Worldwide Pharmaceutical Compliance Requirements - May 5, 2021 All information current as of date above. Material is provided for information ...
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Worldwide Pharmaceutical
Compliance Requirements
May 5, 2021
All information current as of date above. Material is provided for information only.
rfxcel does not guarantee accuracy. Please consult original sources before making business decisions.INTRODUCTION
rfxcel continually monitors the regulatory landscape in order to improve our products and customer service
and maintain our position as the leader in compliance for the industries we serve. We strive to bring you the
most accurate and complete information about news, trends, and other developments at all levels of the
pharmaceutical supply chain — local, national, regional, and global. This is the purpose of our “Worldwide
Pharmaceutical Compliance Requirements” document.
However, we all know that regulations change. They change frequently, often without timely or clear
announcements from regulatory bodies. This makes maintaining an index of compliance requirements, such
as this one, a challenge. On the one hand, we want to provide as much information as possible; on the other,
it’s not possible to confirm that what we’re reporting is 100 percent accurate 100 percent of the time.
Please keep this in mind as you read this guide. If you have any questions or feedback about the information
we present, please let us know. And remember that the best way to ensure you’re getting the absolute
latest supply chain information is to speak with us directly. We will be happy to hear from you and answer
your questions.
Thank you,
The rfxcel Team
May 5, 2021
Email us at sales@rfxcel.com and visit us at rfxcel.com
to learn more about our compliance solutions.ARGENTINA
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
Depends on the substance/active ingredient • Global Trade Item GS1-128, DataMatrix, RFID Yes
• Phase 1: April 30, 2015 Number (GTIN)
• Phase 2: June 30, 2015 • Expiry date
• Phase 3: August 30, 2015 • Batch/Lot
• Serial number (SN)
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
Not required 1 up, 1 down Required — —
AUSTRALIA
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
July 1, 2021 if Therapeutic Goods Order (TGO) 106 is • GTIN DataMatrix No
signed into law • Expiry date
• Batch/Lot
• SN
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
TGO 106 - Data Matrix
Not required N/A Required — Codes and Serialisation Of
Medicines
1
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.BAHRAIN
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
Dec. 31, 2019: Must comply with barcoding and • GTIN DataMatrix Yes
serialization requirements for secondary packaging. • Expiry date
• Batch/Lot
Sept. 1, 2021: Must comply with aggregation • SN
requirements.
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
Bahrain National Health
Required 1 up, 1 down Required — Regulatory Authority
(NHRA) website
BRAZIL
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
Proposed deadlines • GTIN DataMatrix Yes
• Aug. 1, 2020: ANVISA will be open to receive SNs. • ANVISA registration no.
• Dec. 1, 2020: Industry must send SNs to ANVISA; • SN
those who can’t meet this requirement may send • Batch/Lot
serialization plan for ANVISA approval. • Expiry date
• Feb. 28, 2022: Serialization plans due to ANVISA.
• April 28, 2022: Final deadline
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
Supported but not See GS1 Public Policy ANVISA website
N/A Required
required Database
2
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.CHINA
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
2022 • Proprietary Chinese • Linear barcode Yes
Standards in “Guidelines for Drug Traceability eCode: 20-digit code (7- • DataMatrix
Information System Construction” and “Encoding digit product ID + 9-
Requirements for Drug Traceability” must be digit SN + 4-digit check
implemented from the date of publication (April 2019). digits) in a linear
Per the guidance, all drugs will be in the traceability barcode
system in 2022. • GS1 standards using a
GTIN as product code
with the relevant
application identifiers in
a 2D DataMatrix code
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
See GS1 Public Policy National Medical Products
Required 1 up, 1 down Accepted, not required Administration
Database
3
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.EGYPT
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
Dec. 31, 2018 • GTIN DataMatrix Yes
Companies/factories must print 2D barcodes on the • Batch/Lot
secondary package of at least one of their products • Expiry date
before the end of 2018. • SN
Companies/factories must complete the data below, as
well as other data, which will be published on the
Central Administration of Pharmaceutical Affairs
website:
• No. of production lines in each factory/company
• No. of production lines for printing 2D barcodes
• Implementation plan to finalize all production lines by
June 2019
• Companies/factories must fill the GTIN for each
product and the Global Location Number (GLN) for
their locations
All requested data must be completed within 15 days
(i.e., by Nov. 21, 2018)
Pilot to begin by December 2019. Guidelines to be
changed based on pilot results. Sharing components
timeline to be released after the pilot has ended.
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
Central Administration for
See GS1 Public Policy
Required N/A Required Pharmaceutical Affairs
Database
(CAPA)
4
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.INDIA
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
Oct. 1, 2020 (changed from April 1, 2020) 16-digit secondary pack DataMatrix Yes
coding:
1. Pack level (1)
2. Packager code (3)
3. Pack type (1)
4. SN (10)
5. Check digit (1)
14-digit shipper code
1. Pack level (1)
2. Packager code (3)
3. Pack type (1)
4. SN
5. Check digit (1)
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
• IVEDA User Guide
Required 1 up, 1 down Accepted, not required — • IVEDA Guidelines
• Coding Requirements
5
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.INDONESIA
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
December 2020: Updates to deadlines • GTIN or AI (distribution QR Code or DataMatrix Yes, via CSV file upload:
permit number)
1. Reporting of product
Jan. 1, 2023 requirement for identification • SN
acceptance and
(serialization) • Expiry date expenditure
• Not later than 6 months from marketing authorization • Batch/Lot 2. Product sales reporting
date issued via e-registration after the regulation • Requirements at 3. Return reporting; and
enacted tertiary, secondary & recall reporting
• In 2023: all products primary (including SN)
levels
Requirement for authentication (reporting) • Requirement on primary
packaging only if there
• Not later than 2 years from marketing authorization
is not an anti-tampering
date issued via e-registration after the regulation
device on the packaging
enacted
level above
• In 2025 (all products): implementation will be
gradually aligning with the renewal timing.
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
National Agency of Drug
Required 1 up, 1 down Accepted, not required —
and Food Control
6
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.JAPAN
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
March 31, 2021 • GTIN N/A No
• Batch/Lot
• Expiry date
• SN
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
See GS1 Public Policy Ministry of Health, Labor,
Not required N/A Required
Database and Welfare
KAZAKHSTAN
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
April 1, 2022: Manufacturers must comply with labeling • GTIN DataMatrix Yes
and reporting requirements. • SN
• Crypto key
Previous milestones: • Crypto signature
• October 2019: Pilot for medicines launched
• March 2020: The Committee for Quality Control and
Safety of Goods and Services of the Ministry of
Healthcare approved methodological
recommendations for the implementation of a pilot
project for labeling and traceability of medicines.
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
See GS1 Public Policy
Not required N/A Accepted, not required Ministry of Healthcare
Database
7
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.KUWAIT
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
No serialization or reporting requirements found in GS1 N/A N/A N/A
Public Policy Database or on the Kuwait Ministry of
Health, Drug & Food Control Administration website.
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
Kuwait Ministry of Health,
N/A N/A N/A — Drug & Food Control
Administration
LEBANON
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
Jan. 1, 2020: Some products have a grace period until • GTIN DataMatrix Yes
the end of June 2020 due to financial circumstances • Batch/Lot
and the COVID-19 pandemic, especially drugs that • Expiry date
have no similar active ingredients.
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
• Data submission:
See GS1 Public Policy MediTrack Database
Not required N/A Required
Database • Does not appear to
require serialization
8
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.MALAYSIA
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
Jan. 1, 2023 • GTIN DataMatrix Yes
• Expiry date
• Batch/Lot
• SN
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
Ministry of Health of
Required 1 up, 1 down Required — Malaysia
OMAN
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
March 1, 2019 • GTIN DataMatrix No
• Expiry date
• Batch/Lot
• SN
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
See GS1 Public Policy Ministry of Health
Not required N/A Required
Database
9
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.QATAR
• BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
• Short term: Immediately, valid for ongoing orders: • GTIN DataMatrix(secondary); No
Secondary and tertiary packaging identification. • Batch/Lot DataMatrix or GS1 128
Minimal product information • Expiry date (tertiary)
• Medium term (per 1.1.2021): Serial Shipping • Serial number if
Container Code, Electronic dispatch advice applicable on secondary
• Long term (per 1.1.2023 / 1.1.2025): Primary
packaging identification
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
• Does not appear to
Required N/A Required — require serialization
• Ministry of Public Health
RUSSIA
• BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
• Dec. 31, 2019: Seven nosologies • GTIN DataMatrix Yes
• July 1, 2020: Full track and trace system • SN
implemented by all stakeholders. • Crypto key (AI 91)
• Crypto signature (AI 92)
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
See GS1 Public Policy Chestny ZNAK website
Required 1 up, 1 down Required
Database
10
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.SAUDI ARABIA
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
Jan. 7, 2019: Saudi Food & Drug Authority (SFDA) • GTIN DataMatrix Yes
requires all supply chain actors to register at their • Batch/Lot
portal ASAP. Requirements for reporting to start Jan. • Expiry date
7, 2019. • Serial number
August 20, 2020: Deadline was postponed twice due • GLN for local factories
to the COVID-19 pandemic. and warehouses
Commitment to report all operations carried out on the
drug packaging through the system; deadline to be
confirmed
Aggregation applies to all local manufacturers. If global
manufacturers export without aggregation, local
agents should do it on their behalf. The SFDA
aggregation requirement means that all saleable units
must have an identity or data relationship to the case
they are shipped in.
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
See GS1 Public Policy
Required Yes Required
Database
SOUTH AFRICA
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
Proposed phased implementation identification, then • GTIN DataMatrix No
serialization from December 2018 until June 2022. • Batch/lot
• Expiry date
• SN
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
National Department of
Not required N/A Required — Health
11
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.SWITZERLAND
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
No enforcement date available as of June 8, 2020. • Product code [GTIN or DataMatrix Voluntary
Nordic/National Trade
From Swiss Medicines Verification Org. (SMVO) Item Number (NTIN)]
“In order to guarantee an equivalent level of protection • SN
against counterfeit medicines in Switzerland, Art. 17a of • Expiry date
the Swiss Medicines Act (HMG) stipulates that this • Batch/Lot
should be integrated into the Swiss Therapeutic
Products Act. The entry into force of this article
together with the corresponding ordinance is expected
for 2021. Contrary to EU law, the attaching of safety
features and their examination in accordance with Art.
17a HMG is still voluntary.”
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
See GS1 Public Policy
Not supported N/A Required SMVO
Database
TAIWAN
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
• Jan. 1 2018: GTIN/batch and expiry in the relevant • GTIN DataMatrix Yes
code with GS1 standards on secondary and tertiary • Batch/Lot
packaging • Expiry date
• Jan. 1 2019: Add SN • SN
• Jan. 1, 2020: Add “traceability platform” login
• Jan 1, 2021: Add active pharmaceutical ingredient
(API) SN
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
Ministry of Health and
Not required N/A Required — Welfare
12
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.UNITED ARAB EMIRATES
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
June 1, 2020 • GTIN DataMatrix Yes (to BrandSync)
• Batch/Lot
• Expiry date
• SN
• GLNs required for
manufacturers,
dispatchers/warehouses,
importers,
wholesalers/distributors,
pharmacies, hospital
pharmacies
TECHNICAL
AGGREGATION TRACEABILITY GS1 STANDARD ADDITIONAL INFO.
SPECIFICATIONS
• Product Identification
and Barcoding
Not required N/A Required —
• Ministry of Health and
Prevention
13
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.UKRAINE
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
• Jan. 1, 2021: Serialization pilot postponed until Nov. 1, • Drug code (identifies DataMatrix Yes
2020 name of drug, INN,
• Until 1 Jan. 1, 2020: Ministry of Health developing dosage, formulation,
pilot criteria, model, infrastructure, procedure, and SKU)
relevant changes to the Law on Medicines • SN (randomized unique
• Until March 1, 2020: MOH developing list of pilot no. up to 20 symbols)
participants and medicines. Participants have until • Batch/Lot
Feb. 1, 2020 to decide to take part in the pilot. • Expiry date
• Until Oct. 1, 2020: Ministry of Education and Science
developing state system for serialization. (Ministry is
administrator of the state system.)
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
• Ministry of Education
Not required N/A N/A — and Science
• Ministry of Health
UZBEKISTAN
BARCODING REPORTING
COMPLIANCE DEADLINE DATA CARRIER
REQUIREMENTS REQUIREMENTS
Not defined; will be finalized after 6-month pilot. • GTIN DataMatrix Yes
• SN
• Crypto key (AI 91)
• Crypto signature (AI 92)
AGGREGATION TRACEABILITY GS1 STANDARD TECHNICAL SPECIFICATIONS ADDITIONAL INFO.
Required 1 up, 1 down Required — —
14
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.Additional Resources from rfxcel
AUSTRALIA
OFFICIAL DOCUMENT
Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2020
Therapeutic Goods
Order 106.pdf
BRAZIL
WHITE PAPERS
Quick Guide to Brazil’s National Medicine Control System (SNCM) (English)
Guia Rápido para o SNCM – ANVISA (Portuguese)
WEBINARS
Serialização & Rastreabilidade Conforme o SNCM – ANVISA
ANVISA SNCM Traceability and Serialization (Portuguese and English)
Brazil ANVISA's National System for Medicines Control (SNCM)
BLOG
Brazil Serialization Timeline: Milestones and Requirements
Brazil Track and Trace Requirements and Latest Updates
Brazil Pharma Update: SNCM Changes, ANVISA, and Supply Chain News
PRESS RELEASES
rfxcel to Speak at Pharma Logistics Conference in Sao Paulo
rfxcel Supports ANVISA SNCM for Safer, Traceable Medicines
CHINA
BLOG
The Latest About China’s Pharma Regulatory Requirements
15
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.INDIA
BLOG
India Pharma News: FDA Recalls, COVID-19 Vaccine & Ideas Summit 2020
India Limits Drug Exports, Launches iVEDA Portal, Moves Regulatory Deadline Amid COVID-19 Lockdown
PRESS RELEASES
Top 6 India Pharmaceutical Manufacturers Choose rfxcel
INDONESIA
OFFICIAL DOCUMENT
December 2020: Updated Regulations from the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan, or BPOM)
BPOM Regulations BPOM Regulations
Update_Indonesian.pd Update_English.pdf
RUSSIA
WHITE PAPERS
Russia Chestny ZNAK and Pharmaceutical Compliance
Russia 2021: Overview of Chestny ZNAK Compliance for Key Industries
Russia Chestny ZNAK and the Bottled Drinking Water Industry
Russia Chestny ZNAK and Consumer Goods Compliance
Russia Chestny ZNAK and the Dairy Industry
WEBINARS
Russian Pharma Compliance Update (February 2020)
Everything You Need to Know About the Russian Serialization Requirements (December 2019)
Serialization Requirements in Russia (May 2019)
Serialization Requirements in Russia (July 2018)
16
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.RUSSIA (CONT.)
ARTICLES
What the Dairy Industry Needs to Do to Comply with Strict Russian Regulations in 2021, Food & Drink Industry Magazine (October 2020), by
rfxcel Operations Manager, Russia, Victoria Kozlova
Steps to Compliance: How Best to Prepare for Russia’s 2020 Pharma Regulations, World Pharma Today (May 2019), by rfxcel Operations
Manager, Russia, Victoria Kozlova
Asian pharma companies prepare for Russian regulations, BioSpectrum (October 2019), by Victoria Kozlova
Top Four Questions About Russia’s Serialization Laws, Answered, Supply Chain Brain (March 2020) by Victoria Kozlova
An Overview of Russia’s Pharma Serialization Regulations and its National Track and Trace Digital System, Chestny ZNAK, World Pharma
Today (March 2020) by Victoria Kozlova
BLOG
Requirements for Russia’s Textile and Apparel Supply Chain
Mandatory Dairy Product Labeling in Russia to Begin in Two Months
Russia Chestny ZNAK Bottled Drinking Water Pilot Ending Soon
What Does It Mean to Be a CRPT Partner in Russia’s Supply Chain?
New Russian Serialization Pilot for Biologically Active Food Additives
Russia Dairy Serialization Update: Mandatory Labeling for Cheese and Ice Cream
Russia Serialization Pilot to Combat Counterfeit Beer Set to Begin This Spring
Russia Pharma Serialization Update: “Notification Mode” Expedites Product Circulation
Russia Chestny ZNAK Track and Trace: A Refresher Course
rfxcel Continues Winning Streak in Russian Serialization, Track and Trace
rfxcel Takes Big Step as Leader in Russian Aggregation, Serialization & Supply Chain Compliance
Quick News: Russia Changes 2020 Serialization Deadlines for Footwear
Major Deadline Coming for the Footwear Industry in Russia’s Chestny ZNAK Track and Trace System
Russia Serialization Deadlines: More Changes for Pharma & Other Industries | rfxcel Update
rfxcel’s Ultimate Guide to the 2020 Russian Track & Trace Requirements
How Asian Pharma Companies Can Comply with Russia’s New Serialization Requirements
Russia Serialization Update: Changes to Crypto Code Requirements and Packaging
Simplifying Russian Serialization & Crypto Code
5 Aspects of Russian Pharma Compliance You Should Know Right Now
PRESS RELEASES
rfxcel Accredited as IT Company by Russia’s Ministry of Digital Development, Communications, and Mass Media
rfxcel Ready to Help Dairy Industry Comply with Russia’s 2021 Serialization Regulations
Russia Reporting Update
rfxcel Named Russia CRPT Software and Integration Partner for Nine Industries
rfxcel Enhances Pharmaceutical Track and Trace Solution for Russia
rfxcel Becomes Official Partner with Russia’s CRPT
rfxcel Continues Rapid Growth, Success in Russia
17
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.SAUDI ARABIA
BLOG
Saudi Pharma Compliance: New Aggregation Deadline & More
Saudi Food and Drug Authority : A Quick Guide to Saudi Arabia’s Pharma Regulations
EU FALSIFIED MEDICINES DIRECTIVE (FMD)
WHITE PAPERS
A Quick Guide to The EU Falsified Medicines Directive
Countdown to Complying with the Serialization Requirements of the Falsified Medicines Directive
WEBINARS
The EU Falsified Medicines Directive for Pharmaceutical Dispensers
The EU Falsified Medicines Directive: Data Integrity in a Serialized World (June 2018)
EMVO Onboarding & EU Falsified Medicines Directive (March 2018)
EU Falsified Medicines Directive Webinar: What to Know & Where to Begin (January 2018)
BLOG
What Does the EU COVID-19 Vaccine Distribution Plan Look Like?
Are You Ready for EU FMD? Urgency, Consistency & Planning Are Key
European Union Falsified Medicines Directive is Nearing
ARTICLES
Drastic Measures: What Marketing Authorisation Holders Should Know About the EU FMD
PRESS RELEASES
rfxcel Announces FMD Compliance Solution for Pharma Dispensers
U.S. DRUG SUPPLY CHAIN SECURITY ACT (DSCSA)
WHITE PAPERS
Dispensers and the DSCSA: A Guide to Phases I & II of the U.S. Drug Supply Chain Security Act
DSCSA Verification (VRS Basics)
WEBINARS
DSCSA Guidance, Q&A Session, with Brian Files, DSCSA Strategic Advisor
VRS Update: Understand VRS but Want to Know More? Hear the Latest Updates on the VRS Effort Here (February 2019)
DSCSA and the Verification Router Service: Timelines and Updates (August 2018)
DSCSA & the Verification Router Service Timelines and Updates (August 2018)
DSCSA for Wholesale Distributors (March 2018)
60 Days to DSCSA Compliance (October 2017)
18
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.U.S. DSCSA (CONT.)
ARTICLES
What Pharma Dispensers Need to Do to Comply with U.S. Drug Supply Chain Security Act, Supply & Demand Chain Executive (October
2020), by Brian Files, rfxcel DSCSA Strategic Advisor
BLOG
DSCSA 2023: The Future of Pharmaceutical Traceability in the United States
DSCSA 2023: Understanding DSCSA Authorized Trading Partners, Part 1
DSCSA 2023: Understanding DSCSA Authorized Trading Partners, Part 2
FDA Delays Enforcement of DSCSA Saleable Returns Requirement
Industry Reaction to Delayed Enforcement of DSCSA Saleable Returns
DSCSA 2020: November Is Coming & It’s Time to Comply
DSCSA Saleable Returns Verification Requirement: Just the Facts
FDA DSCSA Guidance Update: Transaction and Distribution Activities During COVID-19 Emergency
New GS1 Guidance for Product Identifiers in the DSCSA Saleable Returns Verification Requirement
What Do Pharma Dispensers Have to Do for the DSCSA?
What Dispensers Need to Know About the DSCSA in 2020
What’s Happening with the DSCSA? Year-End Reflections with Herb Wong, rfxcel’s VP of Marketing & Strategic Initiatives
FDA Delays Enforcement of DSCSA Saleable Returns Verification Requirement
How VRS Can Help the Pharma Industry Prep for the November DSCSA Deadline
Prepping for DSCSA Compliance: A Comprehensive Timeline
Serialization & DSCSA Compliance
What Are the T3 Data Requirements for DSCSA?
PRESS RELEASES
rfxcel Adopts Open Credentialing Initiative (OCI) to meet DSCSA Authorized Trading Partner (ATP) requirements
Ohio Department of Veterans Affairs to Utilize rfxcel’s Drug Supply Chain Security Act Compliance Software
rfxcel to Exhibit, Discuss DSCSA VRS at HDA Traceability Seminar in D.C.
rfxcel Begins Verification Router Service Pilot for the FDA
FDA Approves rfxcel for DSCSA VRS Pilot
19
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.PHARMACEUTICAL SUPPLY CHAIN
WEBINARS
COVID-19 Healthcare Coalition: Coordinating a National Response to Counterfeit Mitigation
COVID-19 Healthcare Coalition Webinar Series on Counterfeit Mitigation: Building a Counterfeit-Resistant Procurement Environment
ARTICLES
Why real-time environmental monitoring is the most important aspect of the modern pharmaceutical cold chain, European Pharmaceutical
Review (March 2021) by rfxcel CEO Glenn Abood
How to optimize the pharma supply chain to aid smooth delivery of COVID-19 vaccines, Biopharma-Reporter (October 2020) interview with
rfxcel CEO Glenn Abood
IoT Is the Key to Supply Chain Continuity, Visibility, and Productivity, World Pharma Today (March 2019) by rfxcel CEO Glenn Abood
Common Hurdles in Cargo Monitoring Logistics for Pharmaceutical Companies — and How to Clear Them, Pharmaceutical Outsourcing
(March 2019) by rfxcel Growth Product Manager Tea Rajic
Temperature-Controlled Innovative Solutions: The Smart Cold Chain, Journal for Clinical Studies, pp. 52-55 (March 2019) by rfxcel Growth
Product Manager Tea Rajic
Future-Proofing Product Alerts And Recalls, Healthcare Purchasing News (December 2019) by rfxcel VP of Marketing and Strategic Initiatives
Herb Wong
Securing the Pharma Supply Chain: A Look Back at How We Got Here and Where We’re Going, International Pharmaceutical Industry
(December 2019) rfxcel CEO Glenn Abood
The Elegant Fundamentals, European Biopharmaceutical Review (January 2020) by rfxcel VP of Quality Management Amit Sewak
BLOG
What Does the EU COVID-19 Vaccine Distribution Plan Look Like?
How the COVID-19 Vaccine Track and Trace Systems Work in the United States
PRESS RELEASES
rfxcel Responds to Unprecedented Cold Chain Requirements and Logistics Challenges as COVID-19 Vaccine Distribution Nears
rfxcel Teams with ICRC for Compliance, Supply Chain Security
rfxcel Working to Reduce Supply Chain Issues
rfxcel Joins the COVID-19 Healthcare Coalition
rfxcel Announces Accurate Immunization Management Solution to Aid in the Fight Against COVID-19
20
Last updated May 5, 2021. rfxcel does not guarantee information reflects each country’s current requirements and deadlines.Contact one of our compliance experts today.
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