Follow us on

 
 
 
Italian Medicines Agency Agenzia Italiana del Farmaco

Clarification on the applicability of Legislative Decree 116/2020 to the labelling of medicinal products - Clarification on the applicability of Legislative Decree 116/2020 to the labelling of medicinal products

Asset Publisher

Clarification on the applicability of Legislative Decree 116/2020 to the labelling of medicinal products

Following the numerous requests for clarification concerning the applicability of Legislative Decree 116/2020 (Implementation of Directive (EU) 2018/851 amending Directive 2008/98/EC on waste and of Directive (EU) 2018/852 amending Directive 1994/62/EC on packaging and packaging waste) to waste derived from medicinal products for human use, the following is hereby clarified.

Legislative Decree 116/2020 introduced amendments to Part IV of Legislative Decree 152/2006 concerning the rules for waste management and rehabilitation of polluted sites. Conversely, Article 227, paragraph 1, letter b), of Legislative Decree 152/2006 was not amended and is still in force.

Therefore, pursuant to the above-mentioned Article 227, paragraph 1, letter b), any specific, national and European provisions relating to other types of waste are not affected, in particular those concerning health-care waste, as introduced by Presidential Decree No 254 of 15 July 2003 (Regulation governing the management of health-care waste pursuant to Article 24 of Law No 179 of 31 July 2002).

It should be also noted that Article 73, paragraph 1, letter l), of Legislative Decree 219/2006 on medicinal products for human use only establishes that the outer packaging or the immediate packaging of medicinal products should bear particulars on precautions for the disposal of the unused medicinal product or waste materials derived from such medicinal product, “if appropriate”, as provided for by the above-mentioned Presidential Decree No 254 of 15 July 2003.

It follows that the provisions of Legislative Decree 219/2006 have not been amended by Legislative Decree 116/2020.


Published on: 14 January 2021

Asset Publisher

Asset Publisher

Galleria

Nested Applications

Last tweets

Go to Twitter profile

Multimedia

Campagna sull'uso consapevole degli antibiotici

Go to YouTube channel

go to beginning of content