Act No. 117 / 2000 Coll.
Act amending Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended by Act No. 354 / 1999 Coll., and Act No. 368 / 1992 Coll., on administrative fees, as amended
Valid
Law
Effective from 30.06.2000
117
THE LAW
of 6 April 2000
amending Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended by Act No. 354 / 1999 Coll., and Act No. 368 / 1992 Coll., on administrative fees, as amended
Parliament has decided on this law of the Czech Republic:
Amendment to the REC
Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended by Act No. 354 / 1999 Coll., is amended as follows:
1. in Paragraph 1 (2) (a), including footnote 2, the following shall be added:
"(a) in pharmaceutical products, (2) with the exception of medicinal products containing ephedrine and medicinal products containing more than 30 mg of pseudoephedrine per unit of pharmaceutical form,
2) Paragraph 2 (3) of Act No. 79 / 1997 Coll., on Medicines and on the amendment and addition of certain related laws. "
2. In Paragraph 1 (2) (b), the words "used or recovered by means of available means' are replaced by the words" easy to use or recovered by easy to use methods'.
3. In Article 2 (d), the words "or Annex No 11 'shall be inserted after the words" Annex No 10'.
4. In the second sentence of Paragraph 3 (2), the word "or 'is replaced by a comma, and at the end the words" or, for other purposes, by the permission of the Ministry of Health' are added.
5. In Article 5 (1), the words "or preparations containing ephedrine and pseudoephedrine 'are inserted after the words" is containing'.
6. in Article 5 (1) (a), the following footnote (2a) is inserted after the word "pharmacy":
"2a) § 16 (5) of Act No. 79 / 1997 Coll. '.
7. In Article 5 (1) (b), the words "if not stored 'shall be inserted after the word" dispose'.
8. In Article 5 (2), the words "and preparations containing ephedrine and pseudoephedrine 'shall be inserted after the words" this Act'.
9. in Article 5 (2) (f):
"(f) according to the medical form completed and signed (hereinafter referred to as" the recipe ") or the orders of natural and legal persons authorised to provide medical or veterinary care (hereinafter referred to as" the letter ") to prepare and issue pharmacists in pharmacies,"
10. in Article 5 (2), at the end of point (j), the dot is replaced by a comma and the following point (k) is added:
"(k) to acquire, retain, store, transport or use contracting entities or examiners in the preparation or conduct of a clinical trial of veterinary medicinal products under specific legislation. (a)
5a) § 39 of Act No. 79 / 1997 Coll. '.
11. in Article 5 (4), the words "and preparations containing ephedrine and pseudoephedrine" shall be inserted after the words "the Law."
12. in Article 6 (1) (c), the words "if not stored" shall be inserted after the word "dispose of."
13. in Article 8 (3), "1 year" is replaced by "2 years."
14. In Article 8 (5), the first sentence is replaced by the following: "A right of treatment may be granted only to a natural person who is resident in the Czech Republic or to a legal person established in the Czech Republic. The condition of permanent residence or registered office in the Czech Republic does not apply if it is a citizen of a Member State of the European Union, a citizen of the Czech Republic who does not reside in the Czech Republic, or a legal person established in a Member State of the European Union. The legal person shall be required to demonstrate the integrity of natural persons registered as authorised to act for it; a legal person who is not registered shall demonstrate the integrity of natural persons who are identified in the instruments of incorporation as authorised to act as such. ';
15. in Article 8, the following paragraph 9 is added:
"(9) If a natural or legal person ceases to engage in an activity for which he has been granted a right of treatment, he shall immediately notify the Ministry of Health which shall revoke the right of treatment by his decision. ';
16. in Paragraph 9 (3):
"(3) The person responsible may be appointed a natural person with permanent residence in the Czech Republic. The condition of permanent residence in the Czech Republic does not apply if it is a citizen of a Member State of the European Union or a citizen of the Czech Republic who does not reside in the Czech Republic. This person must fulfil the conditions of general, medical and professional competence for the treatment of addictive substances. ';
17. in Article 9, the following paragraph 4 is inserted after paragraph 3:
"(4) The medical fitness of the responsible person shall be demonstrated by a medical assessment. The medical assessment shall be carried out by the medical assessor on the basis of the result of a medical examination or any other professional examinations. In cases where the person responsible is an employee in the employment relationship, the assessor is a doctor of the preventive care plant, in other cases a registered practitioner. The medical opinion of the responsible person shall be valid for 2 years from the date of its issue, unless there is a change in health status. A person who has a reasonable suspicion that his or her health or the life of other persons might be at risk in the performance of his or her duties may not be recognised as a competent person. ';
Paragraphs 4 to 9 shall be renumbered paragraphs 5 to 10.
18. in Paragraph 9 (10), "30" is replaced by "10."
19. In Paragraph 10 (1), the words "windows and doors" shall be replaced by the words "and" comma, "and at the end, the words" metal "shall be replaced by the words" steel or special purpose lockable equipment, which is inseparably anchored in a wall, ceiling or floor made of solid materials (for example, bricks or concrete panels). "
20. In Article 10 (4), the following sentence is inserted after the first sentence: "Storage in such cases must, however, be ensured in such a way that no unauthorised person can access the stored substances. 'and in the last sentence the words" Annex No 1 or 5' are replaced by the words "Annex No 1, 3, 4 or 5 '.
21. In Article 12, the current text becomes paragraph 1 and the following paragraph 2 is added:
"(2) Excipients listed in Annex 10 to this Act may be sold only to persons who are entitled to treat them and who submit a completed declaration to the seller using a form issued by the Ministry of Health. ';
22. Paragraph 13, including the title and footnotes 6) and 6a), reads as follows:
Formula forms and blue stripe requests
(1) Medicinal products (6) containing addictive substances and medicinal products containing ephedrine and medicinal products containing more than 30 mg pseudoephedrine per unit of pharmaceutical form may be issued in a pharmacy to a person who has not been authorised for treatment only for a prescription or a requisition. In the case of medicinal products containing addictive substances listed in Annexes 1 and 5 to this Act, the recipe or demand must be marked with a blue stripe from the lower left corner to the upper right corner. In the case of medicinal products containing addictive substances listed in Annexes 1 and 5 to this Act and listed in Annex 8 to this Act at the same time, they may be issued in a prescription pharmacy or a requisition without a blue stripe.
(2) Formula forms and blue stripe applications bearing the serial number of the form and the district code which issued them are subject to registration.
(3) Only the persons referred to in Article 5 (2) (a) and (b) of this Law may order and withdraw from the local competent district office by means of their authorised representatives. These persons shall keep a record of any further use.
(4) The production and distribution of recipes and blue stripe requests are provided by the district authorities.
(5) The district authorities keep records of the output, return and depreciation of returned recipes and blue stripe requests.
(6) Impaired prescription forms or blue stripe applications shall be required to be submitted to the district office which issued them in Section 5 (2) (a) and (b) of this Act.
(7) Persons who have ceased to comply with the conditions laid down in Article 5 (2) (a) and (b) of this Act are required to submit unused or invalidated recipes or requests to the district office which issued them within 5 days. The district office shall issue a certificate of receipt of the forms submitted.
(8) In the event of the death of a person who has been issued with recipes or requests with a blue stripe authorised by the representative or directly by the district office, the person who has lived with the deceased in the common household shall be obliged to submit those forms within 10 days of the date of death to the authorised representative if the person who has been engaged in an activity of employment or similar relationship, in other cases, to the district office.
(9) Specific legislation provides for the distribution, return, disposal and keeping of recipes and blue-striped vouchers. 6a)
(10) Medicinal products containing addictive substances and medicinal products containing ephedrine and pseudoephedrine cannot be re-issued per recipe.
6) Article 2 (1) of Act No. 79 / 1997 Coll.
6a) Decree No 343 / 1997 Coll., laying down the procedure for the prescription of medicinal products, the formalities for prescription and the rules for their use. '
23. Paragraph 14 (2), including footnote 6b, reads:
"(2) The disposal of unused addictive substances, preparations and precursors, as well as waste containing them, which are medicinal products, is governed by specific legislation. (b)
6b) § 50 of Act No. 79 / 1997 Coll. '
24. In Section 16, the words "exporters, importers and sellers' shall be inserted after the words" producers'.
25. In Article 16, the words "or export or import of any of the ingredients listed in Annexes 10 and 11 to this Act or the sales of any of the ingredients listed in Annex 10 to this Act 'are deleted after the word" manufacture' and the word "manufacture 'is replaced by the word" activity' at the end of the first sentence.
26. In Paragraph 20 (1), the first sentence is replaced by the following: "For each individual export of addictive substances, preparations, precursors and auxiliary substances in the cases referred to in paragraph 3, authorisation by the Ministry of Health (hereinafter referred to as" export authorisation ') shall be required.
27. in Article 20 (2) (a), the words "Annex No 2, 6 or 7 to this Act" shall be replaced by "Annex No 2, 6, 7 or 8 to this Act, or preparations containing ephedrine or pseudoephedrine."
28. in Article 20 (2) (b), the words "or preparations containing ephedrine or pseudoephedrine" shall be inserted after the words "listed in Annex 8 to this Law" and the words "or preparations containing ephedrine or pseudoephedrine" shall be added at the end.
29. in Article 20 (2) (c), the words "Annex 2, 5, 6 or 7 to this Act" shall be replaced by "Annex 2, 5, 6, 7 or 8 to this Act, or preparations containing ephedrine or pseudoephedrine."
30. in Article 20 (2) (d), the words "Annex No 1, 2, 5, 6 or 7 to this Act" shall be replaced by "Annex No 1, 2, 5, 6, 7 or 8 to this Act, or preparations containing ephedrine or pseudoephedrine."
31st Paragraph 20 (3) reads as follows:
"(3) The Ministry of Health shall provide by decree for cases where export permits for the export of auxiliary substances are required if the export of auxiliary substances without export authorisation does not allow for an international treaty which the Czech Republic is bound by, or where the requirement for export permits is recommended by an international governmental organisation dealing with the fight against the illicit manufacture and trafficking of addictive substances. The Ministry of Health shall inform the competent authority of the State to which the export is to be made of the intended export of the excipients listed in Annex 10 if that authority requests information through an international governmental organisation dealing with the fight against the illicit manufacture and trafficking of addictive substances. ';
32. in Article 21 (2) (a), the words "Annex 2, 6 or 7 to this Act" shall be replaced by the words "Annex 2, 6, 7 or 8 to this Act, or preparations containing ephedrine or pseudoephedrine."
33. In Article 21 (2) (b), the words "or preparations containing ephedrine or pseudoephedrine" shall be inserted after the words "listed in Annex 8 to this Law."
34. in Article 21 (2) (c), the words "Annex 2, 5, 6 or 7 to this Act" shall be replaced by "Annex 2, 5, 6, 7 or 8 to this Act, or preparations containing ephedrine or pseudoephedrine,"
35. in Paragraph 21 (2), the dot is replaced by a comma at the end of point (d) and the following point (e) is added:
"(e) imports of mass-produced medicinal products containing addictive substances listed in Annex 1, 2, 5, 6, 7 or 8 to this Act, or medicinal products containing ephedrine or pseudoephedrine, provided that they are imported by troops of the Army of the Czech Republic on completion or restriction of their activity abroad as the balance of the stock they have been equipped for their activities."
36. in Article 26 (1), the words "except for the products listed in Annex 8," shall be added at the end of point (b);
37. in Paragraph 26 (1), the words "except for the products listed in Annex 8" shall be added at the end of point (c).
38. In Article 27, the words "which has established a pharmacy or a pharmacy 'shall be inserted after the words" the Authority' and the words "except for the products listed in Annex 8 to this Law 'shall be added at the end.
39. The following Paragraph 27a is inserted after Paragraph 27, including footnote 10a:
(1) Persons operating a pharmacy and distributors of pharmaceuticals (10a) are required to report, by 10 January of a calendar year at the latest, to the competent district or municipal veterinary authorities the collection of products containing addictive substances listed in Annexes 1 and 5 to this Act, with the exception of those listed in Annex 8 to this Law, by veterinary surgeons for the previous calendar year.
(2) County and municipal veterinary administrations are required to transmit to the Institute for State Control of Veterinary Bioprafts and Medicines by the end of January of the calendar year of the notification for the previous calendar year of the consumption of products containing addictive substances listed in Annexes 1 and 5 to this Law, with the exception of those listed in Annex 8 to this Law, by veterinary surgeons.
(3) The Institute of State Control of Veterinary Bioprafts and Medicaments is required to report to the Ministry of Health by the end of February of the calendar year for the previous calendar year on the consumption of products containing addictive substances listed in Annexes 1 and 5 to this Act, with the exception of those listed in Annex 8 to this Act, by veterinary surgeons.
10a) § 4 (3) of Act No. 79 / 1997 Coll. '.
40. In Section 28, the words "exporters and importers' shall be inserted after the words" producers'.
41. In Section 28, the words "as producers of auxiliary substances' are deleted, after the words" (Article 16) 'are inserted, "except for sales of auxiliary substances', the words", export and import 'are inserted after the word "production' and the words" listed in Annexes 10 and 11 to this Act 'are added at the end.
42. In Paragraph 32, the following paragraph 2 is inserted after paragraph 1:
"(2) The export and import of the excipients shall also be subject to registration by persons subject to the provisions of Section 20 (3) of this Act. '
Paragraph 2 shall become paragraph 3.
43. In Paragraph 33 (1), the words "preparations, precursors and excipients" shall be inserted after the words "substances."
44. In Annex 1, in the column "International Non-Proprietary Name (INN) in the Czech language ', the words" Concentrated from poppy straw' are replaced by the words "Concentrate from poppy seed 'and in the column" Note' the words "half-product for the manufacture of alkaloids obtained by the technological treatment of poppy seed 'are added.
45. In Annex 1, column "Note ', the words" Isomer dextromethorphan [(+) -3-methoxy-N-methylmorphine] shall be deleted from the list of narcotic substances set out in that Annex' are added to the column "Note '.
46. In Annex 1, column "Note ', for the narcotic substance" Levorphanol', the words "Isomer dextrorphanol [(+) -3-hydroxy-N-methylmorphine] are deleted from the list of narcotic substances set out in that Annex '.
47. In Annex 1, in the column "Note 'for the narcotic substance" opium', the words "D6 or CH5 'are replaced by" D4 or CH2'.
48. The text of the note at the end of Annex No 1 shall read: "Including the isomers of the narcotic substances listed in this list, the esters and ethers of the narcotic substances listed therein and the salts of the narcotic substances listed therein, including salts of isomers, esters and ethers in all cases where such salts may exist."
49. The text of the note at the end of Annex 2 shall read: "Including the isomers of the narcotic substances listed in this list, the salts of the narcotic substances listed in that list, including the salts of the isomers of the substances listed in that list in all cases where such salts may exist."
50. In Annex 5, column "Other international non-proprietary name or generic name ', the text" PCP' is added to the psychotropic substance "Fencyclidine '.
51. In Annex 5, in the column "International Non-Proprietary Name (INN) in the Czech language ', the word" Dronabinol' is inserted under the word "Secobarbital 'and in the column" Note' the text "Corresponding to the stereochemical variants of delta- 9-THC such as [(-) -transdelta- 9-THC] 'is added.
52. In Annex 6, in the column "Other international non-proprietary name or common name ', the word" [(+) -norpseudoephedrine' is added to the entry "Kathin '.
53.
"Annex No 8 to Act No 167 / 1998 Coll.
Preparations included in list III under the Single Convention on Narcotic Drugs
(Decree No 47 / 1965 Coll., as amended by Communication No 458 / 1991 Coll.)
| Přípravky obsahující: | Podmínky: | |
|---|---|---|
| 1) | jednu z omamných látek: Acetyldihydrokodein Dihydrokodein Ethylmorfin Folkodin Kodein Nikodikodin Nikokodin Norkodein | Mohou obsahovat jednu nebo více dalších látek (nikoliv však omamných) a množství omamné látky a) v jedné tabletě, tobolce, ampuli, čípku, příp. v jiné lékové formě nesmí přesáhnout 100 mg, b) v roztoku nesmí být koncentrace vyšší než 2,5 %. |
| 2) | Difenoxin | a) Množství difenoxinu nesmí přesáhnout v jedné tabletě, tobolce, ampuli, čípku, příp. v jiné lékové formě 0,5 mg. b) Množství síranu atropinia musí být nejméně 5 % k množství difenoxinu v jedné tabletě, kapsli, ampuli, čípku, popř. jiné lékové formě. |
| 3) | Difenoxylát | a) Množství difenoxylátu nesmí přesáhnout v jedné tabletě, tobolce, ampuli, čípku, příp. v jiné lékové formě 2,5 mg. b) Množství síranu atropinia musí být nejméně 1 % k množství difenoxylátu v jedné tabletě, tobolce, ampuli, čípku, popř. v jiné lékové formě. |
| 4) | Dextropropoxyfen | Množství dextropropoxyfenu a) nesmí přesáhnout 135 mg v jedné tabletě, tobolce, ampuli, čípku, příp. v jiné lékové formě, b) v roztoku nesmí být koncentrace vyšší než 2,5 %. Přípravek nesmí obsahovat žádnou psychotropní látku. |
| 5) | Kokain | Množství kokainu nesmí přesáhnout 0,1 % kokainu. |
| 6) | Opium nebo morfin | a) Množství morfinu nesmí přesáhnout 0,2 %. b) Dále mohou obsahovat jednu nebo více dalších látek (nikoliv však omamných). Omamná látka v přípravku obsažená nesmí být snadno získána zpět v takovém množství, aby ohrozila veřejné zdraví. |
| 7) | Ipekakuanhový prášek s opiem | a) Množství opia v prášku nesmí být vyšší než 10 %. b) Množství ipekakuanhového kořene nesmí být vyšší než 10 %. c) Množství jedné nebo více dalších látek (nikoliv však omamných) nesmí být nižší než 80 %. |
| 8) | Propiram | a) Množství propiramu nesmí přesáhnout 100 mg v jedné tabletě, tobolce, ampuli, čípku, příp. v jiné lékové formě, b) Množství methylcelulózy v přípravku musí být nejméně stejné nebo vyšší než propiramu. |
Including homeopathic products with a dilution rate greater than D4 or CH2. ';
54.
"Annex 10 to Act No. 167 / 1998 Coll.
AID SUBSTANCES included in Table II under the United Nations Convention against Illicit Trade in Narcotic Drugs and Psychotropic Substances
(Communication No 462 / 1991 Coll.)
| Mezinárodní nechráněný název (INN) v českém jazyce | Chemický název |
|---|---|
| Kyselina antranilová | kyselina 2-aminobenzoová |
| Kyselina fenyloctová | kyselina fenyloctová |
| Piperidin | hexahydropyridin |
| Anhydrid kyseliny octové | acetanhydrid |
Including salts of scheduled substances in all cases where the existence of such salts is possible. ';
55. The following Annex 11 is inserted after Annex 10:
"Annex No 11 to Act No. 167 / 1998 Coll.
AID SUBSTANCES included in Table II under the United Nations Convention against Illicit Trade in Narcotic Drugs and Psychotropic Substances
(Communication No 462 / 1991 Coll.)
| Mezinárodní nechráněný název (INN) v českém jazyce | Chemický název |
|---|---|
| Aceton | 2-propanon |
| Ether | Diethylether |
| Kyselina chlorovodíková | kyselina chlorovodíková |
| Kyselina sírová | kyselina sírová |
| Manganistan draselný | Manganistan draselný |
| Methylethylketon | 2-butanon |
| Toluen | methylbenzen |
Including salts of scheduled substances in all cases where the existence of such salts is possible, except hydrochloric acid and sulphuric acid salts. '
Amendment of the Administrative Charges Act
Act No. 368 / 1992 Coll., on Administrative Charges, as amended by Act No. 10 / 1993 Coll., Act No. 72 / 1994 Coll., Act No. 85 / 1994 Coll., Act No. 273 / 1994 Coll., Act No. 36 / 1995 Coll., Act No. 118 / 1995 Coll., Act No. 160 / 1995 Coll., Act No. 301 / 1995 Coll., Act No. 151 / 1997 Coll., Act No. 350 / 1999 Coll., Act No. 167 / 1999 Coll., Act No. 223 / 1999 Coll., Act No. 157 / 1999 Coll., Act No. 352 / 1999 Coll.
The following points (d) and (e) are added to the Administrative Fees Sub-heading 131b:
| „d) | Registrace výrobců, dovozců a vývozců pomocných látek | Kč | 1 000,- |
| e) | Registrace prodejců pomocných látek | Kč | 1 000,- |
Note: The fee referred to in point (d) of this item shall be levied on the registration of manufacturers, importers and exporters of the excipients listed in Annexes 10 and 11 to Act No 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws, as amended by Act No 117 / 2000 Coll.; the fee referred to in point (e) of this item shall be levied on the registration of sales of auxiliary substances listed in Annex 10 to that Act. '
EFFECTIVE
This Law shall take effect on 30 June 2000, with the exception of Article I (22) as regards the provisions of Paragraph 13 (2), which shall take effect on 30 June 2001.
Klaus v. r.
Havel v. r.
Zeman v. r.
Contents
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Act No. 117 / 2000 Coll., amending Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended by Act No. 354 / 1999 Coll., and Act No. 368 / 1992 Coll., on administrative fees, as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 10.05.2000 |
|---|---|
| Effective from | 30.06.2000 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
Comments 0