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Safety features

The safety features will enable to verify the authenticity and integrity of the medicinal product before it is supplied to the Patient.

Safety features are the elements to be placed on the packaging of the medicinal products covered by the Directive and by the Delegated Regulation that will jointly enable the verification of the authenticity of a medicinal product in an end-to-end verification system.

The safety features to be placed on the packaging are the unique identifier and the anti-tampering device. The verification of the authenticity of the unique identifier aims at ensuring that the medicinal product originates from the legitimate manufacturer. The verification of the integrity of the anti-tampering device shows whether the packaging has been opened or altered since it left the manufacturer, thereby ensuring that the content of the packaging is authentic.

Unique identifier

The unique identifier is the safety feature enabling the verification of the authenticity and the identification of an individual pack of a medicinal product.

The unique identifier is composed of the following elements:

  • Product code (GTIN);
  • Serial number;
  • Batch;
  • Expiry date;
  • Registration number (número de registo).
imagem2
PC: 05601234560015
SN: 765E321
L: LV2001
E: 190213
NR: 1234567

 

The elements mentioned above will be encoded in a two-dimensional DataMatrix barcode (standard GS1).

The five elements mentioned above must be printed on the pack. There is no pre-established order for printing the elements and they can be placed on any side of the pack although it is desirable that, whenever possible, they are placed on the same side of the DataMatrix code.

More information can be found here.

Anti-tampering device

The anti-tampering device is the safety feature allowing the verification of whether the pack of a medicinal product has been tampered with.

Neither the Directive nor the Delegated Regulation lay down technical specifications for the anti-tampering device. It is considered that the decisions concerning specifications must be taken by the manufacturers. More information can be found in the document Safety Features for Medicinal Products for Human Use - Questions And Answers - Version 12;

Medicinal products that are required to bear safety features

Pursuant to article 54-A of Directive 2001/83/CE, amended by Directive 2017/83/EU, medicinal products subject to prescription shall bear safety features.

Annex I of the Delegated Regulation contains the list of medicinal products subject to prescription that shall not bear the safety features:

Name of active substance or product category

Pharmaceutical form

Strength

Homeopathic medicinal products

Any

Any

Radionuclide generators

Any

Any

Kits

Any Any

Radionuclide precursors

Any

Any

Advanced therapy medicinal products which contain or consist of tissues or cells

Any

Any

Medicinal gases

Medicinal gas

Any

Solutions for parenteral nutrition having an anatomical therapeutical chemical (‘ATC’) code beginning with B05BA

Solution for infusion

Any

Solutions affecting the electrolyte balance having an ATC code beginning with B05BB

Solution for infusion

Any

Solutions producing osmotic diuresis having an ATC code beginning with B05BC

Solution for infusion

Any

Intravenous solution additives having an ATC code beginning with B05X

Any

Any

Solvents and diluting agents, including irrigating solutions, having an ATC code beginning with V07AB

Any

Any

Contrast media having an ATC code beginning with V08

Any

Any

Tests for allergic diseases having an ATC code beginning with V04CL

Any

Any

Allergen extracts having an ATC code beginning with V01AA

Any

Any

Annex II of the Delegated Regulation contains the list of medicinal products not subject to prescription that shall bear safety features:

Name of active substance or product category

Pharmaceutical form

Strength

Omeprazole

gastro-resistant capsule, hard

20 mg

Omeprazole

gastro-resistant capsule, hard

40 mg

In addition, pursuant to number 2 of article 105-A of Decree Law 26/2018 of 24 April, the medicinal products not subject to prescription that are subject to reimbursement and are exclusively sold in pharmacies (MNSRM-EF) shall bear safety features. More can be found in  number 2 of the document Dispositivos de Segurança – FAQ prepared by the INFARMED, I.P.

More information can be found here and 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.

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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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fa fa-cog

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
fa fa-flash

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