Applicable Laws & Regulations

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ORDINANCE № 1 of 09.02.2015 on the requirements concerning activities involved in collecting and processing waste on the territory of medical and health establishments – This Ordinance sets out the requirements for activities related to the collection and processing of waste on the territory of:

  1. Medical establishments, as defined in Art.8, Art.9 and Art.10 of the Healthcare Establishments Act;
  2. Health establishments, as defined in Art.21 of the Health Act.

ORDINANCE №2 of 23 July 2014 on the classification of waste – This Ordinance regulates the conditions and procedures for the classification of waste according to types and properties.
The aim of this Ordinance is to establish a classification of waste ensuring environmentally friendly waste management in accordance with the Waste Management Act (WMA) and all applicable regulations and by-laws related to its application.

ORDINANCE № 1 of 4.06.2014 of the procedures and sample forms that have to be complied with when providing information on activities involved in handling waste, as well as the conditions and procedures for keeping public registers. – The following are set out in this Ordinance:

  1. Procedures and sample forms for record-keeping related to the handling of waste;
  2. Procedures and sample forms for providing information on waste handling;
  3. Procedures for providing information by parties releasing on the market products the use of which results in the generation of ordinary waste;
  4. Procedures for keeping public registers in accordance with Art.45, para.1 of the Waste Management Act (WMA);
  5. Designing and maintaining an information system on waste.

ORDINANCE № 28 of 14 December 2000 on the conditions and procedures for the disposal, processing or utilization for other purposes of medicines – This Ordinance regulates the conditions and procedures for the disposal, processing or utilization for other purposes of medicinal products.

ORDINANCE on the requirements concerning the handling, processing and shipment of production and hazardous waste – This Ordinance is aimed at ensuring that there necessary measures in place for the prevention or, if prevention is impossible, for limiting as much as possible the expected adverse effects on the environment, in particular, the pollution of the air, the soil, the gound and underground water, and risks for the health of the population ensuing from the treatment and shipment of production and hazardous waste.

WASTE MANAGEMENT ACT – promulgated in the State Gazette, issue 53 of 13th July 2012, in effect as of 13th July 2012.
This Act regulates the environmentally friendly waste management as a set of rights and obligations, solutions, actions and activities, connected with the generation, handling and treatment of waste, as well as the forms of control over these activities.

MEDICAL DEVICES ACT – promulgated in the State Gazette, issue 14 of 19th February 2016, amended in issue 43 of 7th June 2016. – This Act regulates and sets out:

  1. Conditions and procedures for marketing and/or commissioning medical devices;
  2. Obligations of the manufacturer, its legally authorized representative and the importer of medical devices.