Application for Registration of Category 2 Scheduled
Substances
Applications are made in accordance with the following legislation:
Commission Delegated Regulation (EU) 2015/1011, supplementing Regulation (EC) 273/2004 of
the European Parliament and of the Council on drug precursors and Council Regulation (EC)
111/2005, lays down rules for the monitoring of trade between the Union and third countries in
drug precursors, and repeals Commission Regulation (EC) 1277/2005.
Commission Implementing Regulation (EU) 2015/1013 lays down rules in respect of Regulation
(EC) 273/2004 of the European Parliament and of the Council on drug precursors, and Council
Regulation (EC) 111/2005 lays down rules for the monitoring of trade between the Union and third
countries in drug precursors.
Council Regulation (EC) No. 273/2004, as amended, lays down the basic rules governing the
monitoring of intra-Community trade.
Council Regulation (EC) No. 111/2005, as amended, lays down rules for the monitoring of trade
between the Community and third countries in drug precursors.
1.1
SECTION 1: APPLICANT DETAILS
Applicant contact details
Name:
Address:
Company registered address (if different):
Company registration number:
Telephone:
Fax:
E-mail:
2.1
SECTION 2: RESPONSIBLE OFFICER
(See Note 2)
Responsible Officer contact details
Name:
Address:
Telephone:
Fax:
E-mail:
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2.2
Description of the position and tasks of the Responsible Officer
SECTION 3: PREMISES
3.1
Business premises address
3.2
Description of all places of production, manufacture and/or intermediary activities
involving scheduled substances (attach separate document if necessary)
3.3
Measures taken to prevent the unauthorised removal of scheduled substances from
the places listed in point 3.2 (attach separate document if necessary)
4.1
SECTION 4: ACTIVITIES
Purpose for which registration is required
(State briefly e.g. manufacturing, wholesale dealing, import, export, placing on the market
and/or intermediary activities. Sufficient information should be supplied in order to justify
registration).
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SECTION 5: TYPE OF REGISTRATION REQUIRED
(Indicate with a tick the drugs and primary activities for which registration is required)
Type of Registration
Scheduled
Substance
(including their
salts wherever
such exist)
Acetic
anhydride
CN Code as
per Annex I
to
Regulation
(EC) No
273/2004
To produce
base drug
(including
salts)
preparations
(a)
(b)
To supply or
offer to
supply
(c)
Possess/end user
(d)
2915 24 00
Anthranilic acid
2922 43 00
N/A
Phenylacetic
acid
2916 34 00
N/A
Piperidine
2933 32 00
N/A
Potassium
permanganate
2841 61 00
N/A
Note: This includes the salts of these substances whenever the existence of such salts is possible.
Operators are exempt from registration where the quantities supplied or placed on the market
within the EU do not exceed those indicated below, over the period of one year. Please inform
the Controlled Drugs section of any recipients exceeding these annual thresholds.
Substance
Annual threshold
Acetic anhydride
Potassium permanganate
Anthranilic acid and its salts
Phenylacetic acid and its salts
Piperidine and its salts
100 litres
100 kg
1 kg
1 kg
0.5 kg
Annual estimated
quantity
Please note this exemption does not apply to the above scheduled substances when involved in
external trade (i.e. imports, exports and/or intermediary activities outside the EU).
Import, export or intermediary activities
Summary of intended import, export or intermediary activities involving the above scheduled
substances (Please tick the relevant activities below and give a summary of the activities)
Import (‘Import’ means any entry of scheduled substances having the status as noncommunity goods into the customs territory of the Community, including temporary storage,
the placing in a free zone or free warehouse, the placing under a suspensive procedure and the
release for free circulation)
Export (‘Export’ means any departure of scheduled substances from the customs territory of
the Community, including the departure of scheduled substances that requires a customs
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declaration and the departure of scheduled substances after their storage in a free zone of
control type I or free warehouse)
Intermediary activities (‘Intermediary activities’ means any activity to arrange purchase and
sale or supply of scheduled substances carried out by any natural or legal person who aims to
obtain agreement between two parties or to do so through acting on behalf of at least one of
these parties without taking these substances into its possession or taking control of the
carrying out of such transaction; this definition shall also include any activity carried out by any
natural or legal person established in the Community involving purchase and sale or supply of
scheduled substances without these substances being introduced into the Community customs
territory)
Scale of usage
Anticipated annual scale of usage of the scheduled substance(s):
Preparations produced
List any preparations or other products to be produced under the authority of the registration
for which application is made:
Control of supplies
Details of the precautions to be taken to prevent supply of scheduled substance(s) to
unauthorised persons:
SECTION 6: DECLARATION
In the event of the registration being granted, I undertake to ensure fulfilment of the obligations
arising by virtue of the terms and conditions of the registration and declare that the above
particulars are, to the best of my knowledge and belief, correct.
Signature:
____________________________________________
Date:
(Applications must bear the signature of the Responsible Officer)
Notes:
1.
This application should be sent to:
Licensing Section
Compliance Department
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Terrace
Dublin 2
2.
Operators are exempt from registration where the quantities supplied or placed on the
market within the EU do not exceed those indicated below, over the period of one year.
Please inform the Controlled Drugs section of any recipients exceeding these annual
thresholds.
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Substance
Acetic anhydride
Potassium permanganate
Anthranilic acid and its salts
Phenylacetic acid and its salts
Piperidine and its salts
Annual threshold
100 litres
100 kg
1 kg
1 kg
0.5 kg
Please note this exemption does not apply to the above scheduled substances when involved in
external trade (i.e. imports, exports and/or intermediary activities outside the EU).
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