Regulation (EC) No 273/2004 of the European Parliament and of the CouncilDangos y teitl llawn

[F1 Article 3 U.K. Requirements for the placing on the market of scheduled substances

1. Operators wishing to place on the market scheduled substances of categories 1 and 2 of Annex I shall be required to appoint an officer responsible for the trade in scheduled substances, to notify the competent authorities of the name and contact details of that officer and to notify them immediately of any subsequent modification of this information. The officer shall ensure that the trade in scheduled substances conducted by the operator takes place in compliance with this Regulation. The officer shall be empowered to represent the operator and to take the decisions necessary for performing the tasks specified above.

[F2 2. Operators and users shall obtain a licence from the competent authorities F3 ... before they may possess or place on the market scheduled substances of category 1 of Annex I. The competent authorities may grant special licences to pharmacies, dispensaries of veterinary medicine, certain types of public authorities or armed forces. Such special licences shall be valid only for the use of scheduled substances of category 1 of Annex I within the scope of the official duties of the operators concerned.

3. Any operator holding a licence shall supply scheduled substances of category 1 of Annex I only to operators or users who also hold a licence and have signed a customer declaration as provided for in Article 4(1).]

4. When considering whether to grant a licence, the competent authorities shall take into account in particular the competence and integrity of the applicant. The licence is to be refused if there are reasonable grounds for doubting the suitability and reliability of the applicant or of the officer responsible for the trade in scheduled substances. The licence may be suspended or revoked by the competent authorities whenever there are reasonable grounds for believing that the holder is no longer a fit and proper person to hold a licence, or that the conditions under which the licence was granted are no longer fulfilled.

[F2 5. Without prejudice to paragraph 8, the competent authorities may either limit the validity of the licence to a period not exceeding three years or may oblige the operators and users to demonstrate at intervals not exceeding three years that the conditions under which the licence was granted are still fulfilled. The licence shall mention the operation or operations for which it is valid, as well as the scheduled substances concerned. The competent authorities shall, in principle, grant special licences for an unlimited duration but may suspend or revoke them where there are reasonable grounds for believing that the holder is no longer a fit and proper person to hold a licence, or that the conditions under which the licence was granted are no longer fulfilled.

6. Operators shall obtain registration from the competent authorities F4 ... before placing on the market scheduled substances of category 2 of Annex I. From 1 July 2015 users shall obtain a registration from the competent authorities F4 ... before possessing scheduled substances of subcategory 2A of Annex I. The competent authorities may grant special registrations to pharmacies, dispensaries of veterinary medicine, certain types of public authorities or the armed forces. Such special registrations shall be considered valid only for the use of scheduled substances of category 2 of Annex I within the scope of the official duties of the operators or users concerned.

6a. Any operator holding a registration shall supply scheduled substances of subcategory 2A of Annex I only to other operators or users who also hold a registration and have signed a customer declaration as provided for in Article 4(1).

6b. When considering whether to grant registration, the competent authorities shall take into account, in particular, the competence and integrity of the applicant. They shall refuse registration if there are reasonable grounds for doubting the suitability and reliability of the applicant or of the officer responsible for the trade in scheduled substances. They may suspend or revoke registration where there are reasonable grounds for believing that the holder is no longer a fit and proper person to hold a registration, or that the conditions under which registration was granted are no longer fulfilled.

6c. The competent authorities may require operators and users to pay a fee for the application for a licence or for registration.

Where a fee is levied, competent authorities shall consider adjusting the level of the fee depending on the size of the enterprise. Such a fee shall be levied in a non-discriminatory manner and shall not exceed the cost of processing the application.

F5 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8. [F6 The Secretary of State may prescribe by regulations] the requirements and conditions [F7 (including, in the case of a licence or registration, the payment of a prescribed fee)] for:

(a) granting the licence, including, where relevant, the categories of personal data to be provided;

(b) granting registration, including where relevant the categories of personal data to be provided;

F8 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F9 ...]]

Textual Amendments

F1 Regulation revoked (N.I.) (29.6.2026) by The Controlled Drugs (Drug Precursors) (Amendment and Revocation) Regulations 2026 (S.I. 2026/607), reg. 1(1), Sch.

F2 Substituted by Regulation (EU) No 1258/2013 of the European Parliament and of the Council of 20 November 2013 amending Regulation (EC) No 273/2004 on drug precursors (Text with EEA relevance).

F3 Words in Art. 3(2) omitted (31.12.2020) by virtue of The Law Enforcement and Security (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/742), regs. 1, 13(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 3(6) omitted (31.12.2020) by virtue of The Law Enforcement and Security (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/742), regs. 1, 13(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F5 Art. 3(7) omitted (31.12.2020) by virtue of The Law Enforcement and Security (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/742), regs. 1, 13(4)(c); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 3(8) substituted (31.12.2020) by The Law Enforcement and Security (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/742), regs. 1, 13(4)(d)(i); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 3(8) inserted (E.W.S.) (29.6.2026) by The Controlled Drugs (Drug Precursors) (Amendment and Revocation) Regulations 2026 (S.I. 2026/607), regs. 1(1), 5(4)(a)

F8 Art. 3(8)(c) omitted (31.12.2020) by virtue of The Law Enforcement and Security (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/742), regs. 1, 13(4)(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Art. 3(8) omitted (E.W.S.) (29.6.2026) by virtue of The Controlled Drugs (Drug Precursors) (Amendment and Revocation) Regulations 2026 (S.I. 2026/607), regs. 1(1), 5(4)(b)