What is Decree No. 125 / 2006 Coll.?

Decree No. 125 / 2006 Coll., laying down forms of forms pursuant to Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended — Decree laying down forms of forms pursuant to Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended.

When it became Decree No. 125 / 2006 Coll. effectiveness?

Decree No. 125 / 2006 Coll. became effective 11.04.2006.

Is Decree No. 125 / 2006 Coll. still valid?

Yes, Decree No. 125 / 2006 Coll. is still valid and effective.

Decree No. 125 / 2006 Coll.

Decree laying down forms of forms pursuant to Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended

Valid Effective from 11.04.2006

§ 1 § 2

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125

DECLARATION

of 31 March 2006

laying down forms of forms under Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended

According to Section 44b of Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended by Act No. 74 / 2006 Coll., (hereinafter referred to as "the Act"):

§ 1

(1) This decree sets out the following forms of forms:

(a) in Annex No 1, an application for authorisation for the treatment of addictive substances and preparations under Section 8 (7) of the Act;

(b) in Annex 2, an application for authorisation to handle precursors - licences under the directly applicable rules of the European Communities (1);

(c) in Annex 3, the application for inclusion in the list of legal and natural persons, specifying their places of work for whose activity no authorisation is required for the treatment of addictive substances, preparations containing them and precursors pursuant to § 5 (7) and § 6 (3) of the Act,

(d) in Annex 4, the application for modification of the authorisation for the treatment of substances and preparations referred to in Article 9 (10) of the Act;

(e) in Annex 5, the application for revocation of the authorisation for the treatment of substances and preparations referred to in Article 8 (11) of the Act;

(f) in Annex 6, an application for registration of the manufacturer of the excipients listed in Category 2 in accordance with the directly applicable Regulation of the European Communities (2);

(g) in Annex 7, an application for registration of an exporter of excipients listed in categories 2 and 3 under the directly applicable Regulation of the European Communities (3);

(h) in Annex 8, an application for registration of an importer of the excipients referred to in category 2 in accordance with the directly applicable Regulation of the European Communities (3);

(i) in Annex 9, an application for registration of persons intending to place on the market the excipients listed in Category 2 in accordance with the directly applicable Regulation of the European Communities (2);

(j) in Annex 10, the application for authorisation to export addictive substances and preparations pursuant to Section 22 (2) of the Act;

(k) in Annex 11, an application for authorisation to export precursors in accordance with the directly applicable Regulation of the European Communities (3);

(l) in Annex 12, an application for authorisation to export excipients in accordance with the directly applicable Regulation of the European Communities (3);

(m) in Annex 13, an application for authorisation to export excipients by a simplified procedure in accordance with the directly applicable Regulation of the European Communities (3);

(n) in Annex No 14, an application for authorisation to import addictive substances and preparations pursuant to Section 22 (2) of the Act;

(o) in Annex 15, an application for authorisation to import precursors under the directly applicable Regulation of the European Communities (3);

(p) in Annex 16, the application for authorisation to export the macadamia referred to in Article 25 (1) of the Act;

(q) in Annex No 17, an application for authorisation to import macaquin pursuant to Article 25 (1) of the Act,

(r) in Annex No 18, the monthly report on imports of addictive substances and preparations pursuant to Section 26 (1) (c) of the Act;

(s) in Annex 19, the report on imports of precursors carried out pursuant to the directly applicable Regulation of the European Communities (3);

(t) in Annex No 20, the monthly declaration of exports of addictive substances and preparations pursuant to Section 26 (1) (c) of the Act;

(u) in Annex 21, the report on the export of precursors carried out pursuant to the directly applicable Regulation of the European Communities (3);

(v) in Annex 22, the report on the export of the excipients pursuant to Paragraph 28 (1) (b) of the Act;

(w) in Annex 23, the quarterly report on the exports of macaquin pursuant to Section 30 of the Act;

(x) in Annex 24, the quarterly report on imports of macaquin pursuant to Section 30 of the Act;

(y) in Annex 25, the summary of the annual report on the treatment of addictive substances, preparations and precursors referred to in Section 26 (1) (a) of the Act;

(z) Annex No 26, Annex I, Annual report on the treatment of addictive substances, preparations and precursors - income from domestic suppliers.

(2) This decree also provides for the following forms:

(a) Annex 27, Annex II, annual report on the treatment of addictive substances, preparations and precursors - supply to domestic customers,

(b) Annex 28, Annex III, the annual report on the treatment of addictive substances, preparations and precursors - details of production,

(c) in Annex 29, Annex IV, the annual report on the treatment of addictive substances, preparations and precursors - production - delivered to the undertaking;

(d) Annex No 30, Annex No V, annual report on the treatment of addictive substances, preparations and precursors - production - detail of stocks,

(e) in Annex 31, the annual reporting of persons operating a pharmacy pursuant to Article 27 of the Act;

(f) in Annex 32, the summary of the annual report on the production of the excipients referred to in Section 28 (1) (a) of the Act;

(g) Annex I, Annex 33, to the annual report on the production of excipients - detail of the quantities consumed for own purposes,

(h) in Annex 34, the summary of the annual export report of the excipients referred to in Section 28 (1) (a) of the Act;

(i) Annex No 35, Annex I, to the annual export report of the excipients - detail of the total quantity exported,

(j) in Annex 36, the summary of the annual import report for the excipients referred to in category 2 referred to in Section 28 (1) (a) of the Act;

(k) Annex I, Annex 37, to the annual import report of the excipients listed in category 2 - detail of the total quantity imported,

(l) in Annex 38, Annex II to the annual report on imports of the excipients referred to in category 2 - detail of the quantity consumed for own purposes,

(m) in Annex 39, the annual report of the Directorate-General for Customs on poppy seed and hemp pursuant to § 43 (6) (b) of the Act,

(n) in Annex 40, the statement by the Directorate-General for Customs on poppy and hemp sown areas and their estimates pursuant to § 43 (6) (a) of the Act;

(o) in Annex 41, the estimate of imports of addictive substances and preparations pursuant to Article 26 (1) (b) of the Act;

(p) In Annex 42, the estimate of the production of addictive substances, preparations and precursors pursuant to § 26 (1) (b) of the Act.

§ 2

Efficacy

This decree shall take effect on the day of its publication.

Minister:

MUDr. Rath v. r.

Příloha č. 1

Annex No 1 to Decree No. 125 / 2006 Coll.

APPLICATION FOR AUTHORIZATION TO handle substance and preparation

Příloha č. 2

Annex No. 2 to Decree No. 125 / 2006 Coll.

APPLICATION FOR PERMISSION FOR THE Treatment of precursors - LICENCE

Příloha č. 3

Annex No. 3 to Decree No. 125 / 2006 Coll.

APPLICATION FOR DISCLOSURE

legal and natural persons, specifying their places of work, for whose activities no authorisation to handle addictive substances is required, products containing them and precursors

Příloha č. 4

Annex No. 4 to Decree No. 125 / 2006 Coll.

APPLICATION FOR AMENDMENT OF AUTHORISATIONS FOR THE Treatment of addictive substances and preparations

Příloha č. 5

Annex No 5 to Decree No. 125 / 2006 Coll.

REQUEST FOR REPEAL OF AUTHORISATIONS FOR THE Treatment of substance and preparation

Příloha č. 6

Annex No 6 to Decree No. 125 / 2006 Coll.

MARKETING AUTHORISATION NUMBER (S)

Příloha č. 7

Annex No 7 to Decree No. 125 / 2006 Coll.

MARKETING AUTHORISATION REQUEST for the exporter of the excipients referred to in categories 2 and 3

Příloha č. 8

Annex No 8 to Decree No. 125 / 2006 Coll.

MARKETING AUTHORISATION HOLDER

Příloha č. 9

Annex No 9 to Decree No. 125 / 2006 Coll.

APPLICATION FOR THE MARKETING AUTHORISATION OF a person intending to place on the market the excipients listed in Category 2

Příloha č. 10

Annex No. 10 to Decree No. 125 / 2006 Coll.

APPLICATION FOR EXPOSURE TO EXPORT STANDARDS AND PREPARATIONS

Příloha č. 11

Annex No 11 to Decree No. 125 / 2006 Coll.

REQUEST FOR PERFORMANCE TO EXPORT OF PRECURSOR

Příloha č. 12

Annex No 12 to Decree No. 125 / 2006 Coll.

APPLICATION FOR AUTHORIZATION TO EXPORT THE AID SUBSTANCE

Příloha č. 13

Annex No. 13 to Decree No. 125 / 2006 Coll.

REQUEST FOR THE EXPORTING AUTHORITY BY A Simplified PROCEDURE

Příloha č. 14

Annex No 14 to Decree No. 125 / 2006 Coll.

APPLICATION FOR AUTHORISATION TO IMPORT STANDARDS AND PREPARATIONS

Příloha č. 15

Annex No 15 to Decree No. 125 / 2006 Coll.

APPLICATION FOR PERFORMANCE TO IMPORT PRECURSOR

Příloha č. 16

Annex No. 16 to Decree No. 125 / 2006 Coll.

APPLICATION FOR EXPOSURE TO EXPORT MACHINE

Příloha č. 17

Annex No. 17 to Decree No. 125 / 2006 Coll.

APPLICATION FOR AUTHORIZATION FOR IMPORTATION OF MAX

Příloha č. 18

Annex No. 18 to Decree No. 125 / 2006 Coll.

MONTHLY DECLARATION ON IMPORTS OF addictive substances and preparations

Příloha č. 19

Annex No 19 to Decree No. 125 / 2006 Coll.

DECLARATION OF IMPORTS OF precursors implemented

Příloha č. 20

Annex No 20 to Decree No. 125 / 2006 Coll.

MONTHLY DECLARATION ON EXPORT OF addictive substances and preparations

Příloha č. 21

Annex No 21 to Decree No. 125 / 2006 Coll.

DECLARATION OF EXPORT OF precursors

Příloha č. 22

Annex No 22 to Decree No. 125 / 2006 Coll.

DECLARATION OF EXPORT OF EXEMPTIONS

Příloha č. 23

Annex No 23 to Decree No. 125 / 2006 Coll.

QUARTER REPORT ON EXPORT OF MAJOR

Příloha č. 24

Annex No 24 to Decree No. 125 / 2006 Coll.

QUARTERLY REPORT ON IMPORTS OF MAJOR

Příloha č. 25

Annex No. 25 to Decree No. 125 / 2006 Coll.

ANNUAL REPORT ON THE MANAGEMENT OF EDIBLE SUBSTANCES, PREPARATIONS AND RESULTS

Příloha č. 26

Annex No. 26 to Decree No. 125 / 2006 Coll.

ANNUAL DECLARATION ON THE MANAGEMENT OF EDIBLE SUBSTANCES, PREPARATIONS AND PRECIDENTS Annex I REVENUE FROM SUPPLIERS IN THE TOWN

Příloha č. 27

Annex No. 27 to Decree No. 125 / 2006 Coll.

ANNUAL DECLARATION ON THE MANAGEMENT OF INDIVIDUAL SUBSTANCES, PREPARATIONS AND PRECIDENTS Annex No II TO THURSAIRS (excluding pharmacies)

Příloha č. 28

Annex No 28 to Decree No. 125 / 2006 Coll.

ANNUAL DECLARATION ON THE MANAGEMENT OF COMPETENT SUBSTANCES, PRODUCTS AND PRECIDENTS Annex No III DETAIL PRODUCTS

Příloha č. 29

Annex No 29 to Decree No. 125 / 2006 Coll.

ANNUAL DECLARATION ON THE MANAGEMENT OF COMPETENT SUBSTANCES, PREPARATIONS AND PRECIDENTS Annex No IV PRODUCTION - INVESTMENT

Příloha č. 30

Annex No. 30 to Decree No. 125 / 2006 Coll.

ANNUAL DECLARATION ON THE MANAGEMENT OF COMPETENT SUBSTANCES, PRODUCTS AND PRECIDENTS

Příloha č. 31

Annex No. 31 to Decree No. 125 / 2006 Coll.

ANNUAL DECLARATION of persons operating a pharmacy on the reception, supply and stock of narcotic drugs listed in Annex 1 to Law No 167 / 1998 Coll. and psychotropic substances listed in Annex 5 to Law No 167 / 1998 Coll. and preparations containing them

Příloha č. 32

Annex No 32 to Decree No. 125 / 2006 Coll.

ANNUAL REPORT ON THE PRODUCTION OF AMENDMENTS

Příloha č. 33

Annex No. 33 to Decree No. 125 / 2006 Coll.

ANNUAL DECLARATION ON THE PRODUCTION OF EXECUTIVE SUBSTANCES Annex I TO THE DETAILED MILITARY FOR OWN PURPOSES

Příloha č. 34

Annex No. 34 to Decree No. 125 / 2006 Coll.

ANNUAL STATEMENT OF EXPORT OF AMENDMENTS

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