EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2015) XXX  draft 
ANNEXES 1 to 4 
  
ANNEXES 
 
to the 
Commission Implementing Act 
laying down rules for the im plementation of Regulation  (EC) No 27 3/2004 of the 
European Parliament and of the Council on drug precursors and for Council Regulation 
(EC) No 111/2005 laying down ru les for the monitoring of trade between the Union and 
third countries in drug precursors 
  
EN 2  
 EN  ANNEX I  
 
 
 
European Union 
Licence  
(Article 3(2) of Regulation (EC) No.  273/2004) 
(Article 6(1) of  Regulation (EC) No. 111/2005)  
  
  
MS: ………………………….............................. 
   (Licence Number )  ORIGINAL  1. Licence holder 
(name, address, phone, fax, email)  2.  Issuing authority  
 1a. Additional information  1b. Additional information  
 3. Validity  
 Beginning:  End :  
 4. The licence covers the following:  
 Scheduled substance(s)  CN Code  Operation  Business premises  
     
     
     
     
     
 5. Additional information/conditions   
EN 3  
 EN   6.  Date                                                Signature                                          Stamp 
 
 
     Name  
  
EN 4  
 EN   
Notes 
1. The layout of the model is not binding. 
2. The order numbers and the text of the model are binding. The completion of the boxes marked in bold is 
mandatory. 
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 inter-
vals 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 mix-
ture 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. The Member States may provide for boxes for national purposes. These boxes shall be indicated by an order 
number followed by a capital letter (e.g. 4A).  
EN 5  
 EN   
ANNEX II  
 
 
 
European Union 
Registration  
(Article 3(6) of Regulation (EC) No.  273/2004) 
(Article 7(1) of  Regulation (EC) No. 111/2005)  
  
  
MS: ……………………………......................... 
   (Registration Number )  ORIGINAL  1. Registration holder 
(name, address, phone, fax, email)  2.  Issuing authority  
 1a. Additional information  1b. Additional information  
 3. Validity 
 
 Beginning:  End: 
 
 4. The registration covers the following:  
 Scheduled substance(s)  CN Code  Operation  Business premises  
     
     
     
     
     
 5. Additional information/conditions   
EN 6  
 EN   6.  Date                                                Signature                                          Stamp 
 
 
     Name  
 
 
Notes 
1. The layout of the model is not binding. 
2. The order numbers and the text of the model are binding. The completion of the boxes marked in bold is 
mandatory. 
3. Details of the boxes: 
Box 1 (Registration holder): The name of the responsible officer may be added. 
Box 3 (validity/end):  Specify the term of validity or whether registration holders are obliged to demonstrate at 
intervals not exceeding three years that the conditions under which the registration 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 mix-
ture 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. The Member States may provide for boxes for national purposes. These boxes shall be indicated by an order 
number followed by a capital letter (e.g. 4A).  
EN 7  
 EN   
ANNEX III  
EUROPEAN UNION 
GOODS SUBJECT TO EXPORT CONTROL 
 
DRUG PRECURSORS – REGULATION (EC) NO 111/2005    EXPORT AUTHORISATION  
1 2. AUTHORISATION  Number: __________________________ 
Issued (date): ___________________ at:  _______________________  
3. Simplified export authorisation  procedure    YES…….. /NO ………..  1. Exporter (name and address) 
4. Period of validity: 
Beginning :                                         End:  
5. Importer in the country of destination (name and address) 
 
Import authorisation No  6. (For  completion by the issuing authority)  Issuing Authority   
(name, address, phone, fax, email)  
7. Other Operator(s)/ (name and address)  8. Customs office where the customs declaration will be made (name and 
address)  
10. Point of exit  11. Point of entry into the import-ing country 9. Ultmate consignee (name and address)  
12.Means of transport  13. Itinerary  
15a. CN-Code  
16a. Net weight   
 
C
OP
Y
 
FOR
 
TH
E
 
I
SSU
I
N
G
 
AUTHO
R
I
TY 17a. % of mixture
  
   
 
 
1 14a.Scheduled Substance  
18a. Invoice number  
 15b. CN-Code  
 16b.  Net weight  
 17b. % of mixture  
 14b. Scheduled Substance  
18b. Invoice number   
EN 8  
 EN   19. Declaration by the applicant 
Name: _____________________________________                                   
Representing : ______________________________   (Applicant) 
Signature :  __________________________   Date _______  20. (For completion by the customs o ffice where the export declaration is 
made, unless the simplified export authorisation procedure is applied) 
Reference number of customs declaration 
………………..  Stamp 
 21. (For completion by issuing authority unless the  simplified export 
authorisation procedure is applied)) 
Box 18  information  still required:            YES…….. /NO ……….. 
 Boxes 7, 8, 10-13 information still required        YES………/NO……………  Signature: ______________________________________________ 
Function : ____________________________________________ 
Date _______   Stamp:
 22.  CONFIRMATION OF EXIT FROM THE EU 
      ( For completion by the competent authorities at the point of exit from 
the customs territory of the Union unless the  simplified export authorisa-
tion procedure is applied) 
Date of exit:: 
_________________________________________________ 
Signature of officer :      
_____________________________________________ 
Function: ________________________ 
Place :    __________________       Date : 
________________________Stamp:  
  
EN 9  
 EN   
EUROPEAN UNION 
GOODS SUBJECT TO EXPORT CONTROL 
 
DRUG PRECURSORS –  REGULATION (EC) NO 111/2005                  EXPORT AUTHORISATION 
2 2. AUTHORISATION  Number: __________________________ 
Issued (date): ___________________ at:  _______________________  
3. Simplified export authorisation  procedure    YES…….. /NO ………..  1. Exporter (name and address) 
4. Period of validity: 
Beginning :                                         End:  
5. Importer in the country of  destination (name and address) 
 
Import authorisation N°  6. (For  completion by the issuing authority)  Issuing Authority   
(name, address, phone, fax, email)  
7. Other Operator(s)/ (name and address)  8. Customs office where the customs declaration will be made (name and 
address) 
10. Point of exit  11. Point of entry into the importing 
country 9. Ultmate consignee (name and address)  
12.Means of transport  13. Itinerary  
15a. CN-Code  
16a. Net weight  COPY TO ACCOMPANY THE GOODS TO POINT OF EXIT (*)  
17a. % of mixture   
    
 
2 14a.Scheduled Substance  
18a. Invoice number  
 15b. CN-Code  
 16b. Net weight  
 17b. % of mixture  
 14b. Scheduled Substance  
18b. Invoice number  
 19. Declaration by the applicant 
Name: _____________________________________                                               Representing : ______________________________   (Applicant) 
Signature :  __________________________   Date _______
 20. (For completion by the customs offi ce where the customs declaration is made 
unless the  simplified export aut horisation procedure is applied) 
Reference number of customs declaration 
………………..  Stamp   
EN 10  
 EN   21. (For completion by issuing authority unless the  simplified export authorisa-
tion procedure is applied) 
Box 18  information still required:            YES…….. /NO ……….. 
 
Boxes 7, 8, 10-13 information still required        YES………/NO……………  
 
Signature: ______________________________________________ 
Function : ____________________________________________ 
Date _______   Stamp:  22.  CONFIRMATION OF EXIT FROM THE UC 
      ( For completion by the competent authorities at the point of exit from the customs territory of the Union unless the  simplified export authorisation proce-dure is applied) 
Date of exit:: _________________________________________________ 
Signature of officer :      _____________________________________________ Function: ________________________ Place :    __________________       Date : ________________________Stamp:
 
 
 
 
 
  
EN 11  
 EN   
Simplified export authorisation procedure  
23 Net weight  
24 Available 
quantity (1) and 
partial export quantity (2)  25 Partial export quantity in 
words 26 Customs declarations (refer-
ence number and date)  27  (For completion by the customs office where the customs declaration is made) 
Member State, name and address of the 
customs office, date, stamp and signature of the officer.
 
1 
2    
1 
2    
1 
2    
1 
2    
1 
2    
1 
2    
1 
2    
1 
2    
1 
2    
1     
EN 12  
 EN  2 
1 
2    
 
     
EN 13  
 EN   
EUROPEAN UNION 
GOODS SUBJECT TO EXPORT CONTROL 
DRUG PRECURSORS –  REGULATION (EC) NO 111/2005                  EXPORT AUTHORISATION 
3 2. AUTHORISATION  Number: __________________________ 
Issued (date): ___________________ at:  _______________________  
3. Simplified export  authorisati on procedure    YES…….. /NO ………..  1. Exporter (name and address) 
4. Period of validity: 
Beginning :                                         End:  
5. Importer in the country of  destination (name and address) 
 Import authorisation N°
 6. (For  completion by the issuing authority)  Issuing Authority   
(name, address, phone, fax, email)  
7. Other Operator(s)/ (name and address)  8. Customs office where the customs declaration will be made (name and address) 
10. Point of exit  11. Point of entry into the importing country 9. Ultmate consignee (name and address)  
12.Means of transport  13. Itinerary  
15a. CN-Code  
16a. Net weight  COPY TO ACCOMPANY THE GOODS TO IMPORTING COUNTRY  
17a. % of mixture   
   
 
 
3 14a.Scheduled Substance  
18a. Invoice number  
 15b. CN-Code  
 16b. Net weight  
 17b. % of mixture  
 14b. Scheduled Substance  
18b. Invoice number  
 19. Declaration by the applicant 
Name: _____________________________________                                               
Representing : ______________________________   (Applicant) 
Signature :  __________________________   Date _______  20. (For completion by the customs offi ce where the export declaration is made 
unless the  simplified export aut horisation procedure is applied) 
Reference number of customs declaration ………………..   Stamp:  
EN 14  
 EN   21. (For completion by issuing authority unless the  simplified export authorisa-
tion procedure is applied) 
Box 18  information  still required:            YES…….. /NO ……….. 
 
Boxes 7, 8, 10-13 information still required        YES………/NO……………  
 
Signature: ______________________________________________ 
Function : ____________________________________________ 
Date _______   Stamp:  22.  CONFIRMATION OF EXIT FROM THE EU 
(For completion by the competent authorities at the point of exit from the customs territory of the Union unless the  si mplified export authoris ation procedure is 
applied) 
Date of exit:: _________________________________________________ 
Signature of officer :      _____________________________________________ Function: ________________________ Place :    __________________       Date : ________________________Stamp:
 
 
 
 
 
  
EN 15  
 EN   
EUROPEAN UNION 
GOODS SUBJECT TO EXPORT CONTROL 
DRUG PRECURSORS –  REGULATION (EC) NO 111/2005                  EXPORT AUTHORISATION 
4 2. AUTHORISATION  Number: __________________________ 
Issued (date): ___________________ at:  _______________________  
3. Simplified export  authorisati on procedure    YES…….. /NO ………..  1. Exporter (name and address) 
4. Period of validity: 
Beginning :                                         End:  
5. Importer in the country of  destination (name and address) 
 Import authorisation N°
 6. (For  completion by the issuing authority)  Issuing Authority   
(name, address, phone, fax, email)  
7. Other Operator(s)/ (name and address)  8. Customs office where the customs declaration will be made (name and address) 
10. Point of exit  11. Point of entry into the importing country 9. Ultmate consignee (name and address)  
12.Means of transport  13. Itinerary  
15a. CN-Code  
16a.  Net weight  COPY FOR THE EXPORTER  
17a. % of mixture   
   
 
 
4 14a.Scheduled Substance  
18a. Invoice number  
 15b. CN-Code  
 16b. Net weight  
 17b. % of mixture  
 14b. Scheduled Substance  
18b. Invoice number  
 19. Declaration by the applicant) 
Name: _____________________________________                                               
Representing : ______________________________   (Applicant) 
Signature :  __________________________   Date _______  20. (For completion by the customs offi ce where the export declaration is made 
unless the  simplified export aut horisation procedure is applied) 
Reference number of customs declaration ………………..  Stamp
  
EN 16  
 EN   21. (For completion by issuing authority unless the  simplified export authorisa-
tion procedure is applied) 
Box 18 information still required:            YES…….. /NO ………..
 
Boxes 7, 8, 10- 13 info rmation still required        YES………/NO……………
 
Signature: ______________________________________________ 
Function : ____________________________________________ 
Date _______   Stamp:  22.  CONFIRMATION OF EXIT (s) FROM THE EU 
      ( For completion by the competent authorities at the point of exit from the  customs territory of the Union unless the  simplified export authorisation proce-dure is applied) 
Date of exit:: _________________________________________________ 
Signature of officer :      _____________________________________________ Function: ________________________ Place :    __________________       Date : ________________________Stamp:
 
 
 
 
 
  
EN 17  
 EN   
 
Notes 
I.  
1. The authorisation shall be completed in one of the o fficial languages of the Union; if it is hand-written, 
it shall be completed in ink in capital letters. 
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 informa-
tion is not known at the time of the request. In this  case, the information for box 18 is to be supple-
mented at the latest when the expor t 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 the customs territory 
of the Union at the latest before the physical departure of the goods. 
3. Boxes 1, 5, 7 and 9: Enter full names and addresses (phone, fax, email). 
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, email) of any other operator involved in the export 
operation such as transporters, in termediaries, customs agents.  
6. Box 9: Enter full name and address (phone, fax, email) 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 Member State, po rt, airport or border po int, 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 Regula-
tion (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 applican t or, where appropriate, of the authorised repre-
sentative who signs this application.  
– The signature by the ap plicant or authorised representative, according to the modalities provided 
for by the Member State concerne d, indicates that the person con cerned 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 re-
sponsibility, under the provisions in force in the Member States, in respect of the following:  
– the accuracy of the informati on given in the declaration;  
– the authenticity of an y documents attached;   
EN 18  
 EN  – 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 i ssued 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.  
 
II. (Simplified export au thorisation procedure) 
1. In the case of a simplified export authorisation procedure, boxes 7 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 prod-ucts. 
 Column 24: Indicate the quantity available in part 1 and the quantity of the partial export quan-
tity 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. 
_____________  
EN 19  
 EN   
ANNEX IV  
EUROPEAN UNION 
GOODS SUBJECT TO IMPORT CONTROL 
DRUG PRECURSORS –  REGULATION (EC) NO 111/2005                    IMPORT AUTHORISATION 
1 2. AUTHORISATION 
Number: __________________________ 
Issued (date): ___________________ at:  _______________________  1. Importer (name and address) 
3. Period of validity: 
Beginning :    End:  
4. Exporter ((name and address)  5. (For  completion by the issuing authority)  Issuing Authority   (name, address, telephone, fax, email of responsible officer)) 
6. Other Operator(s) (name and address)  7. Competent authority of the exporting country  
9. Point of entry into the Community Customs territory  8. Ultimate consignee (name and address)  
10. Methods/Means of transport  
12a. CN-Code  
13a.  Net weight  COPY FOR ISSUING AUTHORITY  
14a. % of mixture   
   
 
 
1 11a.Scheduled Substance  
15a. Invoice number  
 12b. CN-Code  
 13b. Net weight  
 14b. % of mixture  
 11b. Scheduled Substance  
15b. Invoice number  
 16. Declaration by the applicant) 
Name: _____________________________________                                                 Representing : ____________________ __________   (Applicant) 
Signature :  __________________________   Date _______   
EN 20  
 EN   17. (For completion by issuing authority) 
Signature: ______________________________________________ Function : ____________________________________________ Date _______   Stamp:
 18. ( For completion by the customs office in the Union) Customs Reference  _________________________ 
(declaration of entry into the procedur e or reference number to the custom 
approved treatment or use) 
Signature of officer :      _____________________________________________ 
Function: ________________________ Place :    __________________       Date : ________________________Stamp:
 
 
 
  
  
EN 21  
 EN   
 
EUROPEAN UNION 
GOODS SUBJECT TO IMPORT CONTROL 
DRUG PRECURSORS –  REGULATION (EC) NO 111/2005                    IMPORT AUTHORISATION 
2 2. AUTHORISATION 
Number: __________________________ 
Issued (date): ___________________ at:  _______________________  1. Importer (name and address) 
3. Period of validity: 
Beginning :    End:  
4. Exporter (name and address)  5. (For  completion by the issuing authority)  Issuing Authority   (name, address, telephone, fax, email of responsible officer)) 
6. Other Operator(s) (name and address)  7. Competent authority of the exporting country  
9 Point of entry into the Customs territory of the Union  8. Ultimate consignee (name and address)  
10. Methods/Means of transport  
12a. CN-Code  
13a.  Net weight  COPY AUTHORITY OF COUNTRY OF EXPORT  
14a. % of mixture   
   
 
 
2 11a.Scheduled Substance  
15a. Invoice number  
 12b. CN-Code  
 13b. Net weight  
 14b. % of mixture  
 11b. Scheduled Substance  
15b. Invoice number  
 16. Declaration by the applicant) 
Name: _____________________________________                                                 Representing : ____________________ __________   (Applicant) 
Signature :  __________________________   Date _______   
EN 22  
 EN   17. (For completion by issuing authority) 
Signature: ______________________________________________ Function : ____________________________________________ Date _______   Stamp:
 18. ( For completion by the customs office in the Union Customs Reference  _________________________ 
(declaration of entry into the procedur e or reference number to the custom 
approved treatment or use) 
Signature of officer :      _____________________________________________ 
Function: ________________________ Place :    __________________       Date : ________________________Stamp:
 
 
 
  
  
EN 23  
 EN   
EUROPEAN UNION 
GOODS SUBJECT TO IMPORT CONTROL 
DRUG PRECURSORS –  REGULATION (EC) NO 111/2005                    IMPORT AUTHORISATION 
3 2. AUTHORISATION 
Number: __________________________ 
Issued (date): ___________________ at:  _______________________  1. Importer (name and address) 
3. Period of validity: 
Beginning :    End:  
4. Exporter (name and address)  5. (For  completion by the issuing authority)  Issuing Authority   (name, address, telephone, fax, email of responsible officer)) 
6. Other Operator(s) (name and address)  7. Competent authority of the exporting country  
9. Point of entry into the Community Customs territory  8. Ultimate consignee  
10. Methods/Means of transport  
12a. CN-Code  
13a.  Net weight  COPY TO ACCOMPANY THE GOODS  
14a. % of mixture   
   
 
 
3 11a.Scheduled Substance  
15a. Invoice number  
 12. CN-Code  
 13b. Net weight  
 14b. % of mixture  
 11b. Scheduled Substance  
15b. Invoice number  
 16. Declaration by the applicant) 
Name: _____________________________________                                                 Representing : ____________________ __________   (Applicant) 
Signature :  __________________________   Date _______   
EN 24  
 EN   17. (For completion by issuing authority) 
Signature: ______________________________________________ Function : ____________________________________________ Date _______   Stamp:
 18. ( For completion by the customs office in the Union) Customs Reference  _________________________ 
(declaration of entry into the procedur e or reference number to the custom 
approved treatment or use) 
Signature of officer :      _____________________________________________ 
Function: ________________________ Place :    __________________       Date : ________________________Stamp:
 
 
 
  
 
  
EN 25  
 EN   
 
EUROPEAN UNION 
GOODS SUBJECT TO IMPORT CONTROL 
DRUG PRECURSORS –  REGULATION (EC) NO 111/2005                    IMPORT AUTHORISATION 
4 2. AUTHORISATION 
Number: __________________________ 
Issued (date): ___________________ at:  _______________________  1. Importer (name and address) 
3. Period of validity: 
Beginning :    End:  
4. Exporter (name and address)  5. (For  completion by the issuing authority)  Issuing Authority   (name, address, telephone, fax, email of responsible officer)) 
6. Other Operator(s) (name and address)  7. Competent authority of the exporting country  
9. Point of entry into the Customs territory of the Union  8. Ultimate consignee (name and address)  
10. Methods/Means of transport  
12a. CN-Code  
13a. Net weight  COPY FOR THE IMPORTER  
14a. % of mixture   
   
 
 
4 11a.Scheduled Substance  
15a. Invoice number  
 12b. CN-Code  
 13b. Net weight  
 14b. % of mixture  
 11b. Scheduled Substance  
15b. Invoice number  
 16. Declaration by the applicant) 
Name: _____________________________________                                                 Representing : ____________________ __________   (Applicant) 
Signature :  __________________________   Date _______   
EN 26  
 EN   17. (For completion by issuing authority) 
Signature: ______________________________________________ Function : ____________________________________________ Date _______   Stamp:
 18. ( For completion by the customs office in the Union) Customs Reference  _________________________ 
(declaration of entry into the procedur e or reference number to the custom 
approved treatment or use) 
Signature of officer :      _____________________________________________ 
Function: ________________________ Place :    __________________       Date : ________________________Stamp:
 
 
 
  
 
  
EN 27  
 EN   
Notes  
1. The authorisation shall be completed in one of the official languages of the Union. If it is hand-written, 
it shall be completed in ink in capital letters. 
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 in-formation is to be supplemented at the latest when the goods are entered into the customs territory of the 
Union. 
3. Boxes 1, 4: Enter full names and addresses (phone, fax, email). 4.  Box 6: Enter full name and address (phone, fax, email) of any  other operator involved in the import 
operation such as transporter, intermediaries, customs agent. 
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, email) of the third country authority. 7. Box 9: Give the name of the Member State and 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 w ith precision (e.g. 2 cans of 5 litres each). In the 
case of a mixture, a natural product or prepara tions, 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 Regula-
tion (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 appli cant or, where appropriate,  of his authorised rep-
resentative who signs this application. 
- The signature by the applicant or his authorised representative, according to the modalities 
provided for by the Member State concerned, in dicates that the person concerned is declaring 
that all the particulars provided on the applica tion are correctly and fully stated. Without prej-
udice to the possible application of penal provisions, this declaration is equivalent to the en-
gagement of responsibility, under the provisions in force in the Member States, in respect of 
the following : 
the accuracy of the information; 
the authenticity of an y 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.