinal Cannabis Expo Johannesburg

Welcome

Trevor Schoerie –Managing DirectorNovember 2019

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About PharmOut

PharmOut is a leading international consultancy offering architectural, engineering, compliance, validation, regulatory, consulting services to the pharmaceutical, blood & tissue, pesticides and veterinary and medical device manufacturers, and more recently medicinal cannabis (3 years).

PharmOut holds ISO 9001:2015 certification from LRQA. Our Quality Management System is certified to the ISO 9001:2015 standard for the provision of architectural design and consultancy services.

SA Company and Local OfficesSince April 2019

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Our Cannabis Specific Services

• Licensing, any country

• EU-PIC/S Compliance

• Regulatory submissions

• Quality Management Systems

• Cultivation Consulting

• GACP/GMP Cultivation Training

• Master & Strategic planning

• Architecture and design

• Engineering

• Equipment selection

• Qualification and Validation

• Temp., Light & RH Mapping

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Two Pillars of ALL Pharmaceutical Products beforeyou can sell product

Marketing Authorisation

• Double blind ClinicalEvidence that it prevents, cures or alleviates symptoms.

Good Manufacturing Practice (GMP)

• Evidence of systems to ensure safe and reproducibleproduction

Product Registration and Manufacturing License

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United Nations Single Drug Convention 1964

• Most countries are signatories to this convention

• Countries have since 1964 enacted laws to control drugs (beneficial and harmful drugs)

• Cannabis remains a banned substance, but it is changing

• Poisons scheduling

• Cannabis for non medicines are schedule 9 (Aus) 7 or 8 (SA) drugs, no useful medical use, but CBD and THC have clinical evidence

• USA THC from a botanical source is banned (USP).

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PIC/S Guide to GMP

Currently 54 authorities have adopted (28 from Europe)

•GMP Guidance’s used as regulatory requirements by EU and Asia-Pacific countries, including South Africa

•Is an informal “Cooperative Arrangement” between GMP regulatory authorities; i.e. it’s not a legal treaty.

PIC/S – Pharmaceutical Inspection Co-op Scheme

No obligation for member authorities to accept inspection reports of other members.

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54 PIC/S member authorities (1 January 2019)

4 Partners

EDQMEMA

UNICEFWHO

New Zealand

Iceland

Canada

USA

Argentina

South Africa

Australia

Malaysia

Taiwan

Switzerland

Norway

Indonesia

Ukraine

Singapore

Israel

Liechtenstein

EUROPEAN UNION Member States Agencies (29)

Japan

South Korea

Hong Kong

Thailand

Mexico

Iran

Turkey

Newest members 1 Jan 2018

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Introduction to PIC/S GMP Guidelines

PIC/S PE 009 Guide to Good Manufacturing Practices is in 3 parts:

Guide to Good Manufacturing Practice for Medicinal Products Part I

Guide to Good Manufacturing Practice for Medicinal Products Part II (API manufacturing)

Guide to Good Manufacturing Practice for Medicinal Products Annexes

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Pharmacopeia

1. Pharmacopoea Slovaca

2. Indonesian Pharmacopoeia

3. Brazilian Pharmacopoeia

4. British Pharmacopoeia (BP)

5. British Pharmaceutical Codex

6. Pharmacopoeia of the People's Republic of China (Chinese Pharmacopoeia)

7. Czechoslovak Pharmacopoeia

8. German Pharmacopoeia (GP)

9. Pharmacopoeia of the United Mexican States (Mexican Pharmacopoeia)

10.Portuguese Pharmacopoeia

11.Indian Pharmacopoeia

12.Japanese Pharmacopoeia (JP)

13.Minimum Requirements for Antibiotic Products of Japan

14.Czech Pharmacopoeia

15.European Pharmacopoeia (EP)

16.French Pharmacopoeia

17.Swiss Pharmacopoeia

18.Hungarian Pharmacopoeia

19.International Pharmacopoeia

20.Royal Spanish Pharmacopoeia

21.United States Pharmacopeia (USP)

22.State Pharmacopoeia of the Union of Soviet Socialist Republics (Soviet Pharmacopoeia)

23.Yugoslav Pharmacopoeia

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Exporting to Australia?Jump onto the TGA website

Therapeutic Goods Orders - 93

https://www.tga.gov.au/sites/default/files/conforming-tgo-93-standard-medicinal-cannabis.pdf

https://www.tga.gov.au/publication/australian-manufacturing-licences-and-overseas-gmp-certification

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Is it a medicine at all? Type of Medicine?

https://www.pharmout.net/downloads/white-paper-how-to-list-or-register-medicines-in-australia.pdf

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Sponsor

This is the person or corporation who:

• exports, or arranges the export of the medicines from Australia; or

• imports, or arranges the importation of the medicines into Australia; or

• in Australia, manufactures complementary medicines or arranges for another person to manufacture them for supply.

Foreign manufacturers often appoint domestic sponsors in Australia to act on their behalf.

The Sponsor is legally accountable for the product quality on the Australian market.

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Manufacturer

This is the person, corporation or organisation in Australia or elsewhere who:

• produces medicines; or

• engages in any part of the process of producing the medicines or bringing the medicines to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the medicines or of any component or ingredient of the medicines as part of that process.

Only products that are manufactured in GMP Approved Facilities are allowed to be imported and distributed.

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Agent

This can be any consultant, corporation or other organisation or person who is appointed by the Sponsor or Australian Manufacturer to represent them in consultations with TGA.

The Agent cannot be a member of the particular sponsor/manufacturer client.

Agent does not mean a sponsor who is the ‘Australian Agent’/distributor of an overseas manufacturer.

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Distributor

This is the person, corporation or organisation in Australia that will be responsible for the sale and distribution of the product.

The overall GMP and legal responsibility of all the above parties will be discussed later.

All legal responsibilities must be clearly defined and documented in a Quality or GMP Agreement.

• Pharmacovigilance

• Recalls

• Complaints +

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Getting “Approved”

Only products that are manufactured in facilities that have been TGA authorised are allowed into Australia.

Note that the TGA treats manufacturing facilities differently, depending on where they are located:

• Domestic Manufacturers - If the facility is located in Australia then the TGA issues a Manufacturing Licence

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Getting “Approved” – Overseas clearance pathway

• International Manufacturers - If the facility is located outside of Australia then

• the TGA inspects the manufacturer and, if acceptable, issues a Manufacturing Certificate, or

• the manufacturer can go through the Overseas Clearance process, which is the cheapest and quickest method.

In all instances the manufacturing facility must first comply with the TGA’s current Good Manufacturing Practices (cGMP) requirements before a TGA approval application is made for the product.

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What is EU GMP?And how can you tell?Google “EUDRA”

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Pharmaceutical Manufacturers Approved from -

• Australia - 84

• Canada -23

• South Africa – 14

• Lesotho – 0

• Zimbabwe – 0

• Botswana – 0

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Samples of certificates

Australia – Issued by the TGA

South Africa – Issued by the MHRA (UK)

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Who is approved from Canada?

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Who is approved from Canada?

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Thank you

Trevor Schoerie

Trevor.Schoerie@pharmout.net www.pharmout.net

I’m very happy to share my presentation.