Decree of the Ministry of Health No. 82 / 2002 Coll.
Ordinance of the Ministry of Health amending Decree of the Ministry of Health No. 304 / 1998 Coll., laying down cases where no export permit for the export of excipients is required, details of the registration of addicts, preparations and precursors and of the substance documentation, as amended by Decree No. 143 / 2000 Coll.
Valid
Order
Effective from 06.03.2002
Text versions:
06.03.2002
82
DECLARATION
Ministry of Health
of 21 February 2002
amending Decree No. 304 / 1998 of the Ministry of Health Coll., laying down cases where no export authorisation for the export of excipients is required, details of the registration of addicts, preparations and precursors and of the substance documentation, as amended by Decree No. 143 / 2000 Coll.
The Ministry of Health provides, pursuant to § 20 (3), § 32 (3) and § 33 (2) of Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended by Act No. 117 / 2000 Coll., ("the Act '):
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 by Decree No. 143 / 2000 Coll., is hereby amended as follows:
1. in Article 3 (1), the words "except for the register for pharmacies" shall be added at the end of point (e).
2. In Article 4 (1), comma and the words "or medicinal products containing narcotic substances listed in Annex 1 to the Act and listed in Annex 8 to the Act or medicinal products containing ephedrine or medicinal products containing more than 30 mg of pseudoephedrine in the unit of the pharmaceutical form shall be inserted after the word" the Law. "
3. In Article 4 (2), "listed in Annexes 2, 6 and 7 'is replaced by" containing addictive substances listed in Annexes 2, 6 and 7 to the Act, medicinal products containing narcotic substances listed in Annex 1 to the Act and listed in Annex 8 to the Act at the same time'.
4. In Article 5, at the end of paragraph 1, the words "the manner laid down in paragraph 2, with the exception of medicinal products containing narcotic substances listed in Annex 1 to the Act and listed in Annex 8 to the Act at the same time 'are added.
5. in Article 5, the following paragraphs 3, 4 and 5 are inserted after paragraph 2:
"(3) The pharmacy shall also keep records of addictive substances listed in Annexes 2, 6 and 7 to the Act and of preparations containing, precursors listed in Annex 9 to the Act, preparations containing ephedrine and preparations containing pseudoephedrine in quantities greater than 30 mg per unit of pharmaceutical form, using the data contained in the register under a specific legislation. (2a) This record may be kept by computer. The record shall contain the following information:
(a) the name, for the preparation including its strengths (2b) and package size,
(b) the date of receipt and the date of issue;
(c) the number of the receipt document;
(d) the quantity received and the quantity issued,
(e) current stocks.
(4) Where the records referred to in paragraph 3 are kept, there is no obligation to carry out the inventory pursuant to Article 2 (4).
(5) The registration referred to in paragraph 3 shall not be subject to the provisions of Section 4. Where a pharmacy keeps records using computer techniques, it shall keep data media containing the records referred to in Section 11.
2a) § 21 (1) (e) and (g) of Act No. 79 / 1997 Coll., as amended by Act No. 149 / 2000 Coll.
(2b) Paragraph 3 (5) (c) (2) of 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. '
Paragraph 3 shall become paragraph 6.
6. In the introductory wording of Section 9 (1), the words "and documentation on the handling of the ingredients' shall be inserted after the words" precursors'.
7. In the second sentence of Article 9 (1) (l), the word "Requirements' is replaced by the word" Model 'and the words "listed' are replaced by the words" given '.
8. In Section 11, the words "documentation of handling 'shall be inserted after the words" preparations, precursors and'.
9. Annex 1 shall read as follows:
"Annex No 1 to Decree No 304 / 1998 Coll.
Cases in which authorisation to export excipients is required
(the countries of destination are marked with an asterisk (*) under the heading of the relevant additive)
| Země určení | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mezinárodní nechráněný název (INN) v českém jazyce | Argentina | Benin | Bolívie | Brazílie | Česká republika | Ekvádor | Etiopie | Filipíny | Guatemala | Honduras | Hongkong | Chile | Indie | Indonesie | Irán | Jihoafrická rep. | Jordánsko | Kajmanské ostrovy | Kolumbie | Kostarika | Kypr | Libanon |
| Aceton | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||
| Anhydrid kyseliny octové | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | |
| Ether | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||
| Kyselina antranilová | * | * | * | * | * | |||||||||||||||||
| Kyselina fenyloctová | * | * | * | * | ||||||||||||||||||
| Kyselina chlorovodíková | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||
| Kyselina sírová | * | * | * | * | * | * | * | * | * | * | ||||||||||||
| Manganistan draselný | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||
| Methylethylketon | * | * | * | * | * | * | * | * | * | * | ||||||||||||
| Piperidin | * | * | * | * | ||||||||||||||||||
| Toluen | * | * | * | * | * | * | * | * | * | * | ||||||||||||
| Země určení | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mezinárodní nechráněný název (INN) v českém jazyce | Makao | Malajsie | Mexiko | Moldávie | Myanmar | Nigérie | Panama | Paraguay | Peru | Ruská federace | Salvador | Saudská Arábie | Singapur | Spoj.arab.emir. | Srí Lanka | Sýrie | Tadžikistán | Thajsko | Turecko | Uruguay | U.S.A | Venezuela |
| Aceton | * | * | * | * | * | * | * | * | * | * | * | * | * | |||||||||
| Anhydrid kyseliny octové | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||
| Ether | * | * | * | * | * | * | * | * | * | * | * | * | * | |||||||||
| Kyselina antranilová | * | * | * | * | ||||||||||||||||||
| Kyselina fenyloctová | * | * | * | * | * | |||||||||||||||||
| Kyselina chlorovodíková | * | * | * | * | * | * | * | * | * | * | * | * | ||||||||||
| Kyselina sírová | * | * | * | * | * | * | * | * | * | |||||||||||||
| Manganistan draselný | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | * | ||||
| Methylethylketon | * | * | * | * | * | * | * | * | * | |||||||||||||
| Piperidin | * | * | * | * | * | |||||||||||||||||
| Toluen | * | * | * | * | * | * | * | * | * | |||||||||||||
Including salts of scheduled substances in all cases where the existence of such salts is possible, except hydrochloric acid and sulphuric acid.
10. Annex 7 shall read as follows:
"Annex No 7 to Decree No. 304 / 1998 Coll.
MODEL OF DECLARATION
legal persons and natural persons - entrepreneurs dealing with auxiliary substances listed in Annex 10 to the Act
Efficacy
This decree shall take effect on the day of its publication.
Minister:
Prof. MUDr. Fisher, CSc.
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Regulation Information
| Citation | Decree of the Ministry of Health No. 82 / 2002 Coll., amending Decree of the Ministry of Health No. 304 / 1998 Coll., laying down cases where no export permit for the export of excipients is required, details of the registration of addictive substances, preparations and precursors and the documentation of addicts, as amended by Decree No. 143 / 2000 Coll. |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 06.03.2002 |
|---|---|
| Effective from | 06.03.2002 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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