™

[Link]

Number: 1280010803 VivaChek Laboratories, Inc. ™

Effective Date: 2019-11-11 913 N Market Street, Suite 200,
2019 VivaChek Laboratories, Inc. Wilmington, DE19801, USA
 INDEX
1 About VivaChek

2 Milestones

3 VivaGuard ™ Diabetes Management Solution

4 VivaChek ™ Multi-function Monitoring Systems

5 VivaChek™ Blood Glucose Monitoring Systems

15 VQPET™ H Blood Glucose Monitoring Systems

17 VivaDiag™ POCT Analyzer

19 VivaDiag™ POCT Test Devices

21 VivaDiag™ Hemoglobin Testing System

22 VivaDiag™ Lipid Testing System

23 Konfort™ Blood Pressure Monitors

28 Konfort™ Digital Thermometers

31 VivaChek™ Insulin Pen Needles

33 VivaChek™ Safety Lancets & Twist Lancets

35 Certificates
About VivaChek Milestones
VivaChek is a professional BGM 1 and POCT 2 manufacturer headquartered in Wilmington, DE, USA. We develop, manufac-
Jun 2013 - VivaChek established
ture and distribute high quality BGM, cloud-based diabetes management solution, POCT analyzers and tests worldwide.

VivaChek has the most comprehensive series of BGM in the industry, including traditional BGM, wireless BGM (Bluetooth,
Jul 2014 - First patent granted
GSM, 4G, Wi-Fi, NB-IoT or LoRa), and POC BGM for hospital use.

Our manufacturing facility, VivaChek Biotech (Hangzhou) Co., Ltd, located in Hangzhou, has a stable and efficient quality
May 2015 - ISO 13485 certified, VivaChek™ Ino BGM CE & ISO 15197:2013 certified
management system that strictly follows all regulations established by the US FDA, the European Union, China FDA, EN ISO

13485 and others. Apr 2016 - BGM with GDH-FAD enzyme CE & EN ISO 15197:2015 certified

Apr 2017 - VivaChek™ Ino BGM US FDA 510k cleared

Dec 2018 - VivaChek™ Ino Smart and other 5 BGM US FDA 510K cleared

Mar 2019 - Launch of POCT immunofluorescence analyzer and CRP, PCT, HbA1c tests etc

VivaChek Europe (Under establishment) Able Diagnostics,CA,USA VivaChek Laboratories Wilmington, USA
VivaChek Biotech (Hangzhou), China

VivaChek Lifecare Chennai, India Oct 2019 - Launch of Blood Ketone, HB and Lipid profile (TC, TG, HDL, LDL)

Nov 2019 - Launch of cloud-based web app for diabetes management

Nov 2019 - Products available in 70+ countries, including USA, Germany, UK, Italy etc
Our goal is to grow as a global trustworthy BGM and POCT manufacturer that exceeds customers’ expectations.

Together, we will create a successful company that we all will be proud of in our lifetime to help and benefit the healthcare

industry and our customers worldwide.

1. BGM: blood glucose monitoring

2. POCT: point-of-care testing

1 2
 TM

Multi-function
A cloud-based platform to link patients and healthcare professionals

Multi-function• Monitoring• Systems

18:35

Mega

TM
VivaGuard Web App
View patients' timely data
TM
Via USB cable, Bluetooth, GSM or NB-IoT. Patients can upload the data by VivaGuard
Mobile App or Web App, data will be synchronized in doctor's account remotely

Bluetooth 4.2 Strip ejector Multi-function

Personal info protection
Patient and doctor can only be connected by an invitation code

Track patients' activities

Feature Ketone Uric Acid Glucose (GDH-FAD) Glucose (GOD)

Patients can add daily activities and diabetes data which will be included in the reports

Coding No coding Code chip No coding No coding

Review and analyze patients' data accurately and efficiently
TM Testing time About 10 seconds About 15 seconds About 5 seconds About 5 seconds
VivaGuard provides a serials of tables, charts and patterns which help analyzing the data
Sample size About 0.8 µL About 2 µL About 0.5 µL About 0.5 µL

Free record keeping Fresh whole blood Fresh whole blood Fresh whole blood Fresh whole blood
Sample type
Print out patient data as hard copy records, or save PDFs for paper (capillary, venous) (capillary, venous) (capillary, venous, arterial) (capillary)

Operation temperature 7.5-45°C 4-38°C 5-45°C 5-45°C

patients portal: [Link]
professionals portal: [Link]
Hematocrit range 20-65% 30-60% 0-70% 20-70%

3 4
 BGMS
Blood Glucose Monitoring Systems Advanced Technologies

HCT The system detects the hematocrit signal of blood sample

Correction then reduces the interference within ±10%

Auto-coding The system detects the coding information of each test strip
automatically

Temperature The system detects the temperature signal then compensates

Compensation the effect within ±5%

Unique Unique formulation in the test strip which is very stable in extreme
formulation environments

Unique After detecting signals of various common sources of interferences,

Algorithm the meter runs a unique algorithm producing highly accurate results

Advanced 8 Electrodes
Code calibration (auto-coding)

Eliminate the HCT (hematocrit) interference

Eliminate the temperature interference

Check for the humidity exposure

Ensure sufficient sample size

Confirm if the sample is blood or

control solution

Check for the possible damage

of the test strip

Check the test strip compatiable or not

5 6
 BGMS
TM
TM

Auto sync Bluetooth 4.1 5s test time

No coding Can test neonates, Strip ejector
pregnant women
& anemia people
Feature Specification
Feature Specification
Enzyme Glucose oxidase
Enzyme Glucose oxidase
Sample size About 0.5 µL
Sample size About 0.5 µL
Testing time About 5 seconds
Testing time About 5 seconds
Coding method No coding
Coding method No coding
Hematocrit range 20-70%
Hematocrit range 20-70%
Battery 250 mAh 3.7 V rechargeable battery
Memory 900 results with time and date
Battery life About 150 tests after fully charged
Test averaging 7, 14 and 30-day average
Operation temperature 5- 45°C (41-113°F)
Operation temperature 5-45°C (41-113°F)
Operation humidity 10- 90% (non-condensing)
Operation humidity 10-90% (non-condensing)
Bluetooth version Bluetooth 4.1
Test reminders (alarms) 5

Meal markers Before and after meals

TM
TM

Auto sync Bluetooth 4.1 GDH-FAD

GDH-FAD 8 electrodes HCT 0-70% enzyme
enzyme
Feature Specification
Feature Specification Sample type Fresh whole blood
(capillary, venous & arterial)
Sample type Fresh whole blood
(capillary, venous & arterial) Hematocrit range 0-70%

Strip ejector Yes Operation temperature 5- 45°C (41-113°F)

Hematocrit range 0-70% Operation humidity 10-90% (non-condensing)

Memory 900 results with time and date Test strip storage temperature 2- 30°C (36-86°F)

Sample size About 0.5 µL Battery 250 mAh 3.7 V rechargeable battery

Testing time About 5 seconds Battery life About 150 tests after fully charged

Operation temperature 5-45°C (41-113°F) Bluetooth version Bluetooth 4.1

7 8
 BGMS
TM TM

Talking Strip ejector Backlight & strip light

No coding Simple & accurate 5s test time
dm
Feature Specification
Feature Specification
Talking Optional
Enzyme Glucose oxidase
Enzyme Glucose oxidase
Sample size About 0.5 µL
Sample size About 0.5 µL
Testing time About 5 seconds
Testing time About 5 seconds
Test strip storage temperature 2- 30°C (36- 86°F)
Battery life 1,000 without Bluetooth; 500 with Bluetooth
Test strip unopened shelf life 24 months
Data transfer Micro USB or Bluetooth (optional)
Hematocrit range 20-70%
Memory 1,000 results with time and date
Memory 300 results with time and date
Backlight & strip port light Optional
Automatic shutoff 120 seconds after last action
Bluetooth version Optional

Eco Plus
TM
TM

Talking GDH-FAD Backlight & strip light

8 electrodes Easy-to-use 5s test time enzyme

Feature Specification
Feature Specification
Talking Optional
Enzyme Glucose oxidase Enzyme Glucose dehydrogenase

Sample size About 0.5 µL

Sample size About 0.5 µL
Testing time About 5 seconds
Test strip storage temperature 2- 30°C (36- 86°F)
Sample type Fresh whole blood (capillary, venous and arterial )

Test strip unopened shelf life 24 months Battery life 1,000 without Bluetooth; 500 with Bluetooth

Hematocrit range 20-70% Data transfer Micro USB or Bluetooth (optional)

Memory 1,000 results with time and date

Memory 300 results with time and date
Backlight & strip port light Optional
Automatic shutoff 120 seconds after last action

9 10
 BGMS
™

Blood• Glucose• Monitoring• System

Large screen No coding HCT 20-70% 8 electrodes

4.2

Bluetooth 4.2 0.5 µL blood sample Insufficient sample Strip ejector

(optional) & 5s testing time detection

11 12
 BGMS
TM

Mega
TM

4.0
GSM
Bluetooth 4.2 Target range Auto sync
indicator
Touch screen Bluetooth & GSM Smart data
analysis
Feature Specification
Enzyme Glucose oxidase Feature Specification
Sample size About 0.5 µL Enzyme Glucose oxidase

Testing time About 5 seconds Sample size About 0.5 µL

Test strip storage temperature 2- 30°C (36- 86°F) Testing time About 5 seconds

Test strip unopened shelf life 24 months Hematocrit range 20-70%

Memory 300 results with time and date Battery life About 150 tests after fully charged

Automatic shutoff 120 seconds after last action Data transfer Bluetooth & GSM

Bluetooth version Bluetooth 4.2 New Memory 1,000 results with time and date New

TM

TM

For hospital use

4.0
GSM

Barcode scanner HIS / LIS Patient Color display Bluetooth & GSM Data analysis
connection management

Feature Specification Feature Specification

Enzyme GDH-FAD Enzyme Glucose oxidase

Sample size About 0.5 µL Sample size About 0.5 µL

Testing time About 5 seconds Testing time About 5 seconds

Screen size 4.5-inch touch screen Memory 1,000 results with time and date
Storage 8G (up to 3000 patitens or 10000 tests) Battery life About 150 tests after fully charged

Scanner Infrared scanner Operation temperature 5-45°C (41-113°F)

Data transfer Wi-Fi, Bluetooth & LAN Operation humidity 10-90% (non-condensing)
New New Data transfer Bluetooth & GSM

13 14
 BGMS
TM

Bluetooth 4.2 Strip ejector Backlight & strip light

Feature Specification

Enzyme Glucose oxidase

Sample size About 0.5 µL

Testing time About 5 seconds

Battery life 1,000 without Bluetooth; 500 with Bluetooth

Data transfer Micro USB or bluetooth (optional)

Memory 1,000 results with time and date

Operation temperature 5-45°C (41-113°F)
Operation humidity 10-90% (non-condensing)

Professional Use For Pets TM

VQPET H Feature

Enzyme
Specification

GDH-FAD
GDH-FAD 8 electrodes Bluetooth 4.2

Sample type Fresh whole blood Feature Specification

(capillary, venous) Enzyme Glucose dehydrogenase
Sample size About 0.5 µL Sample size About 0.5 µL
Testing time About 5 seconds Testing time About 5 seconds
No coding Calibrated for Accurate & precise Alternative site testing Inner lip, callus of leg, paw, ear Sample type Fresh whole blood (capillary, venous & arterial)
cats and dogs Memory 300 results with time and date Battery life 1,000 without Bluetooth; 500 with Bluetooth
Automatic shutoff 120 seconds after last action Data transfer Micro USB or Bluetooth (optional)

Memory 1,000 results with time and date

Operation temperature 5-45°C (41-113°F)
Operation humidity 10-90% (non-condensing)

15 16
 2
TM TM

POCT
Barcode reader Simple operation Fast & reliable Touch screen Auto calibration Easy carry

Feature Specification Feature Specification Feature Specification Feature Specification

Weight 1.5 kg Barcode identification 2D Weight 2.5 kg Barcode identification 2D

Dimension 173×210×75.8 mm Operation temperature 5-40 ℃ (41-104°F) Dimension 192×205×161 mm Operation temperature 5-40 ℃ (41-104°F)

Channel Single Connectivity USB & COM Channel Single Connectivity USB

Display 3.5'' LCD Battery AC/DC adapter Display 7'' color touch screen Battery AC/DC adapter & UPS

Coding Code chip Memory 50,000 results Coding NFC Memory 10,000 results

17 18
 Category Catalog Item Specimen Reaction Measurement
time range
TM VID09-03-011 * CTN-I S/P 15 min 0.1-50 ng/mL
Test Devices VID10-03-011 CK-MB WB/S/P 10 min 0.5-200 ng/mL
VID11-03-011 * D-Dimer WB/P 10 min 0.1-10 µg/mL

Cardiac VID12-03-011 MYO WB/S/P 10 min 10-1,000 ng/mL

markers VID13-03-011 * H-FABP WB/S/P 10 min 5-100 ng/mL

POCT
VID14-03-011 NT-ProBNP WB/S/P 10 min 18-35,000 pg/mL

VID15-03-011 Combo 10 min Same with single

WB/S/P
TM (CTN-I/CK-MB/MYO) item

VID24-06-011 PSA S/P 10 min 2-100 ng/mL

VID25-06-011 AFP S/P 10 min 5-400 ng/mL

Tumor
TM markers VID26-06-011 CEA S/P 10 min 1-500 ng/mL

VID27-06-011 iFOB F 10 min 25-1,000 ng/mL

TM TM

VID01-01-011 * hsCRP/CRP WB/S/P 3 min 0.5-200 mg/L

VID02-01-011 * PCT WB/S/P 10 min 0.1-50 ng/mL

Infection
VID04-01-011 * SAA WB/S/P 10 min 5-100 mg/L

VID05-01-011 IL-6 WB/S/P 10 min 3-4,000 pg/mL

VID03-02-011 * CYS C WB/S/P 3 min 0.5-10 mg/L

VID06-02-011 * MAU U 3 min 10-200 mg/L

Renal
function VID07-02-011 * β2-MG WB/S/P 3 min 0.5-20 mg/L

VID08-02-011 * NGAL WB/S/P 3 min 25-1,600 ng/mL

VID16-04-011 * HbA1C WB 8 min 4.0-16%

Diabetes VID17-04-011 C-P WB/S/P 10 min 0.4-20 ng/mL

2D barcode Simple operation Multiple test items
VID18-04-011 INS WB/S/P 10 min 0.5-100 mIU/L

VID19-05-011 * β-hCG S/P 15 min 10-10,000 mIU/mL

Feature Specification Feature Specification VID20-05-011 * TSH S/P 15 min 0.5-100 mIU/L
* T3
Test Principle Fluorescence immunochromatography Storage temperature 2-30℃ (35.6-86°F) Hormone VID21-05-011 S/P 15 min 0.5-5 ng/mL

Coding Code chip / NFC Humidity 10-90% (non-condensing) VID22-05-011 * T4 S/P 15 min 20-300 nmol/L
VID23-05-011 * LH WB/S/P 10 min 1-200 mIU/mL
Reaction time 3-15 min Shelf life 18 months

VID28-07-011 * FER S/P 10 min 5-1,500 ng/mL

Others
VID29-07-011 VD WB/S/P 15 min 8-70 ng/mL

*Available item WB=Whole blood; S=Serum; P=Plasma; F=Feces; U=Urine; min=minutes

19 20
 TM TM

Hemoglobin Testing System

Lipid
HB

Test items:
3 in 1
TC
TG
HDL
LDL (calculated
(calculated）
(calculated）
TC/HDL ratio (calculated

15s

Wide measurement 15s test time Easy-to-use Smart testing Small blood Fast results
range

Feature Specification Feature Specification Feature Specification Feature Specification

Test principle Reflectance photometer Operation temperature 2-40°C (35.6-104°F) Test principle Reflectance photometer Operation temperature 15-40°C (59 -104°F)

Code Code chip Automatic shutoff 8 minutes after last use Coding Code chip Test device shelf life 18 months

Test time ≤ 15 seconds Strip shelf life 24 months Fresh whole blood (capillary, venous)， Meter: 0-50°C (32-122°F)
Sample type Storage temperature
serum, plasma Test device: 2-30°C (35.6-86°F)
Sample volume 10 µL Memory 1,000 results
Sample volume 25 µL for lipid; 10 µL for individual Connectivity Mini USB
Fresh whole blood Meter: 0-50°C (32-122°F)
Sample type Storage temperature
(capillary, venous) Test device: 2-30°C (35.6-86°F) Test time ≤ 2 minutes Memory 200 results

21 22
 Blood Pressure Monitors Accurate Extra-large Com-fast
display inflation

Upper Arm Blood Pressure Monitor

Konfort™ BP-35A

BPM
WHO Indicator Konfort™ BP-35I
Feature Specification Feature Specification
Type Upper arm Type Upper arm
Dimension 95×125×60 mm Dimension 105×140×62 mm
LCD size 46×59 mm LCD size 59×79 mm
Backlight No Backlight Optional
Talking No Talking No
Date and time No Date and time No
Automatic inflation and deflation Yes Automatic inflation and deflation Yes
Memory 60 Memory 70
Auto power-off Yes Auto power-off Yes
Low battery indication Yes Low battery indication Yes
Irregular heartbeat detection No Irregular heartbeat detection No
Excessive body movement detection Yes Excessive body movement detection Yes

Konfort™ BP-35E Konfort™ BP-35X WHO Indicator

Feature Specification Feature Specification

Type Upper arm Type Upper arm
Dimension 105×140×65 mm Dimension 150×110×74 mm
LCD size 60×80 mm LCD size 65×90 mm
Backlight No Backlight Optional
Talking No Talking Optional
Date and time Yes Date and time Yes
Automatic inflation and deflation Yes Automatic inflation and deflation Yes
Memory 120 Memory 120
Auto power-off Yes Auto power-off Yes
Low battery indication Yes Low battery indication Yes
Irregular heartbeat detection Yes Irregular heartbeat detection Yes
Excessive body movement detection Yes Excessive body movement detection Yes

23 24
 Konfort™ BP-101

BPM
Bluetooth optional WHO Indicator

Feature Specification
55G

Type Upper arm

Dimension 166×114×72 mm
LCD size 110×70 mm
Backlight Optional
Wrist Blood Pressure Monitor
Talking
Date and time
Optional
Yes
Konfort™ BP-55G
Automatic inflation and deflation Yes
Memory 2×90 (Two groups) Feature Specification
Auto power-off Yes
Type Wrist Automatic inflation and deflation Yes
Low battery indication Yes
Dimension 90×66×26 mm Memory 60
Irregular heartbeat detection Yes
LCD size 60×45 mm Auto power-off Yes
Excessive body movement detection No
Backlight No Low battery indication Yes
Talking No Irregular heartbeat detection Yes
Date and time No Excessive body movement detection Yes

Konfort™ BP-103
Bluetooth optional

Feature Specification
Package (pcs/CTN)
Type Upper arm
Dimension 138×90×58 mm Konfort™ Upper Arm Blood Pressure Monitor BP-35A 16 pcs
LCD size 80×51 mm
Konfort™ Upper Arm Blood Pressure Monitor BP-35E 16 pcs
Backlight Optional
Talking Optional Konfort™ Upper Arm Blood Pressure Monitor BP-35I 16 pcs
Date and time Yes
Konfort™ Upper Arm Blood Pressure Monitor BP-35X 16 pcs
Automatic inflation and deflation Yes
Memory 2×90 (Two groups) Konfort™ Upper Arm Blood Pressure Monitor BP-101 48 pcs
Auto power-off Yes
Konfort™ Upper Arm Blood Pressure Monitor BP-103 48 pcs
Low battery indication Yes
Irregular heartbeat detection Yes Konfort™ Wrist Blood Pressure Monitor BP-55G 45 pcs
Excessive body movement detection No

25 26
 Digital Thermometers
Digital Thermometer

Infrared Forehead & Ear Thermometer Konfort™ MT-101

Konfort™ EF-100A
Feature Specification
Test time 10 seconds
Feature Specification Range 32.0-42.9℃ (90.0-109.9℉)

Test time 1 second Accuracy ±0.1℃ (±0.2℉)

Range 32.0-43.0℃ (89.6-109.4℉) ℉/℃ switchable Optional

Accuracy ±0.2℃ (±0.4℉) Flexible tip No
℉/℃ switchable Yes Jumbo LCD No
Jumbo LCD Yes Waterproof No

DT
Waterproof No Memory 1
Memory 20 Fever alarm Yes
Fever alarm Yes Battery life >200 hours
Battery life > 3000 tests Battery replaceable Yes
Battery replaceable Yes Auto-shut off Yes
Auto-shut off Yes
Backlight Yes
Bluetooth Optional

Flexible Digital Thermometer

Infrared Forehead Thermometer Konfort™ MT-506

Konfort™ FT-100A Feature
Test time
Specification
10 seconds
Feature Specification
Range 32.0-42.9℃ (90.0-109.9℉)
Test time 1 second Accuracy ±0.1℃ (±0.2℉)
Range 32.0-43.0℃ (89.6-109.4℉) ℉/℃ switchable Optional
Accuracy ±0.2℃ (±0.4℉) Flexible tip Yes
℉/℃ switchable Yes Jumbo LCD Yes
Jumbo LCD Yes Waterproof Yes
Waterproof No Memory 1
Memory 20
Fever alarm Yes
Fever alarm Yes
Battery life >200 hours
Battery life > 3000 tests
Battery replaceable Yes
Battery replaceable Yes
Auto-shut off Yes
Auto-shut off Yes
Backlight Yes
Bluetooth Optional

27 28
 Cartoon Digital Thermometer

Konfort™ MT-509A
Feature Specification
Test time 10 seconds
Range 32.0-42.9℃ (90.0-109.9℉)

DT
Accuracy ±0.1℃ (±0.2℉)
℉/℃ switchable Optional
Flexible tip Yes
Jumbo LCD Yes
Waterproof Yes
Memory 1
Fever alarm Yes
Battery life >200 hours
Battery replaceable Yes
Auto-shut off Yes

Package (pcs/CTN)
Konfort™ Infrared Forehead & Ear Thermometer EF-100A 40 pcs

Konfort™ Infrared Forehead Thermometer FT-100A 40 pcs

Konfort™ Digital Thermometer MT-101 360 pcs

Konfort™ Flexible Digital Thermometer MT-506 300 pcs

Konfort™ Cartoon Digital Thermometer MT-509A 200 pcs

29 30
 VivaChek™ Insulin Pen Needles Premium Features

Silicone lubricant coating Silicone oil for strong

Triple beveled adhesive effects

Triple beveled cannula for easy penetration Facilicate needle penetration

and operation for painless injection

Precise Comfortable Reliable

IPN
Thin wall technology Inner cannula electropolishing process

Less pressure reduces pain and duration of injection, Avoid scabbing after long term insulin injection
and lower risks of insulin leakage

Ordering Information

Package (pcs/CTN)
202106
140710

VivaChek™ Insulin Pen Needle VGL03-001a 31G, 5 mm 50 pcs

VivaChek™ Insulin Pen Needle VGL03-001b 31G, 6 mm 50 pcs
202106
140710

VivaChek™ Insulin Pen Needle VGL03-001c 31G, 8 mm 50 pcs

VivaChek™ Insulin Pen Needle VGL03-001d 32G, 4 mm 50 pcs

31 32
 Safety Lancets & Twist Lancets
TM

Secure Simple Painless

Twist lancets are designed to fit the most commonly used lancing devices and have a variety of gauges (21-33G). Safety lancets provide extra safety to patients and clinicians with wide variety of gauges (26-30G).

Feature

LANCET
• Sterile

• Pain-free

• Fits most commonly used lancing devices 26-30G

21-33G

Steps of use safety lancets

Package (pcs/CTN)
VivaChek™ Safety Lancet 50s VGL02-001 50 safety lancets

Virtually Pain Free ! 33G

VivaChek™ Safety Lancet 100s VGL02-002 100 safety lancets
VivaChek™ Lancet 50s VGL01-002 50 lancets
VivaChek™ Lancet 100s VGL01-003 100 lancets
VivaChek™ Lancet 25s VGL01-004 25 lancets

33 34
 Certificates

US FDA EN ISO15197:2015 CE

Drug Tariff Team

Ground Floor, Stella House
Goldcrest Way
Newburn Riverside
Newcastle Upon Tyne
NE15 8NY

Tel: 0191 229 3652

Fax: 0191 264 8801
Email: [Link]@[Link]
Website: [Link]/prescriptions
Ref: ZCE 66/58/1
Date : 23 June 2016

VivaChek Ino

I am pleased to confirm that the application for the above product to be included within
Drug Tariff Part IX has been successful.

We intend to list this product in the September 2016 edition of the Drug Tariff unless you
inform us that you require listing to be delayed.

As a manufacturer of a new addition to Drug Tariff Part IX, we need to advise you of the
price rise procedure for products listed in Part IX. The procedure (as agreed between the
Department of Health (DH) and the Drug Tariff Part IX Forum) is as follows.
“Manufacturers may seek price rises for a product once a year or any longer period. The
maximum rise will be the forecast of the gross domestic product (GDP) deflator minus
0.75”. Further details of this agreement are available on our website
[Link]

It has been agreed with the DH that you complete an annual declaration confirming that
you still provide the free services you have specified in your application. Therefore, a
CRSDF01 form will need to be completed prior to entry into the Drug Tariff and annually
thereafter by 31 March each year. This is available at
[Link] If this declaration is not
received an automatic 3% price reduct ion will be applied.

As communicated through the Part IX Drug Tariff Forum, there is an initiative to provide a
wider and up to date coverage of GTIN (formerly European Article Number) codes on the
NHS dm+d. Please provide the GTINs for your recently approved product, if they are
available, on the attached spreadsheet. Inclusion of GTINs in dm+d will help support
future prescribing and pharmacy working practices, patient safety, and NHS business
processes. However, we appreciate that it may not be possible or appropriate to provide
GTINs for all products and their supply is not obligatory. Please note that we can only
receive GTINs provided to us electronically on the spreadsheet provided.

ISO 13485:2016 UK MHRA UKCE

NHS

35