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Amendment Of The Decree On The Method Of Prescribing Medicinal Products

Original Language Title: změna vyhlášky o způsobu předepisování léčivých přípravků

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190/Sb.



DECREE



of 28 June. June 2013,



amending Decree No. 54/2008 Coll., about how the prescription of

medicinal products on medical prescription information to be entered and the

terms of use of prescriptions



The Ministry of health in consultation with the Ministry of agriculture,

The Ministry of Defense, Ministry of Interior and the Ministry of

Justice shall determine pursuant to section 114 para. 3 and to implement section 80 and 82 para.

1 of law No. 378/2007 Coll., on pharmaceuticals and on changes of some

related laws (law on medicinal products), as amended by Act No. 50/Sb.

and Act No. 70/Coll.:



Article. (I)



Decree No. 54/2008 Coll., about how the prescription of medicinal products,

information to be entered on the medical prescription and the rules of use

of prescriptions, as amended by Decree No. 405/2008 Coll. and Decree No.

177/2010 Coll., shall be amended as follows:



1. In article 1 (1). 2 (a). and) point 2 and § 12 para. 2, the words "health

care "shall be replaced by" health services ".



2. In article 1 (1). 2 (b)):



"(b) providers of health care services) of the order (hereinafter referred to as

"provider") and natural or legal persons empowered to carry out

^ 5 veterinary activities), the medicines, including blood

products, except for the medicinal products referred to in point (a)), point 1

(hereinafter referred to as "requisition"), ".



3. Footnote 4 is repealed.



4. In section 1 (1). 3 (b). and) the words "fitted with advanced electronic

the signature of the prescribing physician, based on a qualified

certificate "shall be replaced by" signed by a recognized electronic

the signature of the prescribing physician. "



5. In section 1 (1). 3 (b). (b)), the words "operator of the medical

device "shall be replaced by the word" provider ", the words" bearing

electronic signature "shall be replaced by the words" signed by an electronic

the signature "and the last is deleted.



6. In section 1 (1). 4, the words "on medical prescription cannot be placed"

replaced by the words "on medical prescription and on the statement from the recipe may not

be located "and at the end of text in a paragraph, the words" or that

should the advertising character ".



7. in section 3, paragraph 3. 5, the words "a book of prescriptions" shall be replaced by

"the book of forms".



8. In section 4, paragraph 4. 2, after the word "Devalued" the words "or

unnecessary "and after the words" these prescriptions ", the words" before the

spoilage "are deleted.



9. in section 4, paragraph 4. 3 the first sentence after the word "impaired" the words

"or unnecessary" and in the second sentence, the words "these designs

the debased "shall be replaced by" such ".



10. In section 4, paragraph 4. 4, the words "for the reasons stated in other legal

prescription ^ 9) "are deleted.



11. in section 4, paragraph 4. 5, the word "waste" is replaced by the word "treatment".



12. in § 5 para. 1 at the end of the text of the letter b), the words "; If it is to

According to § 6 paragraph 1. 4 issue of the recipe prescribed number of packages

repeat, can prescribe two types of medicinal products only if they are

the number of repetitions in each species of medicinal products, the same ".



13. in § 5 para. 4, the words ", with the exception of blood products,"

be deleted and the words "medical prescription" shall be replaced by the word "recipe".



14. in § 5 para. 6 (a). and the word ") marked" replaced by the word "intended".



15. in section 6 (1). 1 (b). and the word ") is" shall be replaced by "should be" and the

end of the text, the words "shall be added to point (a); If the medicinal product

does not have to be paid from public health insurance ^ 9), it is reported on the

the recipe of the words "Paid Sick" that States, even if that

the prescriber does not have a contract with a health insurance company

the patient-the insured person ^ 9), unless it is an emergency or acute care

referred to in subparagraph (d)), section 6 ".



16. in section 6 (1). 1 (b). (b)), the words "; If the medicine is not

paid from public health insurance ^ 9), it is stated on the recipe

"Paid Sick", which is also in the case that the prescriber

does not have a contract with the patient's health insurance company-insurance-těnce ^ 9), if

It's not about acute and emergency care in accordance with subparagraph (d)), section 6 "be deleted and the

the words "in the case of a provider in the prison service of the Czech Republic

patient's address, accused of an offence shall indicate the name and address of the

the remand prison and a patient convicted of an offence shall bear the

the prison's address and name, "shall be replaced by the words" in the case of persons in the performance of

custody, imprisonment or detention shall state the address of the security

the existing remand prison or the prison ".



17. in paragraph 6 (1). 1 (b). (c)) and § 13 para. 1 (b). (b)) at the end of paragraph 1

the word "or" shall be deleted and the following point 2 is added:



"2. the international non-proprietary name recommended by the World Health

Organization with an indication of the required dosage form, strength and quantity, or ".



Point 2 becomes point 3.



18. in section 6 (1). 1 (b). c) point 3 and § 13 para. 1 (b). (b) in point (3))

the word "Pharmacopoeia ^ 11)" the words "or the name of the active or auxiliary

substances referred to in the list established by specific legislation or

name of the substance for which the permit was issued by the Ministry for use

health care according to the law on pharmaceuticals ".



19. in section 6 (1). 1 (b). (d)), paragraph 4, the words "including standby service

dental and constitutional "is replaced by" medical emergency

service and emergency service in the field of dentistry ".



20. In paragraph 6 (1). 1 (b). d) point 6 is added:



"6." urgent care "or" acute care ", if the medicinal product

prescribed on account of the non-contracted doctor general health insurance system ^ 9)

in the context of paid emergency or acute care ".



21. in section 6 (1). 1 (b). (e)), after the word "remuneration", the words "or in the

If it is předpisován Medicine awarded to medical

prescription pursuant to § 39 para. 4 of the law on medicinal products or

individually prepared a medicine containing cannabis for therapeutic

the purposes of ".



22. in section 6 (1). 2, the number "2" is replaced by "(2)".



23. in section 6 (1). 2 (a). (b)), point 1, after the word "last" words

"identification number assigned to the health insurance company".



24. in section 6 (1). 2 (a). (b)), point 2 is deleted.



The former item 3 becomes item 2.



25. In section 6 (1). 2 (a). (b)) point 2, the words "referred to in paragraph 2" shall be deleted.



26. in section 6 (1). 3, after the word "marked" the words "on the front

side "and at the end of the text of the paragraph the words" or a note

"ZSZS", if it is a payment pursuant to section 83 of the Act treatment of specific

health services ".



27. in paragraph 4, section 6, including footnote No 22:



"(4) If a dispersing on the recipe required package

of repeat, enter on the front of the recipe, in addition to data

referred to in paragraphs 1 to 3, the instruction to issue,

as a rule, the word "Repetatur", and the words of the indication of the number and the total number of

issues. Each newly launched issue is considered to be the first issue of the

packaging prescribed medicinal product and as such is subject to the

the regulatory fee pursuant to the Act on public health insurance.

The amount prescribed for an individual issue is subject to the restrictions referred to in § 5

paragraph. 2. in the case of medicinal products containing addictive substances ^ 13) according to the

legislation governing the treatment of addictive substances or

precursors by directly applicable European Union legislation ^ 22)

a recurring issue cannot be used.



22) European Parliament and Council Regulation (EC) No 273/2004 of the

drug precursors. ".



28. in section 6 (1). 5 at the end of the introductory part of the text of the provisions complement

the words "on the back of the recipe above approved payment or to be

medicine fully paid the words "full payment", and later ".



29. in section 6 (1). 5 (b). a) and b), the words "on the back of the recipe"

shall be deleted.



30. In paragraph 6 (1). 5 (b). (b)), the words "in which" shall be replaced by the words "for

which ".



31. in section 6 (1). 6, after the words "and", the words "on the front of the

the recipe ".



32. in paragraph 6, the following new section 6a, which including the title and notes

line # 23:



"§ 6a



Particulars to appear on the recipe in cross-border care



(1) on the recipe at the request of the patient, things which it intends to use the

in another Member State ^ 23), at least the following information:



and, where appropriate,) the name, first name, surname, date of birth, telephone number,

the patient and the address of the place where he resides,



(b)) the international non-proprietary name recommended by the world of active substance

Health Organization with an indication of the required dosage form, strength, and

the amount,



c) instructions for use of the medicinal product, including the dosage,



(d) the name or names), surname, expertise of the prescribing physician,

address of the place of the regular delivery of health services including the

the State's name, email address, and phone number or fax, stating the

International preferences



e) stamp and signature of the prescriber; in the case of

electronic recipe with stamp and signature of the prescriber

replaced by his electronic signature, and the



f) release date recipe.




(2) by way of derogation from paragraph 1 (a). (b)) the prescriber shall apply

a protected name under which was a medicinal product is authorised, under

dosage form, strength and package size in the case that



and) is a biological medicinal product, or



(b)) is in accordance with the prescribing physician is necessary having regard to the patient's

the State of health; in this case, the recipe must be briefly listed

the reasons for such a procedure.



23) implementing the directive Commission 2012/52/EU of 20. December 2012,

laying down measures to facilitate the recognition of prescriptions

issued in another Member State. '.



33. In section 7 paragraph 2 reads as follows:



"(2) the electronic recipe contains the information set out in paragraph 6 apply mutatis mutandis.

If no health insurance identification number allocated, the

in the box "00000000". It may also be an electronic recipe

supplemented by other data, which are of particular note:



and for issuing pharmacist)



(b)) for the patient,



(c)) regarding the prescribed medicinal product. ".



34. In paragraph 7, the following paragraph 7 is added:



"(7) if it is not based on an electronic recipe made picking,

terminates such electronic recipe date of expiry of the validity thereof. ".



35. in section 11 is added to § 11a, which including the title reads as follows:



"§ 11a



The registry entry for medicinal products with restrictions



(1) the doctor to access the register of medicinal products restricted uses

the same login as for communication with a central repository

electronic prescriptions. For communication with the registry for medicinal products

limited to § 11 shall apply mutatis mutandis. Through the registry for

the restricted medicines the doctors immediately told whether they are fulfilled

conditions for the prescription of a medicinal product with the restriction.



(2) the conditions are fulfilled for the prescription of a medicinal product with a

restrictions, the doctor will issue the electronic prescription. Through

a central repository of electronic prescriptions is the registry of medicinal

products with restrictions inserted record of prescribed medicine with

limitations and the prescriber is immediately communicated to the identification mark,

which is sent by an electronic recipe bears. ".



36. In § 13 para. 1 letter c) is added:



"(c)) the number of packages or benefits of a medicinal product; in the case of

preparations containing addictive substances, listed the Roman numeral and

words in Latin, ".



37. In § 13 para. 2 (a). (d)), the words "(ABO and Rh (D))" shall be replaced by

"(The AB0 and RhD)".



38. In § 13 para. 2 (a). (e)), after the words "transfusion", the words ",

transfusional reactions. "



39. In § 14 para. 1 (b)):



"(b)) other medicinal products, valid for 14 calendar days starting from

the date of its issuance, unless the doctor otherwise, but no longer than 1 year. ".



40. in article 14, paragraph 3 reads:



"(3) a prescription issued by a medical emergency service or emergency

service in the field of dentistry, or if the recipe stated

"Acute care" or "urgent care" according to § 6 paragraph 1. 1 (b). (d)), section 6,

valid until the end of the first calendar day following the date

its exposure. ".



41. In article 15, paragraph 2. 1 the words "Similarly in the case of repeated

issues under section 6 (1). 4 if it is necessary to document "shall be replaced by recipe

the words "repeated dispensing pursuant to § 6 paragraph 1. 4, unless it is a

the last issue, the pharmacist shall issue the certificates issued from the recipe listing packages,

which serves as a document ".



Article. (II)



The effectiveness of the



This Decree shall take effect on the 15th day following its publication.



Minister:



doc. MUDr. Heger, CSc., r.