Decree No. 521 / 2021 Coll.
Decree amending Decree No. 123 / 2006 Coll., on the registration and documentation of addictive substances and preparations, as amended by Decree No. 72 / 2014 Coll.
Valid
Order
Effective from 01.01.2022
Text versions:
01.01.2022
23.12.2021
521
DECLARATION
of 16 December 2021
amending Decree No 123 / 2006 Coll., on the registration and documentation of addictive substances and preparations, as amended by Decree No 72 / 2014 Coll.
The Ministry of Health provides pursuant to Sections 32 (2) and 33 (2) of Act No. 167 / 1998 Coll., on addictive substances and on amending certain other laws, as amended by Act No. 117 / 2000 Coll., Act No. 362 / 2004 Coll., Act No. 74 / 2006 Coll., Act No. 273 / 2013 Coll. and Act No. 366 / 2021 Coll.:
Decree No. 123 / 2006 Coll., on the registration and documentation of addictive substances and preparations, as amended by Decree No. 72 / 2014 Coll., is amended as follows:
1. in Article 2 (1) (a), the word "name" shall be replaced by the words "name, if applicable, names, and surnames."
2. in Article 2 (1) (b), the words "name or, where appropriate, the names" shall be replaced by the words "name and surname" and the word "residence" shall be replaced by the words "address of the place of permanent residence and, if there is no permanent residence, the address of residence."
3. In Article 3 (6) (b), the words "twice a year 'are replaced by the words" at least once every six months' and the words "or the advance of the data file from which the data can be reconstructed shall be added at the end of the text of point (b) and shall be replaced by the words" or the advance of the data file from which the data can be reconstructed on a data medium different from the hardware equipment used to keep electronic records'.
4. in Article 3 (7) (g) and (h), the words "name and residence" shall be replaced by the words "name, names, and surnames, as appropriate, and surnames."
5. In Paragraph 4, at the end of paragraph 1, the sentence "If the last day of the calendar month on Saturday, Sunday or Saturday 15) is added, the monthly inventory may be made on the next working day."
Footnote 15:
"15) § 1 and 2 of Act No. 245 / 2000 Coll., on public holidays, on other holidays, on significant days and on working days."
6. in Article 4 (2) (d):
"(d) the situation on the last day of the calendar month.";
7. In Paragraph 4 (4), the sentence "If the last day of the calendar month is Saturday, Sunday or Saturday 15) is inserted after the first sentence, the quarterly inventory may be made on the next working day."
8. in Article 4 (4) (d):
"(d) the situation at the last day of the calendar quarter."
9. In Article 5, the word "mutatis mutandis' shall be added at the end of paragraph 1.
10. in Article 5 (3) (m), the word "name" shall be replaced by the words "name or surname, if applicable."
11. The following Section 5a is inserted after Section 5:
Registration for substance and preparation research
(1) The records of substance and preparation research shall be treated mutatis mutandis in accordance with Sections 1, 2 and 4.
(2) The registration of substance and preparation research shall include the name of the project or objective of the research activity. A separate register shall be kept for each research project or objective.
(3) The register referred to in paragraph 2 shall contain the following records:
(a) the name of the substance or preparation;
(b) the name of a substance which is not an addictive substance but will be used for research into the production of a substance;
(c) the serial number of the registration;
(d) the date of use of the substance, preparation or substance which is not an substance but will be used for research into the production of the substance;
(e) the quantity of the substance, preparation or substance used, which is not an substance but will be used for research into the production of the substance;
(f) the number of the experiment or other identification of the substance or preparation produced;
(g) the way in which an addictive substance, a preparation or a substance which is not an addictive substance is consumed but will be used for research into the production of the substance;
(h) the name and, where appropriate, the names and surname, function and signature of the official carrying out the registration. ';
12. In Section 6, at the end of paragraph 1, the word "mutatis mutandis' shall be added.
13. in Article 6 (3) (g) and (h), the words "name and residence" shall be replaced by the words "name, names, and surnames, where appropriate."
14. In Article 7, at the end of paragraph 1, the word "mutatis mutandis' shall be added.
15. in Article 7 (3) (e) and (f), the words "name and residence" shall be replaced by the words "name, names, and surnames, as appropriate, and surnames."
16. In Paragraph 8, at the end of paragraph 1, the word "mutatis mutandis' shall be added.
17. in § 8 (3) (f):
"(f) the name and, where appropriate, the name and surname of the doctor and the name, registered office of the prescribing health service provider and the name and, where appropriate, the name and address of the patient's place of residence and, if there is no permanent residence, the address of the patient's residence at the time of issue,";
18. in Paragraph 8 (3) (g), the word "name" shall be replaced by the words "name, if applicable, names, and surnames."
19. in Article 8 (2), the words' in the register 'shall be deleted and the words' in the register or in the form of electronic records' shall be added at the end of the text of the paragraph;
20. In Paragraph 8, the following paragraph 4 is inserted after paragraph 3:
"(4) The electronic registration referred to in paragraph 2 shall include the following information:
(a) the name of the substance or the name of the preparation, including its strengths (3), the pharmaceutical form and the packaging size;
(b) the date of receipt;
(c) the date of issue;
(d) the name and, where applicable, the names of the doctor and the name and address of the prescribing health service provider at issue;
(e) the name and, where applicable, the names and surname and address of the patient's permanent residence and, if he is not resident, the address of the patient's residence at the time of issue;
(f) the electronic recipe identifier at issue;
(g) the name and, where appropriate, the names and surname or registered office of the supplier upon receipt;
(h) the number of the receipt document;
(i) unit of quantity;
(j) the quantity accepted;
(k) the quantity issued,
(l) current stocks,
(m) the name and, where appropriate, the names and surnames of the person making the entry; and
(n) a qualified electronic signature of the person making the entry. ';
Paragraphs 4 to 6 shall be renumbered paragraphs 5 to 7.
21. in Article 8 (5) (a):
"(a) the name of the substance or the name of the preparation, including its strengths (3), the pharmaceutical form and the packaging size, ';
22. in Article 8 (5), point (b) is deleted;
Points (c) to (i) shall be renumbered (b) to (h).
23. in Paragraph 8 (5) (h), "name" is replaced by "identification."
24. in Article 8 (6) and (7):
"(6) Where electronic records are kept of addictive substances listed in Annex 1, 3, 4 or 5 to the Government Ordinance on the lists of addictive substances (12) and preparations containing these substances, a monthly inventory shall be made under the conditions set out in the second sentence of Article 4 (4). Where the electronic records referred to in paragraph 5 are kept, the inventory referred to in Article 4 (4) shall not be carried out.
(7) In the case of electronic records, it is necessary to ensure that the record allows the immediate single electronic output to be made in the .xml format, which correctly displays all the facts required by this decree during the reference period. At the same time, it is necessary to ensure that records allow a uniform print output. '
25. in Paragraph 8, paragraphs 8 and 9 are added:
"(8) Where the register is kept in electronic form in accordance with paragraph 2 or 5, the person operating the pharmacy shall keep the data media referred to in paragraphs 13 and 15 containing the information referred to in paragraph 4 or 5. The person operating the pharmacy shall ensure regular backup of the data from which the data kept in the register can be reconstructed. The person operating the pharmacy shall ensure the backup of data on media different from the hardware equipment used to keep electronic records. Backup shall be carried out according to a predetermined schedule by the person operating the pharmacy, but without undue delay after the closing of the operating day.
(9) The person operating the pharmacy shall draw up and maintain the organisational and technical security of the electronic record keeping referred to in paragraph 2 in a written form, in which he shall lay down at least:
(a) conditions for access by users to the record keeping system, the scope of access rights and the setting-up process, including how to decide on the scope of access rights of individual users and decide on their changes;
(b) the procedure and timing of the data backup referred to in paragraph 8;
(c) the procedure for the reconstruction of data kept in the back-up data register;
(d) the way documents are kept;
(e) the procedure for dealing with situations where the functions of the record keeping system are malfunctioning, including the way in which the replacement operation is ensured;
(f) a procedure for dealing with a situation where the means used to keep records under contract with another person cannot be used anymore;
(g) the error correction procedure in the register and the content of the record of the correction carried out, including the traceability of the original record;
(h) the manner in which users are trained and the way in which documentation of the training carried out is kept. ";
26. In Paragraph 9, at the end of paragraph 1, the word "mutatis mutandis' shall be added.
27. in Article 9 (3) (e), the word "name" shall be replaced by the words "name, where appropriate, names, and surnames."
28. In Section 10, at the end of paragraph 1, the word "mutatis mutandis' shall be added.
29. in Article 10 (3) (g), (h) and (i), the words "name and residence" shall be replaced by the words "name and surname, if any, and surname."
30. In Paragraph 11, at the end of paragraph 1, the word "mutatis mutandis' shall be added.
31. in Article 11 (3) (g) and (h), the words "name and residence" shall be replaced by the words "name, names, and surnames, as appropriate, and surnames."
32. In Article 12, at the end of paragraph 1, the word "mutatis mutandis' shall be added.
33. in Article 12 (3) (g) and (h), the words "name and residence" shall be replaced by the words "name, names, and surnames, where appropriate."
34. The following Section 12a is inserted after Section 12:
Evidence of growing cannabis plants for scientific purposes
(1) The registration of cultivation of hemp plants for scientific purposes shall be treated mutatis mutandis in accordance with Sections 1, 2 and 4.
(2) For the cultivation of hemp plants from hemp plants for scientific purposes on the basis of the authorisation to handle the records, they shall keep a register.
(3) The register referred to in paragraph 2 shall contain the following records:
(a) the name of the growing type of hemp plant;
(b) the quantity of hemp grown in pieces;
(c) the serial number of the registration;
(d) the date of registration;
(e) the designation of hemp produced;
(f) the quantity of hemp produced;
(g) the quantity of hemp plant waste;
(h) the name and, where appropriate, the names and surname, function and signature of the official carrying out the registration. ';
35. in Paragraph 13 (1), the words "and media with recorded back-up electronic registration data" shall be added at the end of the text in point (b).
36. in Paragraph 13 (1), the words "and hemp plant waste" shall be added at the end of the text in point (e).
37. in Article 13 (2) (a), "Article 13 (2)" is replaced by "Article 13 (4)."
38. In Article 13 (3), the words "and, in the case of a resident social service provider 'are deleted.
(39) footnotes 8, 9 and 11 shall read:
"8) Paragraph 19 (1) (a) (1) of Decree No. 329 / 2019 Coll., on the prescription of medicinal products in the provision of health services.
9) Paragraph 19 (1) (b) (1) of Decree No 329 / 2019 Coll.
11) Act No. 110 / 2019 Coll., on the processing of personal data. '.
Efficacy
This Decree shall take effect on 1 January 2022.
Minister:
Mgr. et Mgr. Vojtěch, MHA, v. r.
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Regulation Information
| Citation | Decree No. 521 / 2021 Coll., amending Decree No. 123 / 2006 Coll., on the registration and documentation of addictive substances and preparations, as amended by Decree No. 72 / 2014 Coll. |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 23.12.2021 |
|---|---|
| Effective from | 01.01.2022 |
| Effective until | - |
| Status | Valid |
Public Contracts 1
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