Decree No. 72 / 2014 Coll.
Decree amending Decree No. 123 / 2006 Coll., on the Registration and Documentation of Drugs and Products
Valid
Effective from 01.05.2014
72
DECLARATION
of 8 April 2014
amending Decree No. 123 / 2006 Coll., on the Registration and Documentation of Drugs and Products
The Ministry of Health provides pursuant to Sections 32 (2) 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., Act No. 362 / 2004 Coll., Act No. 74 / 2006 Coll. and Act No. 273 / 2013 Coll.:
Decree No 123 / 2006 Coll., on the registration and documentation of addictive substances and preparations, is amended as follows:
1. In Article 1 (2), the words "by conclusive means' are replaced by the words" in accordance with this Decree '.
2. Paragraph 1 (3), including footnotes 1, 2 and 12, reads as follows:
"(3) The addictive substances are identified by the name given in the Government Regulation on the lists of addictive substances (12), medicines (1) and their registered names (2).
1) Paragraph 2 (1) of Act No. 378 / 2007 Coll., on Medicines and on the amendment and amendment of certain related laws (the Law on Medicines), as amended.
2) Sections 4 (1) and 13 (2) (a) (1) of Act No. 378 / 2007 Coll., as amended.
12) Government Regulation No. 463 / 2013 Coll., on substance lists. '
3. in Article 2 (1) (a):
"(a) the name, business name, or the name and address of the registered office of the person holding the register, including the name and address of the establishment where the substances and preparations which are subject to registration under the law and this decree are actually carried out, provided that the address of that establishment is different from that of the registered office;"
4. In Article 2 (1), the word "overall 'shall be added at the beginning of point (d).
5. in Article 2 (1) (e):
"(e) a list of registered addicts and preparations, indicating the number of sheets reserved for the registration of individual addicts and preparations; the obligation to list the numbers of sheets reserved for the registration of individual addictive substances and preparations does not apply to the records in the pharmacy. ';
6. In Article 2, at the end of the text of paragraph 3, the words "and, unless otherwise specified, the signature of the person making the entry shall be 'shall be added.
7. In Article 4 (4), the words "inventory protocol 'are replaced by the words" inventory record';
8. In Paragraph 4 (5), the words "Inventory Protocol 'are replaced by the words" Inventory record'.
9. Sections 6 to 8, including the headings and footnotes Nos 3 to 5, 13 and 14, read:
Storage records with the manufacturer or distributor
(1) Storage records for the production4) or distribution5) shall be carried out in accordance with Sections 1 to 4.
(2) In the case of storage for products4) or distribution5) addictive substances and products containing addictive substances listed in Annexes 1, 3, 4 or 5 to the Government Ordination12), the register records are kept in the register, with the exception of products containing addictive substances listed in Annex 1 to the Government Ordinance on addictive substances 12) and also in Annex 8 to the Government Ordinance on addictive substances 12).
(3) The register referred to in paragraph 2 shall contain the following records:
(a) the name of the substance or preparation, including its strengths (3), pharmaceutical form and package size,
(b) the date of receipt;
(c) the date of issue;
(d) the number of the receipt document;
(e) the number of the proof of issue,
(f) the batch number and, where applicable, the test number, if any, provided;
(g) the name and address of the supplier;
(h) the name and address of the consignee;
(i) the quantity accepted;
(j) the quantity issued;
(k) unit quantity; and
(l) stocks.
(4) The storage shall also keep records of products containing addictive substances listed in Annexes 2, 6 or 7 to the Government Ordinance on the List of addictive substances (12), or of products containing addictive substances listed in Annex 1 to the Government Ordinance on the List of addictive substances (12) and, at the same time, of Annex 8 to the Government Regulation on the List of addictive substances (12), or of medicinal products containing that substance, category 113). In this case, electronic records may be kept. Electronic records shall contain the information referred to in paragraph 3.
Records where addictive substances and preparations are not stored
(1) The registration of addictive substances and preparations in cases where they are not stored shall be carried out in accordance with Sections 1 to 3.
(2) The registration of addictive substances and preparations containing addictive substances listed in Annexes 1, 3, 4 or 5 to the Government Ordinance on the List of Addiction12) shall be kept in the register, with the exception of products containing addictive substances listed in Annex 1 to the Government Ordinance on the List of Addiction12) and also in Annex 8 to the Government Ordinance on the List of Addiction12).
(3) The register referred to in paragraph 2 shall contain the following records:
(a) the name of the substance or preparation, including its strengths (3), pharmaceutical form and package size,
(b) the date of delivery and the date of issue;
(c) the number of the proof of delivery and of delivery;
(d) the batch number and, where appropriate, the test number, if they are indicated,
(e) the name and address of the supplier;
(f) the name and address of the purchaser;
(g) quantities delivered and issued; and
(h) unit quantity.
(4) In cases where products are not stored, the records of products containing addictive substances listed in Annexes 2, 6 or 7 to the Government Ordinance on the lists of addictive substances (12) or those containing addictive substances listed in Annex 1 to the Government Regulation on the lists of addictive substances (12) shall also be kept and listed in Annex 8 to the Government Regulation on the lists of addictive substances (12) or medicinal products containing that substance, category 113). In this case, electronic records may be kept. Electronic records shall contain the information referred to in paragraph 3.
Registration at the pharmacy
(1) The records at the pharmacy shall be carried out in accordance with Sections 1 to 4.
(2) The pharmacy shall keep records of addictive substances listed in Annexes 1, 3, 4 or 5 to the Government Ordinance on the List of Addiction12) and preparations containing these substances in the Register, with the exception of products containing addictive substances listed in Annex 1 to the Government Ordinance on the List of Addiction12) and also listed in Annex 8 to the Government Ordinance on the List of Addiction12).
(3) The register referred to in paragraph 2 shall contain the following records:
(a) the name of the substance or preparation, including its strengths (3), pharmaceutical form and package size,
(b) column numbers,
(c) the serial number of the document,
(d) the date of receipt;
(e) the date of issue;
(f) the name of the doctor and the name and address of the prescribing health service provider and the name and address of the patient at issue;
(g) the name and address of the supplier on receipt;
(h) unit quantity,
(i) the quantity accepted; and
(j) the quantity issued.
(4) The pharmacy shall also keep records of addictive substances listed in Annexes 2, 6 and 7 to the Government Ordinance on the lists of addictive substances (12), products containing these substances and medicinal products containing that substance in category 113) using the data contained in the register under the specific legislation14). In this case, electronic records may be kept. Electronic registration shall include the following information:
(a) the name of the substance;
(b) the name of the preparation, including its strengths (3), pharmaceutical form and package size,
(c) the date of receipt;
(d) the date of issue;
(e) the number of the receipt document;
(f) the quantity accepted;
(g) the quantity issued;
(h) current stocks; and
(i) the name of the person who made the entry.
(5) Where the records referred to in paragraph 4 are kept, the inventory shall not be made in accordance with Paragraph 4 (4).
(6) Where the register is kept in accordance with paragraph 4, the pharmacy shall keep the data media (§ 13) containing the information referred to in paragraph 4.
3) Paragraph 4 (2) of Act No. 378 / 2007 Coll., as amended.
4) Paragraph 6 (1) (a) of Act No. 378 / 2007 Coll., as amended.
5) Paragraph 6 (1) (b) of Act No. 378 / 2007 Coll., as amended.
13) § 34 of Act No. 272 / 2013 Coll., on drug precursors.
14) Paragraph 83 (6) (b) of Act No. 378 / 2007 Coll., as amended. '
(10) footnotes 6 and 10 are deleted.
11. In Section 9 of the heading: "Registration by a health service provider not mentioned in Section 8 and a social residence service provider."
12. in Article 9 (1) and (2):
"(1) The records kept with the health service provider not mentioned in § 8 and with the resident social service provider shall be treated in accordance with § 1, 2 and 4.
(2) For a health service provider other than § 8 and for a resident social service provider, records of products containing addictive substances listed in Annexes 1, 3, 4 or 5 to the Government Ordinance on addictive lacquers (12) shall be kept in the registers, with the exception of products containing addictive substances listed in Annex 1 to the Government Ordinance on addictive lacquers (12), and also in Annex 8 to the Government Ordinance on addictive little12). "
13. in Article 9 (3) (a), the words "and pharmaceutical forms" are replaced by the words "pharmaceutical forms and pack sizes."
14. Paragraph 10 (2) reads as follows:
"(2) In the provision of veterinary care, records shall be kept in the register for the treatment of addictive substances and products containing addictive substances listed in Annexes 1, 3 or 5 to the Government Ordinance on the lists of addictive substances (12), with the exception of products containing addictive substances listed in Annex 1 to the Government Ordinance on the lists of addictive substances (12) and listed in Annex 8 to the Government Ordinance on addictive substances (12). ';
15. in Article 10 (3) (a):
'(a) the name of the preparation, including its strengths (3), the pharmaceutical form and the package size,'
16. in Paragraph 12 (2):
"(2) In the treatment of addictive substances, products containing addictive substances listed in Annexes 1, 3, 4 or 5 to the Government Ordinance on the lists of addictive substances (12), with the exception of products containing addictive substances listed in Annex 1 to the Government Ordinance on addictive substances (12) and listed in Annex 8 to the Government Ordinance on addictive substances (12), registration records shall be kept in the register for persons listed in Section 5 (7) of the Act. '
17. in Paragraph 13 (1) (c), the words "inventory protocols" are replaced by the words "inventory records."
18. in Paragraph 13 (1) (h), the word "copies" is replaced by the word "copies."
19. in Paragraph 13 (1) (i), the words "including the relevant customs documents" shall be inserted after the words "preparations."
20. Paragraph 13 (2) and (3), including footnotes 8 and 9, read:
"(2) The pharmacy shall be kept in addition to the documentation referred to in paragraph 1:
(a) the first receptions8) and requests9) with a blue stripe and, where appropriate, the first certificate of reception8) with a blue stripe (§ 13 (2) of the Act), if the products are covered by the patient,
(b) data media containing records of the sending of electronic information on the electronic receipt (Section 13 (1) of the Act) to the central repository of electronic recipes.
(3) For a health service provider not listed in § 8 and for a resident social service provider, they shall be kept in addition to the documentation referred to in paragraph 1.
(a) all second subscriptions of the recipes used (8) with the blue stripe and the first sheets and all second and third subscriptions of the applied request9) with the blue stripe (§ 13 (2) of the Act);
(b) data media containing records of identifiers of electronic recipes issued (Section 13 (1) of the Act).
8) Paragraph 5 (6) (a) of Decree No. 54 / 2008 Coll., on the method of prescribing medicinal products, the data on the prescription and the rules of use of the prescription.
9) Paragraph 5 (7) of Decree No. 54 / 2008 Coll. '.
21. In Paragraph 15 (1), the words "damage," shall be inserted after the words "impairment, loss."
Final provision
This Decree was notified in accordance with Directive 98 / 34 / EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations for information society services, as amended.
Efficacy
This Decision shall enter into force on 1 May 2014.
Minister:
MUDr.
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Regulation Information
| Citation | Decree No. 72 / 2014 Coll., amending Decree No. 123 / 2006 Coll., on the Registration and Documentation of Drugs and Products |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 14.04.2014 |
|---|---|
| Effective from | 01.05.2014 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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