Decree No. 190 / 2013 Coll.
Decree amending Decree No. 54 / 2008 Coll., on the method of prescribing medicinal products, the particulars on the prescription and the rules on the use of the prescription
Valid
Order
Effective from 25.07.2013
Text versions:
25.07.2013
10.07.2013
190
DECLARATION
of 28 June 2013
amending Decree No. 54 / 2008 Coll., on the method of prescribing medicinal products, the particulars on the prescription and the rules on the use of the prescription
The Ministry of Health, after consulting the Ministry of Agriculture, the Ministry of Defence, the Ministry of Interior and the Ministry of Justice, provides pursuant to § 114 (3) and to implement § 80 and 82 (1) of Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Act on Medicines), as amended by Act No. 50 / 2013 Coll. and Act No. 70 / 2013 Coll.:
Decree No. 54 / 2008 Coll., on the method of prescribing medicinal products, the data on the prescription and the rules on the use of the prescription, as amended by Decree No. 405 / 2008 Coll. and Decree No. 177 / 2010 Coll., are amended as follows:
1. in Articles 1 (2) (a) (2) and 12 (2), the words "health care" shall be replaced by the words "health services."
2. in Paragraph 1 (2) (b):
"(b) orders from health service providers (hereinafter referred to as" the provider ") and natural or legal persons authorised to carry out veterinary activities (5), for medicinal products, including transfusion products, with the exception of medicinal products referred to in point (a) (1) (" vouchers "),"
3. footnote 4 is deleted.
4. in Article 1 (3) (a), the words "accompanied by a guaranteed electronic signature by a prescribing doctor based on a qualified certificate" shall be replaced by "signed by a recognised electronic signature by a prescribing doctor."
5. in Article 1 (3) (b), the words "operator of a medical establishment" shall be replaced by the words "provider," the words "signed by electronic signature" shall be replaced by the words "signed by electronic signature," and the last sentence shall be deleted;
6. In Paragraph 1 (4), the words "No placing on the prescription 'are replaced by the words" No placing on the prescription and no listing from the prescription' and the words "or which would be of an advertising character 'are added at the end of the text of the paragraph.
7. in Article 3 (5), the words "the medical prescription book 'are replaced by the words" the form book';
8. In Paragraph 4 (2), the words "or unnecessary 'shall be inserted after the words" before impairment' and the words "before deterioration 'shall be deleted after the words" before deterioration'.
9. In the first sentence of Article 4 (3), the words "or unnecessary 'shall be inserted after the word" impaired' and in the sentence of the second sentence, the words "surrendered impaired 'shall be replaced by the words" such'.
10. in Paragraph 4 (4), the words "for the reasons set out in another legislation9)" shall be deleted;
11. in Article 4 (5), the word "loading" is replaced by the word "handling."
(12) In Article 5 (1), the words "if, in accordance with Article 6 (4), the delivery on the prescription of the prescribed number of packages is to be repeated, two types of medicinal products may be prescribed only if the number of repetitions for both medicinal products is the same."
13. in Article 5 (4), the words "except transfusions," shall be deleted and the words "prescription" shall be replaced by the words "recipe."
14. in Article 5 (6) (a), the word "marked" shall be replaced by "designated."
15. in Article 6 (1) (a), the word "is" shall be replaced by "and the words" shall be added at the end of the text of the letter "; if the medicinal product is not to be covered by public health insurance (9), the recipe shall include the words" Castle sick, "which shall be indicated even if the prescribing physician does not have a contract with the health insurance insure9), unless it is urgent or acute care as referred to in point (d) (6)."
16. in Article 6 (1) (b), the words "if the medicinal product is not covered by public health insurance 9) shall appear on the recipe" Hádí spora "which shall be indicated even if the prescribing doctor does not have a contract with the patient's health insurance insurance (9), unless the necessary and urgent care is provided under point (d) (6)," shall be deleted, and the words "in the case of a provider in the Czech Prison Service, the address of the patient accused of the offence shall be indicated and the address and address of the patient sentenced for the offence," shall be replaced by the words "in the case of persons in custody, imprisonment or security detention, the address of the current detention or prison,"
17. in Articles 6 (1) (c) and 13 (1) (b), at the end of point 1, the word "or" shall be deleted and the following point 2 shall be added:
"2. the international non-proprietary name recommended by the World Health Organisation, indicating the required dosage form, strength and quantity, or ';
Point 2 is renumbered point 3.
18. in Articles 6 (1) (c) (3) and 13 (1) (b) (3), the words "or the name of a medicinal or auxiliary substance in the list provided for by a specific legislation or the name of the substance for which authorisation has been granted by the Ministry of Health under the Law on Medicines" shall be inserted after the word "pharmacopoeia 11";
19. in Article 6 (1) (d) (4), the words "emergency services, including dental and constitutional services," shall be replaced by the words "emergency or dental emergency services."
20. in Article 6 (1) (d) (6):
'6. "Urgent care" or "Acute care," where a medicinal product is prescribed for the public health insurance account by non-contracting medicine9) within the framework of the emergency or emergency care provided by it, '.
21. In Article 6 (1) (e), the words "or where a prescription medicinal product is prescribed subject to the restriction of Article 39 (4) of the Law on Medicines or an individually prepared medicinal product containing cannabis for medical purposes" shall be inserted after the word "reimbursement."
22. in Paragraph 6 (2), "2." is replaced by "(2)."
23. in Article 6 (2) (b) (1), the words ", the identification number allocated by the health insurance undertaking" shall be inserted after the word "surname."
24. in Article 6 (2) (b), point 2 is deleted;
Point 3 is renumbered point 2.
25. in Article 6 (2) (b) (2), the words "under point 2" shall be deleted;
26. in Article 6 (3), the words "on the front" shall be inserted after the words "on the front page" and the words "or the note" ZZSS "shall be added at the end of the text of the paragraph as regards reimbursement of treatment under Section 83 of the Law on Specific Health Services."
27. in Paragraph 6 (4), including footnote 22,
"(4) If the issue on the prescription of the prescribed number of packages of the medicinal product is to be repeated, the order for re-dispensing shall be given on the front of the recipe, in addition to the information referred to in paragraphs 1 to 3, as a general rule by the word" Repetatur, "and by the figure and by the words" total number of dispensements. "Any newly launched dispensation is considered to be the first of the packages of the prescribed medicinal product and as such is subject to the regulatory fee under the Public Health Insurance Act. The quantity prescribed for each consignment shall be subject to the restriction laid down in Article 5 (2). For medicinal products containing addiction13) under the legislation governing the treatment of addictive substances or precursors under the directly applicable European Union22), repeated output cannot be used.
22) Regulation (EC) No 273 / 2004 of the European Parliament and of the Council on drug precursors. '
28. In Article 6 (5), at the end of the text of the introductory part of the provision, the words "on the back of the formula of the above-approved remuneration or if the medicinal product is to be fully covered by the words" full payment 'and "further' shall be added.
29. in Article 6 (5) (a) and (b), the words "on the back of the recipe" shall be deleted;
30. in Paragraph 6 (5) (b), the words "in which" shall be replaced by "in which."
31. in Article 6 (6), the words "on the front of the recipe" shall be inserted after the words "and is."
32. The following Section 6a is inserted after Section 6, including the title and footnote 23:
Data on the cross-border care recipe
(1) A recipe issued at the request of a patient intending to apply it in another Member State (23) shall contain at least the following information:
(a) the name and, where appropriate, the name, surname, date of birth, patient telephone number and address of the place of residence;
(b) the international non-proprietary name of the active substance recommended by the World Health Organisation, indicating the required dosage form, strength and quantity;
(c) instructions for use of the medicinal product, including dosage,
(d) the name or, where applicable, the name, surname, professional capacity of the prescriber, address of the place of regular provision of health services, including indication of the name of the State, e-mail address and telephone number or fax, indicating the international choice;
(e) the stamp and signature of the prescribing doctor; in the case of an electronic recipe, the stamp and signature of the prescriber shall be replaced by an electronic signature; and
(f) the date of issue of the recipe.
(2) By way of derogation from paragraph 1 (b), prescribing physician shall use the protected name under which the medicinal product was authorised, indicating the pharmaceutical form, strength and package size where:
(a) it is a biological medicinal product; or
(b) according to the prescribing physician, this is necessary in relation to the patient's medical condition; in which case the recipe shall briefly state the reasons for such action.
23) Commission Implementing Directive 2012 / 52 / EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescription issued in another Member State. '
33.In Paragraph 7 (2):
"(2) The electronic recipe contains the information set out in Section 6 mutatis mutandis. If no identification number has been assigned to the health insurance undertaking, it shall be entered in the relevant field" 00000000 '. In addition, the electronic recipe may be supplemented by additional information, including, in particular, notes:
(a) for the issuing pharmacist,
(b) for the patient,
(c) concerning the prescribed medicinal product. "
34. In Article 7, the following paragraph 7 is added:
"(7) If no delivery has been made on the basis of the electronic recipe, such electronic recipe shall cease to be valid on the date of expiry. '
35. The following Section 11a is inserted after Section 11:
Record in the restricted medicinal product register
(1) The doctor uses the same access data as for communication with the central repository of electronic recipes to access the restricted medicinal product registry. Paragraph 11 shall apply mutatis mutandis to communication with the restricted medicinal product register. Through the restricted medicinal product register, the physician is informed whether the conditions for prescribing the restricted medicinal product are met.
(2) If the conditions for prescribing the medicinal product are met, the doctor will issue an electronic prescription. Through the central repository of electronic recipes, a record of the prescribed medicinal product is entered in the restricted register of medicinal products and the prescribing physician shall, in turn, be provided with the identification mark to which the electronic recipe is provided. ';
36. in Article 13 (1) (c):
'(c) the number of packages or doses of the medicinal product; in the case of medicinal products containing addictive substances with Roman numerals and words in Latin,'.
37.In Paragraph 13 (2) (d), "(ABO and Rh D)" is replaced by "(AB0 and RhD)."
38. in Article 13 (2) (e), the words "post-transfusion reaction" shall be inserted after the words "transfusion."
39. in Paragraph 14 (1) (b):
"(b) other medicinal products shall be valid for 14 calendar days from the date of issue, unless otherwise specified by the doctor, but not more than 1 year."
40. Paragraph 14 (3) reads as follows:
"(3) A recipe issued by an emergency medical or dental emergency service, or if the recipe states" Acute care "or" Urgent care "in accordance with Paragraph 6 (1) (d) (6), shall be valid until the end of the first calendar day following its issue. '
41. In Article 15 (1), the words "In the case of repeated expenditure pursuant to Article 6 (4), where the recipe is a necessary document" shall be replaced by the words "In the case of repeated expenditure pursuant to Article 6 (4), if not the last issue, the pharmacist shall issue an extract of the recipe serving as a document on the packages issued."
Efficacy
This decree shall take effect on the 15th day following its publication.
Minister:
Doc. MUDr. Heger, CSc., v. r.
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Regulation Information
| Citation | Decree No. 190 / 2013 Coll., amending Decree No. 54 / 2008 Coll., on the method of prescribing medicinal products, the particulars on the prescription and the rules on the use of the prescription |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 10.07.2013 |
|---|---|
| Effective from | 25.07.2013 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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