What are drug precursors?

The trade of drug precursors cannot be prohibited, as they have a wide range of legitimate uses in various industrial processes and in the manufacture of different products (medicinal products, perfumes, plastics, cosmetics etc). Both at international and at EU level, specific regulatory frameworks have been put in place to ensure that diversion of drug precursors is prevented through control of their legitimate trade at EU borders and in the internal market. The legislation aims to strike a balance between the necessary control to prevent diversion of drug precursors and allowing their legitimate trade without creating unnecessary administrative burdens.

Special licence and special registration: depending on the specific drug precursor and the purpose of the handling, the companies handling drug precursors have to obtain a special licence or register themselves. Check from this scheme wheter a licence or registration is required.

Import and export authorisations: depending on the specific drug precursor, purpose of the handling and amount handled, the companies handling drug precursors have to obtain an export or import authorisation. Check from this scheme whether an import or export authorisation is required.

Please note that state fees apply for the applications for a special licence and for an export authorisation.

Appoint a responsible officer. In order to place on the market category 1 and 2 substances and in order to obtain a licence/registration to handle drug precursors the operator shall appoint an officer responsible for the trade in drug precursors.

Documentation. All transactions leading to the placing on the market of category 1 and 2 drug precursors must be properly documented. This includes invoices, cargo manifests, administrative documents, transport and other shipping documents that must contain information on the drug precursor, the name quantity and weight of the drug precursor and on all parties to the transaction. The documentation and records  shall be kept for at least three years from the end of the calendar year in which the transaction.

Customer declaration. Any operator that holds a licence/registration who supplies a customer with category 1 and 2 drug precursors, shall obtain a declaration from the customer which shows the specific use or uses of the scheduled substances.

Labelling. Operators shall ensure that labels are affixed on any packaging containing drug precursors indicating their name and CN code, or, in the case of a mixture or a natural product, its name and the name of any drug precursor contained in the mixture or in the natural product. Operators may, in addition, affix their customary labels.

Notification on suspicious transactions. Operators handling drug precursors must notify the State Agency of Medicines of any suspicious transactions concerning drug precursors, including unusual orders and other types of transactions that may indicate that drug precursors may be diverted from the legal supply chain in order to produce illicit drugs. In case of suspicion, please submit at least the name and the quantity and weight of the drug precursor and other relevant details of the transaction. 

Annual reports on the handling of category 1 and 2 drug precursors must be submitted by 15th of February each calendar year. Please submit the annual reports in electronic form and signed digitally to email address [email protected].