Article 1 Subject matter

This Regulation lays down uniform procedural rules for the implementation of Regulation (EC) No 273/2004 and of Regulation (EC) No 111/2005 as regards the licensing and registration of operators and users and their listing in the European database on drug precursors, the provision by operators of information required to monitor trade and authorisation of exports and imports in the field of drug precursors.

Article 2 Definitions

For the purposes of this Regulation, ‘business premises’ shall mean building(s) together with the land occupied by an operator at each single location.

Article 3 Licence granting procedure

1.An operator or user shall submit to the competent authority an application to obtain a licence referred to in Article 3(2) of Regulation (EC) No 273/2004 or Article 6(1) of Regulation (EC) No 111/2005, electronically or in writing as prescribed by the [^F2 Secretary of State^F2] .

An application shall be deemed to be complete when it contains all the information listed in Article 3(2)(b) of Commission Delegated Regulation (EU) 2015/1011(4).

2.When assessing an application to obtain a licence, the competent authority may also take into consideration the results of any previous assessments or audits carried out on the applying operator holding the status of [^F3 Authorised Economic Operator for customs simplification (AEOC), to the extent they are relevant for the examination of the conditions for granting a licence.^F3]

By derogation from Article 3(1) of this Regulation, the competent authority may authorise operators holding the status of [^F4 AEOC^F4] not to submit all the information listed in Article 3(2)(b) of Delegated Regulation (EU) 2015/1011 when they are submitting an application.

3.The competent authority shall first assess the completeness of an application.

Where an application is not deemed to be complete, the competent authority shall indicate so to the applicant and invite that applicant to provide any missing or relevant additional information.

Where an application is deemed to be complete, the competent authority shall confirm the receipt of a complete application to the applicant.

4.The competent authority shall take a decision to grant or not to grant a licence within 60 working days from the date of receipt of a complete application in the case of a new licence, and within 30 working days in the case of a renewal of a licence.

5.Any decision not to grant a licence shall be reasoned and notified to the applicant electronically or in writing.

6.The licence may cover the operations referred to in Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005.

Article 4 Scope of the licence

The competent authority may grant a licence:

Article 5 Format of the licence

A licence referred to in Article 3(2) of Regulation (EC) No 273/2004 or Article 6(1) of Regulation (EC) No 111/2005 shall be issued in the format set out in Annex I to this Regulation.

Article 6 Subsequent changes

Where, after a licence has been granted, information provided in the application for that licence, other than information referred to in Article 3(9) of Delegated Regulation (EU) 2015/1011, has changed, the licence holder shall inform the competent authority electronically or in writing within 10 working days following the change.

Where, after the change, the conditions referred to in Article 3 of Delegated Regulation (EU) 2015/1011 continue to be fulfilled, and the information to be changed is contained in the licence, the competent authority shall amend the licence accordingly.

Article 7 Validity, suspension and revocation of licences

1.Where the validity of a licence has expired, or where a license has been revoked, the licence holder shall return a licence which is no longer valid to the competent authority within 10 working days following the date of expiry of validity or the date of revocation.

2.Where a competent authority decides to suspend or revoke a licence, the decision shall be submitted to the licence holder electronically or in writing and shall specify the grounds that justify the suspension or revocation.

Article 8 Special licences

Articles 3 to 7 of this Regulation shall not apply to special licences referred to in Article 3(2) of Regulation (EC) No 273/2004.

Article 9 Registration procedure

1.Articles 3, 4, 6 and 7 shall apply to the procedure for registration pursuant to Article 3(6) of Regulation (EC) No 273/2004 or Article 7(1) of Regulation (EC) No 111/2005.

2.Registration pursuant to Article 3(6) of Regulation (EC) No 273/2004 or Article 7(1) of Regulation (EC) No 111/2005 shall be granted in the format set out in Annex II.

3.By way of derogation from paragraph 2, the competent authority may grant registration on a form printed before the date of entry into force of this Regulation and complying with national rules in place before the date of entry into force of this Regulation until the stocks are exhausted.

4.Paragraphs 1, 2 and 3 shall not apply to special registrations referred to in Article 3(6) of Regulation (EC) No 273/2004.

Article 10 Information required to monitor trade

1.Operators shall provide the information referred to in Article 8(2) of Regulation (EC) No 273/2004 electronically or in writing, [^F6 as specified by the Secretary of State^F6] , before 15 February of each calendar year for scheduled substances of Categories 1 and 2 of Annex I to that Regulation.

2.Operators shall provide the information referred to in Article 9(2) of Regulation (EC) No 111/2005 electronically or in writing, [^F7 as specified by the Secretary of State^F7] , before 15 February of each calendar year.

3.An operator shall submit the annual reports referred to in paragraphs 1 and 2 even where no transactions have taken place in a given year.

Article 11 Export and import authorisations

1.The export and import authorisations referred to in Article 28 of Regulation (EC) No 111/2005 shall have the format set out in Annex III or IV to this Regulation, respectively.

By way of derogation from the first subparagraph, the box relating to the authorisation number may have a different format in cases where the export or import authorisation is granted by electronic means.

2.An export authorisation shall be established in four copies numbered 1 to 4. Copy No 1 shall be kept by the authority issuing the authorisation. Copies No 2 and No 3 shall accompany the scheduled substance and be presented to the customs office where the customs export declaration is made, and subsequently to the competent authority at the point of exit from [^F8 Great Britain^F8] . The competent authority at the point of exit shall return Copy No 2 to the issuing authority. Copy No 3 shall accompany the scheduled substances to the competent authority of the importing country [^F9 or Northern Ireland^F9] . Copy No 4 shall be kept by the exporter.

3.An import authorisation shall be established in four copies numbered 1 to 4. Copy No 1 shall be kept by the authority issuing the authorisation. Copy No 2 shall be sent to the competent authority of the exporting country [^F10 or Northern Ireland^F10] by the issuing authority. Copy No 3 shall accompany the scheduled substance from the point of entry into [^F11 Great Britain^F11] to the business premises of the importer, who shall send this copy to the issuing authority. Copy No 4 shall be kept by the importer.

4.One single export or import authorisation shall not cover more than two scheduled substances.

5.^F12... Unless [^F13 an authorisation^F13] is granted by electronic means, it shall have A4 format and a printed guilloche pattern background making any falsification by mechanical or chemical means apparent to the eye.

6.[^F14 The Secretary of State^F14] may print the authorisation forms ^F15... or have them printed by printers approved by [^F16 the Secretary of State^F16] . In the latter case, each authorisation form must include a reference of such approval and bear the name and address of the printer or a mark by which the printer can be identified.

^F177.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8.Export authorisations granted by simplified procedure shall be established using copies No 1, 2 and 4 of the form set out in Annex III. Copy No 1 shall be kept by the authority issuing the authorisation. Copy No 2 and Copy No 4 shall remain with the exporter. The exporter shall indicate details of each export operation on the back side of Copy No 2, in particular the quantity of the scheduled substance of each export operation and the remaining quantity. Copy No 2 shall be presented to the customs office when the customs declaration is made. That customs office shall confirm the details and return Copy No 2 to the exporter.

9. The operator shall enter the authorisation number and the words ‘simplified export authorisation procedure’ on the customs declaration for each export operation. ^F18 ...

10.The exporter shall return Copy No 2 to the issuing authority at the latest 10 working days following the expiry of the period of validity of the export authorisation granted by simplified procedure.

^F19Article 12 Listing of operators and users in the European database on drug precursors

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 13 Entry into force and application

This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

^F21,F22,F23ANNEX I

Notes

^F26,F27,F28ANNEX II

Notes

ANNEX III

^{F31,F32,F33,F34,F35,F36,F31,F32,F33,F34,F35,F36,F31,F32,F33,F34,F35,F36,F31,F32,F33,F34,F35,F36}Notes

I.

1. ^F37...

2. Boxes 1, 3, 5, 7, 9 to 19 are to be provided by the applicant at the time of the request; however, the information required in boxes 7, 8 and 10 to 13 and 18 may be supplied at a later stage, if the information is not known at the time of the request. In this case, the information for box 18 is to be supplemented at the latest when the export declaration is made and the supplementary information for boxes 7, 8, 10 to 13 is to be given to the customs or other authority at the point of exit from [^F38Great Britain^F38] at the latest before the physical departure of the goods.

3. Boxes 1, 5, 7 and 9: Enter full names and addresses (phone, fax, e-mail).

4. Box 5: Enter reference number to the import authorisation document of the third country importer, (for example a ‘letter of no-objection’, import permit, other statement of the third country of destination), where appropriate.

5. Box 7: Enter full name and address (phone, fax, e-mail) of any other operator involved in the export operation such as transporters, intermediaries, customs agents.

6. Box 9: Enter full name and address (phone, fax, e-mail) of the person or company to which the goods are delivered in the country of destination (not necessarily the end-user).

7. Box 10: Give the name of the ^F39... port, airport or border point, where appropriate.

8. Box 11: Give the name of the country, port, airport or border point, where appropriate.

9. Box 12: Specify all means of transport to be used (e.g. lorry, ship, plane, train, etc.). In the case of an export authorisation covering several export operations, this box need not be filled in.

10. Box 13: Give as full details as possible of the route to be taken.

11. Boxes 14a, 14b: Enter name of the scheduled substance as stated in the Annex to Regulation (EC) No 111/2005, the commercial name of the medicinal product listed in Category 4, the number of units in the consignment, the number of tablets/ampoules in each unit, the content of the scheduled substance in a single unit (per tablet/ampoule) or in the case of a mixture or natural product, enter the name and the 8 digit CN code, as well as the commercial name.

12. Boxes 15a, 15b: Enter the 8 digit CN code of the scheduled substance as stated in the Annex to Regulation (EC) No 111/2005.

13. Box 16a, 16b: for Category 4, enter the total net weight of the scheduled substance contained in the consignment of medicinal products.

14. Box 19:

• Indicate in block letters the name of the applicant or, where appropriate, of the authorised representative who signs this application.

• The signature by the applicant or authorised representative ^F40... indicates that the person concerned is declaring that all the particulars provided on the application are correctly and fully stated. Without prejudice to the possible application of penal provisions, this declaration is equivalent to the engagement of responsibility, under the provisions in force ^F40..., in respect of the following:

  • the accuracy of the information given in the declaration;

  • the authenticity of any documents attached;

  • the observance of all the obligations inherent in the export of scheduled substances listed in the Annex to Regulation (EC) No 111/2005.

• Whenever the authorisation is issued by means of a computerised procedure, that authorisation may not contain the signature of the applicant in this box, if the application as such contains such signature.

(Simplified export authorisation procedure)

1. In the case of a simplified export authorisation procedure, boxes 7, 8, 10 to 13 and 18 need not be completed.

2. On the backside of copy No 2, boxes 24 to 27 must be completed for each export operation.

3. Box 23: Indicate the authorised maximum quantity and net weight. For Category 4, enter the total net weight of the scheduled substance contained in the consignment of medicinal products.

Column 24: Indicate the quantity available in part 1 and the quantity of the partial export quantity in part 2. For Category 4, enter the total net weight quantity of the scheduled substance contained in the consignment of medicinal products.

Column 25: Indicate the partial export quantity in words.

Box 26: Reference number and the date of the customs declaration.

^F41. . . . . . . . . . . . . . . . . . . . . . .

ANNEX IV

^{F42,F43,F44,F45,F42,F43,F44,F45,F42,F43,F44,F45,F42,F43,F44,F45}Notes

1. ^F46...

2. Boxes 1, 4, 6, 8 and 11 to 16 are to be provided by the applicant at the time of the request; however, information as required in boxes 7, 9, 10 and 15 may be supplied at a later stage. In this case, this information is to be supplemented at the latest when the goods are entered into [^F47Great Britain^F47] .

3. Boxes 1, 4: Enter full names and addresses (phone, fax, e-mail).

4. Box 6: Enter full name and address (phone, fax, e-mail) of any other operator involved in the import operation such as transporters, intermediaries, customs agents.

5. Box 8: Enter full name and address of the ultimate consignee. The ultimate consignee may be identical with the importer.

6. Box 7: Enter name and address (phone, fax, e-mail) of the third country authority.

7. Box 9: Give the name of ^F48... the port, airport or border point.

8. Box 10: Specify all means of transport to be used (e.g. lorry, ship, plane, train, etc.).

9. Boxes 11a, 11b: Enter name of the scheduled substance as stated in the Annex to Regulation (EC) No 111/2005, the commercial name of the medicinal product listed in Category 4, the number of units in the consignment, the number of tablets/ampoules in each unit, the content of the scheduled substance in a single unit (per tablet/ampoule) or in the case of a mixture or natural product enter the name and the 8 digit CN code, as well as the commercial name

10. Boxes 11a, 11b: Identify packages and substances with precision (e.g. 2 cans of 5 litres each). In the case of a mixture, a natural product or preparations, indicate the commercial name concerned.

11. Boxes 12a, 12b: Enter the 8 digit CN code of the scheduled substance as stated in the Annex of Regulation (EC) No 111/2005.

Box 13 a, 13b: for Category 4, enter the total net weight of the scheduled substance contained in the consignment of medicinal products.

12. Box 16:

• Indicate in block letters the name of the applicant or, where appropriate, of his authorised representative who signs this application.

• The signature by the applicant or his authorised representative^F49... indicates that the person concerned is declaring that all the particulars provided on the application are correctly and fully stated. Without prejudice to the possible application of penal provisions, this declaration is equivalent to the engagement of responsibility, under the provisions in force ^F49..., in respect of the following:

  • the accuracy of the information;

  • the authenticity of any documents attached;

  • the observance of all other obligations.

• Whenever the authorisation is issued by means of a computerised procedure, that authorisation may not contain the signature of the applicant in this box, if the application as such contains such signature.

13. ^F50...^F1]