A new tax and new obligations for manufacturers / importers of medicinal products. The draft law on the management of medicinal products waste from the population was adopted by the Senate

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EY Romania

14 Oct 2021
Subject Tax Alert
Categories Corporate Tax
Jurisdictions Romania

On 11 October 2021, was adopted by the Senat the Law no. 353 on the management of medicinal products waste from the population.

This project of law has been ocurred as a measure to protect the environment against pollution from medicinal products waste and regulates the regime of medicinal products waste held by the population, for example, due to expiration, deterioration of packaging or withdrawal from the market by the manufacturer.

Manufacturers and importers of medicinal products have the obligation to manage packaging waste and they will have to pay an annual contribution of 30 RON/kg for waste that has not been collected and disposed.

The draft of the law specifies both the obligations of producers and the obligations of implementing organizations regarding extended producer responsibility ("OIREP"), among which we mention:

  • the costs of managing medicinal products waste from the population will be borne by the producers/importers of medicinal products which are responsible for financing the collection and disposal of waste. They have the possibility to achieve the objectives both individually and through an OIREP.  OIREPs will only be able to operate after approval by a Commission, which will be regulated by the Ministry of Environment Water and Forests;
  • for  placing on the market the products that are subject to Law no. 353/2021, the producers need to register to the Environmental Fund Adminsitration and have the obligation to report to the Medicines Policy Directorate, a quantitative evidence;
  • similarly, OIREPs have the obligation to report monthly to the  Environmental Fund Administration, on the basis of supporting documents, the amount of pharmaceutical substance waste collected and disposed;
  • OIREPs have the obligation to pay annually, to the Environmental Fund Administration, the contribution of RON 30 per kilogram of waste, for waste that has not been collected and disposed, but if OIREP enters in the insolvency procedure, this obligation will be charged  to the manufacturer;
  • the annual targets for waste collection and disposal are the following:
    • a.  for 2021 - 10% from the weight of the substance pharmaceutical products placed on the market in the previous year;
    •  for 2022 - 20% from the weight of the substance pharmaceutical products placed on the market in the previous year;
    •  starting with 2023 - a percentage calculated by Ministry of Environment Waters and Forests, at the latest until 15 September 2022.
  • non-registration to the EFA of the producers/ importers is considered offence and is penal sanctionated or with a fine. Also, some acts considered contraventions (e.g. lack of evidences) are sanctioned with a fine of up to 1% of the total turnover from the financial year prior to the sanction.

There are also highlighted the obligations for the points of sale that sell medicinal products to the final consumers, and among of the most important we mention:

  • to conclude contracts for the waste management with authorized economic operators;
  • to ensure, free of charge and without requesting personal data, for the population, the possibility to dispose of waste in dedicated containers;
  • to keep a monthly evidence of the waste taken over and handed over for disposal and to report it to the Environmental Fund Administration;
  • the points of sale that sell medicinal products to the final consumers are not considered collectors within the meaning of Law no. 211/2011 on the waste regime, and do not have the obligation to be additionally authorized to fulfill these obligations.

How does the above influence the activity of your company?

Considering the implications in the management of medicinal products  waste as well and the tough sanctions of this draft of the law, we recommend that you analyze the impact of these provisions on your company.

Our dedicated team on Environment Fund would be pleased to assist you with such analysis.

 

Prepared by:

  • Daniela Neagoe - Senior Manager, Indirect Tax
  • Mihai Petre - Director, Indirect Tax

For additional information, please contact:

  • Alex Milcev ― Tax & Law Leader Romania
  • Georgiana Iancu, Partner - Leader of the Indirect Tax Department