February 6, 2020

Stability Law 2020: news about homeopathic medicines

Stability Law 2020 (Law No. 160 of December 27, 2019) extended the period for homeopathic medicines available on the Italian market on June 6, 1995 to remain on the market, subject to the regulation provided by Article 20 of the Pharmaceutical Code (Legislative Decree No. 219 of April 24, 2006) and Article 1 (590) of Law No. 190 of December 23, 2014.

On the one hand, Stability Law 2020 clarified that companies that had applied for renewal of marketing authorization (MA) by June 30, 2017 will be able to keep the relevant products on the market until the outcome of Italian Medicines Agency (AIFA) assessments are known. Those assessments are taking a considerable amount of time due to the large number of products submitted for consideration. On the other hand, Stability Law 2020 set a peremptory deadline for the marketing of homeopathic medicines on the market on January 1, 2020 that are not subject to renewal procedures.

Specifically, Article 1 (464) of Stability Law 2020 provides as follows:

  • that a homeopathic medicine (i) already on the Italian market on June 6, 1995 and (ii) subject to an MA renewal procedure filed with AIFA by June 30, 2017 will be kept on the market until the assessment carried out by AIFA is completed;
  • that a homeopathic medicine (i) already on the Italian market on June 6, 1995, (ii) not subject to an MA renewal procedure filed by June 30, 2017, and (iii) present in the distribution channel on January 1, 2020 shall be kept on the market until the expiration date of the medicine indicated on its label, but no later than January 1, 2022.

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