Registration Insights

& Pricing Structure

Across The MENA Region

Mr Yahya A. Al jefri.

CEO, Annahdah Medical Company, Saudi

Arabia.

1

10-2017

AMC company profile

2

AMC establishment

Established in 1971, AMC is

considered to be one of the top ten

Saudi companies in its domain.

Founded as a family business by

Mr. Abdullah Al-Jefri, Chairman of

the BOD, former Passport &

Nationality General Manager, former

Mayor of Jeddah.

3

Mr. Yahya Al Jefri (VP, CEO)

MBA, King A/Aziz University-

Jeddah

VP of Pharmaceuticals Committee

– Jeddah Chamber of

Commerce (JCC).

International trainer in strategic

planning & management.

4

46 years’ AMC milestones

Closed Share Holding Company

The Highest Growing Company In Pharma Saudi Market (31%)

Restructure & Pharmaceutical Focus

AMC Establishment 1971

2005

2012

2016

5

Head office in Jeddah

West

South

Cente

r

East

4 branches through

KSA

7

Sales dep. structure

Promotion Team:

• 5 line managers.

• 14 supervisors.

• 56 medical reps.

Sales department

Sales Team:

• 4 Branch sales

managers.

• 20 Sales reps.

8

Marketing dep. structure

4 product managers:

• 1 for Pharmaceutical

ranges.

• 1 for Food Supp. ranges.

• 2 for Medicated Cosm.

ranges.

Marketing department

9

Governmental sales dep.

structure

2 Gov. sales

reps

Regional sales

manager

(West & South)

Regional sales

manager

(Center & East)

2 Gov. sales

reps

Follow up by:MR per line

10

Distribution Fleet

27 refrigerated vehicles

covering the cities and

the remote areas KSA

11

Annahdah customer

categories

Governmental Sector

Military Sector

MOH and

GCCNUPCO

Indep.

centers

12

Annahdah customer

categories

Private Sector

Polyclinics

Private Hospital

s

Pharmacies (chain & street)

Wholesalers

13

Partners

Business models

Agency & distribution

Marketing, agency &

distribution

14

AMC partnerships across the

world

&

expanding

15

Agency & dist. partners1416

Marketing, agency & dist. partners

Pharma:

17

17

Marketing, agency & dist. partners

Medicated cosmetics:

18

18

Marketing, agency & dist. partners

Food supplements:1719

Services for partners

Regulatory Activities:

Manufacturing Facility GMP Certification,

registration & renewal.

Product Registration & pricing.

Distribution, Sales & Marketing in Private and

Governmental sectors.

Post Marketing analysis.

20

Registration Insights

& Pricing Structure

Across The MENA Region

Mr Yahya A. Al jefri.

CEO, Annahdah Medical Company, Saudi

Arabia.

21

10-2017

Topics

- Requirements for introducing medical products into MENA region:

1- Bioequivalence study.

2- Stability study.

3- Raw material API.

4- Minimum batches.

5- Analysis.

6- Site registration.

7- Reference countries.

8- Pricing.

- MENA region registration time intervals & fees.

22

Bioequivalence study

BE centers should be approved by the country’s

authorities.

GCC requirements:

- In general, 24 healthy non smoking volunteers, 18 – 55 years,

within 15% range of ideal BMI.

- Special requirements for specific products.

Required for:

- Products with systemic effects.

23

Exclusions:

- Syrups, IV injections & aqu. IM

injections.

- Dosage forms without systemic effects;

creams, supp. & sprays.

- Immediate release tablets (based on

Biopharmaceutics Classification

Stability study

Some countries require an approved laboratory.

GCC States are categorized in climatic zones III & IVa.

General case:

- Long-term: 30˚C ± 2˚C/ 65% RH± 5% / 12 months.

- Accelerated: 40˚C ± 2˚C/ 75% RH± 5% / 6 months.

Refrigerated products:

- Long-term: 5˚C ± 3˚C. / 12 months.

- Accelerated: 30˚C± 2˚C/ 65% RH± 5% / 6 m.

Frozen products:

- Long-term: -20˚C ± 5˚C / 12 months.

24

Raw materials

(API) certificate from supplier for active ingredient.

Certificate of suitability.

Complete DMF (Drug Master file) & letter of

access to it.

25

GCC needs a clarification

letter:

- No alcohol content.

- Pork free ingredients.

- For soft gel capsules; certif. of

suitability about the source.

- In some cases: “Halal certificate”. In some MENA countries; commitment letter that

the source is not from a country of conflict.

Minimum batches

Matching with ICH guidelines (International

Conference on Harmonisation of Technical

Requirements for Registration of Pharmaceuticals for

Human Use).

GCC: 3 different batches.

26

Analysis

Certificate of analysis for FP (Finished Product).

Certificate of analysis for reference standard.

No. of samples according to the country authority

guidelines.

Analysis in MOH lab or

from a specified list (Lebanon).

27

Site registration

General requirements:

- SMF (Site Master File).

- Valid & legalized GMP.

- Valid & legalized ML (Manufacturing License).

- List of countries where the site is registered.

- List of the products produced by the manufacturer.

28

A must in most MENA countries.

Not needed in some countries like

Algeria & Libya; factory chart &

documentation are included in

product reg. files.

References countries

In which the product must be registered before

starting registration in the targeted country.

KSA: the product should be registered &

marketed in COO (country of origin).

Lebanon: 2 references.

Iraq: 2 references.

Oman, Qatar & Bahrain:

to be registered in GCC.

29

File submission

Online filling of the application form.

Drug submission file includes:

Application form +product file + drug sample.

Submissions are classified mainly as:

Drugs, food supplement, cosmetics, medical device

& health products.

Fees payment.

A scheduled appointment

(long queue in some countries).

30

Registration Box

Some countries have quota of reg. products per

AI;

- UAE & Lebanon: 1 + 6.

- Egypt: 5 products.

- KSA: Not specified.

Some countries have national list for protected

products produced within the country like Algeria

(will be cancelled after WTO treaty).

31

Pricing

Required data for GCC & SFDA:

- CIF price.

- Ex-Factory price.

- Wholesaler price in COO.

- Public price in COO.

- Price certificate form

(form 30).

32

Registration time & fees

33

Country Type Body InspectionCTD or

eCTD

Fees $

/Pharma.

Fees $

/Cosm.

Fees $

/MDReg. time

KSA

Manuf.

SFDA or GCCGCC

Inspection

eCTD

(pharma)

CTD

(herbal &

health)

File subm.:

2,700

Audit visit:

Acc. to site

location as

below

NA

4,000

–

6,000

acc. to

class

Biological

& brand:

290 WD

Generics:

165 WD

Herbal &

Health:

155 WD

MD:

35 WD

Products

Biological &

brand:

25,000

Generics:

10,500

Herbal &

Health:

5,300

Inspection fees per region:

Gulf, Levante & Egypt = 16,000$. N. Africa = 23,000$.

Europe & Turkey = 32,000$. N. & S. America = 43,000$

China = 27,000$. Japan = 39,000$

Australia = 49,000$.

Registration time & fees

34

Country Type Body InspectionCTD or

eCTD

Fees $

/Pharma.

Fees $

/Cosm.

Fees $

/MDReg. time

UAE

Manuf. Ministry of Health

Drug Control

Department

GCC

InspectionCTD

350

70 1507 – 12

monthsProducts 272

Kuwait

Manuf.Ministry of Health

Drug and Food Control

GCC

inspectionCTD

995

NA NA7 – 11

monthsProducts 331

Oman

Manuf. Ministry of Health.

Medicines Regulatory

Authority.

GCC

inspectione CTD

259

65 7797 – 14

monthsProducts 195

Registration time & fees

35

Country Type Body InspectionCTD or

eCTD

Fees $

/Pharma.

Fees $

/Cosm.

Fees $

/MD

Reg. time

(months)

Bahrain

Manuf.National Health

Regulatory Authority

GCC

inspectionCTD

100

NA NA 6 – 9

Products 146

Qatar

Manuf.Supreme Council of

Health

GCC

inspectionCTD No fees NA NA 7 – 11

Products

Yemen

Manuf.Ministry Of Health No inspection Normal

200

100 150 5 – 10

Products 250

Iraq

Manuf.Ministry of Health No inspection Index

1,711

NA NA 13 – 20

Products855

Iran

Manuf.National Drug

Selection Council Inspection CTD

NA

NA 120 13 – 20

Products 450

Country Type Body InspectionCTD or

eCTD

Fees $

/Pharma.

Fees $

/Cosm.

Fees $

/MD

Reg. time

(months)

Palestine

Manuf. Ministry of Health.

General Directorate of

Pharmacy.No inspection Index

1,000

425 425 7 - 11

Products 900

Jordan

Manuf.Jordan Food & Drug

AdministrationInspection CTD

Line/1000

125 300 7 - 14

Products 883

Lebanon

Manuf.

Ministry of Public Health No inspection e CTD

Depend on

inspection

cost NA NA 9 - 13

Products 3,150

36

Registration time & fees

Country Type Body InspectionCTD or

eCTD

Fees $

/Pharma.

Fees $

/Cosm.

Fees $

/MD

Reg. time

(months)

Egypt

Manuf.Ministry of Health and

PopulationInspection Index

Depend on

inspection

cost 225 225 24 – 60

Products 500

Morocco

Manuf.Ministry of Health No inspection CTD

Not required

NA NA 36

Products 1,476

Algeria

Manuf.Laboratoire National de

Contrôle Des Produits

Pharmac.,

ministère de la Santé

No inspection CTD

Not required

35 50 24 – 36

Products 435

Tunis

Manufactu

rerMinistère de la Santé

Direction de la Pharmacie

et du Medicament

No inspection Index

1,200

NA 50 7 - 10

products 1,131

Libya

Manufactu

rerNational Transitional

Council

Ministry Of Health

No inspection Index

150

NA NA 3 - 6

products 150

Sudan

Manuf.National Medicines and

Poisons BoardNo inspection CTD

800

200 200 5 - 9

Products 350

37

Registration time & fees

Price structure; Pharmaceutical

products

KSA:

Retail price = CIF price + 10% wholesaler markup +

15% pharmacy markup.

(1st generic is 65% or less from the originator for KSA &

gulf).

Oman:

Retail price = 1.55 times of CIF price (including wholesaler

margin of 22%).

Jordan:

Retail price = CIF + 3% customs + 10% clearance + 0.7%

transportation + 15% agent markup + 21% Pharmacy

markup.

(1st generic is 80% or less from the originator).

38

Price structure; Pharmaceutical

products

Palestine:

Retail price = CIF + 7 % -13% customs & clearance + 23%

distribution + 24% pharmacy markup.

Iraq:

Retail price = CIF + 50 – 100% marketing +10-20% distribution

+ 20-30% pharmacy markup (Customs & clearance can be

avoided).

(1st generic is 50% or less from the originator).

Libya:

Retail price = CIF price +12 - 20% expenses (Taxes - Shipping

- Customs) + 35 % wholesaler margin (marketing expenses to

be added) + 40 % pharmacy margin.

Sudan:

Retail price = CIF price + 20-25% Wholesaler + 20% ph.

39

Price structure; Food

supplements

KSA:

Herbal products are freely priced.

Minerals are freely priced below a specified

concentration.

Vitamins are priced.

UAE , Oman & Yemen:

Retail price = CIF price * 3.2.

Jordan , Palestine , Lebanon & Mauritania:

Retail price = CIF price * 2.4.

40

In brief41

BE center should

be approvedStability study for

zone III & IVa

Raw materials

(alcohol & pork

free)

Site registration(pre-audit

recommended)

eCTD & CTD filesFees, pricing &

time / country

Need for well experienced

& knowledgeable agent

Thank

you

42

Web site: www.amc.com.sa

E. Mail: info@amc.com.sa

Tel: +966 12 6579933 ext. 103

Fax: +966 12 6531316

43

Contact us

MENA Market Size44

2014 2015 2016f 2017f 2018f 2019f 2020f

Pharma sales $bn 34.7 33.7 35.8 38.5 41.9 45.5 49.3

% of GDP 1.1 1.2 1.3 1.2 1.2 1.2 1.2

f = BMI forecast. Source: World Health Organization, BMI

MENA MARKET

SEGMENTATIONS

Levant15%

North Africa35%

GCC50%

Pharma market sales

45