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The "certification" remains with the producers

Sara Todaro – 26 June 2013 – Il Sole24Ore

It will still be up to pharmaceutical manufacturers to certify that the raw materials used for the production of their products - including those imported from third countries - comply with good manufacturing practices, without prejudice to the possibility for the Italian Medicines Agency to carry out inspections to ensure that the raw materials correspond to the certification given by the qualified person responsible for the production of the relative medicine.

This is provided for by article 44 of the "decreto del fare", which extends the deadline of 3 July next, the date from which the raw materials in question, even if imported from third countries, should have been accompanied by the required certificate of conformity issued to the production workshop by the regulatory authorities of a European Union state.

The "fare" decree cancels the deadline by repealing paragraph 3 of article 54 of Legislative Decree 219/2006 which provided for it, leaving the pre-existing regulatory framework unchanged and postpones the adoption of the new procedures to the entry into force of the Legislative Decree transposing directive 2011/62/EU, better known as the "anti-counterfeiting directive".

The latter - approved in June 2011 and in force in the EU since 2 July - modifies the EU medicines code by dictating rules aimed at preventing the entry of falsified medicines into the legal supply chain.

The directive is destined to have a significant impact on the control activity carried out by the European regulatory authorities in the context of the production and importation of active ingredients, as it establishes that the producers and importers of active ingredients must be compulsorily registered with the national regulatory authorities, which, therefore, will have to develop an adequate evaluation system of the production workshops and importers of active ingredients which also includes inspection activities. The active substances must be accompanied by written confirmation from the competent authority of the exporting third country which certifies compliance with standards at least equivalent to those valid in the EU as well as the execution of periodic, rigorous and transparent controls, with repeated inspections and without notice.

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco