Decree No. 32 / 2020 Coll.
Ordinance amending Decree No. 84 / 2008 Coll., on good pharmacy practice, closer treatment conditions in pharmacies, medical devices and other operators and devices issuing medicinal products, as amended
Valid
Order
Effective from 01.03.2020
32
DECLARATION
of 31 January 2020
amending Decree No. 84 / 2008 Coll., on good pharmacy practice, closer treatment conditions for medicinal products in pharmacies, medical devices and for other operators and devices issuing medicinal products, as amended
The Ministry of Health and the Ministry of Agriculture shall determine, pursuant to Article 114 (1) and (2) of Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws, as amended by Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll., Act No. 66 / 2017 Coll., Act No. 44 / 2019 Coll., and Act No. 262 / 2019 Coll., hereinafter referred to as "the Law on Medicines', to implement Sections 8 (1) and (5), § 39 (5), § 77 (5) (b), § 79 (2) and (10), § 81g (5), § 82 (1) and (4 and § 83 (2), (3), (5) and (7) of the Law on medicinal products:
Regulation No 84 / 2008 Coll., on the correct practice of pharmaceuticals, the conditions for the treatment of medicinal products in pharmacies, medical devices and other medicinal product-issuing operators, as amended by Decree No 254 / 2013 Coll., Decree No 414 / 2017 Coll. and Decree No 204 / 2018 Coll., is amended as follows:
1. In Article 6 (1), the words "the amendment shall be marked on the medical prescription and endorsed by its signature 'shall be replaced by the words" and this shall be indicated in the request for the creation of a record of expenditure made pursuant to Article 13 (1)'.
2. In Article 6 (2), the words "This change shall be marked on the medical prescription, endorsed by its signature 'shall be replaced by the words" The pharmacist shall indicate the change made in the requirement to create a record of expenditure made in accordance with Article 13 (1)'.
3. In Article 6 (3), the words "the amendment shall be marked on the medical prescription, endorsed by its signature 'shall be replaced by the words" the change made by the pharmacist shall be indicated in the request for an entry to be made on the issue made pursuant to Article 13 (1)'.
4. In Article 6, the following paragraph 4 is added:
"(4) On a paper-based recipe, the pharmacist shall indicate the change made in accordance with paragraphs 1 to 3 and confirm it with his signature. ';
5. in Article 8 (1) (a) and Article 41 (2) (b), the words "narcotic substances and psychotropic substances (12)" shall be replaced by the words "addicts listed in Annex 1 and Annex 5 to the Government Regulation on lists of addictive substances (12)";
Footnote 12 reads:
"(12) Government Regulation No. 463 / 2013 Coll., on substance lists, as amended. '
6. In Article 10 (2), the word "humane 'is inserted after the word" quality', the word "human 'is inserted after the word" for veterinary medicinal products' and the sentence "In the case of veterinary medicinal products, information and other relevant information for animal health shall be collected and processed mutatis mutandis and the information shall be notified without delay to the Institute for State Control of Veterinary Bioprafts and Medicines'.
7. in Article 10 (3) (a), the words "their" shall be deleted after the words "application," the words "medicinal products used" and the words "delays" shall be inserted; where applicable, the reason for the non-publication shall refer to the recipe 'shall be replaced by the words' delay, reason for the change or omission shall be indicated in the request for a record of the issue made pursuant to Paragraph 13 (1) and, in the case of a recipe in paper form, shall indicate the reason on the prescription and confirm it by signature, ';
footnote 15 is deleted.
8. In Article 10 (3), the words "on a paper-based recipe 'shall be inserted at the beginning of point (b).
9. in Article 10 (3) (c) and (d):
"(c) consult the prescribing physician
1. the issue of a prescribed medicinal product, the payment of which by public health insurance under the Public Health Insurance Act is subject to approval by the medical examiner of the relevant health insurance undertaking and for which the recipe does not specify the amount of the approved remuneration,
2. dosing in case the dosage is exceeded according to the Summary of Product Characteristics or according to the Czech Pharmacopoeia and this is not indicated on the recipe,
(d) in the case referred to in point (c), if no overdosage is indicated and the prescribing physician is unattainable, he shall adjust the dosage according to the Summary of Product Characteristics or the data provided in the Czech Pharmacopoeia and inform the prescriber as soon as possible. "
10. In Article 10 (5) of the Introductory Part of the provision, the words "in paper form 'are inserted after the word" recipe'.
11. in Article 12 (1), the introductory part of the provision reads:
"The recipe in paper form and the extract from the recipe in paper form shall be provided at the time of issue."
12. in Article 12 (1) (c), the part of the sentence after the semicolon, including the semicolon, is deleted;
13. In Article 12, paragraphs 3 to 5, including footnotes 18 and 19, are deleted.
Paragraph 6 shall become paragraph 3.
14. In Paragraph 13 (1), the introductory part of the provision reads: "When dispensing a medicinal product on the basis of an electronic prescription, the issuing pharmacist shall make a request for a record of the expenditure he contains."
15. in Article 13 (1) (a):
"(a) the identifier of the electronic recipe on which the medicinal product is to be issued;"
16. in Paragraph 13 (1) (b), the word "issued" shall be inserted after the word "code" and the words "allocated" shall be added at the end of the text of the letter.
17. in Article 13 (1) (c), the word "issued" shall be inserted after the word "quantity."
18. In Article 13, at the end of paragraph 1, the dot is replaced by a comma and the following point (f) is added:
"(f) the recognised electronic signature of the issuing pharmacist.";
19. Paragraph 13 (2), including footnote 38, reads:
"(2) The requirement to create an output record is sent through the information system of the issuing pharmacist to the eRecept system in accordance with the procedures and conditions for communication with the eRecept system, which provides for another legislation38).
38) Decree No. 329 / 2019 Coll., on the prescription of medicinal products for the provision of health services. '.
20. Paragraph 13 (3) is deleted.
Paragraph 4 shall become paragraph 3.
21. in Article 13 (3), the words "the central repository of electronic recipes" are replaced by the words "the eRecept system" and the words "acceptance, processing" are replaced by the words "acceptance and processing of the requirement."
22. In Article 13, the following paragraph 4 is added:
"(4) For the purpose of carrying out a record of the issue, the electronic recipe shall also mean an electronic prescription issued in another Member State on the basis of which the delivery of the prescribed medicinal product is carried out under Section 83b of the Drug Act. ';
23. After Paragraph 13, the following Section 13a is inserted:
How to convert the recipe data in paper form into electronic form
(1) When dispensing a medicinal product on the basis of a prescription issued in paper form, the issuing pharmacist shall transfer the data referred to in Section 81g (5) of the Drug Code to an electronic form in the form of an electronic record sent to the eRecept system.
(2) If the operational reasons on the part of the issuing pharmacist do not allow the electronic record to be sent to the eRecept system immediately on the delivery of the medicinal product, the pharmacist shall send the electronic record no later than the end of the working day following the day on which the medicinal product was delivered.
(3) If the eRecept does not allow the eRecept to send an electronic record to the eRecept system for operational reasons, the pharmacist shall send an electronic record no later than the end of the working day following the day on which the full availability of eRecept is restored.
(4) The electronic record provided for in Section 81g (5) of the Drug Act is made through the information system of the issuing pharmacist. Paragraph 13 (2) and (3) shall apply mutatis mutandis to communication with eRecept when sending an electronic alert. ';
24. Paragraph 14, including the title, reads:
Change of data in the output record
Paragraph 13 (2) and (3) shall apply mutatis mutandis to the change of the data in the output record for which eRecept has been confirmed by the storage system. '
25. In Section 15, the words "sent to the central repository of electronic recipes' are deleted.
26. In Section 15 (1) of the introductory part of the provision, the words "sent to the central repository 'are replaced by the words" stored in the central repository'.
27. in Article 15 (1) (b), the words "creation requirement" and "central repository of electronic recipes" shall be inserted after the words "eRecept system," or "
28. in Paragraph 15 (1), the semicolon and the will shall be deleted at the end of (c).
29. In Article 15, the following paragraph 2 is inserted after paragraph 1:
"(2) A cancellation of the entry referred to in paragraph 1 shall be possible only if the pharmacist simultaneously ensures that the medicinal product is withdrawn from the patient if it has been issued. '
Paragraphs 2 to 4 shall become paragraphs 3 to 5.
30. In Article 15 (4), the word "Cancellation 'is replaced by the words" Request for cancellation', the word "sent 'is replaced by the word" sent' and the words "to the central repository of electronic recipes in the format of the labelling language 'are replaced by the words" to the eRecept system in the form of structured data under the Decree on the prescription of medicinal products in the provision of health services'.
31. in Article 15 (5), the words "the central repository of electronic recipes" are replaced by the words "the eRecept system."
32. Article 17 shall be deleted, including the title.
33.In Article 17a (3), the first sentence shall be deleted, the words "Sections 13 to 16 'shall be replaced by the words" Sections 13 to 15' and the words "the restricted medicinal product register 'shall be replaced by the words" the eRecept system';
Article 34 (17b), including the title, shall be deleted.
35. The heading of Section 20 reads: "Medicinal products containing addictive substances or drug precursors."
36. in Article 20 (1), the words "narcotic substances or psychotropic substances (12)" shall be replaced by the words "addictive substance under the legislation governing the treatment of addictive substances (39), or, for medicinal products containing category 1 scheduled substance (1), by the directly applicable European Union drug precursor regulation (40)," and the words "not for a single recipe" shall be deleted;
Footnote 39 reads:
"39) § 2 (a) of Act No. 167 / 1998 Coll. '.
Footnote 40 reads as follows:
"40) Regulation (EC) No 273 / 2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors, as amended."
37. in Article 20 (2), the words "narcotic substances or psychotropic substances 12)" shall be replaced by the words "addicts listed in Annex 1 and 5 to the Government Regulation on the lists of addictive substances 12)."
38. in Article 20 (3), the words "narcotic substances or psychotropic substances (12)" shall be replaced by the words "addictive substance under the legislation governing the treatment of addiction39), or for medicinal products containing that substance category 1 under the directly applicable European Union drug precursor regulation (40)."
39. in Paragraph 21 (4), the words "Narcotic substances and psychotropic substances (12)" shall be replaced by the words "addicts listed in Annex 1 and 5 to the Government Regulation on the lists of addictive substances (12) and medicinal products containing them."
40. Paragraph 21 (5) reads:
"(5) Unregistered medicinal products shall be kept under conditions specified by the manufacturer and shall be kept separately from other medicinal products. Unregulated medicinal products under the specific treatment programme shall be stored under conditions specified by the specific treatment programme. The investigational medicinal products shall be kept under the conditions laid down by the sponsor of the clinical trial and shall be kept separate from other medicinal products in a manner which allows the medicinal products to be distinguished from each clinical trial. ';
41.In Paragraph 22 (2) (a) (11):
"11. sending a request for an alert on the medicinal product 's output pursuant to § 13 and an electronic record pursuant to § 13a to the eRecept system,'.
42. In Paragraph 22 (2) (d), the words "in paper form" shall be inserted after the words "recipes."
43. In Paragraph 22 (2) (g), the words "narcotic substances and psychotropic substances 24)" are replaced by "addictive substances and precursors 24)."
44. in Article 22 (2) (j), the words "narcotic substances and psychotropic substances (12)" shall be replaced by the words "addicts listed in Annex 1 and 5 to the Government Regulation on the lists of addictive substances (12)";
45. Part Five, including the title and footnotes No 33 and 34, shall be deleted.
46. In Section 34, at the end of the first sentence, the words "medicinal products' are added, the words" investigational medicinal products' are deleted, after the words "dialysis solutions', the words" and 'are replaced by a comma and the words "and evaluated medicinal products of the category of gases used in the provision of health services, advanced therapy medicinal products, infusion, hemofiltration and dialysis solutions and immunological products for vaccination' are inserted.
47. in § 35, the text "§ 4 (1)" is replaced by "§ 4 (1) and (2)."
48. In Paragraph 37, at the end of paragraph 2, the dot is replaced by a comma and the following point (d) is added:
"(d) the registration of medicinal products containing addictive substances listed in Annex 1 and Annex 5 to the Government Ordinance on the lists of addictive substances (12) under other legislation24)."
49. in Article 38b (c) (1), the words "the name of the medicinal product, its strengths, pharmaceutical form, package size," shall be deleted and the words "where the code has not been assigned, the name of the medicinal product, its strengths, pharmaceutical form, package size, number of packages or quantity details," shall be added at the end of the text;
50. in Paragraph 38b, the following points 7 and 8 are added at the end of point (c):
'7. sales prices with value added tax on medicinal products for which payment has been established from public health insurance,
8. the purchase prices of the pharmacy, excluding value added tax on medicinal products for which payment has been established from public health insurance, '.
51. in Paragraph 40 (4), the words "narcotic substances or psychotropic substances 12)" shall be replaced by the words "addicts listed in Annex 1 and 5 to the Government Regulation on lists of addictive substances 12)."
Efficacy
This Decision shall enter into force on 1 March 2020, with the exception of point 22, which shall take effect on 1 April 2020.
Minister for Health:
Mgr. et Mgr. Vojtěch, MHA, v. r.
Minister for Agriculture:
Ing. Toman, CSc., v. r.
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Regulation Information
| Citation | Decree No. 32 / 2020 Coll., amending Decree No. 84 / 2008 Coll., on Good Drug Practice, Closer Treatment Conditions for Medicines in Pharmacy, Medical Devices and for Other Operators and Medicinal Products Issuers, as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 06.02.2020 |
|---|---|
| Effective from | 01.03.2020 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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