On August 12, 2017, Decree No. 11/2017 (VI. 12.) of the Minister of Human Capacities on the waste management activities related to pharmaceutical waste generated in the course of supplying patients and consumers with medicinal products (the "Decree") entered into force. The Decree replaced Decree No. 20/2005 (VI. 10.) of the Minister of Health on the waste management of human medicines and their packaging materials.
The Decree sets forth the obligations of pharmaceutical waste collection, management and disposal of pharmaceutical waste generated in the course of supplying the population with medicinal products. For the purposes of the Decree the marketing authorization holder of medicinal products qualify as pharmaceutical manufacturer, irrespective of whether it was the actual manufacturer of the pharmaceutical product. Pharmaceutical distributors may also carry out medicinal waste management obligations of pharmaceutical manufacturers.
The main obligations of pharmaceutical manufacturers are the following:
Waste collection containers
Installing and regularly collecting and transporting collection containers from collection points to special waste disposal facilities.
- The Decree allows pharmaceutical manufacturers to outsource these activities under an agreement complying with specific conditions via pharmaceutical distributors or intermediary facilitators.
- In the latter case, the agreement must be submitted for approval with the National Environmental Government Authority.
Publishing simple, Hungarian language information on the obligations of pharmaceutical manufacturers for the collection and management of pharmaceutical waste on the SPC, PIL and label of medicinal products.
- Display similar information in publicly accessible and clearly visible areas of pharmacies and non-pharmacy businesses that sell medicinal products to consumers.
- Pharmaceutical manufacturers may perform these obligations in cooperation with another pharmaceutical manufacturer or via an intermediary facilitator.
Notifying the National Environmental Government Authority
Notification of the National Environmental Government Authority on complying with the above obligations.
- The notification obligation must be performed with the content set forth in the Decree within 60 days from the effective date of the Decree.
Financial security for ensuring the compliance
In order to ensure compliance with the pharmaceutical waste management obligations, pharmaceutical manufacturers must provide financial security (bond).
- The amount of the financial security is one million Hungarian Forint (HUF), that is approximately EUR 3,000 or the number of boxes of medicinal products distributed in the year preceding the reference year multiplied by the partial amount of the security corresponding to one mass unit
- The partial amount of the security corresponding to one mass unit equals HUF 0.5 per box. Compliance with the obligation of providing a security must be certified within six months following the effective date of the Decree.
- The security may be provided in the following forms:
- guarantee undertaken by a credit institution or an insurance company or an equivalent bank guarantee,
- promissory note – including a joint and several guarantee – issued under an insurance contract,
- separate blocked amount of money deposited with a credit institution for the purpose to undertake the guarantee, or
- insurance contract.
Recyclomed Kft - Intermediary waste management facilitator
In Hungary Recyclomed Kft is the designated non-profit limited liability company registered as an intermediary waste management facilitator.
If the pharmaceutical manufacturer decides to carry out its waste management obligations via an intermediary facilitator, the pharmaceutical manufacturer must enter into a pre-approved service agreement with this company.
Notifying the Government on the method of compliance
Irrespective of whether the pharmaceutical manufacturer performs its pharmaceutical waste management obligations directly or via an intermediary facilitator, it is the pharmaceutical manufacturer's obligation to notify the government authority on the method of compliance with the Decree.
The notification has to be submitted on a notification form delivered by hand or sent by registered mail with the Department of Environmental and Natural Protection of the Pest County Government Office.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.