Title II of the Drug Quality and Security Act (DQSA), known as the Drug Supply Chain Security Act (DSCSA).

“The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), Critical steps are outlined in the DSCSA to build an electronic, “interoperable” system by November 27, 2023 and improve detection and removal of potentially harmful products from the pharmaceutical distribution supply chain.”

https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

The DQSA can be found here:
https://www.govinfo.gov/content/pkg/PLAW-113publ54/pdf/PLAW-113publ54.pdf

Authority: ANMAT – Administración Nacional de Medicamentos, Alimentos y Tecnología Médica/The National Administration of Medicines, Food and Medical Technology) – Ministry of Health
Status: Published/Adopted
Data Carrier: GS1-128; GS1 Data Matrix; RFID:EPC
Law/Regulation: Disposición ANMAT N° 3683/2011

Google Translate from Spanish to English
Article 1.- “The Drug Traceability System that must be implemented by natural or legal persons involved in the chain of marketing, distribution, and dispensing of medicinal specialties included in the Registry of Medicinal Specialties (REM) of this National Administration in the terms established in article 1 and following of the Resolution of the Ministry of Health No. 435/11, will be applicable, in a first stage, to all those medicinal specialties, already registered or that will be registered in the future, that contain in their composition the Active Pharmaceutical Ingredients (IFA’s) included in ANNEX I that forms an integral part of the present, either as a monodrug or in association with any other IFA’s and in the pharmaceutical forms established in the aforementioned annex.
The established traceability system must be implemented for all the aforementioned medicinal specialties, with the scope and according to the schedule established in ANNEX II, which is an integral part of this Provision.” Disposición ANMAT N° 3683/2011

ANMAT regulations can be found here:
https://agendaregulatoria.anmat.gob.ar/Home

“ANMAT, the Argentinian regulating authority in the sphere of healthcare products, has published a new regulation dedicated to Good Technovigilance Practices in 03.10.2023. The document outlines the requirements that are mandatory for all holders of medical product authorization in the post-market stage.”
(Provision 8194/2023 / DI-2023-8194-APN-ANMAT#MS)

https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-8194-2023-390870/texto

Authority: Ministry of Health and Welfare, Food and Drug Administration
Status: Published
Law/Regulation: Pharmaceutical Affairs Act; Regulations Governing the Trace and Track System for Medicinal Products;

Article 2 – “The “Trace and Track System” stated in the Act 6.1.1 refers to distributors and manufacturers with the medicinal products which categorized and announced by the central competent health authority (hereinafter referred to as medicinal products), shall establish their own information system for tracing the source and tracking the flow of the medicinal products according to manufacturing, import, sale or export process and establish the information system and management measures.
The “Trace and Track System” stated in the Act 6.1.2 refers to the system established by central competent health authority in order to manage the system stated in the preceding paragraph.” Regulations Governing the Trace and Track System for Medicinal Products
https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0030083

Authority: ANVISA (Agência Nacional de Vigilância Sanitária)

Designation: SNCM (National Medicine Control System), RDC ANVISA No 157/2017, Law No. 5.991/1973.

Status: On hold

Data Carrier: GS1 2D Data Matrix

The SNCM requires unit-level serialization, track and trace, and monitoring environmental conditions as products move through the supply chain. Every item must be visible at the unit level, and all products must have a GS1 2D DataMatrix code with the following information:
-Global Trade Item Number (GTIN)
-13-digit ANVISA Medicine Registry Number
-Unique 13-digit serial number
-Expiration date (in the MM/YY format for human-readable form)
-Lot/batch number (up to 20 alphanumeric characters)

There are three key requirements for April 2022:
-All prescription medicines must be serialized.
-All manufacturers and importers must have a “serialization plan” in the SNCM portal.
-All supply chain stakeholders must submit product event reports to the SNCM.

https://www.gov.br/anvisa/pt-br

Authority: Medicines and Healthcare Products Regulatory Agency
Status: Published/Adopted
Data Carrier: GTIN+GLN
Law/Regulation: Medicinal and Medical Devices Act

After Brexit, The United Kingdom has no intend to follow the standard set by EU. Under Medicinal and Medical Device Act Part 2, Chapter 4 Falsified Medicine, in order to prevent supply of falsified human medicine, provisions may be made that medicine packages should carry unique identifiers and anti-tamper devices.
On the other hand, Northern Ireland intend to follow the EU standard FMD due to Protocol on Ireland/ Northern Ireland.
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#full-publication-update-history

Authority: European Medicines Agency (EMA)
Law/Regulation: Falsified Medicines Directive (FMD); COMMISSION DELEGATED REGULATION (EU) 2016/161

Paragraph 9, “In order to facilitate enforcement of and control of compliance with Union rules relating to active substances, the manufacturers, importers or distributors of those substances should notify the competent authorities concerned of their activities.”–DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 8 June 2011

Paragraph 4, “This Regulation sets out a system where the identification and the authentication of medicinal products is guaranteed by an end-to-end verification of all medicinal products bearing the safety features, supplemented by the verification by wholesalers of certain medicinal products at higher risk of falsification. In practice, the authenticity and integrity of the safety features placed on the packaging of a medicinal product at the beginning of the supply chain should be verified at the time the medicinal product is supplied to the public, although certain derogations may apply. However, medicinal products at higher risk of falsification should be additionally verified by wholesalers throughout the supply chain, to minimise the risk of falsified medicinal products circulating undetected for lengthy periods of time. The verification of the authenticity of a unique identifier should be performed by comparing that unique identifier with the legitimate unique identifiers stored in a repositories system. When the pack is supplied to the public, or is distributed outside the Union, or in other specific situations, the unique identifier on that pack should be decommissioned in the repositories system so any other pack bearing the same unique identifier could not be successfully verified. “–COMMISSION DELEGATED REGULATION (EU) 2016/161

The European Commission did not specify a method for serialization, but it gave technical specifications (linear barcode, 2D barcode, RFID, etc.) to manufacturers/countries.
See: https://www.drugtrackandtrace.com/tracktrace-systems-in-europe/

Authority: Ministry of Health
Status: Draft
Data Carrier: Blockchain
Law/Regulation: N/A

Mongolia planned on adopting blockchain technology to put pharmaceutical track and trace into action. The company they sought was Farmatrust.
“FarmaTrust provides an enterprise ready blockchain solution which provides end to end provenance of pharmaceutical products. Our solution seals the pharmaceutical supply chain from fake or substandard medicines, thereby safeguarding consumers who can use our free Consumer Confidence App to check the authenticity of medicinal products.”

https://www.farmatrust.com/copy-of-pharmaceutical-tracking-dat

Authority: Ministry of Health & Welfare (MoHW)- Korea Pharmaceutical Information Service (KPIS)
Status: Published/Adopted
Law/Regulation: Pharmaceutical Affairs Act; Enforcement Regulation of the Pharmaceutical Affairs Act Notification of revision of Article 45 (Executive order made by MoHW, No. 363, Nov. 11, 2015); Guideline for Pharmaceutical Serialization System
Data Carrier: Korea Drug Code (KD code) – GTIN-13, RFID tag

Notes: Article 47-2 Paragraph 2 of the Pharmaceutical Affairs Act, “Where deemed necessary, the Minister of Health and Wealth may request the submission of the expense report, books related thereto, and base data under paragraph (1). In such cases, a drug provider shall comply therewith without justifiable grounds.”

Article 45 of the Pharmaceutical Affairs Act (Licenses of Drug Distribution Business)

According to Article 47-2 Paragraph 2 of the Pharmaceutical Affairs Act, and Article
45 (Drug transaction record report, etc.) of the Enforcement Regulation of the
Pharmaceutical Affairs Act, when persons who obtained permission for drug items,
drug importers or pharmaceutical wholesalers supply finished drugs (including
narcotics, ultra-narcotics and psychotropic drugs) to healthcare providers, pharmacies,
wholesalers or convenient store, the transaction transaction records shall be reported
to KPIS in the provided form.

See: Guideline for Pharmaceutical Serialization System, https://www.hira.or.kr/eng/news/01/__icsFiles/afieldfile/2016/04/18/YCXC4fxrdefQ.pdf

See also: Korea Law Translation Center, PHARMACEUTICAL AFFAIRS ACT of Korea, https://elaw.klri.re.kr/eng_service/lawView.do?hseq=40196&lang=ENG

Authority: Ministry of Health, Labour and Welfare(厚生労働省)
Status: Published/Adopted
Data Carrier: GS1 Data Matrix
Law/Regulation: Act on Securing Quality, Efficacy and Safety of Products
Including Pharmaceuticals and Medical Devices (Japan Pharmaceutical Affairs Act)

Notes: Google Translate from Japanese to English
Article 52 (Inscription of Codes, etc. on Containers, etc.)
Medicines (excluding medicines prescribed in the following paragraph) shall be packaged or encapsulated in a method that uses an electronic information processing system or other information communication technology, and that is specified by an Ordinance of the Ministry of Health, Labor and Welfare. Numbers, symbols and other codes required to obtain information such as precautions prescribed in Article 68-2, paragraph (2) that have been made public pursuant to the provisions of Article 68-2, paragraph (1) shall be entered according to what is specified. must. provided, however, that this shall not apply when otherwise provided for by an Ordinance of the Ministry of Health, Labor and Welfare.
2. Guidance-required drugs, over-the-counter drugs, and other drugs specified by an Ordinance of the Ministry of Health, Labor and Welfare shall include the following matters based on the knowledge obtained from the latest papers on the drug, etc. must be stated. provided, however, that this shall not apply when otherwise provided for by an Ordinance of the Ministry of Health, Labor and Welfare.

1. Usage, dosage and other necessary precautions for use and handling
2. For pharmaceuticals listed in the Japanese Pharmacopoeia, matters specified in the Japanese Pharmacopoeia to be described as matters related to the quality, efficacy and safety of the pharmaceuticals.
3. In the case of in-vitro diagnostics for which the standards have been established pursuant to the provisions of Article 41, paragraph 3, state the matters related to the quality, efficacy and safety of the in-vitro diagnostics in the standards. Matters defined as
4. In the case of pharmaceuticals for which the standards have been established pursuant to the provisions of Article 42, paragraph 1, the matters stipulated in the standards to be stated as matters related to the quality, efficacy and safety of the pharmaceuticals.
5. In addition to the items listed in the preceding items, matters specified by the Ministry of Health, Labor and Welfare Ordinance

See: Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律) https://elaws.e-gov.go.jp/document?lawid=335AC0000000145_20220525_504AC0000000048&keyword=%E8%96%AC

Authority: NMPA – National Medical Products Administration (former CFDA)

Status: Published/Adopted

Data Carrier: Researchers recommend pharmaceutical companies to use GS1 standards, as it complies to “Identification specification for drug traceability code”

Law/Regulation: Medicinal Product Administration Law of the People’s Republic of China (2019 Revision); Identification specification for drug traceability code NMPAB/T 1011—2022

Notes:
Article 12, Paragraph 1, Medicinal Product Administration Law of the People’s Republic of China (2019 Revision), ”The state shall establish and improve a medicinal product traceability system. The medicinal product regulatory department of the State Council shall develop unified medicinal product traceability standards and specifications, advance the interconnection and mutual sharing of medicinal product traceability information, and achieve medicinal product traceability.”

Translation from: http://lawinfochina.com/display.aspx?id=31583&lib=law

Authority: Ministry of Health and Family Welfare of India
Data Carrier: GS1-128; GS1 Data Matrix
Law/Regulation: Section 5 of the Foreign Trade (Development & Regulation) Act, 1992 (No. 22 of 1992); Foreign Trade Policy 2015-2020; Public Notice No. 13 /2015-2020

Notes:
Paragraph 1, Public Notice No. 13 /2015-2020 (Implementation of the Track and Trace system for export of drug formulations), “In exercise of the powers conferred under Paragraph 2.04 of the Foreign Trade Policy, 2015-20, as amended from time to time, the Director General of Foreign Trade hereby amends Para 2.89 A of Handbook of Procedure, 2015-20, as notified vide Public Notice No. 4/2015-20 dated 01.04.2015, as under, for laying down the procedure for implementation of the Track and Trace system for export consignments of drug formulations.”

See: https://content.dgft.gov.in/Website/pn1315.pdf

Authority: The Therapeutic Goods Administration (TGA) Health and Aged Care

Status: Published/adopted

Data Carrier: GS1 Data Matrix

Law/Regulation: Therapeutic Goods Act 1989; Therapeutic Goods Order No. 91; Therapeutic Goods Order No. 92

Notes:
Section 10, paragraph(2)(c) of the Therapeutic Goods Act 1989, “Without limiting the generality of subsection (1), an order establishing a standard for therapeutic goods may: …require that therapeutic goods or a class of therapeutic goods identified in the order be labelled or packaged in a manner, or kept in containers that comply with requirements, specified in the order.”

Section 10, paragraph(3) of the Therapeutic Goods Act 1989,
“Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard, direct that there be set out, in a manner specified in the order, on:
(a) therapeutic goods or a class of therapeutic goods identified in the order; or
(b) a container or package containing therapeutic goods or a class of therapeutic goods identified in the order; or
(c) a label of therapeutic goods or a class of therapeutic goods identified in the order;
such particulars as are required by the order.”

See: https://www.legislation.gov.au/Details/C2021C00376

Authority: ANVISA (Agência Nacional de Vigilância Sanitária)
Status: On hold
Data Carrier: GS1 Data Matrix
Law/Regulation: Law 11903 of January 14, 2009; BILL 3846

Notes: Google Translate-Paragraph 1, Law 11903 of January 14, 2009, “Provides for tracking the production and consumption of medicines through technology for capturing, storing and electronic data transmission.”

See: Bill 3846, which proposes including a QR code for a digital package insert, also contains text that revokes the requirement to individually serialize a drug. This Bill was approved by Senate on April 12, 2022, thus establishing that drug serialization will no longer be necessary in Brazil. In addition, the Bill revokes the requirement on ANVISA to create the National Drug Control System itself.

See: https://www.optelgroup.com/en/blog/bill-3846-and-the-brazilian-national-drug-control-system/

Authority: Republic of Turkey Ministry of Health – Turkish Medicines and Medical Devices Agency (TİTCK)

Status: Published/Adopted

Data Carrier: GS1 Data Matrix

Law/Regulation: Implementing Regulation on the Labeling, Package Leaflet and Tracing of Human Medicinal Products

Notes:

ARTICLE 1, Implementing Regulation on the Labeling, Package Leaflet and Tracing of Human Medicinal Products, “The objective of this Implementing Regulation is to set the procedures and principles regarding the information which must be available on labeling, package leaflet of authorized
or permitted human medicinal products and allow more effective efforts against defective and falsified human medicinal products by tracing and registration system in supply chain to handle public safety.”
See: https://www.titck.gov.tr/

Authority: Pakistan Drug Regulatory Authority (DRAP); Ministry of National ‘Health Services, Regulations & Coordination, and Ministry of Commerce and Industry

Status: Published/Adopted

Data Carrier: GS1 Data Matrix; GTIN

Law/Regulation: DRAP Track and Trace Regulation for import, export and domestic manufacture; notification S.R.O. 962(I)/2019; Supreme Court decision

Notes:

Supreme Court decision: “[…] We also direct that all the pharmaceutical companies, within a period of three months, shall implement and enforce a bar code not only on the box but also on the wrappers affixed upon the containers/bottles of the pharmaceutical products […]”

See: https://caselaw.shc.gov.pk/caselaw/view-file/MTI1MDA2Y2Ztcy1kYzgz

On August 27, 2019 DRAP published a statutory notification S.R.O. 962(I)/2019 stating that it had amended the regulations with the following deadlines and changes:
– All manufacturers and importers will print 2D barcode in 6 years (August 27, 2025)
– 2D barcode printing on primary package will be
omitted
– AI 240 data element in the 2D barcode will also be omitted

See: https://cdn2.hubspot.net/hubfs/3844090/2020-Regulatory-Updates/Systech-Pakistan-RegUpdate_02-2020.pdf
See also: Notification S.R.O. 962(I)/2019 http://www.pcp.gov.pk/SiteImage/Downloads/1290(19)Ex%20Gaz-II.pdf?iqeiaynzriqnrzpl?nhvomwsihvomfiho?pojqxldxuojzfriq?tdqeiahfrpvhfiqe?zfkegdgtmyufkepc?xsbcojjjjjjjsiqg?omwsrgtdqesrzfke?xbmfkbcvocvqxbmp?dnzargmixskumynk?gdezpojzfbjjzfbz?btkufumywsixlwjs?dxlwskbzrsrplufr?clnhmpeplnaynzah?vxbcoakluojzfrsi?hvxbmfkldnhoaakb?tdnzahyufkegmpcv?dgtmpvqezwjskumi?dxlgkuvhfrgmixbj?rpclgkumywsixuoa?qnahvqgtkegdgdei?pezynhfkbtdgmynz?deihmpegdgtmpegm?wsbjskuvhfiqeiay?xbjccepezydgmyws?myufkegdgdnhfklu

Authority: EU Commission; Ministry of Health

Status: Published/Adopted

Law/Regulation: Article 40 of Law 39/2002

Data Carrier: progressive numeric ID code (“Bollino”)

Notes:

Google translate from Italian to English

Article 40 of Law 39/2002
(Amendment to legislative decree no. 540 of 30 December 1992, regarding the labeling of medicinal products for human use).

1. To the legislative decree 30 December 1992, n. 540, and subsequent amendments, the following is inserted after article 5:
“Art. 5-bis. – (Pharmaceutical stamps). – 1. The Minister of Health
establishes, with its own decree, the technical requirements and procedures
for the adoption, by March 31, 2001, of the letter
progressive, for each package, of self-adhesive stickers with automatic reading of prescription medicines in the context of the National Health Service referred to in the decree of the Minister of Health of February 29, 1988, published in the Official Gazette no. 79 of 5 April 1988, and subsequent amendments. Starting from the sixth month following the date of publication of the decree referred to in the previous period, the packaging of medicines that can be supplied by the National Health Service must be equipped with stamps that comply with the prescriptions of the aforementioned decree. It is established at the
Ministry of Health, a central database which, starting from the production and supply data of the numbered stamps referred to in the first sentence of this paragraph, collects and registers the movements of the individual packages of medical products by detecting the product code and the number identification of the packages affixed to them. By June 30, 2002, the Minister of Health, with its own decree, establishes the methods and times for setting up and operating the database and the methods of accessing it. Producers are required to file and transmit to this database the product code and the identification number of each piece released and its destination; depositaries, wholesalers,
pharmacies open to the public and authorized health centers
for the use of drugs, they are required to file and transmit the product code and the identification number both of each of the pieces entered and of each of the pieces in any case released or used and, respectively, the origin or destination in cases where it is different from the individual final consumer; local health authorities are required to file and transmit the product code number and the identification number of each of the prescribed parts on their own behalf; authorized disposers are required to archive e-transmit the product code and the identification number of each pharmaceutical package sent for disposal as pharmaceutical waste. Starting from January 1, 2003, all packs of medicinal products placed on the market must be equipped with labels that comply with the provisions of this paragraph. Failure or incorrect storage of data or failure or not correct transmission of the same according to the provisions of this paragraph and of the ministerial decree envisaged by the fourth sentence of this paragraph entails the application of a pecuniary administrative sanction from 1,500 euros to 9,000 euros “.

See: Art. 40, LEGGE 1 marzo 2002, n. 39.

Authority: EU Commission; ANSM,National Agency for the Safety of Drugs and Health Products (previous: the French Agency of Sanitary Safety and Health Products (AFSSAPS))

Status: Published/Adopted

Data Carrier: Code CIP

Law/Regulation: Public Health Code Article L5121-5,

Notes: Google Translate from French to English

Article L5121-5, Public Health Code

“The preparation, import, export, wholesale distribution and brokerage activity of medicinal products as well as pharmacovigilance must be carried out in accordance with good practices, the principles of which are defined by decision of the National Agency for drug and health product safety.

For gene therapy preparations and xenogeneic cell therapy preparations mentioned in 12° and 13° of Article L. 5121-1, in addition to the activities mentioned in the first paragraph, these good practices relate to conservation, transfer and export. They are set by decision of the National Agency for the Safety of Medicines and Health Products, after consulting the Director General of the Biomedicine Agency when they concern xenogenic cell therapy preparations.

The preparation, storage, distribution and disposal of the advanced therapy medicinal products mentioned in 17° of Article L. 5121-1 must be carried out in accordance with the good practices mentioned in the first paragraph of this article or with good practices the principles of which are defined by decision of the French Agency for the Safety of Health Products, after consulting the Director General of the Biomedicine Agency, when these good practices concern somatic cell therapy medicinal products, products derived from tissue engineering or advanced therapy combination drugs.

The dispensing, including by electronic means, of medicines must be carried out in accordance with good practices, the principles of which are defined by order of the Minister responsible for health.

These good practices provide in particular for the follow-up methods making it possible to ensure, during each of the above-mentioned operations, the traceability of the medicines. “

Authority: ARCSA – Agencia Nacional de Regulacion, Control y Vigilancia Sanitaria

Status: On hold

Data Carrier: GS1; GS1-128

Law/Regulation: Article 79 of Decree 337

Notes: Article 79 of Decree 337 published by the Ecuadorian government on February 1 describes very high-level requirements for medicines traceability when supplied to the RPIS (Public Health Network). No further details have been made available.

Authority: Canadian Institute for Safe Medication Practices (ISMP), Canadian Patient Safety Institute (CPSI)

Status: Proposed

Law/Regulation: N/A

Notes: N/A

Authority: Conditions for Marketing Authorization of Drug in Tunisia

Status: Draft

Notes: N/A

Authority: EU Commission

Status: Published/Adopted

Data Carrier: GS1 Data Matrix

Law/Regulation: Bundesrecht konsolidiert: Gesamte Rechtsvorschrift für Arzneimittelbetriebsordnung 2009, Fassung vom 04.09.2022 (Google translate: Federal law consolidated: Entire Legal Provision for the Pharmaceutical Operating Regulations 2009, version of 04.09.2022)

Notes: Google Translate from German to English

Article 2 “9. ‘good distribution practice’ means the part of pharmaceutical quality assurance which ensures that the distribution of medicinal products and active substances is carried out consistently in accordance with quality standards which ensure the proper quality of medicinal products and active substances during transport and storage; For the interpretation of the principles of good distribution practice, the generally accepted scientific principles and requirements set out in the guidelines published by the European Commission pursuant to Articles 47(4), 84 and 85b(3) of Directive 2001/83/EC on the Community code relating to medicinal products for human use shall be used. OJ L 311, 28.11.2001, p. 67, as last amended by Directive 2011/62/EU amending Directive 2001/83/EC on the Community code relating to medicinal products for human use as regards the prevention of the entry of falsified medicinal products into the legal supply chain. “

Article 31, Specific storage and labelling requirements, “(3) If a starting material is transferred from the original container to another container, the new container – without prejudice to any further labelling requirements – shall in any case be marked with the following information:

1. name of the substance or article code,
2. entry or control number,
3. weight or dimension in the new container and
4. where applicable, the approach for which the substance has been provided, including the name of the preparation to be manufactured and the batch number.”

Authority: EU Commission

Status: Published/Adopted

Data Carrier: GS1 Data Matrix

Law/Regulation: (Google Translate from Greek to English) Harmonization of Greek legislation with the corresponding EU legislation in the field of production and circulation of medicinal products for human use, in compliance with No. 2001/83/EC Directive “on the Community Code for Medicinal Products for Human Use” (L 311/28.11.2001), as in force and as amended by Directive 2011/62/EU, on preventing falsified medicinal products from entering the legal supply chain (L 174/1.7.2011)

Notes: Google Translate from Greek to English

Article 77 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B 1049/2013

“The outer packaging or, in the absence of an external packaging, the immediate packaging of each medicinal product, is approved by the EOF and must bear the following particulars, in accordance with the particulars and documents on the file and the summary of its characteristics

(a) The name of the medicinal product, accompanied by the strength and pharmaceutical form; Where required, the relevant indication, depending on whether it is intended for infants, children, adults. If the medicinal product contains up to three active substances, the international non-proprietary name (INN) or, in the absence thereof, the generic name shall be indicated,

(b) the qualitative and quantitative composition in active substances per unit dose or, depending on the form of administration, for a specified volume or weight, using the generic names;

(d) a list of excipients whose action or effect is recognised and which are included in detailed guidelines published pursuant to Article 90. However, if the product is injectable or intended for local or ocular use, all excipients must be indicated,

e) the manner and, if necessary, the route of administration. (

f) a specific warning that the medicinal product must be kept out of the reach of children and out of sight,

(g) other special warnings, where appropriate, for the medicinal product,

(h) the expiry date in a clear manner (month/year),

(i) special precautions for the preservation of the medicinal product,

(j) special precautions for disposal of unused medicinal products or waste resulting from medicinal products, where appropriate, as well as an indication of appropriate existing collection systems

(k) The name and address of the marketing authorisation holder and, where applicable, of the representative designated by the marketing authorisation holder

l) the number of the marketing authorization,

m) the production batch number,

n) the instructions for use, in the case of over-the-counter medicinal products subject to the non-prescription regime. (over-the-counter medications).

(o) for medicinal products other than radiopharmaceuticals referred to in Article 78(1), the safety features enabling holders of a wholesale distribution authorisation for medicinal products and persons qualified to supply medicinal products to the public:

– verify the authenticity of the medicinal product and
-verify the identity of individual packages;

as well as a mechanism to verify whether the outer packaging has been tampered with.”

Authority: EU Comission/ The Health Products Regulatory Authority

Status: Published/Adopted

Data Carrier: GS1 Data Matrix

Law/Regulation:

MEDICINAL PRODUCTS (SAFETY FEATURES ON PACKAGING) REGULATIONS 2022; S.I. No. 162/2013 – Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013

Notes:

S.I. No. 162/2013 – Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013.

PART 9

SYSTEM TO PREVENT MEDICINAL PRODUCTS, SUSPECTED OF PRESENTING A DANGER TO HEALTH, REACHING PATIENTS

System to be operated by the Board

1. (1) The Board shall, in accordance with this Regulation, operate a system, which aims to prevent medicinal products that are suspected of presenting a danger to health from reaching patients.

(2) The system referred to in paragraph (1) shall provide for—

(a) the receipt and handling of notifications of suspected falsified medicinal products and suspected quality defects of medicinal products,

(b) the recall from the market of medicinal products by holders of Community marketing authorisations, marketing authorisations, certificates of registration or certificates of traditional-use registration,

(c) the withdrawal from the market of medicinal products from all relevant actors in the supply chain both during and outside normal working hours,

(d) the recall from the market, where necessary with the assistance of health professionals, of medicinal products from patients who have received such products.

(3) If the Board identifies a medicinal product which is suspected of presenting a serious risk to public health, it shall, where necessary and without delay, rapidly transmit a notification to all EEA States and to all actors in the supply chain who are located in the State and who may hold stocks of the relevant medicinal product.

(4) In the event of such a medicinal product referred to in paragraph (3) being deemed to have reached patients, the Board shall, where necessary, issue urgent public announcements within 24 hours in order to recall that medicinal product from the patients.

(5) The announcements referred to in paragraph (4) shall contain sufficient information on the suspected quality defect or falsification of the medicinal product and the risks involved.”.

Authority: Federal Commission for the Protection against Sanitary Risk (COFEPRIS)

Status: Draft

Law/Regulation: N/A

Notes: Google Translate from Spanish to English

OFFICIAL MEXICAN STANDARD NOM-059-SSA1-2015, GOOD MANUFACTURING PRACTICES OF MEDICINES

9.13.5 
They must have a traceability matrix documenting multiple stages of specifications (including revisions) and testing once they have been satisfactorily completed.

Authority: Ministerio de Salud y la Protección Social (Ministry of Health and Social Protection) INVIMA – Instituto Nacional de Vigilencia de Medicamentos y Alimentos – Columbia

Status: Draft

Data Carrier: N/A

Law/Regulation: N/A

Authority: Ministry of Armenia

Status: Published/Adopted

Data Carrier: GS1 Data Matrix

Law/Regulation: Regulation no. 173 (Google Translate)

Notes: Google translate from Armenian to English

Regulation no. 173

5.8.         Supply

Medicines supply need is be accompanied member of states by legislation planned with documents ( invoice , waybill _ bill of lading , international bill of lading , invoice , air bill of lading and: etc. ). Medicines companion in the documents noted are as follows: information: the date of the drug name , serial ( batch ) number , supplied quantity , pharmaceutical form , dosage , supplier the name and: address , cargo recipient the name and: address ( wholesale : of storage location wild address if _ that differs is legal person from address ), as also transportation transportation and: maintenance conditions :

Supply about the records subject to are maintenance so that _ be provided of medicines of movement traceability .

Authority: Ministry of Health

Status: Draft

Data Carrier: GS1 Data Matrix; GTIN

Law/Regulation: N/A

Authority: Ministerio de Salud SubSecretaria de Salud Publica División Juridica

Status: Published/Adopted

Law/Regulation: N/A

Authority: FMOH (Federal Ministry of Health); FMHACA (Food, Medicine and Health Care Administration and Control Authority); PFSA (Pharmaceuticals Fund and Supply Agency)

Status: Published/Adopted

Data Carrier: GS1-128; GS1 Data Matrix

Law/Regulation: The Food and Medicine Administration Proclamation 1112/2019

Notes:

Definition (Article 2)

“barcode” means a machine-readable code in the form of numbers and a pattern of parallel lines printed on and
identifying a product for the purpose of monitoring by the manufacturer or executive organ;

Mandatory Labeling requirements (Article 54)

No person may import or place into use of any medicine or medical device unless its labelling contains a barcode

Detail requirement will be provided in other subsidiary laws (regulation or directive) to be adopted to implement
Proclamation 1112/2019

Effectiveness Date (Article 74)

The mandatory barcode requirement will come it to effect at the eighteenth month from February 5, 2019

Authority: Ministry of Health

Status: Published/Adopted

Data Carrier: GS1 Data Carrier

Law/Regulation: Drug Barcoding Specifications

Notes:

Introduction, Drug Barcoding Specifications, “Unified standards for automatic identification in the health-care field provide an opportunity to make GCC’s drug supply chain safer yet more efficient and accurate. The Gulf Health Council (GHC) Central Drug Registration believes that a standardized identification system from manufacture to patient delivery is imperative to comply with the increasing need for product integrity and traceability.
Therefore, and because the Global Standards (GS1) system, which the global healthcare community has endorsed, is one of the most widely used trade item identification systems worldwide (GS1, 2011), the Gulf Health Council urges all drug manufacturers in GCC and international manufacturers exporting to GCC to adopt GS1 supply-chain standards. This document outlines this project’s new requirements, benefits, and current and future objectives.”

Authority: Ministry of Health

Status: Published/Adopted

Data Carrier: GS1 Data Matrix

Law/Regulations: Guidelines on the implementation of 2D data Matrix Barcode for Pharmaceuticals in Lebanon

Notes:

Introduction, Guidelines on the implementation of 2D data Matrix Barcode for Pharmaceuticals in Lebanon,”With continuing and increasing pressure to reduce healthcare costs and improve patient safety,
there is a perpetual need to identify and refine how proven technologies are used to increase the efficiency of supply chain procurement, replenishment and logistics processes and enhance the quality of patient care.
The objective of these guidelines is to ensure safety and quality of pharmaceutical products on the Lebanese market. It sets out appropriate steps to assist in fulfilling the responsibilities of all stakeholders to provide a track and trace tool that will help build an integrated people centered system that promotes and sustains the health status of the Lebanese community.
The Lebanese Ministry of Public Health issues these guidelines, according to the international guidelines of the GS1. The ministry stresses the importance of adhering to it by all parties involved, as relevant to the particular role that they play, believing that the bar-coding technology adds an extra level of patient safety to the medication administration process, reducing medication errors and making the technology increasingly more popular in hospitals
and health systems.”

Authority: Ministry of Trade and Ministry of Health

Status: Draft

Data Carrier: GS1 Data Matrix

Law/Regulation: N/A

Authority: MoH; Ministerial appointed Quality Improvement Committee; MedSafe

Status:

Law/Regulation: Guideline on the Regulation of Therapeutic Products in New Zealand Part 5, Labelling of medicines and related products

Notes:
Section 4, Best practice guidance on labelling of medicines, 4.2. Barcoding on medicine labels,” Barcoding is an important tool for ensuring correct identification and selection of medicines and reducing medication errors. Whilst it is not mandatory for labels on medicines supplied in New Zealand to include a barcode, sponsors are strongly encouraged to place bar codes on original packs at the point of manufacture/packing. This recommendation applies to single-dose packs as well as multi-dose packs. Given that barcoding is increasingly being used internationally, it is expected that most products will have a barcode and that barcoding will become mandatory in the near future.”

Authority: Ministry of health/ Gulf Health Council

Status: Published/ Adopted

Data Carrier: GS1 Data Matrix

Law/Regulation: Drug Barcoding Specifications

Notes: Introduction, Drug Barcoding Specifications, “Unified standards for automatic identification in the health-care field provide an opportunity to make GCC’s drug supply chain safer yet more efficient and accurate. The Gulf Health Council (GHC) Central Drug Registration believes that a standardized identification system from manufacture to patient delivery is imperative to comply with the increasing need for product integrity and traceability.
Therefore, and because the Global Standards (GS1) system, which the global healthcare community has endorsed, is one of the most widely used trade item identification systems worldwide (GS1, 2011), the Gulf Health Council urges all drug manufacturers in GCC and international manufacturers exporting to GCC to adopt GS1 supply-chain standards. This document outlines this project’s new requirements, benefits, and current and future objectives.”

Authority: Ministry of Health of the Russian Federation

Status: Published/Adopted

Data Carrier: GS1 Data Matrix (Crypto Code)

Law/Regulation: FEDERAL LAW OF THE RUSSIAN FEDERATION No. 61-FZ DATED 04/12/2010 ON THE CIRCULATION OF DRUGS (AS AMENDED IN ACCORDANCE WITH FEDERAL LAW No. 425-FZ DATED 12/28/2017) (Google Translate)

Notes: Google Translate Russian to English

Article 46. Labeling of medicines, section 2, THE CIRCULATION OF DRUGS, “Pharmaceutical substances should be put into circulation if their primary packaging in a well-readable font in Russian indicates the name of the pharmaceutical substance (international non-proprietary, or grouping, or chemical and trade names), the name of the manufacturer of the pharmaceutical substance, the batch number and date of manufacture, the quantity in packaging and quantity units, expiration date and storage conditions.”

Authority: Ministry of Health

Status: Draft

Law/Regulation: N/A