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Decree Law No. 26/2018


Publication: Republic Diary No. 80/2018, Series I of 2018-04-24
  • Issuer: Presidency of the Council of Ministers
  • Diploma Type: Decree Law
  • Number: 26/2018
  • Pages: 1692 - 1697

Summary in plain english

What is it?

This decree-law:

  • introduces into Portuguese law the European directive (EU) 2017/1572 on the best practices in making medicinal products for human use
  • defines how the European Regulation (EU) 2016/61 on safety features of medicine packaging for human use will be applied.
What will change?

The Medicinal Product Statute will be adapted to the new European rules on the safety features that some medicines must have.

The Medicinal Product Statute sets the main guidelines for the production of medicinal products for human use and for investigational medicinal products.

By decision of the European Union, it is now mandatory for certain medicinal products to have a safety feature with a unique identifier to identify and authenticate it to prevent counterfeiting.

Some definitions will be introduced
  • Safety features: features that show if a medicinal product is genuine, identify each package and if the package was counterfeited.
  • Tamper proof feature: safety feature to check if the packaging of a medicinal product was broken or altered.
  • Unique identifier: safety feature that allows the identification of a medicinal product package and check if it is authentic.
  • Pharmaceutical quality system: a set of measures organized to ensure that medicinal products have the required quality for the intended use.
The documentation system will have to protect its data

It will be clarified that the documentation system must ensure not only the quality but also the security of its data.

The documentation system is a registry maintained by each manufacturer with information such as:

  • specifications of products and materials used or obtained during the production process of the medicinal product
  • manufacturing formulas, packaging, sampling and analysis
  • instructions on production, packaging and quality control of the medicinal product
  • procedures and records of its various production, packaging and quality control operations.
There will be new rules to protect electronically stored data

Electronically stored data must be protected — against illegal access, loss or destruction — using:

  • duplication
  • backups
  • transfers to another storage system
  • the creation of verification records.
Manufacturers must have systems to recall medicinal products with complaints

Medicinal product manufacturers were already required to have a system to:

  • register and review complaints about medicinal products’ defects
  • recall any defective medicinal products already in distribution.

They must now routinely assess the effectiveness of their product recall procedure.

Rules for new safety features will be created 1. Medicinal products that require a safety feature

All prescription medicinal products, provided that they are not excluded from the European Commission's list, must have a safety feature. This feature contains a unique identifier that identifies the medicinal product and ensures that it has not been counterfeited.

Non-prescription medicinal products only need to have a safety feature if, after a risk of counterfeiting has been identified, they are included in a list approved by the European Commission.

To ensure better control, the National Authority of Medicines and Health Products (INFARMED — Autoridade Nacional do Medicamento e Produtos de Saúde) can extend the list of medicinal products that need to have a unique identifier safety feature to all prescription medicinal products listed in Annex I of the European regulation on safety features in packaging of medicinal products for human use (EU Delegated Regulation 2016/161).

2. Characteristics of the safety features’ unique identifier

The European Commission has approved the characteristics and technical specifications of the safety features’ unique identifier. In Portugal, the unique identifier must always provide the following information:

  • medicinal product code
  • serial number
  • registration number
  • batch number
  • expiration date.
3. Monitoring the safety feature

The monitoring and deactivation of the unique identifier must be done by:

  • medicinal products manufacturers
  • medicinal product distributors
  • people authorized to supply medicinal products to the public.
4. Damage to the safety feature

A medicinal product can no longer be placed on the market whenever:

  • a unique identifier is unreadable or damaged and therefore cannot be checked or disabled at any point in the supply chain of making a medicinal product available
  • the anti-counterfeiting feature has been tampered with.
5. Data storage of and access to safety features

There will be a system for storing, among other data, information on the unique identifiers of a medicinal product.

This system must be set up and managed by the National Medicines Verification Organization (NMVO), which groups associations representing the different sectors involved in making a medicinal product available on the market.

NMVO must give INFARMED access to the stored information, whenever requested, so that the institute can supervise the operation of the system. It must also send INFARMED reports (based on the models to be approved by the Government following European guidelines).

INFARMED can create a technical group to follow the implementation of this system. This group must consist of:

  • entities that participate in the distribution of medicinal products (for example those that are part of the NMVO)
  • entities representing the professionals who make medicinal products available to the public.
6. Further rules on safety features of packaging of medicinal products can be created

The Government can also create rules by decree on the following aspects of the safety features of packaging of medicinal products:

  • models and requirements for monitoring and disabling hospital safety features
  • how to apply labels with safety features on medicinal products
  • verification and deactivation of medicinal products in emergencies, catastrophes or vaccination programmes.
What are its benefits?

This decree-law is intended to prevent the entry of counterfeit medicinal products into the legal supply chain of medicinal product distribution, adapting the rules on medicinal products for human use to the new European rules on this topic.

When does it come into effect?

This decree-law comes into effect on the first working day of the month after being published.

Original Version

LEGAL TRANSLATOR

  • Legal translator is the translation of texts within the field of law

CONSOLIDATED LEGISLATION

Legislative consolidation integrates the various amendments and rectifications made into an original legal diploma in order to make its consultation more accessible to the citizen.