Service
Destruction of Expired Medicinal Products
The full procedure under Ordinance No. 4 of 2018: from the application through the RZI to the order from the Bulgarian Drug Agency, the transport and the destruction protocol.
What does the service include?
With medicines, waste law is the second half of the job. The first half is Ordinance No. 4 of 16 May 2018: without a written order from the executive director of the Bulgarian Drug Agency nothing moves, and landfill is never an option. This is the most administratively demanding of our three services and the only one where the timescale is measured in months rather than days. That is why we take on the procedure as well as the run.
- Establishing who the applicant is within the meaning of the ordinance, which is often not you
- Preparing the document set and filing it through the relevant RZI
- A destruction contract with a party holding a document under Article 35(1) of the WMA for operation D10 or R1
- Tracking the procedure through to the issuing of the BDA order
- ADR transport for cytotoxic and cytostatic products
- Attendance at the destruction and drawing up of the protocol under Annex 4
How does the process work?
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Who the applicant is
Under Article 5(1) of Ordinance No. 4, wholesalers, importers and manufacturers are obliged to take back, free of charge, the products they supplied to pharmacies and healthcare establishments and to apply for their destruction within six months. A pharmacy, as a retailer, is not the applicant. If you are a pharmacy, the first step is to return the products to your supplier. We say so even when it means a smaller order for us.
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The document set
An application under Annex 1, a write-off order under Annex 2, a destruction contract with a licensed party, and proof of the state fee. It is filed with the executive director of the BDA through the director of the RZI for the place where the products are held.
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Opinions and inspection
The RZI requests an opinion from RIOSV and, where necessary, from the regional directorate of the Ministry of the Interior, carries out an inspection and issues an opinion under Annex 3, then forwards the file to the BDA of its own motion.
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The BDA order
The executive director of the BDA issues a written order within two months. It specifies the method of destruction, the particular installation, the people who are to attend and the deadline for carrying it out.
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Transport and destruction
We haul to the installation named in the order. For codes 20 01 31* and 18 01 08* the carriage is under ADR, with UN-certified packaging, written instructions and a qualified driver.
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The protocol
After destruction a protocol is drawn up under Annex 4, signed by everyone named in the order. A copy goes to the BDA and to the RZI within five days.
Documents, legal compliance and codes
Three frameworks apply at once: the MPHMA and Ordinance No. 4 of 2018 for the procedure itself, the WMA and Ordinance No. 2/2014 for classification and reporting, and [ADR](/blog/adr-transport-opasni-otpadatsi/) for carriage of the hazardous codes. Transport is carried out under registration document No. 12-РД-2661-00, issued by RIOSV.
Two restrictions in Ordinance No. 4 shape the whole project, and it is worth knowing them before you ask for a quote. Incineration only: under Article 7, medicinal products may be destroyed only at sites holding a document under Article 35(1) of the WMA for the operation “incineration on land (D10)” or for recovery R1; landfill is not permitted under any circumstances. No destruction in the country where little shelf life remained: under Article 6, products that at the date of delivery had less than one tenth of their full shelf life remaining cannot be destroyed in Bulgaria; they are exported at the importer’s or supplier’s expense within six months under Regulation (EC) No 1013/2006. The ordinance also prohibits disposal in household waste containers, mixing with other substances and storage in the open.
Typical codes under Ordinance No. 2/2014
| Code | Description | Type |
|---|---|---|
| 20 01 31* | Cytotoxic and cytostatic medicinal products (separately collected fractions) | Hazardous |
| 20 01 32 | Medicinal products other than those mentioned in 20 01 31 | Non-hazardous |
| 18 01 08* | Cytotoxic and cytostatic medicinal products from human healthcare | Hazardous |
| 18 01 09 | Medicinal products other than those mentioned in 18 01 08 | Non-hazardous |
| 18 02 07* / 18 02 08 | The corresponding codes for veterinary healthcare | Hazardous / Non-hazardous |
| 07 05 13* / 07 05 14 | Solid wastes from pharmaceutical manufacture | Hazardous / Non-hazardous |
| 15 01 10* | Packaging containing residues of, or contaminated by, hazardous substances | Hazardous |
* Hazardous waste under Ordinance No. 2/2014
Questions & Answers
We are a pharmacy. Do we file the application?
No. Under Article 5 of Ordinance No. 4 your supplier, meaning the wholesaler, the importer or the manufacturer, is obliged to take the products back free of charge and to apply for their destruction within six months. A handover protocol is drawn up in two copies, which both parties keep for three years. If the supplier refuses, take it up with the RZI.
How long does the procedure take?
Plan for two to three months. The BDA order alone is issued within two months, and before that run the periods for the opinions from RIOSV and the Ministry of the Interior and the ten-day period for the RZI opinion. The run itself is the last step and takes a day.
Can the batch go to landfill if the medicines are not hazardous?
No. The restriction in Article 7 attaches to the product, not to the code. Even non-hazardous medicinal products under 20 01 32 and 18 01 09 are subject only to D10 or R1.
Do you handle psychotropic and narcotic medicines?
They are expressly excluded from Ordinance No. 4 by Article 3(2) and are governed by the Control of Narcotic Substances and Precursors Act, with a separate procedure and a separate supervisory authority. We arrange transport once that procedure has been completed. Contact us in advance, because the timescales are different.
We are a hospital pharmacy. What do we do with medicines returned by patients?
Products returned from home treatment and classified as hazardous waste are kept at the site for preliminary storage of hazardous waste, separately from the rest, and handed over for destruction at least twice a week. That is a WMA regime rather than the BDA procedure, and we work to a schedule.
Is ADR transport mandatory?
For cytotoxic and cytostatic products under 20 01 31* and 18 01 08* it is. For codes 20 01 32 and 18 01 09 it is not, but the requirement for an identification document remains if the waste is classified as hazardous on another ground.
Which document proves destruction to the BDA?
The protocol under Annex 4 to Ordinance No. 4, signed by the people named in the order. That is the evidence for the BDA and the RZI. The weighbridge ticket and the consignment documents under the WMA separately evidence the movement of the waste to RIOSV.
Start the procedure
Send us a list of the products with batch numbers and quantities. We prepare the set for the RZI and take on the tracking through to the BDA order.