Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Teva Pharmaceutical Industries Ltd

Teva Pharmaceutical Industries Ltd
HQ: Tel Aviv, Israel • Ticker: TEVA • Stock exchange: NYSE / TASE • Nr. of employees: 37,000+

CO M PANY SU M MARY
Teva demonstrates its commitment to access to medicine by integrating measurable and time-bound objectives into its business model and corporate strategy.
These objectives are publicly reported and tied to the company’s sustainability-linked financing framework, fostering accountability. While Teva’s businessmodel mostly focuses on high-income countries, the company’s products are soldin approximately 40% of LMICs in scope, with the ten products selected for thisassessment having been prioritised by Teva for registration in upper-middle income
countries. To provide access to its assessed products, Teva employs various strategies, primarily in private markets across regions including sub-Saharan Africa. Teva
reports using tender approaches in public markets. The company did not reportstrategies to increase access in public markets for the ten assessed products. The
company has not been a sublicensee of voluntary licensing agreements withincountries in scope. It leverages its manufacturing network to supply products globally, including in 39 LMICs where it has a sales presence. To ensure reliable productdelivery and minimise shortages, Teva implements various strategies to ensure
continuous supply of its products and to uphold quality standards, while making
efforts to combat substandard and falsified medicines. Teva has not been assessedin R&D since it is not engaged in any adaptive R&D projects under the scope of thisprogramme.

Main therapeutic areas
Anti-infectives; cardiovascular; central nervous system and pain; diabetes; gastrointestinal; immunology;
mental health; oncology; respiratory.
Business segments
Europe; International Markets; North
America.
Product categories
Active pharmaceutical ingredients(APIs); biosimilars; generic medicines;
innovative medicines.
Sales presence*
Teva reports sales in 39 countries inscope.

O PPO RTU N ITI ES FO R TEVA
Explore engagement in mechanisms

six lower-middle income countries. In

patients, Teva can further strengthen

to facilitate registrationline with its access target of increasing

its existing private market access strat-

Teva can explore engaging in mecha-

the number of registrations by 150%

egy to better address ability to pay andnisms to facilitate the registration of

in LMICs** by the end of 2025, Teva

local barriers to access. This approacheligible products, such as the WHO

can expand registration filings acrosscould help low-income and uninsured

Collaborative Registration Procedure,a broader spectrum of countries. For

patients gain access to essential medi-

regional Joint Assessments such as theexample, it can file cisplatin, an essen-cines such as lisinopril.

ASEAN Joint Assessment, the African

tial medicine indicated for multiple can-Regional Joint Assessment initiatives,

cers, for registration in lower-middle

Expand access approaches to

the CARICOM Joint Assessment,

and low-income countries.

incorporate long-term sustainability

ZaZiBoNa Collaborative Procedure,

Teva has set targets to expand afforda-

and Swissmedic MAGHP Procedure.

Improve access strategies forble access to medicines to underserved

For instance, for the ZaZiBoNa

essential medicines to ensureand vulnerable populations in LMICs**

Collaborative Procedure, Teva could

affordability for low-income andthrough donations and access pro-consider the inclusion of carboplatin,

vulnerable people.

grammes. Its partnership with Global

as well as analgesics, antibiotics, anti-

Teva implements an access strategy for

HOPE to donate cancer medicines inneoplastic, and blood thinning agents.

lisinopril in Nigeria, specifically target-

sub-Saharan Africa serves as a strong

ing the private sector. This medicine

starting point. Teva can consider

Prioritise registration of essential

treats hypertension, the most common

expanding and strengthening its accessmedicines in more lower-middle andcardiovascular disease in the country.

programmes towards sustainable

low-income countries

In Nigeria, less than 10% of the popula-approaches and across more thera-

Across its entire portfolio, Teva hastion is covered by any health insurance,

peutic areas. By working with local

registered products in 44 countries inleading patients to heavily rely on out-

partners such as distributors and local

scope. For the subset of ten off-patentof-pocket payments to access healthorganisations, the company can put inproducts selected for assessment, thecare, which poses significant affordabil-place sustainable access models thatcompany has filed for registration in

ity issues. To expand equitable accessincrease the availability and affordabil-

ten upper-middle income countries andand adequate supply for private sector

ity of its essential products.

*Refers to countries in which sales are
conducted through suppliers, pooled procurement and/or the company sales
offices.

**Teva’s definition of LMICs encompasses
127 countries following the 2020 WorldBank classification as outlined within its
sustainability-linked financing framework.
This scope does not precisely match theProgramme’s country scope of 108 LMICs.

42

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Teva Pharmaceutical Industries Ltd

CO M PANY PRESE NCE & REVE N U E
Sales and manufacturing presence in countries in scope

Sales presence and at least
one manufacturing site
Sales presence
No sales presence
Countries not in scope

Revenue by business segment*
2021

7,809

2022

7,452
0

4,000

8,000

4,886 2,032
4,525 1,903
12,00016,000mn USD● North America ● Europe● International Markets

PO RTFO LI O & PRODUCTS ANALYSE D
Products in scope from the company’s portfolio

Products selected for assessment

Out of the 102 products in scope of this analysis,** Teva has 76 products

Of the in-scope products that Teva has in its portfolio, ten off-patent med-

within its portfolio. Teva’s portfolio has a strong focus on non-commu-

icines were selected for analysis for the themes EA2 (product registration)

nicable diseases (NCDs), particularly respiratory diseases and cancer,

and EA3 (expanding access and pricing strategies).

with 18 products for cancer, and 13 products for cardiovascular disease.
Additionally, the company focuses on certain communicable diseases

Product

Indication(CDs), including bacterial infections, for which it has ten antibiotics inAzithromycin

Bacterial infection

Budesonide

Asthmascope.
76 products
These target a range of disease categories, namely NCDs (50); CDs (21);neglected tropical diseases (2); andreproductive, maternal and newborn
conditions (6). Three products fall into
multiple categories.

Product is in Teva's portfolio
Product is not in Teva's portfolio

Chronic obstructive pulmonary disease(COPD)
Capecitabine

CancerCarbamazepine

Epilepsy
Bipolar affective disorder

Carboplatin

Cancer

Cisplatin

CancerFluoxetine

Unipolar depressive disorders
Anxiety disorders

Lisinopril

Hypertensive heart disease

Risperidone

Schizophrenia
Bipolar affective disorder

Sumatriptan*Teva reports revenue by region in thesame regions that represent the businesssegments. Financial year (FY) 2021 covers
January - December 2021. FY 2022 covers January - December 2022.

**The Generic & Biosimilar Medicines
Programme’s product scope includes
102 off-patent medicines, most of which
are listed on the 22nd World HealthOrganization’s Model List of Essential
Medicines. Essential medicines are thosethat satisfy the priority health care needsof a population.

Migraine

43Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Teva Pharmaceutical Industries Ltd

EXPANDING ACCESSE A1 . ACCESS -TO - M E D I CI N E STR ATEGY
Teva integrates its access-to-medicine strategy within its business modelacross six therapeutic areas** by 2025 (using a 2017-2020 baseline) and toand corporate strategy, indicating the company’s commitment to address-

increase product volume by 150% for certain access programmes in LMICs

ing access to medicine in LMICs. This strategy is further supported by theacross the same therapeutic areas by 2025 (using a 2020 baseline). As

company’s Environmental, Social and Governance (ESG) strategy.

per Teva’s 2022 ESG Progress Report, it has accomplished 28% of this tar-

Teva conducted a materiality assessment in 2022 to inform its strategy,

get, translating to 21 submissions. Teva announced a new strategy in 2023,

which includes commitments to quantify savings for health systems, imple-

which involves reallocating resources from generics to innovative medi-

ment initiatives such as access programmes for vulnerable populationscines, focusing on high-value products. The impact on the product portfolio

and patients at the last mile in LMICs,* and establish donation and social

and access strategies is as yet unknown. The responsibility for Teva’sbusiness programmes. Teva sets measurable and time-bound objectives as

ESG and access-to-medicine strategy lies with executive management,

part of its access strategy, which are publicly reported. These objectives

and oversight is provided by the Compliance Committee of the Board ofand the reporting are tied to its sustainability-linked financing framework

Directors. The ESG steering committee governs the implementation ofand sustainability-linked bonds, enhancing transparency and accountability

the strategy, ensuring accountability at the senior level, with the ultimate

for its access commitments. Among the objectives are targets to increase

responsibility resting with the board of directors.

the cumulative number of new regulatory submissions by 150% in LMICs

E A2 . PRO D U C T R EG I STR ATI O NTeva has filed to register or successfully registered at least one productthe 44 LMICs where it has pre-existing regulatory filings.*** Teva’s regis-

within its entire portfolio in 44 LMICs in scope. This demonstrates thetration efforts for these ten products have primarily focused on upper andcompany’s ability to register products with national regulatory authorities

lower-middle income countries. The company has not filed any of these(NRAs) in LMICs in scope.

products in low-income countries.

Of the products within the scope of the Generic & Biosimilar Medicines

Teva does not actively engage in mechanisms to facilitate registration,

Programme, ten off-patent medicines were selected for assessment. Teva

such as the World Health Organization (WHO) Collaborative Registration

has filed at least one of these products for registration in a total of 16 ofProcedure or regional joint assessments.

FIGURE 1 Registration filings of ten products selected for assessment across income categories
This figure shows the number of registrations for the ten off-patent products included in this assessment,
categorised by whether the filing is in a low-, lower-middle or upper-middle income country.
Azithromycin

4

Budesonide3

3

Capecitabine

Budesonide, an asthma and chronic obstructive pulmonary disease (COPD) medication,
has been registered in eight countries inscope, including five upper-middle income
and three lower-middle income countries.

5

2

Carbamazepine

1

Carboplatin

2

Cisplatin

1

Fluoxetine

1

Lisinopril2

Out of the 108 countries in scope, cisplatinis registered in Ukraine and capecitabine isregistered in Mexico and Thailand. These areboth chemotherapy drugs indicated for thetreatment of multiple cancers.

2

Risperidone

1

Sumatriptan
0

2

4

6

8

10

Number of registration filings● Registration filings in low-income countries● Registration filings in lower-middle income countries● Registration filings in upper-middle income countries

Sumatriptan, a migraine treatment,
has not been registered in any
country in scope.

*Teva’s definition of LMICs encompasses
127 countries following the 2020 WorldBank classification as outlined within its
sustainability-linked financing framework.
This scope does not precisely match theProgramme’s country scope of 108 LMICs.

**The six therapeutic areas are: cardiovascular diseases; oncology; respiratory diseases; diabetes; mental health; and pain/
palliative care. This scope does not exactly
coincide with the Programme’s disease
scope.

***Refers to all the countries in scope
where the company has previously filed
for or successfully registered any of its
products. This includes products thatfall outside the scope of the Generic &Biosimilar Medicines Programme.

44Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Teva Pharmaceutical Industries Ltd

EXPANDING ACCESS
E A 3. E XPAN D I N G ACCESS AN D PR I CI N G STR ATEG I ES
For eight out of the ten products included in this assessment, Teva submit-

setting the price by referring to the pricing policies set by the local govern-

ted an example of a strategy to expand access to that product in a specificments. Within the private market in South Africa, an upper-middle income

country in scope. This included examples of access strategies in three

country, Teva supplies budesonide, a treatment indicated for asthma andupper-middle, four lower-middle, and one low-income country.

chronic obstructive pulmonary disease (COPD), at a price aligned with

For six of these products, the examples consist of pricing strate-

the government reference price, ensuring patients can access the treat-gies, with the majority exclusively focused on the private sector. For

ment without making co-payments. In Thailand, an upper-middle income

two of these products, Teva enables access through product donations.

country, Teva supplies capecitabine within the private market, adhering

Additionally, the company provides evidence of the number of patientsto government pricing regulations that set the ceiling price. Teva has pro-reached for all eight products, with evidence of forecasting patient reachvided evidence of product volumes sold within private markets for the six

provided for the two of them (carboplatin and cisplatin).

assessed products.

Among the six products with pricing strategies, Teva provides evi-

For two products, cisplatin and carboplatin, Teva implements prod-

dence of implementing different types of strategies for each of the six

uct donation programmes In Ghana, a lower-middle income country, thecountry-specific examples provided. These include a competitor pricing

company collaborates with Direct Relief and Breast Cancer International

strategy, a transfer pricing model, and pricing strategies that follow local

to supply cisplatin through its breast cancer donation programme. Teva

pricing policies in those specific countries. While Teva adheres to local con-reports that approximately 400 women across two hospitals received

trol pricing policies imposed by governments, which aim to limit producttreatment between January 2020 and March 2023. In Malawi, a low-in-

prices, this may not be sufficient to make the prices affordable for all rele-

come country, the company implements its Global HOPE Donation

vant payers.

programme* in collaboration with Texas Children’s Hospital and Direct

For the other four products which follow local pricing policies, namely,

Relief to provide carboplatin for children with cancer and blood disorders.

azithromycin, carbamazepine, budesonide and capecitabine, Teva reports

FIGURE 2 How many products are covered by an access strategy?
For each of the ten products selected for assessment, Teva was requested to provide one example of acountry-specific access strategy covering that product. The company was asked to include examples
from a minimum of three low-income countries (LICs) and three lower-middle income countries(LMICs). Further examples could come from upper-middle income countries (UMICs). The types ofaccess strategies the company utilises for each product are outlined in this figure. Where details on
country-specific access strategies were not shared, the company was not assessed.
PublicPrivateEvidence

Additional

marketmarketof fore-initiatives toInternational

access/access/Evidence

casting

improve

Nonproprietary

pricing

pricingof patientpatient

affordability

strategies

reachand availability**

Name (INN)Country

strategies

reach  Azithromycin

Uzbekistan (LMIC)●●

Budesonide

South Africa (UMIC)●●

Capecitabine

Thailand (UMIC)●●

Carbamazepine

Ukraine (LMIC)●●

Carboplatin

Malawi (LIC)

●

●

●

Cisplatin

Ghana (LMIC)

●

●

●

Fluoxetine

No country-specificaccess strategy reported

Lisinopril

Nigeria (LMIC)●●

Risperidone

Peru (UMIC)●●

Sumatriptan

No country-specificaccess strategy reported

For cisplatin andcarboplatin, donation programmes
were the only
strategy employed
by Teva to ensure
access.

For capecitabine and budesonide, Teva reports participatingin tenders to supply the public sector. However, it is unknown
whether the company secured and/or were awarded thetender in Thailand and South Africa.

*The Global Hope Donation programme isactive in other countries in scope, which
are not covered under this assessment:
Botswana, Ghana, Rwanda Tanzania, andUganda.

**For example: donations, public-­private
partnerships, or patient assistanceprogrammes.

45

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Teva Pharmaceutical Industries Ltd

EXPANDING ACCESSE A4 . E N GAG I N G I N LI CE N S I N G AC TIVITI ES
During the period of analysis, Teva did not report engaging in any non-exclusive voluntary licensing agreements or exclusive licensing agreements
within the geographic scope of the Programme.

E A 5. I M PROVI N G PRO D U C T AVAI L AB I LIT Y
Teva’s manufacturing network consists of 53 manufacturing sites and 25

manufacturing sites in LMICs in scope is limited. Teva aims to maximise

R&D centres spread across 27 countries. While the specific LMICs where

its global manufacturing capabilities to meet the supply needs of differ-these sites are located are not disclosed by the company, Teva does reportent countries and regions. For instance, the company’s sites in the Latinthat the majority of its production capacity is located in Europe, India,

American and Asia-Pacific regions serve different LMIC markets. Teva also

Israel, Latin America and North America.* Out of the 53 sites, 16 specifi-

reports striving to simplify its network by creating clusters and special-

cally focus on active pharmaceutical ingredient (API) manufacturing. Teva

ised sites focusing on specific manufacturing technologies and products.

recently announced a new strategy in 2023, indicating its intention toThis approach can help enhance efficiency in terms of lead times and cost

adapt its manufacturing footprint and reduce its number of sites to reach

optimisation.

a range of 40 to 44 by 2027. It is uncertain whether the planned closuresinvolve sites in LMICs in scope.
Teva utilises its manufacturing network to ensure product availability in

Teva does not disclose being involved in technology transfers and/or
partnerships to develop or enhance local manufacturing in countries inscope.

the different markets in which it is present, therefore its operation of local*Teva. United States Securities andExchange Commission. Form 10-K. Annual
Report for the Fiscal Year Ended 31
December 2022.

46

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Teva Pharmaceutical Industries Ltd

SUPPLY & QUALITY
SQ1 . D E MAN D PL AN N I N G AN D DATA S HAR I N GTeva reports that is has established an internal system for forecasting anddemand planning, both for its regular supply activities and for new productadjusted accordingly on a monthly basis.
The company reports that in certain circumstances it collaborates withlaunches. This system includes a 24-month forecast which is shared withgovernment agencies and authorities, disclosing information regarding

the company’s manufacturing sites during its annual operational plan andstocks in order to fulfil local needs.

SQ2 . D E LIVE RY PE R FO R MAN CE
Teva uses a global logistics system to track the delivery of its finishedlast-mile tracking systems for product distribution within countries where

goods, and plans to extend the coverage to APIs and raw materials. Teva

delivery takes place, however, it is unknown whether this is also applied

reports measuring On Time in Full (OTIF) for every delivery and aggregat-

in LMICs. The company did not provide any specific examples of how it

ing performance results to a monthly Key Performance Indicator, which

communicates with procurement agencies or the steps it takes to address

is assessed globally. Additionally, the company reports having establishedissues that may impact product delivery.

SQ3. STO CKO UTS AN D S H O RTAG ES M ITI GATI O NTeva has implemented multiple strategies to promote a continuous supply

and meet surges in demand. Teva operates a separate API business thatof its products and mitigate the risk of shortages and stockouts.

produces over 350 APIs for both vertical integration and sale to third par-The company reports that it maintains buffer stocks of APIs, criticalties, while also outsourcing additional APIs from suppliers across Europe,

components and finished goods, alongside having a finished good stock

Asia and the Americas. The company has an API department with dedi-

policy in place. The company reports conducting weekly and monthly

cated teams that engage in prioritisation and risk mitigation. During theregional audits to identify and mitigate out-of-stock risks. Additionally,

COVID-19 pandemic, Teva leveraged its API production and overall man-

Teva reports having developed a special software for optimising global

ufacturing capabilities to meet surges in demand. However, no specificstocks. The company does not disclose holding regional stocks of finishedexamples of these steps were publicly disclosed. The company has also

goods in countries in scope, or taking steps to decentralise stocks of crit-established a Critical Action Committee (CAC) to address emergencies

ical components, as it states leveraging its global network to meet supply

related to drug or API shortages, in all countries where the company oper-

needs in different locations.

ates. There were no concrete examples provided to demonstrate how CAC

The company reports implementing a dual sourcing policy in someinstances, based on the risk profile and portfolio importance. Additionally,

has addressed shortages specifically in LMICs in scope.
To further meet product demand, Teva reports developing a global plat-

Teva states using a mix of global and local suppliers to promptly meetform that facilitates fulfilling product demand in case of emergency needs,

demand but does not report the proportion of locally sourced materials.

allowing the company to move available stocks to other locations.

The company also reports taking steps to maintain the availability of APIs

FIGURE 3 What steps is Teva taking to mitigate stockouts and shortages?
This table shows the approaches the company reports taking to ensure the uninterrupted supply of its
products.
Approaches to mitigate stockouts and shortages
Strategies to maintain sufficient stock for critical components, including buffer and safety stocks●

Conducting regular audits of its stock●

Disclosure of the frequency of stock auditing●

Holding regional stocks and/or making efforts to decentralise stocks of critical components
Strategies to promote third-party supplier diversity, such as establishing alternative sources of APIs,
excipients and packaging materials●

Implementation of sourcing strategies, such as procuring from local suppliers in LMICs
Evidence of a policy or approach for scaling up the production of APIs to quickly adapt to meetsurges in demand, when applicable
Other initiatives to fulfil emergency orders and/or surges in demand

Teva reports implementing
a dual sourcing policy insome instances.

●●

Teva implements a global platformthat allowed it to move 5,000 unitsof vincristine, a cancer treatment (notin scope of this Programme) fromone market to another to address
shortages.

47

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Teva Pharmaceutical Industries Ltd

SUPPLY & QUALITY
SQ4 . MAN U FAC TU R I N G Q UALIT Y A SSU R E D PRO D U C TS
Teva reports that all its manufacturing sites comply with the required regu-

quality management system (QMS) that enables continuous monitoring

latory standards, including current good manufacturing practices (cGMPs)

throughout the manufacturing process. Through this system, the company

and other standards set by organisations such as the International Council

addresses any quality concerns and takes corrective and preventive meas-for Harmonization. These standards are enforced by regulatory authori-ures when necessary. To ensure any quality related issues are addressed,

ties such as the FDA (US), EMA (Europe), MHRA (UK), PMDA (Japan), andthe company monitors the execution of corrective actions on a monthly

NMPA (China). The company reports that most of its sites have stringent

basis. The Senior Vice President of Global Quality and the Chief Quality

regulatory authority (SRA) approval from the EMA or FDA. Its remaining

Officer are ultimately responsible for quality compliance and for establish-sites, located across Latin America, have been approved by national regula-ing, implementing and continuously improving Teva’s QMS.

tory authorities (NRAs). Teva has not submitted any products to the WHO

Teva utilises multiple methods to evaluate its third-party suppliers onprequalification (PQ) programme, which exempts the company from site

GMP and compliance. This includes a certification programme used toinspections by the WHO. No warning letters from the USFDA or non-com-

assess third party suppliers on GMP, which considers suppliers’ audit out-

pliance reports from the EMA were issued at Teva’s sites in countries incomes amongst other criteria. Additionally, Teva requires its suppliers toscope during the period of analysis.

adhere to its Code of Conduct, which includes a requirement for suppliers

The company reports that it prioritises maintaining quality across all
53 of its manufacturing sites. To achieve this, Teva has implemented a

to inform the company immediately of any significant inspection or regulatory issue with national or international authorities.

SQ 5. SAFEG UAR D I N G Q UALIT Y & SAFE T Y O F MAR KE TE D PRO D U C TS
Teva implements strategies to maintain the quality and safety of its prod-

company also works with local health authorities to address potential prod-

ucts. The company reports having strategies in place to combat falsified,

uct recalls and take appropriate action to protect consumers.

substandard and/or unsafe medicines. The company’s Anti-counterfeiting

The company works to keep its supply chain secure through implement-

Policy aims to protect customers’ safety and the integrity of the supply

ing technologies and systems to mitigate the circulation of substandard

chain and applies to all aspects of the company’s supply chain, including

and falsified medicines. For example, the company has implemented

third-party manufacturers.* Teva Global Corporate Security focuses onmechanisms to improve the traceability of its global shipments, includ-

product security and is responsible for enforcing these policies and man-ing ‘Real Time Tracking’ to track its shipped products to increase supply

aging supply chain security. When a falsified medicine is detected, thechain visibility worldwide. This system enables the company to respondcompany alerts the appropriate health or regulatory authorities, along

to any temperature and/or route deviations and ensures that customers

with any immediate trading partners that could have received the product.

maintain visibility of any deviations that may occur. However, no informa-

Additionally, the company engages in several partnerships to help addresstion is publicly available on whether the company makes efforts to disclose

the risk of substandard and falsified medicines. Teva has established pro-the source of finished products, including specifying the primary manu-

cesses for managing crisis events, such as product recalls. These processes

facturing plant, and disclosing product components and materials that areare applied globally, and in compliance with local laws and regulations. The

third-party sourced.

FIGURE 4 Depth and breadth of quality-assurance strategies
This table shows the types of strategies Teva implements to maintain the production of quality-as-●

Teva has set the goal to maintain 100% annual evaluations ofidentified high-risk third-party
partners through its ThirdParty Due Diligence tool, whichscreens for possible compliance risks using a database of
publicly available informationon compliance.

●

Teva reports the majority ofits sites are approved by SRAs,
while others have the approvalof NRAs. However, it does notdisclose any further details.

sured products and to safeguard the quality and safety of products already in the market.
Quality-assurance strategies
Manufacturing quality-as-

Strategies to standardise quality management systems and compliancesured products

monitoring tools across all manufacturing sites
Strategies to assesses third party suppliers on GMP compliance●

Disclosure of the number of manufacturing sites with approval from astringent regulatory authority (SRA) or national regulatory authority(NRA) operating at maturity level 3 or 4 (ML3 or ML4)**
Safeguarding quality & safety

System for recalling products promptly and effectively and alerting theof marketed products

appropriate authorities in a timely and efficent manner
A clear policy to mitigate the circulation of substandard and falsified
medicines, including to which authorities and/or organisations the●company reports encounters of substandard or falsified medicines
Evidence of concrete strategies to mitigate the risk of substandard andfalsified medicines●

Efforts to disclose the source of finished products, including specifying
the primary manufacturing plant and disclosure of product components
and materials that are third-party sourced
The company has an Anti-Counterfeiting
Policy to mitigate the circulation of substandard and falsified products.
*Falsified medicines are included in thecompany’s Anti-Counterfeiting Policy.
Teva states that the terms “falsified” and“counterfeit” are used interchangeably
when addressing this issue. The definitionof falsified medicines used in this report
can be found in the Appendix.

**As benchmarked against WHO Global
Benchmarking Tool (GBT).

48