54/2014 Sb.
DECREE
of 26 March. March 2014
on the forms and patterns of compliance and limit quantities of substances
According to the law on drug precursors
The Ministry of health shall lay down pursuant to § 53 para. 2 of law No.
272/2013 Coll., on drug precursors, (hereinafter referred to as the "Act"):
§ 1
Introductory provisions
This Decree lays down the
a) specimens of the forms
(b) Inspector and the card pattern)
(c) limit the quantity selected) scheduled substances in categories 1 and 2.
§ 2
Specimens of the forms
A model of the form
and new) applications for licences for activities with a scheduled substance of category
1 according to § 2 (2). 1 of the Act, an application for renewal of a license to activities with the
scheduled substance of category 1 in accordance with § 3 (1). 1 of law and applications for
new licenses for activities with a scheduled substance of category 1 because of a change in
the information set out in the licence pursuant to § 3 (2). 1 of the Act is set out in
Appendix No. 1 to this notice,
(b) the issuing of new) special licence to activity with the substance
category 1 pursuant to § 2 (2). 1 of the Act, an application for renewal of the Special
licenses for activities with a scheduled substance of category 1 in accordance with § 3 (1). 1
the Act and the issuing of new licenses to the specific activities with the
substance category 1 because of a change in the particulars specified in the Special
licence pursuant to § 3 (2). 1 of the Act is given in annex 2 to this
the Decree,
c) change request license or a special license to activities with the
substance category 1 pursuant to § 3 (2). 2 of the Act is given in annex 3 to the
This Decree,
(d) the application for authorization to) activity with the substance in category 2 or 3
According to § 5 para. 1 of the law and application for special registration to activities with the
scheduled substance of category 2 according to § 5 para. 2 of the Act is set out in
Annex No 4 to this Decree,
(e) the notification changes) registration data pursuant to section 6 of the Act is set out in
Annex No. 5 to this Decree,
f) notification of activities with a scheduled substance in category 2 or 3, or with
the default or other ingredient under § 7 para. 1 of the Act is set out in
Annex No 6 to this Ordinance,
g) issuance of an export request authorisation for exports of scheduled substances of category
1, 2 or 3 according to § 16 para. 1 of the Act and a request for the grant of an export
authorization for export of scheduled substances of category 3 simplified procedure
According to § 16 para. 1 of the Act is set out in Appendix 7 to this Decree,
h) applications for issuance of the import permits for imports of scheduled substances of category
1 under section 16(1). 1 of the Act is given in annex 8 to this Ordinance,
I) reports on exports and imports of scheduled substances of category 1, 2 and 3 under section
19 para. 2 of the Act is set out in annex 9 to this Decree,
j) estimate of imports or production of communication to scheduled substances of category 1 according to
section 20 (2). 4 and § 29 para. 3 of the Act is set out in Appendix 10 to this
the Decree,
log on to) disposal of scheduled substances of category 1 according to § 26 para. 3
the law is set out in annex 11 to this Decree,
l) reports on the excess quantities of scheduled substances selected
category 1 or 2 in accordance with § 27 para. 3 of the Act is given in annex No. 12
This Decree,
m) provision of comprehensive data on activities involving scheduled substances of category
1 pursuant to section 28 of the Act is given in annex 13 to this Decree,
n) provision of comprehensive data on activities involving scheduled substances of category
2 or 3 under section 28 of the Act is given in annex 14 to this Decree,
o) applications for registration to supply default or adjuvants on the market
The United States and other Member States of the European Union, pursuant to section 36
paragraph. 2 of the Act is given in annex 15 to this Decree,
p) reports on the quantities delivered to the default and auxiliary substances according to § 37
paragraph. 1 (b). and) of the Act is given in annex 16 to this Decree and
q) Declaration of customer default or auxiliary substances according to § 37 para. 2
the law is set out in annex 17 to this Decree.
§ 3
The pattern of compliance Inspector
The pattern of compliance the Inspector pursuant to section 39 paragraph 2. 2 of the Act is given in annex
# 18 of this Decree.
§ 4
Limit the quantity of the selected scheduled substances in categories 1 and 2
Limit the quantity of the selected scheduled substances of category 1 and 2 according to § 27 a
paragraph. 1 of the Act are set out in annex 19 to this Decree.
§ 5
Final provision
This Decree was notified in accordance with the directive of the European Parliament
and Directive 98/34/EC of 22 December 2004. June 1998 on the procedure for the provision
information in the field of standards and technical regulations and rules on services,
the information society, as amended.
§ 6
The effectiveness of the
This Decree shall take effect on the date of 15. April 2014.
Minister:
Mudr. Němeček, MBA, in r.
Annex 1
The REQUEST for the issue of licences for activities with a scheduled substance of category 1
Annex 2
Request to issue SPECIAL licenses for activities with a scheduled substance of category
1
Annex 3
Application for amendment of a LICENCE or a SPECIAL license to activities with the
substance category 1
Annex 4
Application for registration or application for SPECIAL REGISTRATION to activities with the
scheduled substance of category ' 2 or 3
Annex 5
NOTIFICATION OF CHANGES IN REGISTRATION DATA
Annex 6
Notification of activities with a scheduled substance in category 2 or 3, or with the default
or with other ingredient
Annex 7
Application for an export permit for the export of scheduled substances of category 1, 2 or 3
Annex 8
Applications for import permits for imports of scheduled substances of category 1
Annex 9
Reports on exports and imports of scheduled substances of category 1, 2 or 3
Annex 10
The ESTIMATE of IMPORTS or PRODUCTION of scheduled substances of category 1
Annex 11
Protocol on DISPOSAL of scheduled substances of category 1 or waste it
containing the
Annex 12
Reports of EXCESS QUANTITIES of the selected scheduled substances of category 1
or 2
Annex 13
The PROVISION of comprehensive data on ACTIVITIES involving scheduled substances of category 1
Annex 14
The provision of comprehensive data on activities with a scheduled substance in category 2
Annex 15
Application for authorisation to supply default or adjuvants on the market
Annex 16
REPORTS ON THE QUANTITIES DELIVERED TO THE DEFAULT AND AUXILIARY SUBSTANCES
Annex 17
CUSTOMER DECLARATION the default or excipients
Annex 18
Annex 19
Limit the quantity of the selected scheduled substances in categories 1 and 2
