Decree No. 459 / 2023 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 01.01.2024
Text versions:
01.01.2024
29.12.2023
459
DECLARATION
of 20 December 2023
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 provides, pursuant to § 114 paragraphs 1 and 2 of Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Act on Medicines), as amended by Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll., Act No. 66 / 2017 Coll. and Act No. 456 / 2023 Coll., to implement § 82 paragraph 3 (d) of the Act on Medicines:
Decree No. 84 / 2008 Coll., on the correct practice of pharmaceuticals, closer treatment conditions in pharmacies, medical devices and other medicinal product-issuing operators and establishments, as amended by Decree No. 254 / 2013 Coll., Decree No. 414 / 2017 Coll., Decree No. 204 / 2018, Decree No. 32 / 2020 Coll. and Decree No. 526 / 2021 Coll., is amended as follows:
1. In Article 10 (4), the words "the required dosage forms' shall be inserted after the words" strength and quantity 'and at the end of the paragraph the phrase "If no medicinal product is available in the pharmacy with the required quantity of the dosage form, the pharmacist shall issue the medicinal product at the nearest package size, taking into account the expected duration of the therapy.';
Article 2 (11) reads:
(1) If the prescribing physician does not indicate that he insists on the issue of the prescribed medicinal product, the pharmacist may replace the prescribed medicinal product, except for investigational medicinal products, where:
(a) the patient agrees to this procedure and the medicinal product is identical in terms of efficacy and safety; and
(b) the medicinal product contains the same active substance, the same route of administration and the same pharmaceutical form; if the medicinal product contains different amounts of the active substance in the unit of mass, volume or pharmaceutical form, the pharmacist shall adjust the dosage to correspond to that prescribed by the physician.
(2) Replace the prescribed medicinal product for which the physician has indicated that he insists on the issue of the prescribed medicinal product, except for investigational medicinal products, under the conditions laid down in paragraph 1, a pharmacist may only:
(a) does not have the medicinal product prescribed by the doctor, and
(b) immediate release is necessary.
(3) Replace the prescribed medicinal product with another medicinal product with the same active substance, with the same route of administration, but in another pharmaceutical form, or with another medicinal product with another medicinal product corresponding to the therapeutic properties, including in another pharmaceutical form, except the investigational medicinal products, a pharmacist may only:
(a) the medicinal product prescribed by the doctor is not available and it is not possible to follow paragraph 1 or 2;
(b) immediate extradition is necessary; and
(c) the patient and prescribing physician agree to the replacement;
if the medicinal product contains different amounts of the active substance in the unit of mass, volume or pharmaceutical form, the pharmacist shall adjust the dosage to correspond to that prescribed by the physician.
(4) Where a pharmacist progresses in accordance with paragraphs 1 to 3, he shall mark the paper recipe and, in the case of an electronic recipe, shall indicate in the requirement to create a record of the issue, the medicinal product issued, including any changes in payment and dosage.
(5) The supply of the medicinal product prescribed by the veterinarian shall be treated mutatis mutandis in accordance with paragraphs 1 to 4. ';
3. in Paragraph 38b (a):
'(a) the identification number of the person authorised to supply medicinal products, if it is a pharmacy or separated pharmacy department for the supply of medicinal products and medical devices, the workplace identification code assigned by the Institute,';
4. in Article 38b, the following point (c) is inserted after point (b):
"(c) the identification number of the person prescribing the veterinarian or of the person to whom the veterinarian is employed, if assigned;"
Points (c) and (d) shall be renumbered points (d) and (e).
5. in Article 38b (d) of the introductory part of the provisions and in points 1, 3, 4 and 5, the word "humane" shall be inserted before the words "medicinal product."
6. in Article 38b (d) (3) and (5), the word "humane" shall be inserted before the words "medicinal products."
7. In Section 38b (d) (6), the words "human 'shall be inserted after the words" not for issue' and the words "medicinal product 'shall be inserted after the words" prescription issued by a veterinarian or'.
8. In Section 38b (d) (7), the words "human 'are inserted after the words" human' and the words "not for the issue of a medicinal product for human use on a prescription issued by a veterinarian 'are added at the end of the text of the point.
9. In Section 38b (d) (8), the words "human 'are inserted after the words" human' and the words "not for the issue of a medicinal product for human use to a prescription issued by a veterinarian 'are added at the end of the text of the point.
10. in Article 38b (e), the words "the entity to which a medicinal product has been issued" shall be replaced by the words "the patient to whom a medicinal product for human use has been prescribed" and the words "or the supply of a medicinal product for human use to a prescription issued by a veterinarian" shall be added at the end of the text of the letter.
11. the following Article 38c is inserted after Article 38b:
(1) An operator authorised to supply medicinal products shall provide the Institute with the information referred to in Section 82 (3) (d) of the Medicines Act on the quantity of medicinal products for human use,
(a) which is indicated by the "restricted availability" flag under Section 33b of the Drug Act by means of an electronic notification within 1 working day of the date of designation of the medicinal product for human use by the "restricted availability" flag and at the end of each working day in which the designation of the medicinal product for human use took place,
(b) where the Institute has published a call in a way that allows remote access due to a suspected threat of availability, by electronic notification within 3 working days of the date of publication of the call.
(2) Paragraph 38a (2) shall apply mutatis mutandis for the purposes of providing the data referred to in paragraph 1.
(3) Where an operator authorised to supply medicinal products finds that he has entered incomplete or incorrect information in the report, he shall immediately send a new report to the Institute indicating the actual quantity of the medicinal product concerned.
(4) The reports referred to in paragraphs 1 and 3 shall contain:
(a) the identification number of the person authorised to supply medicinal products, if it is a pharmacy or separated pharmacy department for the supply of medicinal products and medical devices, the workplace identification code assigned by the Institute;
(b) the code of the medicinal product for human use allocated by the Institute; and
(c) the number of packages of the medicinal product for human use. ';
Efficacy
This decree shall take effect on the first day of the calendar month following its publication.
Minister for Health:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
Minister for Agriculture:
Mgr. Excellent v. r.
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Regulation Information
| Citation | Decree No. 459 / 2023 Coll., amending Decree No. 84 / 2008 Coll., on the correct practice of pharmacies, closer treatment conditions in pharmacies, medical devices and other operators and devices issuing medicinal products, as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 29.12.2023 |
|---|---|
| Effective from | 01.01.2024 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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