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informacoes

Legislation and documents

legislacao internacional

European Legislation

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001
Lays down a Community 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

legislacao nacional

National Legislation

Information Circular 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 Information Notice by INFARMED, I.P., ACSS, I.P. and SPMS, E.P.E.
Safety features – Implementation in the hospitals of the National Health Service.

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

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

outros documentos

Other relevant documents

Safety Features for Medicinal Products For Human Use - Questions And Answers - Version 12
Frequent questions and answers on the implementation of the rules regarding the safety features for medicinal products for human use.

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.

 

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MA and PIA Holders

MA and PIA Holders

Please find relevant information for holders of marketing authorizations and Parallel Import Authorization holders here.

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Wholesalers

Wholesalers

Relevant information for holders of a wholesale distribution of medicinal products for human use authorization can be found here

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Pharmacies

Pharmacies

Relevant information for pharmacies can be found here.

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Healthcare institutions

Healthcare institutions

Relevant information for healthcare institutions can be found here.

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MA and PIA Holders

MA and PIA Holders

Please find relevant information for holders of marketing authorizations and Parallel Import Authorization holders here.

Learn more
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Wholesalers

Wholesalers

Relevant information for holders of a wholesale distribution of medicinal products for human use authorization can be found here

Learn more
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Pharmacies

Pharmacies

Relevant information for pharmacies can be found here.

Learn more
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Healthcare institutions

Healthcare institutions

Relevant information for healthcare institutions can be found here.

Learn more