Decree of the Ministry of Health No. 143 / 2000 Coll.
Decree 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 documentation of addicts
Valid
Order
Effective from 01.07.2000
Text versions:
01.07.2000
02.06.2000
143
DECLARATION
Ministry of Health
of 25 May 2000
amending Decree No. 304 / 1998 of the Ministry of Health 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
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.:
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 are amended as follows:
1. In Section 1, the words "and Annex No 11 'shall be inserted after the words" Annex 10'.
2. In Article 2, the following shall be added to paragraph 4 at the end of the sentence of the second sentence: "even if there has been no record of movement during the calendar month 'and the following words are added at the end of the paragraph:" including the responsible person, if established. In the absence of the appointment of the responsible person, the record of the inspection shall be signed by the entrepreneur himself if it complies with the requirements imposed on the responsible person within the meaning of Article 8 (6) of the Act.'
3. In Paragraph 4, the following paragraph 2 is inserted after paragraph 1:
"(2) The computerised records shall be kept in such a way as to allow separate daily monitoring of movements and stocks of the individual manufactured bulk-produced medicinal products listed in Annexes 2, 6 and 7 to the Act and medicinal products containing ephedrine or pseudoephedrine to be detected for a period of 5 years. ';
Paragraphs 2 to 4 shall become paragraphs 3 to 5.
4. In Article 4 (5), the second sentence reads: "An inventory report shall be drawn up containing the elements referred to in Article 2 (4), including an indication of the initial state of the reference period, the total revenue and expenditure and the stock at the inventory date for all the items monitored. '
5. The following Section 6a is inserted after Section 6:
The keeping of a register of addictive substances listed in Annexes 3 and 4 to the Act and preparations shall contain:
(1) Legal persons and natural persons - entrepreneurs are responsible for the treatment of the addictive substances listed in Annexes 3 and 4 to the Act and for the preparation of such substances.
(2) The adaptation of the register sheet to keep records referred to in paragraph 1 is laid down in Annex 6 to this Decree. "
6. in Article 9 (1), the following point (h) is inserted after point (g):
"(h) any official decisions concerning the registration of producers, exporters, importers and sellers of excipients and any decisions concerning exports and imports;"
Points (h) to (j) shall be renumbered (i) to (k).
7. In Article 9 (1) (j), in the part of the sentence after the comma, the word "or 'is replaced by a comma and after the word" precursors', the words "or auxiliary substances listed in Annex 10 to the Act 'are added.
8. In Article 9 (1), the dot is replaced by a comma at the end of point (k) and the following point (l) is added:
"(l) a declaration by legal persons and natural persons - entrepreneurs dealing with auxiliary substances listed in Annex 10 to the Act. The elements of this declaration are set out in Annex 7 to this Order. '
9. The second sentence of Paragraph 10 reads: "The minutes referred to in § 9 (1) (c), (d), (e) or (k) must always be signed by the responsible person (§ 9 of the Act). Where the person responsible has not been appointed, the registration shall be signed by the entrepreneur himself if he meets the requirements imposed on the person responsible within the meaning of Article 8 (6) of the Act. '
10. In Article 11, the words "and the ingredients listed in Annexes 10 and 11 to the Act 'shall be replaced by" comma and precursors'.
12. the following Annexes 6 and 7 are inserted after Annex 5:
"Annex 6 to Decree No. 304 / 1998 Coll.
Model for the record book of storage
Příloha č. 7
Annex No 7 to Decree No. 304 / 1998 Coll.
DECLARATION
legal persons and natural persons - auxiliary entrepreneurs listed in Annex 10 to the Act
Efficacy
This Decree shall take effect on 1 July 2000.
Minister:
Prof. MUDr. Fisher, CSc.
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Regulation Information
| Citation | Decree of the Ministry of Health No. 143 / 2000 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 |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 02.06.2000 |
|---|---|
| Effective from | 01.07.2000 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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