Legal alert no. 61

Amendments to the Legal Regime of Medicinal Products for Human Use

On April 24th, it was published, in the Official Gazette of the Republic of Portugal, the Decree-Law no. 26/2018, amending for the eleventh time the Legal Regime of Medicinal Products for Human Use (Decree-Law no. 176/2006, dated from August 30th), transposing into the Portuguese legal system the Directive (EU) 2017/1572, of the Commission, of September 15th, 2017, which complements the Directive 2001/83/CE, of the European Parliament and of the Council, of November 6th, 2001, concerning to the principles and guidelines of good manufacturing practices for medicinal products for human use.

In this regard, new definitions were added to the Legal Regime of Medicinal Products for Human use, namely:

(i) “Safety features”: features that enable manufacturers, distributors and healthcare professionals who supply medicinal products to confirm the authenticity of the medicinal product and identify each pack, as well as to confirm if the pack has been tampered with;

(ii) “Anti-tampering devices”: safety features which enable to confirm if the pack of the medicinal product has been tampered with;

(iii) “Unique identifier”: safety feature which enables the confirmation of the authenticity and the identification of an individual pack of a medicinal product;

(iv) “Pharmaceutical quality system”: the set of organized measures, aimed to ensure that the medicinal products have the required quality for the intended use.

Furthermore, additional obligations were established for the holder of the manufacturing authorization, as regards to the import of medicinal products, namely, to assure that all import operations of medicinal products are completed in compliance with good manufacturing practices and with the relevant manufacturing authorizations.

The manufacturer shall also conduct self-inspections for purposes of taking the necessary preventive measures (and not solely corrective); to have an effective system which will enable to promptly and at any moment recall medicinal products which are already in the distribution network; to keep, at the import site, competent and qualified personnel and in sufficient number to achieve the objectives of the pharmaceutical quality system; to respect the applicable legal provisions regarding staff clothing; and also to keep a documentation system which shall assure the quality and integrity of data.

With regards to data processing, it is foreseen that electronically stored data shall be also protected against illegal access.

Moreover, it was also established that in the manufacture of advanced therapy medical products the guidelines for good manufacturing practices applicable to this kind of medicinal products, referred in article 5.º of Regulation (CE) no. 1394/2007, of the European Parliament and of the Council, of November 13th 2007 shall be take into account.

In order to access the text of the Decree-Law no. 26/2018, of April 24th, please click here.

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