European Legislation

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001
Lays down a Comm ty code relating to medicinal products for human use.

Directive 2011/62/EU of the European Parliament and of the Council, of 8 June 2011
Amends Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.

Commission Delegated Regulation (EU) 2016/161 of 2 October 2015
Supplements Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use

Commission Delegated Regulation (EU) 2021/457, of 13 January 2021
Amending Delegated Regulation (EU) 2016/161 as regards a derogation from the obligation of identifier of products exported to the United Kingdom.

National Legislation

Informative Note no. 108/CD/100.20.200, of 1/09/2017
Implements the safety features for medicinal products for human use.

Decree-Law no. 26/2018 – Diário da República no. 80/2018, Series I of 2018-04-24
Proceeds to the eleventh amendment of Decree-Law no. 176/2006, of 30 August, in its current wording, laying down the legal scheme for medicinal products for human use and transposes Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 as regards the principles and guidelines of good manufacturing practice for medicinal products for human use into the national legal system.

Joint Informative Note by INFARMED, I.P., ACSS, I.P. and SPMS, E.P.E.
Safety features – Implementation in the hospitals of the National Health Service.

Joint Informative Note no. 01/ACSS/INFARMED/SPMS
Implementation of safety features for medicinal products for human use in the hospitals of the National Health Service.

Joint Informative Note nº176/CD, of 17/12/2018
Data entry in the national medicines verification system - MVO Portugal

Informative Note no. 20/CD, of 28/01/2019
Safety features implementation – guidance for post 9th February 2019

Informative Note no. 84/CD, of 14/5/2019
Safety Features – System Implementation – Legal obligations of the entities

Other relevant documents

Safety Features for Medicinal Products For Human Use - Questions And Answers
Frequent questions and answers on the implementation of the rules regarding the safety features for medicinal products for human use.

Questions and answers on regulatory expectations for medicinal products for human use during the covid-19 pandemic
Guidance on regulatory aspects for medicinal products for human use during the covid-19 pandemic.

Safety Features – FAQ
Document with questions and answers prepared by INFARMED, I.P.

Guide for the Coding of Medicinal Products
Guidelines for the application of the rules approved for Portugal for the coding of medicinal products, prepared by GS1.

Health care establishments required to verify and deactivate unique identifiers
Document prepared by INFARMED, I.P.

Health care establishments required to verify and deactivate unique identifiers – Azores
Document prepared by Saudaçor

Madeira Health care establishments required to verify and deactivate unique identifiers – Madeira
Document prepared by IA Saúde

Other relevant technical documents

GS1 manuals and guidelines
Manuals and guidelines from GS1 on Global Trade Item Numbers (GTIN) and data matrix codes

Scanner Datalogic Quickscan QD2403 configuration
Configuration of the Portuguese keyboard, transmission of AIM ID code, decoding normal and inverse codes and several possible configurations of global suffixes and character conversion.

Scanners Honeywell HH660, 1450G, 7580G configuration
Configuration of the Portuguese keyboard, transmission of AIM ID code, decoding normal and inverse codes and several possible configurations of global suffixes and character conversion.

Centering feature configuration on Honeywell handheld devices
The centering feature is used to narrow the imager's field of view so that the imager only reads the barcode which is intended to be read by the user.

Scanner Zebra DS2278 configuration
Configuration of the Portuguese keyboard, transmission of AIM ID code, decoding normal and inverse codes and several possible configurations of global suffixes and character conversion.

Picklist Mode Configuration for Scanner Zebra DS2278
Picklist mode enables the digital scanner to decode only barcodes that are aligned under the laser crosshair or LED aiming dot. It allows users to easily select and scan a single barcode from a field of barcodes.

Scanner Zebra DS2208 configuration for the Glintt Hospital Management System
Specific configuration of the winning scanner model of the public tender No. 00110_2019, aligned with the requirements of the Glintt Hospital Management Software. This configuration was tested in an integrated testing session held between Zebra, Glintt, SPMS and MVO Portugal.

Scanner Zebra DS2208 configuration for the STI Hospital Management System
Specific configuration of the winning scanner model of the public tender No. 00110_2019, aligned with the requirements of the ST+I Hospital Management Software. This configuration was tested in an integrated testing session held between Zebra, ST+I, SPMS and MVO Portugal.