EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2015) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
laying down rules in resp ect of Regulation (EC) No  273/2004 of the European 
Parliament and of the Council on drug pr ecursors and for Council Regulation (EC) 
No 111/2005 laying down rules fo r the monitoring of trade between the Union and third 
countries in drug precursors, and amending Regulation (EC) No 1277/2005 
(Text with EEA relevance) 
 EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
laying down rules in respect of Regulation (EC) No 273/2004 of the European 
Parliament and of the Council on drug precursors and for Council Regulation (EC) 
No 111/2005 laying down rules for the monitori ng of trade between the Union and third 
countries in drug precursors, and am ending Regulation (EC) No 1277/2005 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 273/2004 of the European Parliament and of the 
Council of 11 February 2004 on drug precursors
1, and in particular Article 14 thereof,  
Having regard to Council Regulation (EC)  No 111/2005 of 22 December 2004 laying down 
rules for the monitoring of trade between th e Union and third countries in drug precursors2, 
and in particular Article 6(3), the third subparagraph of Article 9(2) and Article 28 thereof,  
Whereas: (1) Commission Regulatio n (EC) No 1277/2005
3 lays down provisions for the 
implementation of Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005 in 
the field of drug precursors. Both Regul ation (EC) No 273/2004 and Regulation (EC) 
No 111/2005 have been amended after the adoption of Regulation (EC) No 1277/2005 
so as to include empowerments to adopt de legated and implementing acts pursuant to 
Articles 290 and 291 of the treaty. Therefore, new rules should be adopted in accordance with the new empowerments. 
(2) Since Regulation (EC) No 273/2004 and Re gulation (EC) No 111/2005 concerns 
largely the same actors and provide for similar obligations and procedures, the 
implementing provisions should be laid  down in one single implementing act. 
(3) For the purpose of legal certainty, operators and users, as define d in Regulation (EC) 
No 273/2004 and Regulation (EC) No 111/2005, should be entitled to receive a 
decision within a reasonable time following a complete application for a licence or a 
registration, and any refusal, suspensi on or revocation shoul d be justified. 
(4) In order to facilitate enforcement, the fo rmat of licences, regist rations and export and 
import authorisations should be harmonised. 
(5) Changes of factors which are decisive for gr anting a licence or a registration should be 
notified to the competent authority in or der to allow it to make any relevant 
amendments to the licence or registration.  
                                                
 
1 OJ L 47, 18.2.2004, p. 1. 
2 OJ L 22, 26.1.2005, p. 1. 
3  Commission Regulation (EC) No 1277/2005 of 27 July 2005 laying down implementing rules for 
Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and 
for Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the 
Community and third countries in drug precursors (OJ L 202, 3.8.2005, p.7). EN 3   EN (6) Operators should submit the information requir ed to monitor trade on a regular basis. 
(7) In order to ensure data quality and coherence, a nd avoid duplication, in the 
information fed into the European databa se on drug precursors, each Member State 
should establish one single co ntact point transmitting the in formation to the database. 
Information should be transmitted without undue delay. Information on a licence or a registration should include the elements nece ssary for identifying the operator or user 
holding the licence or registration, as well as  the substance(s) covered. Access to the 
information should be restricted to the mi nimum necessary for the public authorities' 
performance of their duties.  In order to enable cont rol and supervision by the 
Commission and by the competent authorities, access to the database should be traceable. 
(8) Transitional rules should allow the use of paper forms issued before the entry into 
force of this Regulation in compliance with previous rules until the stocks of such paper forms have been exhausted. 
(9) In order to ensure consistency, legisla tive coherence and legal certainty, this 
Regulation should apply as of the same da te as the Delegated Regulation replacing 
certain provisions of Regulation (EC) No 1277/2005. 
(10) The measures provided for in this Regulati on are in accordance with the opinion of the 
Drug Precursors Committee, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Subject matter 
This Regulation lays down uniform proce dural rules for the implementation of 
Regulation (EC) No 273/2004 and of Regulatio n (EC) No 111/2005 as regards the licensing 
and registration of operators and users as defined in those Regul ations and their listing in the 
European database on drug precursors, the provis ion by operators of information required to 
monitor trade and authorisation of exports a nd imports in the field of drug precursors. 
Article 2 
Definitions 
For the purposes of this Regulation, ‘business premises’ shall mean buildings together with 
the land occupied by an ope rator at a single location. 
Article 3 
Licence granting procedure 
(1) An operator or user shall submit to the comp etent authority an a pplication to obtain a 
licence referred to in Articl e 3(2) of Regulatio n (EC) No 273/2004 or Article 6(1) of 
Regulation (EC) No 111/2005, electronically or in writing as prescribed by the 
Member State concerned.  
An application shall be deemed to be comp lete when it contains all the information 
listed in Article 3 of Delega ted Regulation (EU) No …/…. [ Publications office: 
Please insert the reference number of the delegated Regulation on Drug Precursors 
to be adopted by the Commission on the day of adoption of  this Regulation ]. EN 4   EN (2) When assessing an applicati on to obtain a licence, the competent authority may also 
take into consideration the results of any previous assessments or audits carried out on an operator holding an authorisation as an Authorised Economic Operator (AEO) 
as defined in Article 5a of Council Regulation (EEC) No 2913/92
4, to the extent they 
are relevant for the examination of the conditions for granting a licence.  
By derogation from Article 3(1) of this  Regulation, the competent authority may 
authorise operators holding an AEO certi ficate not to submit all the information 
listed in Article 3(2)(b) of Dele gated Regulation (EU) No …/…. [ Publications 
office: Please insert the reference num ber of the delegated Regulation on Drug 
Precursors to be adopted by the Commi ssion on the day of adoption of this 
Regulation ] when they are submitting an application. 
(3) The competent authority shall first asse ss 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 applicatio n 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 notifie d to the applicant 
electronically or in writing. 
(6) One single licence may cover operations refe rred to in both Regulation (EC) No 
273/2004 and Regulation (EC) No 111/2005 . 
Article 4 
Scope of the licence  
The competent authority may grant a licence: 
(a) to cover all scheduled substances and all operations per business premises; or 
(b) to cover all scheduled substances an d all operations per operator or user. 
Article 5 
Format of the licence 
A licence referred to in Artic le 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, in formation provided in the application for 
that licence, other than information referred to in Article 3(8) of Delegated Regulation (EU) …/….[ Publications office: Please in sert the reference number of 
                                                
 
4 Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code  
(OJ L 302 19.10.1992, p. 1). EN 5   EN the delegated Regulation on Drug Precurso rs to be adopted by the Commission on 
the day of adoption of this Regulation ], 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) …/…. [ Publications office: Please in sert the reference number of 
the delegated Regulation on Drug Precurso rs to be adopted by the Commission on 
the day of adoption of this Regulation ] continue to be fulfilled, and the information to 
be changed is contained in the licence, the competent authorities 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 whic h is no longer valid to the competent 
authority within 10 working days following the date of expiry of validity or from the 
date of revocation. 
(2) Where a competent authority decides to su spend or revoke a licence, the decision 
shall be submitted to the applicant electronically or in writing and specify the grounds that justify the su spension or revocation. 
Article 8 
Special licences  
Articles 3-7 of this Regulation sha ll not apply to special licences re ferred 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. 
(1) Registration pursuant to Artic le 3(6) of Regulation (EC)  No 273/2004 or Article 7(1) 
of Regulation (EC) No 111/2005 shall be gran ted in the format set out in Annex II. 
(2) By way of derogation from paragraph 2, comp etent authorities may grant registration 
on a form printed before the date of en try 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. 
(3) 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 referr ed to in Article 8(2) of Regulation (EC) 
No 273/2004 electronically or in writing,  as prescribed by the Member State EN 6   EN concerned, before 15 February of each calendar year for scheduled substances of 
Categories 1 and 2 of Anne x I to that Regulation. 
(2) Operators shall provide the information referr ed to in Article 9(2) of Regulation (EC) 
No 111/2005 electronically or in writing,  as prescribed by the Member State 
concerned, before 15 February of each calendar year for information required by Article 9(2) of Delegate d Regulation (EU) No …/… [Publications office: Please 
insert the reference number of the dele gated Regulation on Drug Precursors to be 
adopted by the Commission on the day of adoption of this Regulation ]. 
(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 referre d to in Article 28 of Regulation (EC) 
No 111/2005 shall have the format set out in  Annexes III or IV to this Regulation, 
respectively.  
By way of derogation from the firs t subparagraph, the box relating to the 
authorisation number may have a different  format in cases where the export or 
import authorisation is gr anted by electronic means. 
(2) An export authorisation shall be establishe d in four copies numbered 1 to 4. Copy 
No 1 shall be kept by the authority issuing the authorisation. C opies No 2 and No 3 
shall accompany the scheduled substance a nd 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 the cu stoms territory of the Union. The competent 
authority at the point of exit shall return  Copy No 2 to the i ssuing authority. Copy 
No 3 shall accompany the scheduled substanc es to the competent authority of the 
importing country. Copy No 4 shall be kept by the exporter. 
(3) An import authorisation shall be establishe d in four copies nu mbered 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 exporti ng country by the issuing authority. Copy 
No 3 shall accompany the scheduled substa nce from the point of entry into the 
customs territory of the Union to the busin ess premises of the importer, who shall 
send this copy to the issuing authority. C opy No 4 shall be kept by the importer. 
(4) One single export or import authorisation sh all not cover more than two scheduled 
substances. 
(5) An authorisation shall be issued in one or  more of the official languages of the 
Union. Unless it is granted by electronic means, it shall have  A4 format and a printed 
guilloche pattern background making any fals ification by mechanical or chemical 
means apparent to the eye. 
(6) A Member State may print the authorisation forms itself or have them printed by 
printers approved by it. In the latter case, each authorisation fo rm 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. 
(7) By way of derogation from paragraphs 1-6, a Member State may issue an export or 
import authorisation on a form printed before the date of entry into force of this EN 7   EN Regulation and complying with Commissi on Regulation (EC) No 1277/2005 until 
the stocks are exhausted. 
(8) Export authorisations grante d 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 indi cate 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 ma de. That customs office shall confirm the 
details and return the copy to the exporter. 
(9) The operator shall enter the authorisati on number and the words 'simplified export 
authorisation procedure' on the customs declaration for each export operation. Where 
the customs office of exit is not at the point  of exit from the customs territory of the 
Union, the information shall be provided on the documents accompanying the export consignment. 
(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 va lidity of the export authorisation granted 
by simplified procedure. 
Article 12 
Listing of operators and users in the European database on drug precursors 
(1) For the purpose of listing in the European  database on drug precursors operators and 
users which have obtained a licence or re gistration pursuant to  Article 3(7) of 
Regulation (EC) No 273/2004, each Member State shall nominate one contact point 
and communicate the contact details to the Commission. 
(2) The responsible contact point shall transmit the relevant information electronically 
within 30 working days of having issued th e license or the registration. Where the 
concerned operator or user communicates ch anges to the relevant information to the 
competent authority, or where a license or a regi stration is suspe nded or revoked, the 
responsible contact point sh all update the information within 30 working days of 
accepting the changes or suspending or re voking the license or the registration. 
(3) The Commission shall ensure that: 
(a) the electronic transmission of  information is secure;  
(b) the database is restricted and acce ssible only to the appointed officers 
designated by the Member States and to the Commission officials responsible 
for the European database; 
(c) the database tracks, registers and keeps records of all access to the information 
on operators and user s listed therein. 
(4) The Commission and the competent authorities shall take all necessary measures to 
ensure that the information on operators and us ers listed in the data base is used only 
for the purpose of the offici al duties of the appointed o fficers and of th e Commission 
officials.  
(5)
 Information on operators and users shall in clude the full name, the address, the 
licence or registration number, the validity status of the licence or registration, and EN 8   EN the name and CN code of the scheduled substances which are covered by the 
respective licence or registration. 
(6) The Commission shall keep information on licences and registrations which have 
expired or have been revoked available in  the database for at  least three years 
following the date of expiry of validity. 
Article 13 
Repeal 
Regulation (EC) No 1277/2005 is repealed. 
Article 14 
Entry into force and application 
This Regulation shall enter into force on the third day following its publication in the Official 
Journal of the European Union . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER