Commission Implementing Regulation (EU) 2015/1013 of 25 June 2015 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors (Text with EEA relevance)

1. 1.

   The layout of the model is not binding.

2. 2.

   The order numbers and the text of the model are binding. The completion of the boxes marked in bold is mandatory.

3. 3.

   Details of the boxes:

   • Box 1 (Licence holder): The name of the responsible officer may be added.

   • Box 3 (validity/end): Specify the term of validity or whether licence holders are obliged to demonstrate at intervals not exceeding three years that the conditions under which the licence was granted are still fulfilled.

   • Box 4 (scheduled substances): Name of the scheduled substance as stated in the Annex, or, in the case of a mixture or a natural product, its name and the name of any scheduled substance, as stated in the Annex, contained in the mixture or in the natural product. Indicate salts, where appropriate.

   • Box 4 (CN code): In addition to the CN code, the CAS number may be added.

   • Box 4 (operation): Specify export, import and/or intermediary activities. In the case of import, specify whether storage, working, processing, use, usual forms of handling and/or release for free circulation, where appropriate. For operations covered by Regulation (EC) No 273/2004, specify: storage, production, manufacture, processing, trade, distribution and/or brokering.

   • Box 4 (business premises): In the case of intermediary activities referred to in Article 2 of Regulation (EC) No 111/2005, the business premises need not be specified.

4. 4.

   F2...

5. 5.

   F3...

1. 1.

   The layout of the model is not binding.

2. 2.

   The order numbers and the text of the model are binding. The completion of the boxes marked in bold is mandatory.

3. 3.

   Details of the boxes:

   • Box 1 (Registration holder): The name of the responsible officer may be added.

   • Box 3 (validity/end): Specify the beginning and, where relevant, the end of validity.

   • Box 4 (scheduled substances): Name of the scheduled substance as stated in the Annex, or, in the case of a mixture or a natural product, its name and the name of any scheduled substance, as stated in the Annex, contained in the mixture or in the natural product. Indicate salts, where appropriate.

   • Box 4 (CN code): In addition to the CN code, the CAS number may be added.

   • Box 4 (operation): Specify export, import and/or intermediary activities. In the case of import, specify whether storage, working, processing, use, usual forms of handling and/or release for free circulation, where appropriate. For operations covered by Regulation (EC) No 273/2004, specify: storage, production, manufacture, processing, trade, distribution and/or brokering.

   • Box 4 (business premises): In the case of intermediary activities referred to in Article 2 of Regulation (EC) No 111/2005, the business premises need not be specified.

4. 4.

   F2...

5. 5.

   F3...

I.

F2...

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 F2Great Britain at the latest before the physical departure of the goods.

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

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.

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.

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).

Box 10: Give the name of the F2... port, airport or border point, where appropriate.

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

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.

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

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.

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

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

• 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 F2... 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 ..., 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)

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

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

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.

F2. . . . . . . . . . . . . . . . . . . . . . .

F2...

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 F2Great Britain.

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

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.

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

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

Box 9: Give the name of F2... the port, airport or border point.

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

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

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.

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

• 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 representativeF2... 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 ..., 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.