Decree No. 54 / 2014 Coll.
Ordinance on model forms and certificates of inspector and limit quantities of substances under the drug precursor law
Valid
Effective from 15.04.2014
54
DECLARATION
of 26 March 2014
on models of forms and certificates of inspector and limit quantities of substances under the drug precursor law
According to Section 53 (2) of Act No. 272 / 2013 Coll., on drug precursors ("the Act '), the Ministry of Health provides:
Preliminary provisions
This decree provides
(a) model forms;
(b) the model of the inspector's licence; and
(c) the limit quantities of scheduled substances of categories 1 and 2.
Form models
Model form
(a) applications for the issue of a new licence for the activity of that category 1 substance pursuant to Article 2 (1) of the Act, applications for the extension of the licence for that category 1 substance pursuant to Article 3 (1) of the Act and applications for the issue of a new licence for the activity of that category 1 substance due to a change in the information given in the licence pursuant to Article 3 (1) of the Act are set out in Annex 1 to this Decree;
(b) applications for the issue of a new special licence for the activity of that category 1 substance pursuant to Article 2 (1) of the Act, applications for the extension of a special licence for that category 1 substance pursuant to Article 3 (1) of the Act and applications for the issue of a new special licence for that category 1 substance due to a change in the information contained in the specific licence referred to in Article 3 (1) of the Act are listed in Annex 2 to this Decree,
(c) applications for the amendment of a licence or a special licence to operate with that substance of category 1 pursuant to Article 3 (2) of the Act are listed in Annex 3 to this Decree;
(d) applications for registration to operate with that category 2 or 3 substance pursuant to Article 5 (1) of the Act and applications for specific registration to operate with that category 2 substance pursuant to Article 5 (2) of the Act are listed in Annex 4 to this Decree,
(e) the notification of an amendment to the registration data pursuant to Article 6 of the Act is set out in Annex 5 to this Decree;
(f) the notification of activity with that category 2 or 3 substance or with a source or an excipient pursuant to Article 7 (1) of the Act is set out in Annex 6 to this Decree;
(g) the applications for export authorisation for that category 1 substance pursuant to Article 16 (1) of the Act are set out in Part I of Annex 7 to this Decree; the model of the application form for the issue of an export authorisation for that substance of category 2 or 3 pursuant to Article 16 (1) of the Act and the application for an export authorisation for that substance of category 3 by the simplified procedure referred to in Article 16 (1) of the Act is set out in Part II of Annex 7 to this Decree,
(h) applications for import authorisations for a given substance of category 1 pursuant to Article 16 (1) of the Act are listed in Annex 8 to this Decree;
(i) the export and import reports of scheduled substances of categories 1, 2 and 3 pursuant to Article 19 (2) of the Act are set out in Annex 9 to this Decree;
(j) the statement of estimates of imports or production of scheduled substances of category 1 pursuant to Articles 20 (4) and 29 (3) of the Act is set out in Annex 10 to the present Decree;
(k) the protocol on the disposal of the scheduled substance of category 1 pursuant to Article 26 (3) of the Act is set out in Annex 11 to this Decree;
(l) the report on the excess quantities of scheduled substances of category 1 or 2, as provided for in Article 27 (3) of the Act, is set out in Annex 12 to this Decree,
(m) the provision of aggregated activity data for scheduled substances of category 1 under Section 28 of the Act is set out in Annex 13 to this Decree;
(n) the provision of aggregated activity data on scheduled substances of category 2 or 3 under Section 28 of the Act is set out in Annex 14 to this Decree;
(o) the application for registration for the making available on the market of a starting substance or an auxiliary substance in the Czech Republic or in other Member States of the European Union pursuant to Article 36 (2) of the Act is set out in Annex 15 to this Decree,
(p) the report on the quantities of source and auxiliary substances delivered pursuant to Section 37 (1) (a) of the Act is set out in Annex 16 to this Decree; and
(q) the declaration by the customer of the source or of the aid referred to in Section 37 (2) of the Act is set out in Annex 17 to this Decree.
Model of the inspector's licence
The model of the inspector's licence pursuant to § 39 (2) of the Act is set out in Annex 18 to this Decree.
Limit quantities of scheduled substances of categories 1 and 2
The limit quantities of scheduled substances of categories 1 and 2 under Section 27 (1) of the Act are listed in Annex 19 to this Decree.
Final provision
This Decree was notified in accordance with Directive 98 / 34 / EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services, as amended.
Efficacy
This Decision shall enter into force on 15 April 2014.
Minister:
MUDr.
Příloha č. 1
Annex No 1 to Decree No 54 / 2014 Coll.
REQUEST FOR LICENCING A LICENCE TO WORK WITH THAT Category 1 Substance
Příloha č. 2
Annex No 2 to Decree No 54 / 2014 Coll.
REQUEST FOR THE ISSUE OF SPECIAL LICENCE TO WORK WITH THAT Category 1 Substance
Příloha č. 3
Annex No 3 to Decree No 54 / 2014 Coll.
APPLICATION FOR A CHANGE IN LICENCE OR SPECIAL LICENCE TO WORK WITH THAT Category 1 Substance
Příloha č. 4
Annex No 4 to Decree No 54 / 2014 Coll.
REQUEST FOR THE MARKETING AUTHORISATION OR REQUEST FOR A SPECIAL MARKETING AUTHORISATION TO operate with a scheduled substance of category 2 or 3
Příloha č. 5
Annex No 5 to Decree No 54 / 2014 Coll.
NOTIFICATION OF THE CHANGE IN SPECIFIC DATA
Příloha č. 6
Annex No 6 to Decree No 54 / 2014 Coll.
NOTIFICATION ACTIVITIES WITH Category 2 or 3 scheduled substance or with source or excipient
Příloha č. 7
Annex No. 7, Part I to Decree No. 54 / 2014 Coll.
APPLICATION FOR EXPORT AUTHORISATION FOR EXPORT OF Category 1 scheduled substance
Příloha č. 7
Annex No 7, Part II, to Decree No 54 / 2014 Coll.
APPLICATION FOR EXPORT AUTHORISATION FOR EXPORT FOR EXPORT OF Category 2 or 3 scheduled substance
Příloha č. 8
Annex No 8 to Decree No 54 / 2014 Coll.
APPLICATION FOR IMPORT AUTHORISATION FOR IMPORTATION OF A Category 1 scheduled substance
Příloha č. 9
Annex No 9 to Decree No 54 / 2014 Coll.
STATEMENT OF EXPORT AND IMPORTATION OF scheduled substances of categories 1, 2 and 3
Příloha č. 10
Annex No. 10 to Decree No. 54 / 2014 Coll.
WITHDRAWAL OF IMPORTS OR PRODUCTION OF scheduled substances of category 1
Příloha č. 11
Annex No 11 to Decree No 54 / 2014 Coll.
PROTOCOL ON THE PROTOCOL ON THE DISEASING OF Category 1 scheduled substance or waste containing it
Příloha č. 12
Annex No 12 to Decree No 54 / 2014 Coll.
DECLARATION OF THE NADLIMITINGS OF THE Selected scheduled substances of category 1 or 2
Příloha č. 13
Annex No 13 to Decree No 54 / 2014 Coll.
PROVISION OF SUMMARY DATA ON ACTIVITIES WITH Category 1 scheduled substances
Příloha č. 14
Annex No 14 to Decree No 54 / 2014 Coll.
Provision of aggregated activity data for that category 2 substance pursuant to Article 8 (2) of Regulation (EC) No 273 / 2004 of the European Parliament and of the Council on drug precursors and Article 17 of Commission Regulation (EC) No 1277 / 2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors
Provision of aggregated data on imports and exports and intermediation of scheduled substances of category 2 or 3 pursuant to Article 9 (2) of Council Regulation (EC) No 111 / 2005 laying down rules for the monitoring of trade in drug precursors between the Community and third countries and Article 18 of Commission Regulation (EC) No 1277 / 2005 laying down rules for the monitoring of trade in drug precursors between the Community and third countries
Příloha č. 15
Annex No 15 to Decree No 54 / 2014 Coll.
MARKETING AUTHORISATION NUMBER (S)
Příloha č. 16
Annex No 16 to Decree No 54 / 2014 Coll.
DECLARATION OF THE WEIGHT OF SUPPLIED EDUCATION AND EXCIPIENTS
Příloha č. 17
Annex No. 17 to Decree No. 54 / 2014 Coll.
PROHIBITION OF THE REPRESENTATIVE OF THE ORIGINATOR
Příloha č. 18
Annex No 18 to Decree No 54 / 2014 Coll.
The inspector's card shall bear a photograph of the holder, a stamp of the Ministry of Health and a handwritten signature of the Minister of Health. It is made of paper with protective features, has dimensions of 99 × 68 mm and is stored in plastic packaging with embossed stamp of the Ministry of Health.
Model face-side:
Model of reverse side:
Příloha č. 19
Annex No 19 to Decree No 54 / 2014 Coll.
Limit quantities of scheduled substances of categories 1 and 2
| Seznam vybraných uvedených látek kategorie 1 a 2 | Limitní množství |
|---|---|
| Acetanhydrid | 100 kg za kalendářní rok |
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Regulation Information
| Citation | Decree No. 54 / 2014 Coll., on models of forms and certificates of inspector and limit quantities of substances under the Law on drug precursors |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 07.04.2014 |
|---|---|
| Effective from | 15.04.2014 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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