Decree No. 363 / 2004 Coll.
Decree amending Decree No. 304 / 1998 Coll., laying down cases where no export authorisation is required for the export of excipients, details of the registration of addicts, preparations and precursors and of the substance documentation, as amended
Valid
Order
Effective from 01.07.2004
363
DECLARATION
of 17 May 2004
amending Decree No 304 / 1998 Coll., laying down cases where no export authorisation is required to export excipients, details of the registration of addicts, preparations and precursors and of the substance documentation, as amended
According to § 12 (3), § 20b (2), § 32 (6) and (8) and § 33 (2) of Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended by Act No. 362 / 2004 Coll., (hereinafter "the Act '):
Decree No. 304 / 1998 Coll., laying down cases where no export authorisation is required for the export of excipients, details of the registration of addicts, preparations and precursors and of the substance documentation, as amended by Decree No. 143 / 2000 Coll. and Decree No. 82 / 2002 Coll., is amended as follows:
1. the first part, including the title and footnote 1, shall read:
INTRODUCTORY PROVISIONS AND DETERMINATION OF THE LIMITS OF EXCIPIENTS ON THE MARKET AND EXPORT
Preliminary provisions
This decree sets out, in accordance with the law of the European Communities (1), cases where no export authorisation is required for the export of excipients, details of the registration of addicts, preparations and precursors and the documentation of addicts.
Limited quantities of excipients when placed on the market and exported
(1) A declaration by the customer (Paragraph 12 (2) of the Act) when placing on the market the excipients listed in Annex 10 to the Act, with the exception of potassium permanganate, is not required where the total quantity of such substances placed on the market per calendar year does not exceed that set out in Annex 8 to this Decree.
(2) When placing on the market of the excipients listed in Annex 10 to the Act, documentation, including customer declarations and records, shall not be required in cases where the total quantity of such substances placed on the market in a calendar year does not exceed the quantity listed in Annex 8 to this Decree (Section 32 (6) of the Act).
(3) In the case of exports of potassium permanganate and acetic acid anhydride (Section 20b (2) of the Act), no notification of the anticipated export shall be required if their quantity does not exceed the quantity set out in Annex 9 to this Decree.
1) Council Directive 92 / 109 / EEC of 14 December 1992 on the manufacture and placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances. Commission Directive 93 / 46 / EEC of 22 June 1993 replacing and amending the Annexes to Council Directive 92 / 109 / EEC on the manufacture and placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances. Council Regulation (EEC) No 3677 / 90 of 13 December 1990 on measures to be taken to prevent the diversion of certain substances to the illicit manufacture of narcotic drugs and psychotropic substances, as amended by Council Regulation (EEC) No 900 / 92 and Council Regulation (EC) No 988 / 2002. Commission Regulation (EC) No 1485 / 96 of 26 July 1996 laying down detailed rules for the application of Council Directive 92 / 109 / EEC as regards customer declarations concerning the specific use of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances, as amended by Commission Regulation (EC) No 1533 / 2000. '
footnote (1) shall be renumbered footnote (1a), including the footnote reference.
2. The heading of Part Two reads: "EVIDENCE OF ADJUSTMENTS, PRODUCTS, PREKURSORS AND EXCIPIENTS."
3. in Paragraph 2 (1), including footnotes (1a) and (1b):
"(1) Evidence of the treatment, import and export of addicts and preparations and of the treatment of precursors and consumables (1a) (hereinafter referred to as" the register ") shall be kept in full, in a verifiable manner (in writing or by means of computer technology) in such a way as to show truthfully the facts which are its object. The processing of personal data in the register shall be governed by a special law. (1b)
(1a) Article 2 (3) of Council Regulation (EEC) No 3677 / 90.
1b) Act No. 101 / 2000 Coll., on the protection of personal data and on the amendment of certain laws, as amended. '.
footnote (1a) shall be renumbered footnote (1c), including the footnote reference.
4. In Article 2 (2), "substances and precursors' is replaced by" substances, precursors and excipients 1c) ';
Footnote 1c) reads as follows:
"(1c) Article 2 (2) of Council Regulation (EEC) No 3677 / 90."
footnote 1 (c) shall be renumbered footnote 1 (d), including the footnote references.
5. in Article 3 (1) (a), the words "the trade name or the name and address of the natural person, or" shall be replaced by the words "the name and surname, or the business name, or the place of business, or the address of the place of permanent residence, or the address of residence in the Member State of the European Union (hereinafter referred to as" residence ") of the natural person or business name, or of the name and."
6. in Paragraph 4 (3) (d):
"(d) the name and address of the undertaking of the natural person or business firm or the name and registered office of the legal person or designation and the registered office of its organisational component from which the products have been accepted, or the name and address of the undertaking of the natural person or of the commercial firm, or the name and registered office of the legal person or designation and the registered office of its constituent which have been issued the products in storage;";
7. In Article 4, paragraphs 6 and 7 are added:
"(6) Excipients may be recorded using computer techniques mutatis mutandis in accordance with paragraphs 1 and 2. The records shall include:
(a) for the excipients listed in Annex 10 to the Act, with the exception of the manufacture and placing on the market of potassium permanganate: the name of the auxiliary substance, the date of receipt or delivery, the number of the document of receipt and delivery, the name and address of the undertaking of the natural person or business company, or the name and address of the undertaking of the entity which issued it, the quantity received, issued or produced and the state of stocks,
(b) for the excipients listed in Annex 11 to the Act, similar data as for the excipients listed in Annex 10 to the Act, except for stocks and quantities produced.
(7) The record keeping referred to in paragraph 6 shall not be subject to the inventory obligation referred to in paragraph 5. ';
8. The following Section 6b is inserted after Section 6a, including the title:
Reporting on the treatment of addictive substances, preparations or precursors without authorisation of treatment
(1) When dealing with addictive substances, products containing addictive substances listed in Annex 1 or Annex 5 to the Act or precursors of persons listed in Section 5 (7) or Section 6 (3) of the Act, registration records shall be kept.
(2) The model of the register sheet is set out in Annex 5 to this Decree. "
9. Paragraph 8 (1) reads as follows:
"(1) In the case of the storage of addictive substances, of products containing addictive substances listed in Annex 1 or Annex 5 to the Act or of precursors on the basis of an authorisation to treat them, in the absence of a procedure under Section 5, 6, 6a or Section 7, records shall be kept of the storage of addictive substances, preparations or precursors. ';
10. The first sentence of Paragraph 9 (1) reads: "The documentation on the treatment of addictive substances, preparations, precursors and auxiliary substances shall consist of:"
11. in Article 9 (1) (d), the words "preparations and precursors (Section 14 of the Act)" are replaced by the words "preparations, precursors (Section 14 of the Act) and the ingredients listed in Annex 10 to the Act."
12. in Paragraph 9 (1) (e), the words "preparation or precursor" shall be replaced by the words "preparation, precursor or or excipients listed in Annex 10 to the Act."
13. in Article 9 (1) (h):
"(h) any official decision (Paragraph 16 (6) of the Act) concerning the registration of manufacturers, exporters, importers and sellers of excipients and all decisions, including decisions taken by the competent authorities of the countries of the European Communities or third countries concerning their export or import,";
14. in Article 9 (1) (i), (j) and (l), including footnote (2c) and (2d), the following shall be added:
"(i) copies of reports (Sections 26 to 30 and 43 of the Act);
(j) commercial documents such as invoices, bills of lading, transport and other delivery documents, lists of goods, administrative documents, delivery notes, customs documents containing sufficient information for reliable identification: the name of addicts or precursors, as specified in the annexes to the Act, the quantity and weight of addicts, the name and quantity of products containing addictive substances, the name and quantity of preparations containing ephedrine or preparations containing pseudoephedrine in quantities greater than 30 mg in the unit of pharmaceutical form, the quantity and weight of precursors, in the case of a mixture of quantities and weight of products, as well as well as well as the quantity and weight of preparations and percentages of precursors which are included in the product as referred to in Section 1 (2) (b) of the Act], the name and residence of the undertaking of the natural person or of the company or of the name and of the legal persons involved in the substance, products and of the product,
(l) a completed declaration by the customer in accordance with special legislation 2d) for precursors and auxiliary substances listed in Annex 10 to the Act.
(2c) Article 2 (1) of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EEC) No 900 / 92 and Council Regulation (EC) No 988 / 2002.
(2d) Commission Regulation (EC) No 1485 / 96, as amended by Commission Directive 93 / 46 / EEC and Commission Regulation (EC) No 1533 / 2000. ';
15. in Paragraph 9 (1), the dot is replaced by a comma at the end of point (l) and the following point (m) is added:
"(m) the registration issued (Paragraph 16 (1) of the Act), commercial documents such as invoices, bills of lading, transport and other delivery documents, lists of goods, administrative documents, delivery notes, customs documents containing sufficient information for a reliable identification: the name of the auxiliary substances as listed in the Annexes to the Act, the quantity and weight of the excipients, in the case of a mixture of the quantity and weight of the product as well as the quantity and weight or percentage of the auxiliary substances contained in the product, the names and the residence of the operating natural person or the trading company or the name and the registered office of the legal person handling the auxiliary substances, including the final consignee. 2c) '.
16. in Article 9 (2), the words "copies of medical regulations" shall be replaced by the words "first copies of medical regulations, or, where appropriate, first sheets of medical regulations," and the words "copies of the request" shall be replaced by the words "first copies of the request."
17. in Paragraph 9 (3), the words "blocks of used reception3)" shall be replaced by the words "all second passages of used reception3)" and the words "blocks of used request4)" shall be replaced by the words "first sheets and all second and third passages of used request4)."
18. In Article 10, the sentence "In the case of excipients, the entries and protocols referred to in Article 9 (1) (d) and (e) shall be added at the end of the text, the person authorised to act as a legal person or as a natural person or person authorised by them in writing."
19. Paragraph 11, including the title and footnote 5, reads:
Preservation of documentation
(1) The documentation shall be stored in such a way as to prevent its loss, destruction or theft and the possibility of its misuse.
(2) Documentation relating to treatment
(a) addictive substances and preparations containing them shall be kept for a period of 5 years (Paragraph 33 (1) of the Act) from the date of the receipt of the document or, where appropriate, from the last entry therein, whichever is the later;
(b) precursors and auxiliary substances shall be kept for at least 3 years (Paragraph 33 (1) of the Act) from the end of the calendar year in which the treatment took place.
5) Article 2 (4) of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EEC) No 900 / 92. '
20. Annex No 1 to this Decree is deleted.
21. In Annex 5 to this Decree, "1 gram 'is replaced by" gram'.
22. Annex 7 to this Decree is deleted.
23. the following Annexes 8 and 9 are inserted after Annex 7:
"Annex No 8 to Decree No. 304 / 1998 Coll.
Annual limit quantity for persons intending to place on the market the auxiliary substances listed in Annex 10 to the Act (Sections 12 (3) and 32 (6))
| Mezinárodní nechráněný název (INN) v českém jazyce | Množství |
|---|---|
| Anhydrid kyseliny octové | 20 litrů |
| Kyselina antranilová | 1 kg |
| Kyselina fenyloctová | 1 kg |
| Piperidin | 0,5 kg |
Including salts of scheduled substances in all cases where the existence of such salts is possible.
It also applies to mixtures of these substances when converted into the content of the pure substance contained in the mixture.
Příloha č. 9
Annex No. 9 to Decree No. 304 / 1998 Coll.
Limit quantities for persons intending to export acetic acid anhydride or potassium permanganate related to the notification of anticipated exports (Section 20b (2) of the Act)
| Mezinárodní nechráněný název (INN) v českém jazyce | Limitní množství v kg (včetně) |
|---|---|
| Anhydrid kyseliny octové | 100 |
| Manganistan draselný | 100“. |
Efficacy
This decree shall take effect on the first day of the first month following its publication.
Minister:
Dr. Kubinyi, Ph.D. v. r.
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Regulation Information
| Citation | Decree No. 363 / 2004 Coll., amending Decree No. 304 / 1998 Coll., laying down cases where no export authorisation is required for the export of excipients, details of the registration of addicts, preparations and precursors and of the substance documentation, as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 15.06.2004 |
|---|---|
| Effective from | 01.07.2004 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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