Compliance map
Wszystko, co musisz wiedzieć o serializacji
– w jednym miejscu, na bieżąco aktualizowane
Algeria
Regulation name:
National Agency for Pharmaceutical Products traceability mandate
Serialization status:
Initiated in 2025
Argentina
Regulation name:
Resolution 435/2011 – Argentina National Drug Traceability System
Serialization status:
Active
Australia
Regulation name:
TGO 106
Serialization status:
Active
Austria
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Azerbaijan
Regulation name:
Law of the Republic of Azerbaijan on Medicinal Products
Serialization status:
In progress
Bahrain
Regulation name:
Bahrain NHRA Regulation
Serialization status:
Active
Belgium
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Bolivia
Regulation name:
Ley N° 1737 (1996), Decreto Supremo N° 25235 (1998); no current decree on serialization or traceability
Serialization status:
Brazil
Regulation name:
RDC 157/2017, Law 13.410/2016 – National Medicine Control System (SNCM)
Serialization status:
In progress but effectively suspended
Bulgaria
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Canada
Regulation name:
Serialization status:
Not mandatory
Central Africa
Regulation name:
Central Africa Track & Trace Framework
Serialization status:
Regional implementation underway
Chile
Regulation name:
Pilot programs only (no national law yet) – e.g., voluntary GS1 pilots under ANAMED/ISP oversight
Serialization status:
China
Regulation name:
National Medical Products Administration
Serialization status:
Active
Colombia
Regulation name:
Voluntary pilot initiatives (GS1 traceability system under INVIMA); Law 1122/2007 mandates traceability framework but no mandatory serialization yet
Serialization status:
Croatia
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Cyprus
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Czechia
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Denmark
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Ecuador
Regulation name:
Serialization status:
Egypt
Regulation name:
Egyptian Pharmaceutical Track & Trace System (EPTTS)
Serialization status:
Barcoding mandatory since 2022
Estonia
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Ethiopia
Regulation name:
Ethiopian Pharmaceutical Products Traceability Directive (No. 43/2019) and EFDA Traceability Master Data Guideline
Serialization status:
Phased implementation (2022–2027)
Finland
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
France
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Germany
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Ghana
Regulation name:
Ghana Pharmaceutical Traceability Strategy (2022) & FDA traceability guidelines (2023)
Serialization status:
No serialization law; anticounterfeit measures in place
Greece
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Hungary
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Iceland
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
India
Regulation name:
India iVEDA Compliance
Serialization status:
Required for drug exports
Indonesia
Regulation name:
BPOM Regulation No.33 of 2018 on the Application of 2D Barcodes for Food and Drug Control
Serialization status:
In progress
Ireland
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Italy
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Jordan
Regulation name:
JFDA Implementation Guideline for Barcode Labeling of Prescription Drugs
Serialization status:
Serialization on secondary packaging required; extended deadline: June 30, 2025
Kazakhstan
Regulation name:
Order No. 453: On Approval of the Rules for the Labeling and Traceability of Medicinal Products
Serialization status:
Active
Kenya
Regulation name:
Pharmacy and Poisons Board (PPB) Pharmaceutical Traceability Initiative (in development)
Serialization status:
Developing serialization framework
Kyrgyzstan
Regulation name:
Serialization status:
Active
Latvia
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Libya
Regulation name:
Decision No. 379/2023 on Pharmaceutical & Medical Device Serialization
Serialization status:
Mandatory serialization since January 2024
Liechtenstein
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Lithuania
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Luxembourg
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Malta
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Morocco
Regulation name:
Draft national pharmaceutical traceability regulation (under development, not yet enacted)
Serialization status:
Serialization regulations under discussion
Netherlands
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Nigeria
Regulation name:
NAFDAC Pharmaceutical Products Traceability Regulations
Serialization status:
No national serialization mandate
Norway
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Paraguay
Regulation name:
Decree 2479/24 (Sep 2024) – updates Law 1119/97 for registration and labeling; Decree 2942/2024
Serialization status:
Peru
Regulation name:
Legislative Decree No. 1161 (Law on Health Products), Supreme Decree No. 016-2011-SA (DIGEMID regulation)
Serialization status:
Philippines
Regulation name:
Serialization status:
On hold
Poland
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Portugal
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Romania
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Russia
Regulation name:
Federal Law No. 488-FZ
Serialization status:
Active
SADC Region
Regulation name:
SADC Regional Pharmaceutical Traceability Harmonization Initiative
Serialization status:
Progressive adoption across member states
Saudi Arabia
Regulation name:
Saudi Arabia SFDA Compliance
Serialization status:
Active
Slovakia
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Slovenia
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
South Africa
Regulation name:
Government Notice No. 988 of 2017 (NDoH) and SAHPRA serialization guidelines (2022–2024)
Serialization status:
No national serialization mandate
South Korea
Regulation name:
SOUTH KOREAN SERIALIZATION REGULATION
Serialization status:
Active
Spain
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Sweden
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Switzerland
Regulation name:
EU Falsified Medicines Directive
Serialization status:
Active
Tunisia
Regulation name:
No national serialization law; companies voluntarily exploring GS1 serialization (e.g., UNIMED & Laboratoires MédiS) for export compliance
Serialization status:
Exploring serialization implementation
Turkey
Regulation name:
Ürün Takip Sistemi (ÜTS) / Pharmaceuticals Track and Trace System (ITS)
Serialization status:
Active
United Kingdom
Regulation name:
Serialization status:
EU FMD no longer applies to the United Kingdom.
United States
Regulation name:
DSCSA enacted
Serialization status:
Active
Uruguay
Regulation name:
Decree 324/999 & Decree 38/015 regulate medical devices and biologics; no traceability decree currently in place
Serialization status:
Uzbekistan
Regulation name:
Uzbekistan Govt. Decree No.737
Serialization status:
Mandatory
Venezuela
Regulation name:
Ley Orgánica de Salud (1998); no decree mandating serialization or traceability
Serialization status:
Vietnam
Regulation name:
Circular 23/2023/TT-BYT (November 30, 2023) amending Circular 01/2018/TT-BYT on drug labeling and package inserts
Serialization status:
In Progress
Zambia
Regulation name:
Zambia Pharmaceutical Traceability Guideline 2023 (ZAMRA)
Serialization status:
Serialization system under development
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From implementation to ongoing support, we provide end-to-end pharma serialization, track and trace, and compliance services (EU FMD, DSCSA). We design, implement, and manage serialization systems for global supply chains, ensuring seamless and compliant operations.
