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Operators shall obtain registration from the competent authorities of the Member State in which they are established before placing on the market scheduled substances of category 2 of previous mentioned Annex I.

From 1 July 2015 users shall obtain a registration from the competent authorities of the Member State in which they are established before possessing scheduled substances of subcategory 2A of Annex I.

Any operator holding a registration shall supply scheduled substances of subcategory 2A of Annex I only to other operators or users who also hold registration and have signed a customer declaration Operators trading in substances of category 2 have to register by the competent authorities and update the addresses of the establishments where they manufacture these substances or from which they trade in these substances before they start trading.

Cases where registration is not required:

The following categories may be exempt from the registration requirement pursuant to Article 7(1) of Regulation (EC) No 111/2005:

(a) pharmacies, dispensaries of veterinary medicine, customs, police, official laboratories of competent authorities and armed forces, as far as these operators use drug precursors within the scope of their official duties;

(b) operators engaged in the export of scheduled substances listed in Category 3 of the Annex to Regulation (EC) No 111/2005, if the sum of quantities concerned by their exports during the course of the preceding calendar year (1 January-31 December) does not exceed the amounts specified in Annex I to the Commission Delegated Regulation (EU) 2015/1011. When those amounts are exceeded within the current calendar year, the operator shall comply with the registration requirement immediately;

(c) operators engaged in export of mixtures containing scheduled substances listed in Category 3 of the Annex to Regulation (EC) No 111/2005, if the amount of the scheduled substance contained in the mixtures does not exceed, during the course of the preceding calendar year, the amounts specified in Annex I to the Commission Delegated Regulation (EU) 2015/1011. When those amounts are exceeded within the current calendar year, the operator shall comply with the registration requirement immediately.

Operators established in the Union who are not customs agents and carriers, when acting solely in that capacity in the performance of import, export or brokering activities involving scheduled substances listed in Category 2  or exporting substances in Category 3, shall be registered immediately and, where appropriate, update the addresses of the premises in which they carry out these activities. This obligation shall be fulfilled by the competent authority of the Member State in which the contractor is established.

The lists of the individual countries of destination for exports of scheduled substances listed in Category 2 and 3 of the Annex is published on the Commission's website.

Operators exporting substances in Category 3 are exempted from the registration conditions if the quantity in question during the previous calendar year does not exceed the prescribed quantities. If these quantities are exceeded in the current calendar year, the contractor must immediately comply with the provisions for registration.

Operators exporting mixtures containing substances in Category 3 are exempted from the conditions of registration if the quantity of the substance in the list contained in the mixture does not exceed the prescribed quantity during the transitional year.

If these quantities are exceeded in the current calendar year, the contractor must immediately comply with the provisions for registration.

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Last modified:
16. 5. 2022